Human Subject Protection

The purpose of this SOP is to provide guidance on various campus activities that do not meet
the IRB definition of human subjects research and may not require IRB review.

1. General Requirements
   
   Certain activities conducted by UNCW faculty, staff and students do not meet the IRB definition of research with human subjects, and thus do not require IRB review. However, those conducting these activities must conduct them in an ethical and professional manner that is consistent with the code of ethics for the applicable professional discipline. If the activity is conducted by a student, it should be conducted under the close supervision of a faculty advisor.
   
   Individuals conducting these activities are strongly encouraged to submit a brief application in the UNCW OSPREY system to notify the IRB of the activity and to obtain confirmation through the IRB that further review is not required. This allows the IRB to be aware of the activity if IRB staff receive any calls or concerns, and provides the individual(s) conducting the research with documentation that confirmation from the IRB was obtained.
   
   
2. Scope
   
   This SOP pertains to a variety of campus activities that may involve collecting data from individuals or obtaining data that identifies individuals, but does not meet the definition of human subjects research.
   
   
3. Applicable Definitions
   
   
   1. Human subject (45 CFR § 46.102(e))
      
      A living individual, about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
      
      
      1. Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
         
         
      2. Interaction includes communication or interpersonal contact between investigator and subject.
      3. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
      4. Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
      5. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
         
         
   2. Minimal risk
      
      The probability and magnitude of harm or discomfort anticipated in an activity are not greater in and of themselves than those ordinarily encountered in daily life.
      
      
   3. Research (45 CFR § 46.102(l))
      
      A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for the purposes of HHS policy, whether or not they are supported under a program that is considered research for other purposes.
      
      
      1. Systematic Investigation: A cohesive approach involving data collection (quantitative or qualitative) from one or more individuals and analysis to address a question or test a hypothesis.
      2. Generalizable Knowledge: The results or outcomes gained from systematic investigation are expected to contribute to a theoretical framework of an established body of knowledge, be viewed in some way as relevant to a larger population beyond the data collection or population studied, and intended to be replicated in other settings.
         
         
4. Activities That Do Not Involve Human Subjects
   
   
   1. Research on Existing Data
      
      Certain activities involving the analysis of de-identified data, either publicly available or collected from a previously approved human subjects study, do not constitute human subjects research, in that there is no interaction or intervention with an individual to obtain the data, and there is no use of private identifiable data.
      
      Researchers are advised to submit a brief application in the OSPREY system to describe the activity so that IRB staff may confirm that human subjects are not used.
   2. Minors Participating in UNCW Research Activities for Educational Purposes Only
      
      
      1. Generally
         
         When minors are enrolled in UNCW courses, either through the Isaac Bear Early College or because regularly enrolled UNCW students have not yet reached age 18, researchers may allow them to participate in research activities for educational purposes only, provided that:
         
         
         1. The study was reviewed by the IRB through the expedited review process or determined to be exempt;
         2. The researcher does not use any data obtained from the minor for research purposes (thus not constituting research using a human subject); and
         3. The study involves content that a reasonable person would consider appropriate for a minor to be exposed to.
            
            
      2. Waivers of Parental Permission
         
         Researchers who wish to collect data from regularly enrolled UNCW college students who have not yet reached the age of 18 may do so provided that they request approval from the IRB to waive the parental permission requirement.
         
         Researchers interested in this option should refer to the instructions provided in SOP 6.8, section IV.D.2. This option is not allowable for Isaac Bear Early College students.
         
         
   3. Surveying or Interviewing Key Informants
      
      Members of the UNCW community can plan to conduct research that asks individuals to complete surveys or interviews asking for information on certain topics. Those individuals are considered “key informants” or experts on those topics, rather than human subjects, when the survey or interview questions focus on the topic of interest as opposed to attempting to collect personal information about the individual. While conducting these surveys or interviews meets the IRB definition of research, the key informants/experts are not considered human subjects, and thus the activity may not require IRB review and approval.
      
      Researchers are advised to submit a brief application in the OSPREY system to describe the activity, and upload a copy of the survey or interview questions so that IRB staff may confirm that human subjects are not used.
      
      
5. Activities that Do Not Meet the IRB Definition of Research
   
   
   1. Classroom Projects
      
      
      1. General Requirements
         
         Learning how to conduct ethical human subject research is an important part of a student’s educational experience. Research activities that are designed as part of a course requirement for purposes of learning experience only might not meet the IRB definition of “research” in that they are not designed to develop or contribute to generalizable knowledge, and thus may not require IRB review and approval if all of the following conditions are true:
         
         
         1. Results of the research are either:
            
            
            1. viewed only by the course instructor for teaching purposes undisclosed within the classroom for teaching and learning purposes, or
            2. viewed by other, limited members of the campus community through poster presentation or other event that is a required aspect of a course(such as a capstone presentation event);
               
               
         2. The research procedures pose no more than minimal risk to participants;
         3. Vulnerable populations are not targeted (e.g., children under age 18, prisoners, persons who are cognitively impaired, etc.); and
         4. When appropriate, some process is in place to inform participants of the voluntary aspect of the activity.
         5. Students state in recruitment and other materials that the data collection is for a classroom project and do not represent the activity as “research.”
            
            
      2. Responsibility of the Course Instructor
         
         The course instructor is responsible for communicating to the students information related to the ethical conduct of human subject research, ensuring the protection of participants, and for monitoring the students’ progress. Instructors are encouraged to contact IRB staff who will be happy to make a presentation to students on research ethics, even if the activity does not require IRB review. Instructors are also encouraged to instruct students to complete the online human subject protections training offered by the CITI program, although this is not required for activities that do not meet the IRB definition of human subjects research. Instructors are encouraged to direct their students to submit a brief application in the OSPREY system to describe the activity so that IRB staff may confirm that the activity does not meet the IRB definition of human subjects research.
         
         
   2. Quality Assurance/Quality Improvement Studies
      
      
      1. General Requirements
         
         It is important for medical practitioners to have the ability in their organizations to determine if certain clinical or administrative practices are effective in their particular settings. When quality assurance/quality improvement (QA/QI) activities (such as reviewing in-house medical records, collecting new patient or provider data, or testing an established intervention for the purpose of improving patient care and informing internal clinical practices) are undertaken to fulfill a course requirement, the activities might not require IRB review and approval if all of the following conditions are true:
         
         
         1. The activity is not a systematic investigation that intends to collect scientific evidence on an untested clinical intervention to determine how well the intervention achieves intended results;
         2. The student conducting the QA/QI activity is an employee of or placed in the organization/facility in which the data is going to be collected (note: If the student is not an employee or placed in the facility, the project may still reconsidered a program evaluation rather than QI/QA, if the student is acting an external evaluator);
         3. The QA/QI activity procedures pose no more than minimal risk to participants;
         4. The student conducting the activity will not remove identifiable data from the facility in which they work as part of the project (note: All of the data needs to be de-identified before it leaves the premises. Students should work with their faculty advisors and the facility in which the project is conducted to ensure any applicable privacy and confidentiality requirements are maintained); and
         5. The facility in which the activity is conducted, or any affiliated institution,does not require IRB review and approval (note: some QA/QI activities meet the definition of human subjects research. Even if an activity does not meet the UNCW IRB definition of human subjects research, some IRBs interpret the regulations differently or have internal policies that consider all QA/QIactivities to be human subjects research. If a QA/QI activity is conducted at a medical center or other institution with its own IRB, the UNCW IRB will likely not have jurisdiction over this determination, and will defer to any determination made by the presiding IRB.)
            
            
      2. Responsibility of the Faculty Advisor
         
         The faculty advisor of a student who will conduct a QA/QI activity to fulfill a course requirement is responsible for ensuring that the student has a comprehensive understanding of how to conduct QA/QI activities in an ethical manner, ensuring the protection of participants, particularly in protecting the confidentiality of their data, and for monitoring the student’s progress. Faculty advisors are encouraged to contact IRB staff who will be happy to make a presentation to students on research ethics, even if the activity does not require IRB review. Faculty advisors are encouraged to instruct students to submit a brief application in the OSPREY system to describe the activity so that IRB staff may make a determination that the activity does not constitute human subjects research. Faculty advisors and students are also encouraged to refer to additional guidance documents posted on the UNCW Human Subjects Research website related to QA/QI projects.
         
         
   3. Program Evaluations
      
      Members of the UNCW community can be presented with the opportunity to conduct evaluations of specific internal or external programs to determine if the programs are effective. When the results of those evaluations will be shared within the organization to be used solely for organizational decision making, and are not intended to be generalized to other institutions or populations, the activities might not meet the IRB definition of “research” in that they are not designed to develop or contribute to generalizable knowledge, and thus may not require IRB review and approval. If evaluators will conduct an evaluation on behalf of an external organization, evaluators should be mindful of the type of data they will receive and comply with any other regulations that may apply, such as HIPAA, SAMHSA, FERPA, etc. Researchers are advised to submit a brief application in the OSPREY system to describe the activity so that IRB staff may make a determination that the activity does not constitute human subjects research.
      
      
6. Responsibilities
   
   
   • IRB Staff: Responsible for reviewing applications to determine if an activity constitutes human subjects research. 
   • Instructors/Faculty Advisors: Responsible for properly informing students about activities that require IRB review, providing oversight on activities that do not require IRB review, and ensuring research activities that are conducted to fulfill course requirements are done so in an ethical and professional way.  
   • Principal Investigators: Responsible for conducting program evaluations or research activities involving key informants or experts in an ethical manner that is consistent with the ethical norms of the applicable profession.
     
     
7. Resources
   
   
   • UNCW IRB Website
   • U.S. Department of Health & Human Services, Office of Human Research Protections website
   • 45 CFR 46 (“Common Rule”)
   • Belmont Report
   • U.S. Department of Health & Human Services, Health Information Privacy
   • U.S. Department of Health & Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA)
   • UNCW Policy 04.150, Student Records & Family Educational Rights and Privacy Act (FERPA)

The purpose of this SOP is to establish steps for appointing and removing IRB members and how a member who has not yet completed his or her term may resign from the committee.

1. General Requirements
   
   UNCW faculty who are interested in serving on the Institutional Review Board (IRB) should indicate preference on the Faculty Senate Committee Preference survey each spring. The IRB requests survey results and determines possible members based on the needs of the committee. IRB administration consults with the institutional official (IO) on committee needs and forwards a request to the chancellor’s office for consideration. The chancellor appoints IRB members for a two-year term based upon the IO’s recommendations.
2. Scope
   
   This SOP pertains to status of members serving on the UNCW Institutional Review Board.
3. Applicable Definitions
   
   
   1. Institutional Official
      
      The individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the terms of the Federalwide Assurance.
4. Procedures
   
   
   1. Qualification of Members
      1. IRB members shall be selected in compliance with federal regulations outlined in 21 CFR § 56.107 and related guidance from the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
      2. IRB members must be knowledgeable about the local research context.
      3. IRB members are expected to interact with each other and researchers in a collegial and constructive manner.
   2. Member Resignation/Removal Procedures
      1. Resignation of Member
         
         If a member needs to resign from the committee before the end of the member’s term, the member must notify IRB staff as soon as the member makes the decision, as resignation could impact the committee’s ability to conduct business depending on the designation of the member.
      2. Member Termination
         1. If IRB staff, an IRB co-chair and/or the IO deem it to be in the best interest of the committee to remove a member from the committee due to the member’s lack of cooperation, lack of participation, noncompliance with IRB policies, or other issue, after failed intervention by the research compliance manager and/or co-chair to alter the issue, the IO will send the member a written notice of membership termination with reasons for the termination.
         2. If the terminated member is also a faculty member, the IO will copy the chancellor and the chair of the department to which the member reports.
         3. If needed the IO may recommend to the chancellor a new member to replace the terminated member.
         4. If the terminated member is also an IRB co-chair, the IO may appoint an interim co-chair until nominations for a new co-chair can be solicited from the committee and formally appointed by the chancellor.
5. Responsibilities
   
   
   • Chancellor: Responsible for appointing IRB members.
   • Institutional Official: Responsible for making recommendations to the chancellor of appropriate individuals to serve on the IRB. Responsible for appointing IRB co-chairs. Responsible for notifying IRB members of removal from the committee.
   • Research Integrity Office Director: Responsible for determining the needs of the IRB based on member expertise and experience. Responsible for reviewing Faculty Senate Committee Preference survey results and contacting potential members to gauge interest in becoming a member.
   • IRB Members:Responsible for completing required training, attending meetings on a regular basis and being prepared to contribute to discussions, and notifying IRB staff at the earliest opportunity if the member is unable to attend a meeting due to a conflicting obligation.
6. Resources
   
   
   • UNCW IRB Website    
   • U.S. Department of Health & Human Services, Office of Human Research Protections Guidance on Institutional Official Responsibilities  
   • 45 CFR 46 (“Common Rule”)    
   • Belmont Report   

v. October 2025

The purpose of this SOP is to clarify review procedures for applications that involve low risk human subjects research and may qualify for a determination of exemption as allowed by 45 CFR 46.

1. General Requirements
   
   All research using human subjects must be reviewed by the University of North Carolina
   Wilmington (UNCW) Institutional Review Board (IRB). Certain categories of human subject research are exempt from Common Rule [45 CFR 46] in that IRB approval, full research consent, and other requirements are not applicable. Thus, determinations of exemption are granted rather than approved. However, this research is not exempt from ethical considerations, such as honoring the principles described in the Belmont Report. Human subjects research qualifying for exemption must still be conducted in an ethical manner, in a manner consistent with sound research practices, and in accordance with UNCW policies and SOPs. Specifically, exempt research fulfills the organization’s ethical standards, such as:
   • The research holds no more than minimal risk to subjects.
   • Selection of subjects is equitable.
   • If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
   • There are adequate provisions to maintain the privacy interests of subjects.
   Individuals involved in making determinations of exemptions for a proposed human subjects research project cannot be involved in the proposed research. Reviewers must not have any apparent or perceived conflict of interest.
2. Scope
   1. This SOP pertains only to those research projects that meet the definition of human subjects research identified in 45 CFR §46.102.
   2. This SOP pertains to human subjects research that meets the criteria set forth in 45 CFR §46.101.
   3. Student research that is not designed to yield generalizable knowledge does not meet the definition of research with human subjects and does not require IRB review. However, this research must be conducted in a responsible manner, be reviewed by the advising/responsible faculty member, and have sufficient oversight, particularly if conducted off campus. More information about activities that do not meet the IRB definition of research is provided in the Activities Not Requiring IRB Review Procedures (SOP #1.1).
3. Applicable Definitions
   
   
   1. Conflict of Interest
      
      As stated in UNCW policy 03.230 Conflict of Interest or Commitment III.A., Conflict of Interest relates to situations in which financial or other personal considerations, circumstances, or relationships may compromise, may involve the potential for compromising, or may have the appearance of compromising a Covered Employee’s objectivity in fulfilling their University duties or responsibilities, including research, service and teaching activities and administrative duties.
   2. Deception
      
      Knowingly providing false information to research subjects or intentionally misleading research subjects about some key aspect of the research.
   3. Minimal Risk
      
      The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
   4. Minors (children)
      
      Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. In North Carolina, the legal age for consent is 18 years.
   5. Prisoners
      
      Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures, which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
4. Procedures
   
   
   1. Applications requesting determinations of exemption in accordance with 45 CFR 46 are subject to initial review for completeness and appropriateness of methods and procedures by IRB staff.
   2. An IRB co-Chair or designee will review and determine whether the research fits one of the following Exempt Categories. Only the following categories will be utilized by UNCW.
      
      (Exemptions 7 and 8 of the Common Rule will not be used by UNCW; rather such activities will be reviewed under expedited review procedure):
      
      1. Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
      2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
         
         1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
         2. Any disclosure of the human subjects’ responses outside of the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational achievement, or reputation; or
         3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects and an IRB conducts a limited review to make the determination required by 45 CFR 46.111(a)(7) (i.e., that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data).
      3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subjects prospectively agrees to the intervention and information collection and at least one of the following is met:
         1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subjects prospectively agrees to the intervention and information collection and at least one of the following is met:
         2. Any disclosure of the human subjects’ responses outside of the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational achievement, or reputation; or
         3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects and an IRB conducts a limited review to make the determination required by 45 CFR 46.111(a)(7) (i.e., that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data).
            1. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play on online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of cash between themselves and someone else.
            2. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purpose of the research.
      4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
         1. The identifiable private information or identifiable biospecimens are publicly available;
         2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify the subjects;
         3. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
         4. The research is conducted by, or on behalf of a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
      5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements such as sections 1115 and 1115A of the Social Security Act, as amended.
         
         Each Federal department or agency conducting or supporting the research and demonstration projects must establish on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
      6. Taste and food quality evaluations and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
   3. Certain types of human subjects research do not qualify for exemptions, such as certain studies involving minors, studies involving the use of deception, and studies that specifically target individuals who are currently incarcerated (prisoners).
   4. The IRB can decide to review an Exempt study by Expedited Review.
   5. Researchers must conduct exempt studies in accordance with the methods and procedures detailed in the exempted application reviewed by the IRB.
   6. If an exempt study involves the use of a consent and/or assent-permission form, IRB staff will send the Principal Investigator of the study an official, approved copy of the consent and/or assent-permission form.  The official, approved version will include an IRB stamp.  Researchers must use this official version when distributing copies to subjects.
   7. Researchers must submit requests to modify exempt studies prior to making any changes to the methods and procedures reviewed by the IRB, as changes to an exempted study may render it no longer exempt.
   8. Exempt determinations do not have a termination date.
   9. Researchers are not required to annually renew studies that have been determined to qualify for exemption.
   10. Researchers must notify the IRB when an exempt research project is complete so that the organization can maintain an accurate database of active research.
5. Other Applicable SOPs
   • Activities Not Requiring IRB Review- SOP 1.1
   • Online Research- SOP 6.2
   • Anonymous Surveys/Questionnaires- SOP 6.3
6. Responsibilities
   
   
   • IRB Co-chair: Responsible for designating IRB staff with the authority to make determinations of exemption. The IRB has designated the Research Integrity Office director (RIO director) to make determinations of exemptions.
     IRB Staff: Responsible for conducting initial reviews of all applications and appropriately referring applications for a determination of exemption, expedited review, or full board review. Responsible for notifying principal investigators on any deficiencies in the application that would prevent approval upon further review, and ensuring the principal investigator receives an official stamped copy of any consent and/or assent permission form approved by the IRB.
     Research Integrity Office director (RIO director): Responsible for conducting secondary reviews of applications that appear to qualify for exemption. Upon confirming that the application is complete and methods and procedures are appropriate, the RIO director may grant an exemption.
     Principal Investigator (PI): Responsible for submitting applications to conduct human subjects research to the IRB prior to initiating activities, ensuring all members of the research team have documentation of required training, representing proposed activities accurately and thoroughly, distributing to subjects only the official replaced stamped copy of any consent and/or assent/permission form approved by the IRB, and otherwise conducting research in accordance with methods and procedures identified in the approved application.
7. Resources
   
   
   • UNCW IRB Website 
   • U.S. Department of Health & Human Services, Office of Human Research Protections website 
   • 45 CFR 46 (“Common Rule”)  
   • Belmont Report

The purpose of this SOP is to provide human subjects researchers with guidance on UNCW procedures for expedited review, and provide researchers with links and resources for more information on expedited review categories, as provided by the Office of Human Research Protections (OHRP).

1. General Requirements
   
   As allowed in 45 CFR 46.110, the UNCW Institutional Review Board (IRB) may review certain categories of research using an expedited review procedure provided the expedited reviewer finds that the research involves no more than minimal risk to subjects.
   
   The UNCW IRB may also review minor changes to studies previously approved by the full board using an expedited review procedure. Expedited review means that one or more voting IRB members may conduct a thorough and rigorous review of an application to conduct human subjects research in lieu of the application being placed on an agenda for a full board meeting.
2. Scope
   This SOP pertains to all human subject research applications submitted to the UNCW Institutional Review Board that does not qualify for exemption or require full board review.
3. Applicable Definitions
   
   
   1. Minimal risk
      
      The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
   2. Minors (Children)
      
      Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. North Carolina law defines a minor as a person under age 18.
4. Procedures
   
   1. Procedures for Application/Submission
      
      The following types of submissions may be considered under expedited review procedures to the IRB:
      1. New Research Studies: For a new protocol that qualifies for expedited review, all applicable documents as described in the IRB SOPs, must be submitted.
      2. Modifications/Amendments to Previously Approved Research Studies: The IRB may approve, by expedited review, non-substantive changes or modifications in the informed consent process or consent forms, advertising and recruitment materials, the protocol, survey instruments, or other items previously approved by the IRB. The instructions for submission of a modification and the IRB review of such changes/modifications are described in the IRB Review of Changes/Modifications in Approved Research SOP.
      3. Continuing Reviews: The IRB may conduct continuing review of certain research studies by expedited review. The instructions for submission of a continuing review and the review by the IRB are described in the IRB Continuing Review of Research SOP.
      Researchers planning to conduct human subjects research that qualifies for expedited review must submit applications to the IRB through the OSPREY system at least ten (10) days prior to the desired start date of their research.
   2. Authority to Conduct Expedited Reviews
      
      1. UNCW IRB co-Chairs may exercise all of the authorities of the full IRB when conducting expedited reviews of research, except that they may not disapprove research.
      2. If an IRB co-Chair is unable to approve an application to conduct human subjects research, the co-Chair may seek consultation with others who have relevant expertise, such as other IRB members, other UNCW staff members, or external consultants.
      3. If an IRB co-Chair is still unable to approve a study, he or she will inform IRB staff and ask them to place the application on the agenda for the next full board meeting.
   3. Expedited Review Procedures and Considerations
      1. Within a reasonable timeframe after receipt, which may vary depending on volume of submissions, UNCW IRB staff will conduct initial reviews of applications submitted to the IRB to confirm the submission is complete and the study qualifies for expedited review using this SOP as guidance.The IRB staff will identify if any deficiencies exist that would prevent approval upon further review. Notification of deficiencies typically occurs by IRB staff returning the application to the Principal Investigator (PI) with specific stipulations. PIs are strongly encouraged to comply with these recommendations to avoid delays in approval. The IRB staff then notifies the IRB Chair when the submission is ready for review.
      2. The review and approval may be conducted by the IRB Chair or by one or more experienced (i.e., qualified) IRB members designated by the Chair.
      3. Expedited review requires the same considerations as would be required by full board review (outlined in 45 CFR 46.111 or 21 CFR 56.111 – see SOP 5.3 for full criteria). All non-exempt human subjects research must have the same criteria applied when conducting expedited review, the only difference is that expedited review is conducted by one or two members rather than the convened board.
      4. The reviewing IRB chair or designee must not review research in which the chair or designee has a conflict of interest (COI), except to provide information requested by the unconflicted member conducting the review.
      5. Research categories included on the list provided by OHRP indicate that a type of research is merely eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
      6. The categories in the OHRP list apply regardless of the age of subjects, except as noted.
      7. Unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal, the expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably:
         1. place them at risk of criminal or civil liability, or
         2. be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing.
      8. The expedited review procedure may not be used for classified research involving human subjects.
      9. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
   4. Research Categories
      The IRB Chair or designee will ensure that every new project approved by expedited review is minimal risk and meets one or more of the following criteria:
      1. Clinical studies of drugs and medical devices only when conditions (a) or (b) is met:
         1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.
         2. Research on medical devices for which:
            1. an investigational device exemption application (21 CFR Part 812) is not required; or
            2. the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
      2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
         1. from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
         2. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
      3. Prospective collection of biological specimens for research purpose noninvasive means.
         1. hair and nail clippings in a non-disfiguring manner;
         2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
         3. permanent teeth if routine patient care indicates a need for extraction;
         4. excreta and external secretions (including sweat);
         5. uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue;
         6. placenta removed at delivery;
         7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
         8. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
         9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
         10. sputum collected after saline mist nebulization.
      4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:
         1. physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
         2. weighing or testing sensory acuity;
         3. magnetic resonance imaging;
         4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow and echocardiography;
         5. moderate exercise, muscular strength testing, body-composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
      5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
      6. Collection of data from voice, video, digital, or image recordings made for research purposes.
      7. Research on individual or group characteristics or behavior (including, but not limited to, research or perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
      8. Continuing review of research previously approved by the convened IRB as follow:
         
         1. where:
            1. the research is permanently closed to the enrollment of new subjects;
            2. all subjects have completed all research-related interventions; and,
            3. the research remains active only for long-term follow-up of subjects, or
         2. where no subjects have been enrolled and no additional risks have been identified; or
         3. where the remaining research activities are limited to data analysis
      9. Continuing review of research, not conducted under an investigational new drug application (IND) or investigational device exemption (IDE) where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk no additional risks have been identified;
      10. Minor administrative changes in previously approved research during the period for which approval is authorized and involves no more than minimal risk.
   5. Approval Procedures
      Within a reasonable timeframe after the PI responds to the stipulations, UNCW IRB staff will confirm that no further revisions are needed. If no further revisions are needed, IRB staff will forward a request to an IRB co-Chair to conduct an expedited review of the application. If the co-Chair approves the application, the co-Chair will generate an approval notification through the OSPREY system.
   6. Post-Approval Procedures
      1. If the study involved the use of an informed consent and/or assent-permission form, IRB staff will send an official, approved version of the consent and/or assent-permission form to the PI of the study. This official version will include a stamp and expiration date (if applicable). PIs must use this stamped official copy of the consent and/or assent-permission form when distributing copies to subjects.
      2. A list of all actions taken through an expedited review process will be provided to the IRB at a convened meeting. Any member of the IRB may request re-review of research approved using an expedited process. If such a request is made, the project will be scheduled for discussion at a full-board meeting.
   7. Continuing Review
      1. Minimal risk studies approved by expedited review do not require annual continuing review, unless the study involves an investigational drug, device, or diagnostic test, or is otherwise regulated by the FDA. All other studies approved by expedited review will not have a continuing review conducted, unless required by the IRB.
      2. The IRB may determine that continuing review of research approved at the expedited review level is necessary to protect human subjects. When this determination is made, the IRB shall prepare and maintain records showing the rationale for this decision and will communicate the expectation to the PI of the study in a timely manner. Otherwise, continuing review of research approved at the expedited review level is not required. The IRB will send periodic reminder notices regarding compliance with IRB policies and SOPs to human subject researchers. It is the responsibility of the PI to monitor study methods and procedures to ensure compliance with IRB policies and SOPs.
      3. For expedited review studies that will no longer require continuing review, the UNCW IRB, will conduct a brief inquiry (called an “administrative check-in”), which will require the researcher to submit a status update to the IRB every year the study remains active, simply to determine whether the research has been completed and hence IRB approval is no longer needed.
      4. This will allow the IRB to remove potential studies from unnecessary oversight by the IRB and keep more accurate metrics regarding the total number of active studies.
      5. The IRB will distinguish in all approval documents and study records the requirements for either a complete continuing review (with the continuing review period) or an annual administrative review.
5. Other Applicable SOPs
   • Informed Consent- SOP 6.8
6. Responsibilities
   • IRB Co-chair: Responsible for reviewing studies that qualify for expedited review.
   • IRB Staff: Responsible for conducting initial reviews of all applications and appropriately referring applications for a determination of exemption, expedited review, or full board review. Responsible for notifying principal investigators on any deficiencies in the application that would prevent approval upon further review, and ensuring the principal investigator receives an official stamped copy of any consent and/or assent permission form approved by the IRB.
   • Principal Investigator (PI): Responsible for submitting applications to conduct human subjects research to the IRB prior to initiating activities, ensuring all members of the research team have documentation of required training, representing proposed activities accurately and thoroughly, distributing to subjects only the official stamped copy of any consent and/or assent/permission form approved by the IRB, and otherwise conducting research in accordance with methods and procedures identified in the approved application. 
7. Resources
   • UNCW IRB Website 
   • U.S. Department of Health & Human Services,   Office of Human Research Protections website 
   • 45 CFR 46  (“Common Rule”)  
   • Belmont Report
     

The purpose of this SOP is to provide human subjects researchers with guidance on and clarify review procedures for human subjects research applications that involve greater than minimal risk.

1. General Requirements
   
   Pursuant to 45 CFR 46.109 and UNCW policy, the UNCW Institutional Review Board (IRB) is responsible for reviewing human subjects research conducted by UNCW faculty, staff, or students (or researchers from other institutions who are conducting such research on the UNCW campus). Research projects that involve more than minimal risk to human subjects or involve certain populations are reviewed at a convened meeting of at least a quorum of IRB members.
2. Scope
   This SOP pertains only to those research projects that meet the definition of human subjects research identified in 45 CFR §46.102 and that do not qualify for exemption or review under the expedited review procedures and any other study that the IRB Chair determines would benefit from additional expertise provided by the convened IRB.
   
   This Standard Operating Procedure (SOP) outlines processes that the IRB performs for the review of research by the convened IRB in accordance with FDA regulations 21 CFR 56 and the Health and Human Services (HHS) regulations (45 CFR 46), and the UNCW policies for the protection of research subjects from research risks.
3. Applicable Definitions
   
   
   1. Deception
      
      Knowingly providing false information or incomplete disclosure to research subjects or intentionally misleading research subjects about some key aspect of the research.
   2. Incomplete disclosure
      
      Withholding information about the specific purpose, nature, or other aspect of a research study from research subjects.
   3. Minimal Risk
      
      The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
   4. Prisoners
      
      Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures, which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
4. Procedures
   
   1. Research Requiring Full Board Review
      
      Depending on the nature of the research methods, subjects and other conditions, research requiring full board review may include, but is not limited to:
      1.  Studies involving more than a minimal risk of the following factors that would exceed what one would experience in everyday life even after reasonable and appropriate protections are implemented: 
         1. Invasion of privacy and/or breach of confidentiality;
         2. Physical discomfort, injury and/or pain, and/or side-effects from medications or other substances;
         3. Psychological and/or emotional distress, including embarrassment, which may be the result of deception of the subjects, or other methods designed to intentionally invoke feelings of aggression, stress, anxiety, anger, rejection or other negative response;
         4. Loss of professional and/or social reputation, income, employment and/or insurability
         5. Disclosures of illegal activity and/or negligence. 
      2. Other research involving one or more of the above risks, even if the magnitude of each risk is minimal.
      3. Research involving certain vulnerable populations, such as prisoners, subjects who have diminished capacity to consent, or other research that an IRB co-chair is unable to approve by the expedited review process.
      4. The full board will also review certain modifications/amendments to research (i.e., substantive changes), Unanticipated Problems Involving Risks to Subjects or Others (UPs), potential noncompliance in accordance with the respective IRB SOP.
   2. Application
      
      A researcher who is planning to conduct human subjects research that is subject to full board review must submit an application to the IRB through the OSPREY system by the deadline posted on the Human Subjects Research website for the meeting during which the researcher desires review.
   3. Initial Review/Pre-Review
      
      Within a reasonable timeframe after receipt, which may vary depending on volume of submissions, UNCW IRB staff will conduct initial reviews of applications submitted to the IRB to identify if any deficiencies exist that would prevent approval upon further review. The Principal Investigator (PI) is strongly encouraged to comply with these recommendations to avoid delays in approval.
   4. Establishing and Maintaining Quorum
      
      The Chair will call the meeting to order once enough members are present to meet quorum requirement. Quorum is established when a majority of the members and at least one non-scientist is present.
      
      1. A quorum must be maintained throughout the meeting for the entire discussion of every item on the agenda.
      2. Should the quorum fail during the meeting or if a non-scientific member is not present, the IRB may not take further action or vote for approval of the review, unless quorum can be restored.
      3. IRB meetings are generally convened via Zoom unless circumstances require a convened meeting. The IRB meeting minutes should document the meeting venue.
      4. All requirements of the regulations and these policies and procedures are upheld regardless of the meeting venue.
      5. IRB staff remind members when the agenda is sent by email that any member who has a real or perceived conflict of interest on an agenda item must notify IRB staff to ensure a quorum will be maintained when that member is recused from deliberations and voting on that agenda item.
      6. The IRB may add one or more consultants for additional expertise for the review of any item on the agenda.
      7. Principal Investigators and/or faculty advisors may be asked to attend the full board meeting when their submission is under review. Researchers are strongly encouraged to attend full board meetings to respond to IRB member questions. This helps expedite the approval process. Invited investigator(s) are required to leave the meeting for subsequent discussion by the IRB (without anyone who may have a conflict) and voting on the protocol.
      8. The official meeting minutes document, the number of votes for, against, or abstaining. A simple majority vote of the members present at the meeting is required for approval.
      9. The meeting minutes must be in sufficient detail to show the actions taken by the IRB, the vote on the actions and a summary of the discussion of controversial issues and their resolution and include all items in accordance with the IRB SOPs.
   5. Operational Details
      1. The UNCW IRB usually meets whenever a full board review is required or minimally every quarter.
      2. The IRB Meeting Agenda will be distributed via email to each board member between seven-ten days prior to meeting for their review and will include the following items, as applicable:
         1. A copy of the IRB meeting minutes from the previous IRB meeting;
         2. A meeting agenda that includes:
            1. List of new studies to be reviewed by the full board;
            2. List of any modifications requiring full-board review;
            3. List of any continuing review requiring full-board review;
            4. List of any unanticipated problems requiring full-board review (when present);
            5. Any incidents of noncompliance that needs full-board review (when present);
            6. Any items or notices for continuing education of IRB members;
            7. List of studies that were approved by expedited review providing the IRB number, the title of the study, and the name of the PI.
         3. IRB Members must review all materials that were submitted in OSPREY for any protocol scheduled on a meeting agenda.
   6. Criteria for IRB Approval of Research
      
      The IRB has the authority to require modifications in research activity or disapprove any study or modification to a study.
      
      All IRB members and staff present during the full-board meeting will consider the following criteria and determine if all the following requirements are satisfied prior to approving the research. IRB staff document compliance with regulatory requirements on behalf of the committee utilizing the Protocol Review Checklist:
      
      1. Risks - Identify the risks associated with participating in the research study and differentiating them from the risks that the subjects would encounter if they were not in the study.
         1. The risks will include physical, psychological, emotional, economical/financial risks, and those related to a loss of privacy or a breach of confidentiality.
         2. The identification of risks is based on review of the protocol, supporting information submitted to the IRB for review, the IRB members’ experience, and knowledge, and from external sources such as a review of the literature.
         3. The IRB must be able to determine whether the potential risks are minimal risk or greater than minimal risks so that the appropriate level of review can be applied to the research.
      2. Minimization of Risks - The study design and study procedures will be evaluated to determine whether risks have been minimized to the extent possible that will still permit the ethical conduct of the study and that study objectives can be met.
         1. Whenever possible, procedures should be utilized that will otherwise be performed on subjects if they were not enrolled in the study (e.g., for biomedical research using diagnostic or treatment that would be conducted in standard practice).
         2. The IRB may minimize risks by any of the following:
            • Removing the risk by removing the procedure, intervention, or interaction that will cause the risks;
            • Substituting an alternative procedure, intervention, or interaction that is associated with less risks;
            • Adding precautions, procedures, interventions, or interactions that will manage or remove the risks;
            • Adding safeguards such as additional monitoring or testing that will identify the risks earlier and allow intervention or removal of the risks before they are exacerbated.
         3. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may be expected to result.
            1. Identify the probable benefits to be derived from the research and determine that the risks are reasonable in relation to the benefits.
            2. The IRB should not consider the possible long-term effects of potential knowledge that may be gained from the study when considering whether to approve the study (e.g., the possible effects of the research on public policy).
         4. Selection of subjects is equitable - Ensure that protocols have appropriate plans for the equitable selection of subjects by reviewing the purpose of the study, the setting in which the research will be conducted and inclusion and exclusion criteria for selection of subjects.
            1. The IRB should also consider the settings and/or communities from which subjects will be recruited and review the recruitment plan, recruitment materials, and even the informed consent document(s) from this perspective (See the Recruitment of Subjects and Informed Consent SOP).
            2. When reviewing these considerations, the IRB should be aware of issues related to the enrollment of vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Decisions on whether vulnerable subjects should be included should be made with consideration of the justice principle of the Belmont Report.
         5. Informed consent – Ensure that protocols have plans to obtain legally-effective informed consent from each prospective subject or the subject’s legally authorized representative, and appropriately documented, unless the requirement for consent is waived by the IRB. NOTE: Since informed consent is such an integral activity for the ethical conduct of research and there are many considerations for effectively obtaining consent from subjects, a separate section is devoted to the topic in Recruitment and Informed Consent (SOP 6.8).
         6. Documentation of Informed Consent – Ensure that the documentation of the informed consent process is documented appropriately to ensure legally-effective consent unless the requirement is waived by the IRB.
         7. Monitoring the data - Where appropriate, the research plan adequately provides for monitoring the data collected to ensure the safety of subjects and to protect their privacy and maintain confidentiality of the data.
            1. All studies that are greater than minimal risk, the IRB should review a safety monitoring plan that details how the study will monitor the data to ensure safety of subjects.
            2. If reviewed, the IRB will determine whether the safety monitoring plan can be managed by the investigator and research team or whether there should be an additional review of safety data by a separate committee (e.g., data monitoring committee/data safety monitoring board) and/or the sponsor. Some considerations for when a monitoring committee will be required include moderate to high-risk research (especially studies that may include death as a risk), inclusion of vulnerable subjects, large number of subjects, and double-blind study designs.
            3. When considering a separate monitoring committee, the IRB may determine that the monitoring board should be entirely independent from the research team(s) and/or the sponsor so to remove all potential conflicts of interest. Additional considerations for when a monitoring committee will be necessary include requirements by the FDA or NIH or the sponsor for research regulated or supported by them.
            4. The IRB shall also determine whether additional monitoring may be required by UNCW when the PI is also the PI of a multicenter study. In such situations, the IRB may determine that the monitoring plan should provide details of how safety data will be collected in a timely manner from all performance sites and how the plan will ensure the safety and well-being of subjects at all sites.
         8. Privacy and Confidentiality - Determine the adequacy of the provisions to protect subject privacy and maintain data confidentiality. If the research study involves greater than minimal risk as a result of a potential breach of confidentiality, a data protection plan will be required for review by the IRB.
         9. Special Consideration for Projects Involving Vulnerable Populations - When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, handicapped or mentally disabled persons, economically or educationally disadvantaged persons, additional safeguards have been included in the research project and in the IRB review process to protect the rights and welfare of these participants.
            1. In reviewing these research projects, the IRB ascertains that the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population.
            2. For approval of research projects involving vulnerable populations, the IRB considers if one of the following conditions is met:
               • The research does not involve more than minimal risk to the subject;
               • The research is likely to benefit the subject directly, even if the risks are considered to be greater than minimal; or
               • The research involves greater than minimal risk with no prospect of direct benefit to individual participants but is likely to yield generalizable knowledge about the subject's disorder or condition.
   7. Actions taken by the IRB at the Time of Initial Review
      
      The IRB can take any of the following actions:
      
      1. Approve the research study - The IRB may approve the study without any conditions or modifications to the protocol.
      2. Approve the study with conditions - Within a reasonable timeframe after full board review, UNCW IRB staff will notify the principal investigator of any revisions needed to secure approval. Notification typically occurs by returning the application to the PI with specific stipulations entered to indicate where revisions are needed.
         1. The IRB may require the PI to make specific changes to the protocol, informed consent, or other materials
         2. The IRB may require the PI to submit additional documents or information.
         3. The IRB should specify whether any conditions need to be satisfied before the PI can initiate research activities
         4. Within a reasonable timeframe, after the PI responds to the stipulations, an IRB co-chair or designate will confirm that no further revisions are needed. If no further revisions are needed, an IRB co-chair approves the application by generating an approval notification through the OSPREY system.
      3. Defer the study for further review by the full board. If the IRB has substantive concerns regarding a study that will require modifications to be made by the PI that cannot be articulated in a specific motion, the study will be deferred or tabled for full-board re- review at a future date after the required modifications have been submitted by the PI.
      4. Disapprove the research
         
         A research study may only be disapproved by the full board (i.e., a study may not be disapproved by expedited review). A vote to disapprove research indicates that the IRB will not allow the research to be conducted.
         
         • Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedure outweighs any benefit to be gained or if the proposed research does not meet the federal criteria for IRB approval.
         • Disapproval generally indicates that even with major revisions to the application the issues preventing approval will not be resolved.
         • The PI will receive written communication describing the reasons for disapproving the protocol through OSPREY. If the study is regulated by FDA, the FDA recommends that the IRB also notify the sponsor of the decision and reason(s) for disapproval.
         • The PI will be given an opportunity to respond to the IRB decision to disapprove the research.
         • The investigators responses will be reviewed at a subsequent convened meeting of the IRB.
   8. Effective Date of Initial IRB Approval
      
      The effective date of the initial approval is the date of the IRB meeting at which the IRB approved the study or the date that a board chair determined any conditions for approval set by the full board had been met.
      
      The expiration date of the initial approval is the one-year anniversary of the effective date, unless the IRB determines that an approval period of less than one year is required due to the risks of the research or some other factor.
      
      Prior to the expiration date the researcher must submit a form in OSPREY to either renew the study or close the study. Although periodic reminder notices regarding expiration of IRB approval are issued from the OSPREY system, it is the responsibility of the researcher to monitor this expiration date and to maintain compliance of the study.
   9. Notification of IRBs Initial Review Determination to the Investigator
      
      After the review, the investigator will receive a letter with the IRB decision.
      
      1. For studies approved – an approval letter with the date of approval and expiration date of IRB approval will be sent to the PI. If the study involved the use of an informed consent and/or assent-permission form, IRB staff will send an official, approved version of the consent and/or assent-permission form to the PI of the study. This official version will include a “stamp” and expiration date. PIs must use this stamped official copy of the consent and/or assent-permission form when distributing copies to subjects.
      2. For studies approved with conditions – IRB staff return the application with specific instructions on how to fulfill the full board’s conditions.
      3. For studies tabled/deferred - (Convened IRB only) indicates that the IRB withholds approval pending submission of major revisions/additional information that must be re-reviewed by the IRB.
         1. The IRB Administrator will send the investigator a letter listing the reasons for deferring the study for re-review by the convened IRB and include a description of the revisions or clarifications requested.
      4. For disapproved research – (Convened IRB only) A vote to disapprove research indicates that the IRB will not allow the research to be conducted. The IRB Administrator will send the investigator a letter describing the reasons for disapproving of the protocol. The investigator will be given an opportunity to respond to the IRB decision [see 6(d)(iv) above].
   10. Appeal of IRB Decisions/Determinations
       1. Investigators may appeal the IRB’s approval, deferral of approval (i.e., requests for changes for a submission), or disapproval decision for the review of any new study, modification or continuing review of an existing study, or review and determinations regarding allegations of noncompliance/review of noncompliance.
       2. An investigator may appeal to the IRB for a formal re-review of a decision whenever there have been more than two unsuccessful efforts by the investigator and the IRB to resolve the investigator’s concerns and the investigator believes that the IRB’s decision is due to: inadequate or inaccurate information; or, IRB non-compliance with UNCW IRB SOPs, state law, or federal regulation.
       3. At the discretion of the IRB Chair, the investigator may make such an appeal in person and/or in writing to the IRB.
       4. The appeal request consists of sending the IRB Administrator a cover letter outlining the basis for the appeal and documents that support the appeal.
       5. The Director of, the Research Integrity Office reviews the appeal request to determine whether an appeal is appropriate. This may include consultation with the investigator, the IRB Chair, select members of the IRB, the IRB staff, or the Institutional Official, as needed. The RIO Director informs the investigator by email whether the request has been accepted for review.
       6. If the decision being appealed was made by the convened IRB, the appeal is heard and considered by the convened IRB. This may be a regularly scheduled IRB meeting, or it may be a meeting convened for this specific purpose. If the decision being appealed was made by the Expedited or Exempt (both minimal risk) process: the IRB Chair will hear the appeal.
       7. The following outlines the process for appeals heard by the convened IRB.
          1. The IRB Chair may hold a closed session of the IRB without the researcher, prior to the appeal portion of the meeting, to establish the key issues and questions to consider.
          2. The researcher is invited to present information and rationale to the IRB.
          3. There is a question-and-answer session with the researcher.
          4. The researcher leaves the meeting room.
          5. The IRB members and other meeting attendees discuss the appeal.
          6. The Director, Research Integrity Office or designee prepares anonymous written ballots to distribute to the members for voting when the discussion has ended. After voting, the ballots are read by the IRB Chair. The IRB moves and then votes whether to take one of the following actions:
             
             • Approve the appeal and modify the original decision;
             • Disapprove the appeal and uphold the original determination; or,
             • Defer the appeal and obtain additional information or consultation in order to make a final decision.
          7. The IRB’s appeal determination, and any other considerations or requirements associated with it, are communicated to the researcher in a letter within 10 business days of the IRB’s determination. If appropriate, the determination may also be communicated by email or telephone call with follow-up email by the Director, HRPP or IRB Chair.
          8. A decision by the IRB to disapprove, suspend, or terminate a project is not subject to reversal by the INCS.
5. Other Applicable SOPs
   • Use of Deception in Human Subjects Research - SOP 6.6
   • Informed Consent - SOP 6.8
6. Responsibilities
   • IRB Co-Chair: Responsible for facilitating full board meetings and verifying that any revisions required by the committee were made prior to granting approval.
   • IRB Staff: Responsible for conducting initial reviews of applications that require full board review, notifying principal investigators on any deficiencies in the application, placing an application on a full board agenda, informing principal investigators of meeting dates, times, and locations, and ensuring the principal investigator receives an official “stamped” copy of any consent and/or assent permission form approved by the IRB.
   • Principal Investigator: Responsible for submitting applications to conduct human subjects research to the IRB prior to initiating activities, ensuring all members of the research team have documentation of required training, representing proposed activities accurately and thoroughly, distributing to subjects only the official “stamped” copy of any consent and/or assent/permission form approved by the IRB, and otherwise conducting research in accordance with methods and procedures identified in the approved application.
7. Resources
   • UNCW IRB Website 
   • U.S. Department of Health & Human Services,   Office of Human Research Protections website 
   • 45 CFR 46  (“Common Rule”)  
   • Belmont Report
     

The purpose of this SOP is to guide the UNCW IRB staff on how to manage and store IRB records in accordance with federal regulations and institutional requirements.

1. General Requirements
   
   It is the policy of the University of North Carolina Wilmington (UNCW) IRB to maintain documentation of all IRB activities in accordance with federal regulations 45 CFR 46.115 and 21 CFR 56.115.
   
   These procedures supplement the Institutional Review Board Policy (the “Policy”).
2. Definitions
   All terms used in these procedures have the same meaning set forth in the Policy, unless otherwise defined in these procedures.
   
   1. Study completion date – the day when all research-related interventions or interactions with participants have been completed and collection and analysis of identifiable private data are finished.
3. Procedures
   
   1. IRB Records
      1.  Prepare and maintain documentation of IRB activities and regulatory requirements to include:
         • Copies of all research proposals reviewed;
         • Scientific evaluations, if any, that were conducted for review of the research proposals;
         • Approved consent document(s);
         • Statements of significant new findings that developed during the course of research in which may relate to the subject’s willingness to continue participation that were provided to subjects as required by 45 CFR 116(b)(5), 21 CFR 50.25(b)(5);
         • IRB review, whether conducted by expedited review or the convened IRB (e.g., in Notes, correspondence, IRB reviewer form), including actions taken by reviewer or Board, approval and expiration dates), determinations (e.g., waiver of informed consent, waiver of documentation of informed consent, Subpart-specific determinations), restrictions (e.g., suspensions, contingencies), and reviewers;
         • Amendments or modifications to protocols;
         • Reportable events, such as unanticipated problems involving risks to subjects;
         • Recruitment and advertisement materials;
         • Investigator Brochure, drug package inserts and Device Manuals (if applicable);
         • Data and Safety Monitoring reports (if applicable);
         • Noncompliance findings/reports and documentation of outcomes;
         • Reporting to federal regulatory agencies and any interactions with agencies regarding compliance matters;
           Progress reports submitted by the Principal Investigator (PI).
      2. Records of continuing review activities.
      3. Copies of all correspondence between the IRB and the PIs, including approval letters and exemption determinations.
      4. IRB Membership.
         1. IRB Roster identified by:
            
            • Representative capacity;
            • Department
            • Name;
            • Earned degree;
         2. IRB chair appointment letters and other relevant correspondence involving membership service (e.g., Confidentiality and COI Agreement if applicable);
         3. Changes in IRB membership that were reported to Office for Human Research Protections (OHRP).
         4. Versions of written IRB SOPs and IRB policies.
   2. IRB Record Retention and Storage
      
      
      The IRB records will be retained for at least three (3) years after completion of the research.
      1. Paper records for the previous three years are maintained and stored in the IRB office at UNCW.
      2. Electronic files and correspondence are in the IRB folder(s) on the UNCW secure server.
         1. Electronic files are only accessible by the RIO Director, IRB Staff, and UNCW administrators responsible for oversight of the UNCW
         2. Records will be accessible for inspection and copying by authorized representatives of the Food and Drug Administration (FDA), Office of Research Protection (OHRP) or any other authorized agency at reasonable times and in a reasonable manner.
         3. IRB staff will obtain and/or make copies of requested records.
      3. Meeting minutes must be retained until all the studies that were reviewed at that meeting have been completed for at least three years.
   3. Minutes of Convened IRB Meetings
      
      Meeting minutes provide a summary of what occurred during a convened meeting.
      
      
      1. Minutes will be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research and a written summary of the discussion of controverted issues and their resolution.
      2. Meeting minutes are electronically prepared after each meeting by the IRB staff.
      3. IRB staff send minutes to all board members by email for acceptance or revision following each full board meeting.
      4. IRB staff send the final version of the minutes to the committee along with the agenda for the next scheduled
      5. Meeting minutes are stored electronically in email records and in the IRB file of the UNCW secure server.
4. Other Applicable SOPs
   • Full Board Review of Applications to Conduct Human Subjects Research- SOP 5.3
   • Identification and Reporting of Adverse Events and Unanticipated Problems- SOP 6.7
   • Recruitment and Informed Consent- SOP 6.8
   • Study Completion, Closure or Expiration Procedures- SOP 6.11
5. Responsibilities
   • IRB Staff: Responsible for ensuring that the appropriate records are maintained according to this SOP.
6. Resources
   • 45 CFR 46.103(b) (3); 
   • 46.115(a) (2) & (b);  
   • 46.116(b) (5); 
   • 21 CFR 56.115 (a) (2); 
   • 56.115 (b) 

The purpose of this SOP is to describe who must complete training on the protections of human research subjects and what type of training is acceptable.

1. General Requirements
   
   The UNCW Institutional Review Board (IRB) requires researchers to complete the online Basic Course for Human Research Protections, or an equivalent course, prior to granting approval to conduct human subjects research.
2. Scope
   
   This SOP pertains only to projects that meet the definition of human subjects research as identified by 45 CFR 46.102, regardless of the source of funding, if any.
   
   This SOP pertains to all persons (UNCW faculty, staff, students, or non-UNCW collaborators) involved in the design and/or conduct of research projects involving human subjects. Examples of persons involved in the design and conduct of research projects include persons engaged in planning the study, writing survey/interview/focus group questions, recruiting subjects, administering study procedures, and analyzing identifiable data. In particular, all individuals who will obtain informed consent from research subjects and who will otherwise directly interact with subjects must have completed the required training.
3. Procedures
   1. Training Website: UNCW subscribes to the Collaborative Institutional Training Initiative (CITI) Program, designed to demonstrate the highest ethical standards and to comply with all laws and regulations. The website can be found at http://www.citiprogram.org/. Other forms of training must be approved on a case-by-case basis by the IRB chair or designee.
   2. Required Courses: Researchers must have documentation of completing the CITI Program Basic course for Human Protections (either social/behavioral or biomedical version). Researchers who completed a Refresher course must be able to produce documentation of completing the original Basic course. Other courses may be required by the IRB depending on the nature of the study under review.
   3. Certification of Training: The IRB office receives certification of training directly through the CITI Program website for users who indicate affiliation with UNCW when registering an account with the CITI Program. Non-UNCW collaborators subject to the training requirement must submit documentation of completion to the IRB office. The IRB office will maintain a record of all training documentation received. IRB staff will not request review of a human subject research application by an IRB co-chair or designee until IRB staff has confirmed completion of training and/or received all relevant training documentation.
   4. Refresher Training: The UNCW IRB does not currently require investigators to complete refresher training. However, UNCW researchers who collaborate with researchers from other institutions may be required to complete refresher training if the collaborating institution’s IRB requires refresher training.
4. Responsibilities
   • IRB Co-Chair or designee: Responsible for determining if alternate training courses are acceptable.
   • IRB Staff: Responsible for conducting initial reviews of human subjects research applications and ensuring documentation of training is on file.
   • Principle Investigator (PI): Prior to submission of an application to the IRB, the Principal Investigator is responsible for completing the required training, ensuring all other persons on the research team involved in the design and conduct of human subjects research have completed the required training, and providing documentation of completion to the IRB upon request by IRB staff.
   • Other investigators: Required to complete the required training and are required to provide the principal investigator with documentation of training completion upon request by the Principal Investigator.
5. Resources

1. • UNCW IRB Website
   • U.S. Department of Health & Human Services, Office of Human Research Protections website
   • 45 CFR 46 (“Common Rule”)
   • Belmont Report

I. General Requirement 
These procedures support the university’s efforts to protect human subjects and UNCW researchers while minimizing institutional risk in conducting blood draws for research purposes. 

II. Scope  
This SOP pertains to all human subjects research projects that involve blood draws. These procedures apply to any blood draws occurring on the UNCW campus or conducted by UNCW’s staff, students, and faculty. 
Please note, if the research blood draws will occur at off-site locations that are not owned or leased by UNCW (such as hospitals or other healthcare facilities or private physician offices) with their own venipuncture or equivalent policy, then that site’s policy supersedes these procedures. If UNCW faculty, staff, or students conduct blood draws at those sites, they must follow the site’s policy.  If the site is contracted by a UNCW principal investigator (PI) to conduct blood draws for research, the off-site personnel must follow the site’s policy.

III. Definitions  
All terms used in these procedures have the same meaning set forth in the policy unless otherwise defined in these procedures.  
A. Children—as defined in the HHS regulations, "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
B. Expedited Review—review conducted by the IRB Chair or by one or more qualified reviewers designated by the chairperson from among members of the IRB. 
C. Finger stick means a type of blood draw where the finger is pricked with a lancet to obtain a small amount of capillary blood.
D. Intravenous (IV) lines mean a thin tube or cannula that is inserted into a vein, typically to administer drugs, blood, or fluid products directly into the bloodstream.
E. Phlebotomy/venipuncture means a type of blood draw in which a needle is used to take blood from a vein. Multiple tubes may be collected; however, it is considered a single blood draw “stick” and the needle is taken out and a bandage is used.

IV. Blood Draws Qualifying for Expedited Review 

A. Expedited Review of Blood Collection
The federal regulations 45 CFR 46.110 and 21 CFR 56.110 allow research activities that present no more than minimal risk to human subjects and involve only procedures listed in an expedited review category may be reviewed by the IRB through the expedited review.  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture is an activity that is included in the Expedited Review Category 2 provided the following requirements are met:

1. The collection is from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period, and collection may not occur more frequently than 2 times per week; or
2. The collection is from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period, and collection may not occur more frequently than 2 times per week.              B. All Other Blood Collection
If the criteria for Expedited Category 2 cannot be met, studies involving blood collection will be reviewed by the full board.

V. Blood Draw Considerations
A. Personnel Qualifications
1) All blood draws must be performed by personnel who are proficient in both phlebotomy and safe handling of blood and human tissues. 
Examples of appropriate credentials include, but are not limited to:
a. Medical or Nursing license 
b. Medical Technologist license or certification
c. Phlebotomist license or certification
d. Advanced EMS certification

2) The PI must justify on the IRB application that the individual(s) who will perform the blood collection will do so within their scope of practice, have appropriate training, and are credentialed appropriately.  
A. Volume
Blood samples must not exceed the minimal amount necessary for analysis. This amount must be documented in the IRB application and approved by the IRB.  Justification for the amount must comply with federal guidelines and the scope/purpose of the study.
B. Subject Screening
There must be no contraindications for blood withdrawal that would injure the subject or contraindications that would undermine the research goals. The PI or designee must create and submit for approval appropriate screening tools to identify contraindications.  The IRB will consider factors, including but not limited to the following, when assessing the risks and benefits of blood collection:
1. Health status of the subject population—a) Blood clotting conditions, b) Receiving chemotherapy, c) Vascular grafts, hematoma
2. Volume of blood the researcher proposes to collect
3. If opportunities exist to collect blood at the same time as a clinical visit

D. Special Informed Consent Requirements
Subjects must be informed through an appropriate informed consent process of the potential risks of blood collection, which may include:
a. Bruising
b. Hematomas
c. Infection at the blood collection site
d. Allergies (e.g., latex, betadine, bandage/tape)
e. Less common risks such as nerve damage or extensive bleeding

VI. Safety Considerations

A. UNCW Environmental Health & Safety Requirements

The PI or designee of the study must upload the completed Bloodborne Pathogen Exposure Control Plan in the Supporting Documents section of the IRB application as documentation of having engaged EH&S.
If a third-party contractor is used to collect blood, the PI must ensure that the contractor has appropriate safety protocols in place and is properly trained and credentialed.

B. Location

When blood draws are conducted on UNCW premises, they must be conducted in an appropriate location inspected by UNCW EH&S before final approval by the IRB:
1. Floors must not be carpeted. If the only option is a carpeted space, plastic or other impervious and cleanable material must be used to cover the carpet.
2. One or more comfortable chairs must be available. Chair covers must be non-porous. If a chair with a nonporous cover is not available, a cleanable and impervious cover must be used on the chair. Chairs must be used for the subject.  When research involves the collection of blood mid-exercise, a chair must be available in case the exercise subject becomes light-headed.
3. Space should have a curtain or door for privacy if possible.
4. Space must not be used for eating or drinking. 

C. Infection Prevention

Per WHO guidance, proper procedures must be followed to prevent infection:
1. The researcher conducting the blood draw must first wash his/her hands, wrists, and in-between fingers with soap and water or an alcohol rub for at least 30 seconds.
2. Personal Protective Equipment must be available and used.  Avoid using latex gloves in case the subject or researcher is allergic to latex.
3. Single-use gloves must be worn during all blood withdrawal procedures. Hands must be washed, and gloves must be changed between subjects. 
4. Tourniquets must be single-use or cleaned before the next use.
5. Only single-use/one-hand cap devices must be used for blood withdrawal.
6. Each subject’s skin must be disinfected prior to blood draw.
7. A sharps container must be no more than four (4) feet from where the blood draw is conducted.
8. Work surfaces must be decontaminated/disinfected for the appropriate contact time immediately after work is complete. Suitable disinfectants include: a) A 1:10 dilution of 5.25%-6.15% sodium hypochlorite (i.e., household bleach) for 10 min contact time. NOTE: A dilution of 70% ethanol may be used to remove chlorine residue following disinfection to reduce the wear on metal surfaces; b) An EPA–registered tuberculocidal disinfectant, used for contact time listed on the disinfectant. 

9. Blood samples that are to be transported outside the building must be sealed in appropriately labelled, leak-proof primary tubes/flasks/containers and disinfected on the outside before being placed into a durable, leak-proof secondary transport container. A biohazard symbol will be placed on the primary container. The secondary container will be disinfected and secured for transport.

VII. References to Other Applicable SOPs 
Expedited Review Procedures 5.2
Full Board Review Procedures 5.3 
Adverse Event, Unanticipated Problem Reporting Procedures  6.7 
Recruitment and Informed Consent 6.8 
Findings of Noncompliance 11.1 
 
IX. Resources 
A. World Health Organization Best Practices for Blood Collection
B. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed- consent/index.html
C. UNCW IRB Website 
D. U.S. Department of Health & Human Services, Office of Human Research Protections website
E. 45 CFR 46 (“Common Rule”)
F. Belmont Report

v. October 2025

The purpose of this SOP is to clarify when and how researchers may use electronic sources while conducting human subjects research.

1. General Requirements
   
   The internet is widely used to conduct human subjects research during the recruitment and consent processes, as well as in data collection. Research using the Internet must provide the same level of protection as any other type of research involving human participants. However, it presents its own unique set of issues and concerns during the IRB review process. Researchers may conduct research using electronic sources such as online survey software, social networking sites (Facebook, Twitter, etc.) or online marketplaces (Craigslist, eBay, etc.) provided they observe certain requirements as outlined below.
2. Scope
   
   This SOP pertains to all human subjects research reviewed by the UNCW Institutional Review Board (IRB).
3. Applicable Definitions
   1. Anonymous
      
      Of unknown authorship or origin; not named or identified; lacking individuality, distinction, or recognizability.
   2. Distress
      
      Pain or suffering affecting the body, a bodily part, or the mind; a painful situation.
   3. Internet Protocol (or IP) Address
      
      A unique identifier associated with every computer connected to the Internet. On many networks, the IP address of a computer is always the same, i.e., fixed or static. On other networks, a random IP address is assigned each time a computer connects to the network, i.e., dynamic. Knowing a fixed IP address is equivalent to knowing the identity of its users.
   4. Privacy Policy
      
      A statement that declares a firm's or website's policy on collecting and releasing information about a visitor. It usually declares what specific information is collected and whether it is kept confidential or shared with, or sold to other firms, researchers, or sellers.
   5. Upset
      
      To trouble mentally or emotionally.
4. Procedures
   1. Anonymous Online Surveys
      1. Anonymity
         1. When a researcher conducts an online survey, the researcher may not refer to the survey as “anonymous” if IP or email addresses are collected from subjects, as they are considered identifiers.
         2. To maintain anonymity of data, researchers should set survey software so that no IP or email addresses are retained.
      2. Recruitment or Introductory Statements
         1. The IRB may require researchers to add the following statement if the online survey involves collection of sensitive or private information, such as financial information or information disclosing illegal activity, and subjects complete the surveys at locations of their choosing (rather than in UNCW-controlled computer labs), “The researchers will keep your responses secure once they are in the researchers’ possession. However, the researcher(s) cannot guarantee security during transmission of data due to keylogging and other spyware technology that may exist on any computer used by the subject to respond to the survey/questionnaire.”
         2. If a researcher must collect IP or email addresses in order to determine if a subject has completed the online survey, the researcher must inform the subject in the opening statement of the survey that these identifiers will be collected.
         3. Other requirements for recruitment/introductory statements may apply. Researchers should review UNCW IRB SOP 6.3 Anonymous Surveys/Questionnaires to view additional requirements.
   2. Collecting Data from Social Media Sites
      
      When a researcher plans to observe comments posted on blogs or other social media websites, the researcher must:
      
      1. Do so in accordance with the site’s privacy policy, and;
      2. Identify him/herself as a person conducting research who will be gathering information from the site for a specified period of time, or;
      3. If, due to the nature of the study, it is not possible for the researcher to identify him/herself, this must be justified on the IRB application along with a description of appropriate opt-out and debriefing procedures.
   3. Privacy Policy of Website
      1. The UNCW IRB will consider websites with no privacy policy to be public sites.  Using data from public sites is akin to observing public behavior which does not meet the definition of research using human subjects.
      2. When a website has a privacy policy, the IRB will assume that the users of the site have a presumption of privacy.  Using data from sites that have privacy policies meets the definition of research using human subjects.
      3. When a website has a privacy policy, the researcher must attach a recent copy of the site’s privacy policy (printed within thirty days of protocol submission) to their IRB application.
      4. When a researcher plans to collect data from a website that has a privacy policy, the research design must conform to all requirements of the site’s privacy policy.
      5. If the researcher is unable to find a copy of the site’s privacy policy, the researcher must contact the site to determine if a policy is available.
      6. If after contacting the site the researcher learns a privacy policy is not available, the researcher must state this on the IRB application.
   4. Email Recruitment
      1. Researchers wishing to recruit UNCW faculty, staff and/or students to participate in human subjects research by email must submit a proposed email recruitment message to the IRB for approval.
      2. Researchers may be required to obtain approval from other UNCW offices to access email addresses or distribution lists, such as the Registrar’s Office, the Office of University Relations, or the Office of Institutional Research and Planning.
      3. Researchers wishing to email all faculty and staff or all students are subject to the UNCW Mass Emails policy 07.200.14.
      4. IRB staff will guide researchers on proper procedures as needed.
5. Other Applicable SOPs
   • Anonymous Surveys/Questionnaires- SOP 6.3
6. Responsibilities
   • IRB Co-chair: Responsible for reviewing applications to conduct human subjects research that qualify for expedited review.
   • IRB Staff: Responsible for conducting initial reviews of applications to conduct human subjects research, assisting PIs with including relevant information in applications and attachments, and directing applications appropriately for determinations of exemption or approval.
   • Research Compliance Manager: Responsible for reviewing applications for determinations of exemption.
   • Principal Investigator (PI): Responsible for submitting applications to conduct human subjects research to the IRB prior to initiating activities, representing proposed activities accurately, and conducting research in accordance with methods and procedures identified in the approved application.
7. Resources

1. • UNCW IRB Website
   • UNCW Mass Emails Policy 07.200.14:   
   • U.S. Department of Health & Human Services, Office of Human Research Protections website   
   • 45 CFR 46 (“Common Rule”)   
   • Belmont Report  

The purpose of this SOP is to explain the requirements for research that involves anonymous paper or online surveys/questionnaires.

1. General Requirements
   
   Anonymous paper or online surveys/questionnaires are generally reviewed by the IRB for a determination of exemption as allowed by 45 CFR 46. The UNCW IRB does not require written consent for completely anonymous surveys/questionnaires. However, the IRB may require a more detailed informed consent statement at the beginning of surveys/questionnaires that ask subjects to react or respond to scenarios, photographs, or information that may cause upset or distress, even when those surveys/questionnaires are anonymous.
2. Scope
   
   This SOP pertains to all human subjects research reviewed by the UNCW Institutional Review Board (IRB).
3. Applicable Definitions
   1. Anonymous
      
      Of unknown authorship or origin; not named or identified; lacking individuality, distinction, or recognizability.
   2. Deductive Disclosure
      
      Deductive disclosure is the identification of an individual's identity using known characteristics of that individual. Even though direct identifiers (e.g., name, addresses) are not solicited or removed from survey data, it may be possible to identify subjects who have unique characteristics, particularly if a sample size is small.
   3. Distress
      
      Pain or suffering affecting the body, a bodily part, or the mind: a painful situation.
   4. Upset
      
      To trouble mentally or emotionally.
4. Procedures
   1. Researchers may not refer to surveys as “anonymous” if the surveys solicit responses that may identify subjects, such as names or email addresses.
   2. The introductory statement of any anonymous survey/questionnaire must, at minimum, include a statement similar to, “Your participation in this research study is entirely voluntary. You may refuse to participate, or you may stop participating at any time without penalty or loss of benefits.”
   3. Researchers are encouraged to include additional information that might be helpful to subjects.
   4. When researchers send recruitment emails to campus populations or other populations where subjects may desire reassurance of ethical oversight, the IRB may require researchers to include a statement in the recruitment email and/or introductory statement for the survey that the study was approved by the UNCW Institutional Review Board, along with the study’s IRB identification number.
   5. Researchers collecting data from studies with small sample sizes must take precautions so that other characteristics collected from subjects will not identify them through deductive disclosure. If adequate precautions cannot be taken, researchers must include language in the introductory statement of the survey to inform subjects of the possibility of deductive disclosure as a risk.
   6. Additional requirements may apply if the survey is conducted online. Researchers should refer to UNCW IRB SOP 6.2 Online Research for additional requirements.
5. References to Other Applicable SOPs
   • Exempt Research- SOP 5.1
   • Online Research- SOP 6.2
6. Responsibilities
   • IRB Co-chair: N/A
   • IRB Staff: Responsible for conducting initial reviews of applications to conduct human subjects research, assisting PIs with including relevant information in applications and attachments, and directing applications appropriately for determinations of exemption or approval.
   • Research Compliance Manager: Responsible for reviewing applications for determinations of exemption.
   • Principal Investigator (PI): Responsible for submitting applications to conduct human subjects research to the IRB prior to initiating activities, representing proposed activities accurately, and conducting research in accordance with methods and procedures identified in the approved application.
7. Resources

1. • UNCW IRB Website  
   • U.S. Department of Health & Human Services, Office of Human Research Protections website 
   • 45 CFR 46 (“Common Rule”)  
   • Belmont Report

The purpose of this SOP is to clarify procedures when human subject research activities will be conducted at non-UNCW locations or will use populations under another entity’s jurisdiction.

1. General Requirements
   
   Researchers are required to provide documentation to the IRB that permission has been granted by a high-level administrator at a non-UNCW organization when the researchers will be physically present to recruit or collect data on premises where the clients, patients, or students served at those organizations have a reasonable or regulatory expectation of privacy, including but not limited to nursing homes, rehabilitation or other medical clinics, public or private schools, or daycare centers.
   
   Researchers may need to obtain additional approvals from non-UNCW IRBs or from tribal governments if research subjects fall under the jurisdiction of another entity.
   
   • Documentation of permission is not required when recruitment or data collection will take place at public locations such as community centers or public libraries.
   • Documentation of permission is not required when researchers will recruit adult subjects who are employed at non-UNCW organizations by email, provided that their email addresses are publicly available (or otherwise known to the researcher) and the researcher will not thereafter collect data on the organization’s premises.
   • Documentation of permission may not be required when a UNCW researcher collaborates with a colleague employed by another organization with its own IRB. This situation is handled on a case-by-case basis, and additional requirements are determined by a number of factors, including the level of “engagement” that UNCW has in the research activities and the other IRB’s willingness to enter into a reliance agreement with UNCW’s IRB. Researchers are encouraged to contact IRB staff so that they can determine how best to proceed.
2. Scope
   
   This SOP pertains to all activities that meet the definition of human subjects research, regardless of review level.
3. Applicable Definitions
   1. Educational Institution
      
      For the purposes of this SOP, “educational institution” means a daycare center, preschool, elementary school, middle school, high school, college, or university, whether publicly or privately funded.
   2. Engagement in Research
      
      Institutions are considered engaged in non-exempt human subjects research project when their employees or agents in that project:
      1. receive an award through a grant, contract, or cooperative agreement even where all activities involving human subjects are carried out by employees or agents of another institution;
      2. intervene or interact for research purposes with any human subjects of the research;
      3. obtain for research purposes identifiable private information or identifiable biological specimens from any source, even if the institution’s employees or agents do not directly interact or intervene with human subjects.
      
      Institutions are not considered engaged in research if they are merely selected as a recruitment site, if their employees or agents inform or provide information to prospective subjects about the availability of research (unless it the information is part of the informed consent process), or if their employees or agents seek or obtain permission from prospective subjects for investigators to contact them.
4. Procedures
   1. Types of Permission Accepted
      1. In General- Researchers must provide documentation that they have support and permission from a high-level administrator or applicable review board at the external organization to conduct the research activities. Researchers must abide by any special requirements identified in sections IV.B (Educational Institutions), IV.C (Medical Facilities), and IV.D (Tribal Populations) below. It must be clear from this documentation:
         1. what role the administrator has at the organization;
         2. how the IRB can contact this administrator if needed;
         3. that the administrator is aware of the nature of the research (it is adequate to cite the principal investigator’s name and title of the study); and
         4. that the administrator supports the research.
      2. Letters of Support- The most common way for a researcher to provide documentation of permission is to ask an appropriate administrator to provide a Letter of Support. A researcher may upload a PDF copy of a Letter of Support to the Attachments section of his or her OSPREY application. In addition to the requirements in section IV.A.1 above, the Letter of Support must be written on the organization’s letterhead and include the signature of the administrator.
      3. Permission Sent by Email- A researcher may upload emailed correspondence between the researcher and an appropriate, high-level administrator in lieu of submitting a Letter of Support, provided the researcher is able to upload a PDF copy of the correspondence to the Attachments section of his or her OSPREY application. In addition to the requirements in section IV.A.1 above, the original header of the email must be intact (From, Sent, To, Subject). (If using Outlook, open the email from the facility administrator, select File, select Print, change the printer setting to Adobe PDF, and save the copy where you can easily retrieve it when uploading as an attachment in OSPREY.)
   2. Special Requirements for Educational Institutions
      1. Family Education Rights and Privacy Act (FERPA)- Researchers who hope to obtain student data from educational institutions must determine if the release of that data is allowed or prohibited under the U.S. Department of Education’s Family Education Rights and Privacy Act (FERPA). Researchers may review the educational institution’s FERPA policy to determine if any special procedures are required. If the UNCW IRB determines during the review process that a release of student information is subject to FERPA requirements, the IRB may require the researcher to obtain documentation from the educational institution that any release of student data will be done in accordance with FERPA.
      2. School Districts with Research Review Boards - Certain school districts in this region require researchers to obtain approval through a Research Review Board or undergo some other district-level approval prior to conducting the activities. When a district requires advance approval, they generally review research requests from a different perspective from that of the IRB. School districts typically consider how intrusive the research is to the teachers and the classroom, how much effort will be required of teachers, if and how the information gained by the research will benefit the school district, and what the impact will be, if any, on the school or district office staff.
         
         • The UNCW IRB cannot advise researchers on individual district requirements. Researchers should contact district offices as early as possible in their planning process to determine what the requirements are for obtaining permission to conduct research in the desired school district(s).
         • Accepted Documentation- A researcher must upload to the Attachments section of their OSPREY application documentation that they have obtained district-level approval (consistent with sections IV.A.1 and IV.A.2 or 3 above) to conduct human subjects research from the district Research Review Board.
      3. Universities and Colleges- In General, most universities and some colleges have their own IRBs. Requirements among IRBs vary regarding external researchers who would like to recruit subjects from their populations or conduct research on their premises. Differences in requirements also occur depending on whether the UNCW researcher is collaborating with a researcher at the other institution.
         
         • Research Collaborations between UNCW Researchers and non-UNCW Researchers- When a UNCW researcher is collaborating on human subjects research with a colleague from another university or college with its own IRB, the IRB encourages both researchers to contact their home IRBs for guidance prior to duplicating application efforts. Depending on the circumstances, the two institutions may be able to agree that one of the IRBs will conduct the review of the study so that the review is as efficient as possible. This may be the best approach when both institutions determine that they are “engaged” in the research, based on the activities conducted by their respective employees. Usually, the IRB at the principal investigator’s institution will conduct a review on behalf of all other engaged institutions. When this agreement is reached, the principal investigator completes the application on behalf of the research team.
         • Non-collaborative Research Conducted at Other Universities by UNCW Researchers- When a UNCW researcher plans to recruit subjects from other universities or colleges and is not collaborating with colleagues at the other locations, the researcher should plan to submit an application through the UNCW OSPREY system, and contact the non-UNCW IRBs to determine their requirements, if any. Some IRBs require researchers to provide documentation of IRB approval from the principal investigator’s home institution, while other IRBs require researchers to submit applications through their IRB for additional approval.
           
           • If another university’s IRB requires documentation of UNCW IRB approval before it will provide its own approval to conduct the research, the researcher should notify the UNCW IRB. Once all aspects of an application are acceptable, other than providing documentation or permission from the non-UNCW IRBs, the UNCW IRB can issue a conditional approval letter to the researcher.
         • Accepted Documentation- A researcher who wishes to access another university’s population must abide by the requirements established by that university’s IRB. Once approval from the university’s IRB is obtained, the researcher must upload it to the Attachments section of their OSPREY application.
      4. Other Educational Institutions- Researchers who plan to conduct human subjects research at educational institutions that do not have Research Review Boards or IRBs must upload to the Attachments section of their OSPREY application documentation that they have obtained approval (consistent with sections IV.A.1 and IV.A.2 or 3 above) to conduct human subjects research from the highest-level administrator of the organization, such as the president or superintendent.
   3. Special Requirements for Medical Facilities with Their Own IRBs
      
      Researchers who intend to conduct research at medical facilities that have their own IRBs should first consult with the UNCW IRB to determine if application through the UNCW IRB is necessary. It is possible that the medical facility’s IRB will require the researcher to apply for approval through its IRB, and the UNCW IRB can likely arrange to defer to the IRB review conducted by the medical facility’s IRB.
      
      Specifically, the New Hanover Regional Medical Center’s IRB has jurisdiction for all research conducted at its medical center or any satellite facility or clinic owned by the organization. UNCW’s IRB has a standing agreement with the NHRMC IRB to defer to any review it conducts of research conducted by UNCW researchers.
   4. Special Requirements for Tribal Populations
      
      The UNCW IRB recognizes and respects the sovereignty of tribal nations to determine when research may be conducted with their people. When proposing to work within tribal boundaries, researchers must obtain permission from tribal governments (or those designated by tribal authorities) to conduct research on reservations. This usually requires permission from the tribal chairperson, or a tribal resolution approved by a convened tribal council.
5. Responsibilities
   • IRB Staff: Responsible for confirming that the researcher has submitted an acceptable letter of support or other authorization meeting the requirements of this SOP for studies that are subject to the requirement.
   • Principal Investigator: Responsible for obtaining and uploading an acceptable letter of support or other authorization meeting the requirements of this SOP for studies that are subject to the requirement.
6. Resources
   • UNCW IRB Website  
   • U.S. Department of Health & Human Services, Office of Human Research Protections website 
   • 45 CFR 46 (“Common Rule”)  
   • Belmont Report  
   • U.S. Department of Education, Family Educational Rights and Privacy Act (FERPA) Guidance 
   • U.S. Department of Health & Human Services, Office of Human Research Protections, Engagement of Institutions in Human Subjects Research Guidance

The purpose of this SOP is to describe the review process and requirements for research that will be conducted by UNCW researchers outside of the United States.

1. General Requirements
   
   The Institutional Review Board (IRB) will review human subjects research studies involving subjects enrolled at international sites by UNCW researchers to ensure that (1) the research complies with all federal regulations and UNCW IRB policy and procedures and (2) that local regulations governing human involvement in research are adequate to ensure proper protections for subjects. When the IRB determines that the research is exempt from the requirements of 45 CFR 46, the investigators are responsible for ensuring that research complies with local regulations and requirements.
2. Scope
   
   These policies and procedures apply to all human subjects research submitted to the IRB that is being conducted by UNCW researchers at an international location.
3. Applicable Definitions
   1. Ethics Committee
      
      A group of persons who have knowledge about the local laws and/or traditions/customs who are also responsible for ensuring the safety of subjects in proposed research projects.
   2. Personal Data
      
      Under the General Data Protection Regulation (GDPR), personal data means any information relating to an identified or identifiable natural person (‘data subject’).
      
      An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
4. Procedures
   1. Local Ethics Requirements
      
      In addition to the usual requirements for approval for research involving human subjects as outlined in SOPs 5.1, 5.2, and 5.3, when UNCW researchers will conduct or supervise research conducted outside the United States, the IRB staff will refer to the OHRP International Compilation of Human Research Protections website for the applicable country or countries to determine local requirements, if any, and will consider the following:
      
      1. Addressing the Needs, Issues or Benefits of the Local Community: The research protocol should generally be designed to address an issue characteristic of the local setting or conditions that affect the local setting, particularly in developing countries. If the research is greater than minimal risk, then the research should be designed to provide potential benefit to the subjects and/or to the local community. If a research study is not designed accordingly, the investigator should provide satisfactory justification as to why the study is proposed to be conducted in the given setting(s).
      2. Local Context: In an effort to gain knowledge of the local setting, the IRB should consider the most appropriate means of obtaining this information, including the experience of the UNCW investigator in working in the area or region and the investigator’s knowledge of the area or region as it relates to the research.
         • The type of research, level of risk, study population, location of the research, and whether collaborative efforts are involved are all factors that will affect the means of obtaining knowledge of the local setting. For international research studies that are greater than minimal risk, researchers should provide details of the local context within the protocol to provide a basis for the IRB review.
         • The IRB may obtain local knowledge from literature, documentation, or available written information or by the inclusion of a consultant knowledgeable of the local setting. For review of minimal risk studies, obtaining knowledge of the local setting by these means may be adequate.
         • For greater than minimal risk studies, consideration should be given to enhancing the local knowledge by obtaining review and approval from an ethical review committee that is local to the study site or has particular knowledge of the local setting. One source for identification of potential international ethical review committees or IRBs is the list of IRBs registered with ORHP.
      3. Approval by the Institution Where the Research Will be Conducted
         
         When the research will be conducted in an institution or organization such as a school, business, or hospital that is not otherwise involved in the research, a letter(s) of agreement should be submitted from the appropriate official(s) (e.g., government officials, school officials, community officials, chief executive officers, etc.) indicating that the research protocol, and any and all instruments to be used, have been reviewed and that the study is acceptable to be conducted in the institution or organization. The letter of agreement must be on letterhead stationery and carry an original signature or otherwise meet acceptable professional standards for a signed document.
         
      4. Informed Consent
         
         A process for obtaining consent that is appropriate given the local laws/customs/traditions.
         
         • Obtaining informed consent in accordance with 45 CFR 46 and 21 CFR 50 in certain international settings may raise challenges due to a difference in the norms of the host country. The process for obtaining and documenting informed consent must also comply with U.S. regulations and with UNCW IRB SOPs.
         • If the legal age of an adult differs in another country from state law (e.g., 18 years of age), the IRB should accept the local age of majority when considering who may provide their own consent.
      5. Translation
         
         When consent and recruitment documents have already been translated into a language other than English, the researcher must submit to the IRB a copy of the document in English and a copy in the language to be used in the foreign location.
         
         • The IRB may require the PI to submit a certification from an appropriate individual that the translated version of the document is complete and does not contain information that is not presented within the context of the approved English version of the document or may obtain its own certification.
         • When the UNCW IRB-approved informed consent document in the local language is reviewed by an international IRB or ethics committee, the UNCW IRB may choose to back-translate the local approved consent document into English by an appropriate individual who will certify that the resulting English version and the local consent document are consistent in content, style, and level of readability.
      6. Plan for Oversight of the Research
         
         The research study should provide a plan for oversight of the research that will be conducted in an international setting, particularly when the UNCW research staff will not be present at the foreign site.
      7. Reporting to the UNCW IRB
         
         The IRB will consider the appropriateness of the provisions for reporting unanticipated problems involving risks to subjects or others, complaints, and non-compliance to the UNCW IRB.
         
      8. Documentation of Local IRB or Ethics Committee Review and Approval
         
         The UNCW IRB will determine whether a local IRB or Ethics Committee review will be required for a given study. The UNCW IRB is more likely to require a local IRB or Ethics Committee to review research that is greater than minimal risk.
         
         When the UNCW IRB will serve as the designated IRB, the IRB will consider the appropriateness of the provisions for the UNCW researcher to ensure ongoing review and approval from the UNCW IRB when applicable.
         
         When applicable, there will be appropriate coordination and communication between the UNCW IRB and the local Research Ethics Committee.
         
         Investigators should recognize that international ethical review committees which are affiliated with an institution may not be willing to review research conducted by investigators outside their institution. Access to local ethical review committees may be facilitated when researchers collaborate with researchers at the local institution.
         
         The local ethical review committee or IRB should comply with the IRB composition requirements of 45 CFR 46.107 or 21 CFR 56.107, as applicable. In order to increase efficiency, review and approval by the local ethics committee or IRB should usually be obtained after review by the UNCW IRB or designated IRB on the FWA.
         
         If a review by a local human research ethics committee cannot be obtained for greater than minimal risk research, the IRB review must include consultation by an expert who is independent of the research team and is familiar with the local site’s culture and norms. The research team may refer such an individual to participate in the review by the convened UNCW IRB.
         
   2. International Data Protection Regulations
      
      Researchers planning to conduct human subjects research that involves obtaining or collecting identifiable data from subjects in countries that have privacy protection regulations in place (such as the General Data Protection Regulations or GDPR) may be subject to additional requirements to ensure compliance with those regulations. 
      
      
   3. General Data Protection Regulations
      
      These regulations apply to certain European Union and related countries and pertain to how “personal data” must be obtained, stored, and destroyed.
      
      
      1. The regulations do not apply to anonymous studies.
      2. The regulations do not apply to citizens of GDPR countries who are physically in the U.S. (but they begin to apply if a researcher continues to monitor those subjects who have returned to their home countries).
      3. The regulations do apply to subjects who are physically in countries subject to the GDPR, even though the researcher is collecting data remotely from the U.S.
      4. The IRB may require researchers to alter the usual consent requirements to ensure compliance with the GDPR.
      5. Data subjects have the right under the GDPR to have their data erased (“right to be forgotten”) that researchers must take into consideration.
      6. Researchers are encouraged to contact the Research Integrity Office prior to designing research that is subject to the GDPR.
   4. Other International Privacy Regulations
      
      IRB staff will assist to the extent possible in determining if privacy regulations apply to other non-U.S. locations. However, it is ultimately the PI’s responsibility to ensure that any local laws and regulations are met.
      
      
5. References to Other Applicable SOPs
   • Determinations of Exemption- SOP 5.1
   • Expedited Review of Research- SOP 5.2
   • Full Board Review of Research- SOP 5.3
   • Identification and Reporting of Adverse Events and Unanticipated Problems- SOP 6.7
   • Informed Consent- SOP 6.8
6. Responsibilities
   • IRB Co-chair:Responsible for reviewing submissions eligible for expedited review or selecting a designee and ensuring that local requirements for human subjects research are met.
   • IRB Staff: Responsible for processing and assisting the IRB reviewer with studies being conducted internationally.
   • Principal Investigator: Responsible for ascertaining and complying with all local requirements for the protection of human subjects research and for providing the IRB with relevant contact information, letters of support or other documentation to demonstrate that local requirements are met.
7. Resources
   • UNCW IRB Website 
   • U.S. Department of Health & Human Services, Office of Human Research Protections Guidance on International Research
   • 45 CFR 46 (“Common Rule”)
   • Belmont Report
   • International Compilation of Human Research Protections
   • GDPR 

The purpose of this SOP is to define different types of deception and clarify the procedures researchers must follow when using deception or incomplete disclosure in human subjects research.

1. General Requirements
   
   The UNCW IRB recognizes that the use of deception and/or incomplete disclosure as a methodology in human subjects research can be necessary to avoid study bias, particularly in human behavior studies, when a subject would be likely to alter his or her behavior if informed that the behavior is being studied. However, the use of deception and/or incomplete disclosure raises ethical concerns as it may interfere with the ability of a potential subject to give informed consent. The main consideration for IRBs in evaluating studies that involve the use of deception and/or incomplete disclosure is whether the committee has a reasonable expectation that subjects would still consent to participate in the study after the investigator informs them of the study methods that include deception and/or incomplete disclosure.
2. Scope
   
   This SOP pertains to all human subjects research conducted by UNCW investigators, including faculty, staff, and student investigators.
3. Applicable Definitions
   1. Deception
      
      Deception, as it applies to this SOP, is a research methodology that occurs when an investigator knowingly gives false or incomplete information (e.g., only part of the purpose of the study) to research subjects or intentionally misleads them about some key aspect of the research. The false, misleading, or incomplete information might relate to the purpose of the research, the role of the researcher or other participants, the true nature of the procedures to be followed, or other aspects of the study.
      
      Examples of deception include but are not limited to, providing subjects with a false or incomplete description of the purpose of the study, telling a subject he or she performed poorly on a quiz or game regardless of the subject’s actual performance, and the use of a “confederate” who poses as a research participant but is a member of the research team whose behavior is part of the experimental design.
   2. Incomplete Disclosure
      
      Incomplete disclosure, as it applies to this SOP, is a research methodology that occurs when an investigator withholds information about the specific purpose, nature, or other aspect of the study.
      
      An example of incomplete disclosure is an investigator instructing a subject to take a survey for research purposes, but the true research question pertains to how well subjects concentrate when there is background noise.
4. Procedures
   1. Level of Review
      1. When a human subjects study involves the use of deception, it may not be reviewed at the exempt level, even if all other aspects of the study qualify for an exemption.
      2. The IRB chair(s) will evaluate studies that involve a form of deception that is designed to intentionally invoke feelings of aggression, stress, anger, rejection, or other negative response to determine if it requires review by the full board.
      3. Studies involving deception that otherwise qualify for expedited review may be reviewed at the expedited level.\
      4. IRB chairs always have discretion to place a study on the full board agenda if they are not comfortable reviewing it at an expedited level.
   2. Justification
      1. The principal investigator (PI) must explain in detail in the IRB application the nature of the deception/incomplete disclosure.
      2. The PI must justify why this methodology is necessary to achieve the goals of the study.
   3. Informed Consent Procedures
      1. Purpose of Informed Consent
         1. The purpose of the informed consent process is to:
         2. provide subjects with pertinent information about certain aspects of the study so that they can decide if they want to participate in the research or not;
         3. to ensure that subjects understand the information provided, and;
         4. to document that subjects voluntarily agree to participate.
      2. False or Misleading Information Prohibited
         
         There are circumstances when it is necessary for the PI of a study to either vaguely describe or omit pertinent information about the research in order to avoid bias or altered behavior during participation. While it is acceptable for a PI to provide vague information about study activities on the consent form, the PI may not include false or misleading information about any aspect of the study. Specifically, the PI must fully explain study risks.
      3. Waiver of Consent
         
         When it is necessary for the PI to omit one or more required elements of informed consent (consistent with UNCW IRB policy 03.380 section VI.C.5.), the PI must request approval for a full or partial waiver of consent. The IRB must determine if the request for a waiver meets the criteria set forth in the regulations as applicable.
   4. Debriefing Procedures
      1. Preferably, debriefing occurs when an individual subject completes his or her participation in a research study.
      2. Delayed debriefing, for example, debriefing at the completion of the study, may be permitted if standard debriefing would compromise study results.
5. References to Other Applicable SOPs
   • Expedited Review of Research- SOP 5.2
   • Full Board Review of Research- SOP 5.3
   • Informed Consent- SOP 6.8
6. Responsibilites
   • IRB Co-chair: Responsible for determining the review level of IRB submissions involving the use of deception and/or incomplete disclosure.
   • IRB Staff: Responsible for interpreting federal regulations, UNCW policies, and Research Integrity SOPs and providing guidance to PIs on requirements.
   • Principal Investigator: Responsible for fully justifying any use of deception and/or incomplete disclosure and for submitting debriefing scripts, as applicable.
7. Resources
   • UNCW IRB Website  
   • U.S. Department of Health & Human Services, Office of Human Research Protections website 
   • 45 CFR 46 (“Common Rule”)  
   • Belmont Report

The purpose of this SOP is to outline the steps for identifying and reporting adverse events or unanticipated problems that occur during the course of conducting human subjects research.

1. General Requirements
   
   The identification, reporting, and review of unanticipated problems and adverse events must occur in a timely, meaningful way so that human subjects can be better protected from avoidable harms. Researchers and the IRB should keep in mind that the vast majority of “adverse events” (which are medical in nature) occurring in human subjects research are anticipated problems. In other words, they are known as possible risks of the research. Similarly, often unanticipated problems that are found are not also “adverse events” because they are not medical in nature.
2. Scope
   
   This SOP pertains to all human subjects research projects that do not qualify for exemption as allowed by 45 CFR 46.101 or as determined by the UNCW IRB.
3. Applicable Definitions
   1. Adverse Event
      
      An untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, physical or psychological, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
   2. Unanticipated Problem
      
      Any incident, experience, or outcome that is:
      
      1. Unexpected in terms of its nature, severity or frequency given the research procedures that are described in the protocol-related materials and the characteristics of the subject population being studied, and
      2. Is related or possibly related to participation in the research, and
      3. Suggests that the research places subjects or others at greater risk of harm (including physical, economic, or social harm) than was previously known or recognized.
4. Procedures
   1. The principal investigator (PI) of a human subjects research study:
      1. Must report serious adverse events that are also unanticipated problems to IRB staff immediately or as soon as possible.
      2. Must report adverse events that are not unanticipated problems during continuing review reporting (if applicable).
      3. Must report unanticipated problems that are not adverse events in a prompt manner, depending on the seriousness of the problem, and no later than two weeks from the PI becoming aware of the incident.
      4. Must provide the IRB with the IRB protocol number, a detailed description of the incident and outcome, and any corrective actions that were taken in response to the incident.
      5. May either contact the IRB office to informally report the incident and obtain guidance or may submit an Incident Report to the IRB via OSPREY to formally report the incident.
   2. If contacted for an informal report, IRB staff will help the PI determine if the incident is an adverse event and/or an unanticipated problem, a risk already identified as possible for the research, or some other unrelated problem.
      
      1. IRB staff may use the Unanticipated Problems and Adverse Events Worksheet (Appendix A) to assist the PI.
      2. If IRB staff believe the incident meets the definition of an adverse event that is also an unanticipated problem, the staff member will instruct the PI to submit the Incident Report as a formal report. IRB staff will request review by an IRB co-chair.
      3. If IRB staff believe the incident is an adverse event that is a known risk of the research and adequate information about the risk was provided to subjects during the informed consent process, therefore not an unanticipated problem, IRB staff will instruct the PI to submit an Incident Report in OSPREY and subsequently report the incident during the continuing review process (when applicable).
   3. When a suspected unanticipated problem is reported regarding a study subject to full board review, IRB staff will place the matter on the next full board meeting agenda, supply the facts of the incident to the committee along with the UP/AE Worksheet (Appendix A) and ask the committee to make a determination on the incident.
      1. If the committee determines that the incident meets all three criteria for an unanticipated problem, the IRB must report the incident within one month of receiving the report from the PI to the Institutional Official and OHRP (if federally funded). Otherwise, no further reporting is required.
   4. The IRB may consider the following actions in response to a report of an unanticipated problem or adverse event to eliminate or mitigate newly identified risks:
      
      1. Change the methods and procedures;
      2. Modify inclusion or exclusion criteria;
      3. Modify or add procedures to monitor subjects;
      4. Suspend enrollment of new subjects;
      5. Suspend research procedures for currently enrolled subjects;
      6. Revise informed consent documents;
      7. Provide additional information to previously enrolled subjects, and/or:
      8. In extreme cases, suspend or terminate study.
5. References to Other Applicable SOPs
   • Full Board Review of Research- SOP 5.3
   • Informed Consent- SOP 6.8
   • Findings of Non-compliance- SOP 11.1
6. Responsibilities
   • IRB Co-chair: Rresponsible for reviewing reports of adverse events and/or unanticipated problems and making determinations based on UNCW policy, SOPs, and OHRP guidance.
   • IRB Staff: Responsible for providing assistance to PIs in determining whether reporting to the IRB is needed, providing facts to the full board for reports that implicate a study subject to full board review, and assisting the IRB in determining further reporting responsibilities.
   • Principal Investigator: Rresponsible for promptly contacting the IRB when s/he learns of an incident that may be an adverse event and/or unanticipated problem, providing complete and accurate information to the IRB regarding the incident, complying with any requirements identified by the IRB to eliminate or mitigate newly identified risks to subjects. 
7. Resources
   • UNCW IRB Website  
   • U.S. Department of Health & Human Services, Office of Human Research Protections website 
   • 45 CFR 46 (“Common Rule”) 
   • Belmont Report

The purpose of this SOP is to describe requirements for researchers to obtain informed consent from human research subjects.

1. General Requirements
   
   It is the policy of University of North Carolina Wilmington (UNCW) that no one may involve a human being as a participant in non-exempt research or in a clinical investigation unless the investigator has obtained Institutional Review Board (IRB) approval and, when required by the IRB, that person’s legally effective informed consent.  The UNCW IRB may alter or waive the requirement of informed consent under the Department of Health and Human Services (DHHS) regulations governing human subject research [46.116(f)]. 
   
   If a study may enroll adult participants who are unable to consent for themselves, the investigator must describe in the submission for IRB approval the process of evaluating the individual’s capacity to provide consent, and if that capacity is lacking in a subject, must obtain informed consent from a legally authorized representative in accordance with State law.  If the participant is a minor, the investigator must describe the consent/assent process in accordance with federal and state law.
2. Scope
   
   This SOP pertains to all human subjects research projects that do not qualify for exemption as allowed by 45 CFR 46.101 or as determined by the UNCW IRB.
3. Applicable Definitions
   1. Assent
      
      An affirmation, verbally or non-verbally, to participate in research by an individual who cannot provide consent (i.e., children or incompetent participants). Mere failure to object should not, absent affirmative agreement, be construed as assent.
   2. Dissent
      
      An expressed desire, verbally or non-verbally, not to participate in the research by an individual who cannot provide consent (i.e., children or incompetent participants).
   3. Excuplatory Language
      
      [As considered by the Office for Human Research Participants (OHRP) and the Food and Drug Administration (FDA)] language, which has the general effect of freeing or appearing to free an individual or an entity from liability, malpractice, negligence, blame, fault, or guilt.
   4. Family Member
      
      Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
   5. Guardian
      
      An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
   6. Informed Consent
      
      An active and ongoing process by which a researcher:
      
      1. Discloses to potential research subjects information needed for them to make an informed decision about participating in a research study;
      2. Promotes the voluntariness of the decision to participate or not in the research study;
      3. Ensures that a subject understands the information that has been disclosed, and;
      4. Obtains documentation of agreement, usually on a written form.
   7. Legally Authorized Representative (LAR)
      
      An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
   8. Minors (Children)
      
      Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. North Carolina law defines a minor as a person under age 18.
   9. Parent
      
      A child's biological or adoptive parent.
   10. Permission
       
       The agreement of parent(s) or guardian to the participation of their child or ward in research.
   11. Ward
       
       A child who welfare is the responsibility of the State or other agency, institution, or entity.
4. Recruitment
   1. Since the informed consent process is considered to start with the recruitment process, the IRB also considers recruitment materials during its review of informed consent.
   2. The IRB will review proposed methods of recruitment and recruitment materials, to ensure that the process will be conducted in a manner that is ethical.
   3. Recruitment material may include flyers, recruitment letters, advertisements, television, or radio ads, and posting on social media, among other strategies.
   4. The IRB review of recruitment materials will ensure that benefits are not overstated or presented in a manner that may be coercive or pose undue influence over a subject’s decision-making process.
   5. For these reasons, the information provided in recruitment materials should be limited to information that will generate interest from the subject, determines their eligibility, and provide contact information for the research team. As relevant, the recruitment material may include following:
      1. an explanation of the purpose of the study;
      2. eligibility information (e.g., brief summary of the main inclusion/exclusion criteria);
      3. a summary or brief list of the benefits;
      4. the name of the researcher and/or research institution or facility;
      5. time or other commitments needed from the subjects;
      6. contact information for the research team.
   6. Advertisements must not:
      1. State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol
      2. Include exculpatory language;
      3. Promise “free treatment” when the intent is only to say subjects will not be charged for taking part in the investigation.
   7. If the recruitment material presents the amount of compensation offered for participation, the amount should not stand out more than the rest of the content in the recruitment material by increasing the font size, bold font, or brighter color.
   8. Only recruitment material that is presented directly to subjects needs review by the IRB. Materials or media coverage about the research that is intended for scientists, educators, health professionals or other individuals not targeted as subjects for the study do not need to be reviewed by the IRB.
5. Screening, Recruiting, or Determining Eligibility
   
   In accordance with 45 CFR 46.116(g), an IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorize representative, if either of the following conditions are met:
   
   1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
   2. The investigator is a UNCW researcher, not acting in their capacity as a private practice clinician (e.g., behavioral therapist, counselor, physician, etc.) who obtains identifiable private information or identifiable biospecimens by accessing the private clinic’s own standard practice (i.e., non-research) records or stored identifiable biospecimens. 
6. Payment/Compensation to Research Subjects
   1. Payment to research subjects may be an incentive for participation or a way to reimburse a participant for travel and other experiences incurred due to participation. However, payment for participation is not considered a research benefit.
   2. Regardless of the form of remuneration, PIs must consider the degree of risk and must exercise care to avoid undue influence for subjects to accept risks that they would not otherwise accept if there was no payment and must also avoid coercion of subjects. Payments should reflect the costs, inconvenience, or discomfort associated with participation or may be used to encourage participation in a study that is not generating interest as long as the payment, as previously stated would not cause undue influence.
   3. The IRB will review both the amount of payment and the proposed method of disbursement to assure that neither entails problems of coercion or undue influence. PIs may allow payment accrual as the study progresses. Payment can be contingent upon the participant completing the entire study, but this fact needs to be made known to the participant at the beginning of the study. If a bonus will be given for completion of the study, the bonus must be reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn; this also must be disclosed at the beginning of the study.
   4. The PI may not offer a “finder’s fee” to individuals such as professors or supervisors to refer prospective subjects when those individuals have a power relationship over the prospective participant. “Bonus payments” used to accelerate recruitment that is tied to the rate or timing of enrollment may not be paid to or accepted by PIs or research staff.
   5. The consent form must describe the terms of payment and the conditions under which subjects would receive partial payment or no payment (e.g., if they withdraw from the study before their participation is completed).
   6. If compensation in any form (e.g., cash, coupons, gift cards or certificates, vouchers) for payment is administered through UNCW, the expenditures of funds for this purpose must fall within all applicable Federal, State and institutional requirements. 
7. Procedures for Consent Process
   
   Informed Consent Process. The UNCW IRB must review the proposed consent process for non-exempt studies.  Investigators must seek consent under such circumstances that provide the prospective participant with sufficient time and opportunity to consider whether or not to participate.  The UNCW IRB’s evaluation of the investigator’s proposed participant selection/recruitment process and informed consent process will include the following four key features:
   1. completely disclosing all critical information needed for the potential research subjects to make an informed decision;
   2. ensure the subjects or their legally authorized representatives adequately understand what has been disclosed to them so they can make informed choices;
   3. promote the voluntariness of the decision about whether or not to participate in the research; and,
   4. consent with subjects is seen as an ongoing process, and not the reading of a stagnant document.
   Additionally, the IRB's evaluation will include:
   1. Considering the capacity of the participant to make an independent and voluntary informed decision whether or not to participate in a study.
   2. reviewing who will obtain consent and under what circumstances.
   3. Deciding whether and how consent will be documented.
8. Elements of the Informed Consent
   1. General Requirements
      1. The investigator must obtain a legally effective informed consent from the subject or the subject’s legally authorized representative prior to (prospectively) involving the human subject in research unless the IRB finds and documents that the informed consent can be waived in accordance with 45 CFR 46.116 (e) or (f).
      2. Investigator shall seek such consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
      3. The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the representative. Any informed consent document that is translated into another language must be approved by the IRB prior to its use. Regardless of the language in which the consent document is written, the document should be written at a reading level that would be understood by subjects (i.e., an 8th grade reading level).
      4. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate and an opportunity to discuss that information.
      5. Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. The concise and focused presentation of key information is not required for minimal risk studies with relatively short consent forms.
      6. Informed consent as a whole must present information in sufficient detail relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
      7. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
   2. Basic Elements of Informed Consent
      
      The following information must be provided to each subject:
      1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed and identification of any procedures which are experimental;
      2. A description of any reasonably foreseeable risks or discomforts to the subject;
      3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
      4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
      5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
         1. Statement(s) should be included to explain who has access to review the research records for inspectional purposes [e.g., UNCW, Food and Drug Administration (FDA) for FDA-regulated research and the Office for Human Research Protections (OHRP) for HHS-supported research];
         2. Additionally, for NIH-supported grants or contracts, language should be included to explain the protections provided by the Certificate of Confidentiality, which are automatically provided for all NIH grants (as of October 1, 2017). For non-NIH-supported grants, an explanation of the protections provided by a Certificate of Confidentiality should be included whenever one has been obtained for the study;
      6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
      7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and,
      8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
      9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
         1. A statement that the identifiers might be removed from the identifiable private information or identifiable private biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative if this might be a possibility; or
         2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
      10. Additional Elements of Informed Consent
          
          When appropriate, the following elements of information shall also be provided to each subject:
          
          1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
          2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative’s consent;
          3. Any additional costs to the subject that may result from participation in the research;
          4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
          5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
          6. The approximate number of subjects involved in the study;
          7. A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
          8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
          9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome of that specimen).
          10. For all clinical trials, the following statement will be included: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time." These statements are usually placed towards the beginning of the consent document after the Purpose section.
          11. An explanation of any payments or compensation to subjects as a result of participation, including any reporting to the Internal Revenue Service (IRS) as a result of the payment (e.g., $600 or more in total payments will result in a Form 1099 be filed to IRS along with the subject’s social security number, name, and address);
          12. For studies involving audio and/or video recordings, an explanation of the use and storage of such recordings and how confidentiality will be protected
      11. Additional Considerations for Studies Collecting Protected Health Information (PHI)
          1. Collecting health information directly from subjects requires no special procedures. Subjects must be fully informed as usual during the informed consent process of:
             1. the research activities in which they are asked to participate;
             2. any sensitive and/or private information will be collected from them during the study; and
             3. how that sensitive and/or private information will be protected.
          2. If an investigator must obtain protected health information (PHI) directly from a healthcare facility that is considered a covered entity under Health Insurance Portability and Accountability Act of 1996 (HIPAA), the covered entity is responsible for ensuring that they have obtained authorization from their patients to release the PHI to the UNCW investigator. UNCW investigators must check with the covered entity to determine if they use a specific authorization template and must follow the covered entity’s procedures for obtaining HIPAA authorization.
      12. UNCW Procedure
          1. The written consent form should identify the association with UNCW either in a letterhead or within the text of the informed consent.
          2. Researchers may submit for approval by the IRB:
             1. A consent form based on a UNCW Informed Consent Form Template and/or Assent/Permission Form Template (available on the IRB website).
             2. An alternate consent format, provided the researcher also submit to the IRB a completed UNCW Informed Consent Checklist (available on the IRB website) to demonstrate that all required elements of informed consent were included.
          3. Documentation of Informed Consent Process
             
             Informed consent will be documented by the use of a written consent form, except as provided in 45 CFR 46.117(c) and 21 CFR 56.109(c) and as described further below.
             
             1. The informed consent process and documentation must be approved by the IRB before use.
             2. Once approved by the IRB, informed consent/assent/permission documents are stamped, initialed, and dated with an expiration date (when applicable).
             3. IRB staff attach a PDF copy of the official stamped and approved copy of the consent/assent/permission form to the OSPREY approval letter sent to the PI of the research study.
             4. Researchers must use the approved document when obtaining consent/assent/permission from subjects/LARs. The consent/assent/permission form will be signed (including in an electronic format) and dated by the subject or the subject’s legally authorized representative at the time of consent.
             5. Researchers must give a copy of the approved consent form to each participant/LAR for his/her records, unless the need to waive this requirement is sufficiently justified by the researcher and approved by the IRB.
             6. When the study is FDA-regulated, subjects/LARs must receive a fully signed copy of the consent form. Otherwise, the copy retained by subjects/LARs can be unsigned.
             7. Researchers must inform subjects/LARs if there are any changes or new information available that may alter the subject’s willingness to participate in the project.
             8. The form may be read to the subject or the subject’s legally authorized representative.
             9. Either the subject or the representative will be given adequate opportunity to read it before it is signed.
             10. For greater than minimal risk research, in addition to having the signed consent form serve as documentation that the consent was obtained, the PI, or delegate, should also document a summary of the consent process. The summary should include details of how others may have participated in the consent process or if there were any controverted issues discussed (e.g., include details of who translated the discussion into another language if the subject is a non-English speaking subject, or who served as a legally authorized representative if the subject was a minor or lacked capacity, etc.).
          4. Translation of Informed Consent for Non-English-Speaking Subjects
             
             1. General Requirements
                1. If a researcher will use an informed consent/assent/permission document written in a language other than English, the researcher must submit to the IRB copies of the document in the foreign language along with an English translation. The IRB may seek guidance from an appropriate consultant to confirm that the translation accurately captures the nuances of the consent message.
                2. If the IRB, during its review of the submission, determines that it is likely that non-English speaking subjects will be enrolled, the IRB may request a translated consent/assent/permission form(s).
                3. The informed consent should be obtained in a language understandable to the subject or the authorized representative. It is expected that the PIs will assess the comprehension and capacity of the subjects to understand the consent language.
                4. The investigator, IRB, and UNCW are all responsible for ensuring legally effective consent/assent/permission. Therefore, the translation of the IRB-approved English version of the consent materials must be translated in a manner that the investigator and IRB have confidence that the translation effectively communicates the content and tone of the English version of the consent/assent/permission form. Appropriate sources of translation include:
                   • A company or organization that provides translations as a service to the public;
                   • An individual who is fluent in both English and the anticipated language of the non-English-speaking subject;
                   • A sponsor, such as NIH or a medical device manufacturer.
                   • For greater than minimal risk studies, the IRB may require a back-translation from another individual who is fluent in both languages to help ensuree correct translation.
             2. Short Form
                1. The regulations permit the use of a short form written consent document, typically for clinical trials when time is of the essence to enroll subjects. A short form document may be used only when:
                   • non-English speakers are recruited
                   • a subject is eligible but speaks a language that was not expected at the time of the last IRB review of the study
                   • time does not permit for the review and approval of a translated “long-form” version of the consent
                2. Documentation of consent must include:
                   • both versions of the consent form and translator information
                   • a statement that all required elements of the informed consent were presented orally to the subject or the subject's legally authorized representative.
                3. For greater than minimal risk studies, the consent process must involve a witness.
                4. If required by the IRB, the consent process must include a certified translator.
             3. Assent and Permission Requirements for Research Involving Minors
                
                1. Permission from Parent or Guardian
                   • A parent or guardian must give permission for a minor to participate in research unless in rare circumstances this requirement is specifically waived by the IRB in accordance with 45 CFR §46.408(c). The IRB has the authority to require researchers to obtain permission from both parents of a subject if the situation warrants this approach.
                2. Assent from Minors
                   • Minors must assent to participate in the research beginning at age 5 unless the IRB finds the subjects are unable to do so due to a disability or other factor. When minors are younger than age 5, researchers may request on the application to conduct human subjects research an alteration of the standard process as described below to seek permission from a parent/guardian without obtaining assent from minors.
                3. Waiving Parental Permission Requirement for University Students
                   
                   • Researchers conducting research on UNCW students may request that the IRB waive the parental permission requirement for minors who are enrolled as regular UNCW students and have not yet reached the age of 18. Researchers should refer to the instructions provided in section I below. This option is not allowable for Isaac Bear Early College students, as they are not regularly enrolled as UNCW students.
                4. Documentation of Assent/Permission
                   
                   • The standard assent/permission process is to provide parents/guardians with a permission form and minors with an assent form. Researchers may use a combined assent/permission form with two signature sections or use two separate forms. Researchers must justify deviations from the standard process on the application to conduct human subjects research.
                5. Assent Variations Due to Age of Subject
                   1. Assent forms or assent sections on permission forms must be written in language appropriate to the age and maturity of the subjects.
                   2. Obtaining assent and documenting assent are two separate processes.
                      1. When minors aged 5-6 are involved in research, the IRB views verbal agreement as sufficient. Researchers must request an alteration of the standard process for documenting assent on the application to conduct human subjects research and must submit the assent script that will be read to subjects to the IRB for approval.
                      2. When minors aged 7 and over are involved in the research, researchers must follow the standard process unless this requirement is specifically waived by the IRB.
                6. Waivers of the Consent/Assent/Permission Requirement
                   1. General Requirements- Under 45 CFR 46.116(f) the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met:
                      1. the research could not practicably be carried out without the waiver or alteration;
                      2. the research involves no more than minimal risk to the subjects;
                      3. if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
                      4. the waiver or alteration will not adversely affect the rights and welfare of the subjects; and
                      5. whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
                   2. Procedures for Requesting Waivers for 17-Year-Old UNCW students - Researchers who are conducting research on UNCW students whose population may include regularly enrolled students who have not yet reached the age of 18 may request a waiver of the parental permission requirement pursuant to 45 CFR 46.408 and 45 CFR 46.116(e). Researchers should provide sufficient justification for this waiver (i.e., regularly enrolled college students are expected to be treated and conduct themselves as adults, and it would be inconsistent with the Belmont Report to disrespect this population by either omitting them from the study or seeking their parent’s permission for their participation).
                   3. Waiver of Documentation of Consent – Verbal Consent - The IRB may waive the requirement for the investigator to obtain a signed consent form (i.e., waiver of the documentation of consent) for some or all subjects in accordance with 45 CFR 46.117(c). The IRB may approve the verbal consent process with or without a summary information sheet that will be handed to subjects, depending on the requirements for consent made by the IRB for a given study. The IRB may waive the requirement only if it finds any of the following:
                      1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern. This waiver criteria cannot be applied to FDA significant risk regulated studies; or
                      2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context; or
                      3. If the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate mechanism for documenting that informed consent was obtained.
9. References to Other Applicable SOPs
   • Exempt Review of Research- SOP 5.1
   • Expedited Review of Research - SOP 5.2
   • Full Board Review of Research - SOP 5.3
   • Training Requirements - SOP 6.1
   • Use of Deception in Research - SOP 6.6
10. Responsibilities
    • IRB Co-chair: Responsible for reviewing non-exempt application to conduct human subjects research, including review of consent/assent/permission forms to ensure that the process, forms and documentation are consistent with UNCW policy, SOPs and 45 CRF §46.116, §46.117, and §46.408, as applicable.
    • IRB Staff: Responsible for conducting initial reviews of new applications, including an initial review of any consent/assent/permission forms to ensure they include all required elements of informed consent and are consistent with UNCW policies and SOPs, and providing guidance to researchers on informed consent requirements.
    • Principal Investigator: Responsible for submitting applications to conduct human subjects research to the IRB, including consent/assent/permission forms as appropriate, and a completed Informed Consent Checklist if an alternate consent format is used. Responsible for conducting an active informed consent process that meets the requirements of UNCW policy, SOPs, and 45 CRF §46.116, §46.117, and §46.408, as applicable.  
11. Resources
    • U.S. Department of Health & Human Services, Office of Human Research
    • Protections Informed Consent FAQs
    • UNCW IRB Website
    • U.S. Department of Health & Human Services, Office of Human Research Protections website
    • 45 CFR 46 (Common Rule)
    • Belmont Report

The purpose of this SOP is to outline additional regulatory requirements when a study is sponsored or funded by the Department of Defense.

1. General Requirements
   
   Research sponsored by the Department of Defense (DoD) involving collaboration with DoD or involving DoD facilities or personnel (military or civilian), is subject to additional special requirements to enhance the protection of human subjects. These requirements include special protections for research participants as well as additional review and reporting requirements for the investigator and IRBs. Investigators must be aware of these special requirements when planning a research project as they may add a significant amount of time to the human subjects review and approval process throughout the research. Each DoD Component may have additional requirements beyond those included in this guidance document. PIs are advised to check with their program manager with the sponsoring Component about any additional requirements.
2. Scope
   
   This SOP is specific to research that is sponsored or funded by the Department of Defense, including the separate components, the Army, Navy, Air Force and Marine Corps, or recruitment of DoD personnel requires compliance with additional federal regulations, Directives and Instructions. This procedure applies to human subject research that is funded by any DOD component or that recruits participants from the DoD.
3. Applicable Definitions
   
   Continuing non-compliance: A pattern of noncompliance that suggests the likelihood that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply, or a persistent lack of knowledge of how to comply with the DoD Instructions 3216.02.
   
   Minimal risk: When following Department of Defense regulations: The definition of minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in everyday life. For example, the risks imposed in certain work environments (emergency responder, pilot soldier in a combat zone) or with certain medical conditions (frequent medical tests or constant pain).
   
   Non compliance: Failure of a person, group, or institution to act in accordance with DoD Instruction 3216.02
   
   Research Involving a Human Being as an Experimental Subject: An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32 CFR 219.103(f) reference (c)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose. Research involving a human being as an experimental subject is a subset of research involving human subjects. The definition relates only to the application of Section 980 of Title 10, U.S.C. as implemented by DoDI 3216.02, paragraph 3.11.; it does not affect the application of Part 219 of Title 32 CFR.
   
   Large Scale Genomic Data (LSGD): Data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. Research involving LSGD may or may not also constitute HSR. Examples of research involving LSGD includes, but is not limited to, projects that involve generating the whole genome sequence data for more than one gene from more than 1,000 individuals or analyzing 100 or more genetic variants in more than 1,000 individuals.
   
   Serious Non-Compliance: Failure of a person, group, or institution to act in a manner such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.
4. Special Requirements for IRB Review of DoD Research
   1. Required Education- Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support, or manage human research supported by the DoD or its components. UNCW requires that individuals conducting human subjects research complete a module on Human Subjects Protection. If research involving a DoD component requires more frequent or other training requirements in addition to those that UNCW requires, the investigator will be responsible for ensuring that the training is completed for those involved in the conduct of the research. Researchers should contact the human research protection officer of the DoD component for their education requirements and obtain documentation confirming the requirements. 
   2. Scientific Merit Review- New research and substantive modifications to approved research must undergo scientific review by a qualified departmental reviewer (department chair or other qualified reviewer) prior to IRB review. Investigators conducting research subject to this SOP must upload a certification form completed by the qualified reviewer in the Supporting Documents section of the IRB application. The qualified reviewer must have sufficient knowledge in the scientific area to be able to determine merit, must not be a member of the research team for the project, and must not have any other conflicting interest in reviewing the project. See Appendix A for the required scientific merit certification form.
   3. Surveys- Research involving surveys or interviews with DoD personnel (military or civilian) or their families may require DoD approval. Check with your DoD component regarding any additional review requirements and the timing of the review (before or after IRB review). Provide documentation of this review to the IRB.
   4. International Research- When DoD-sponsored research involves human subjects who are not U.S. citizens or DoD personnel and the research is conducted outside the United States, and its territories, the Principal Investigator must obtain permission from the host country.  The laws, customs, regulations, and practices of the host country and those required by UNCW IRB will be followed.  An ethics review by the host country, or local DoD IRB with host country representation is required.  Evidence of permission to conduct the research in the host country by certification or local ethics review must be submitted prior to initiation of the project.
   5. Collaborations with Other Institutions- When a UNCW investigator is the lead for a multi-centered study, an agreement or statement of work with all collaborating sites must be executed which outlines each site’s responsibilities. The use of a Single IRB will be required in accordance with 32 CFR 219.114. If a DoD Institution believes that the research is not subject to those provisions, the applicable DoD Component Office of Human Research Protections may determine and document, that use of a single IRB is not appropriate for the particular context of the proposed human subject research. Studies already in progress before January 20, 2020 are not required to transition to a single IRB, nor request an exception.
   6. Compliance Checklist- Investigators conducting research subject to the SOP must upload a completed compliance checklist in the Supporting Documents section of the IRB application to document that all special considerations for DoD-related research have been met. See Appendix B for the required checklist.
5. Consent Issues
   
   1. Consent Language Requirement- The consent must include: 1) a statement that the DoD or a DoD organization is funding the study; and 2) a statement that representatives of the DoD are authorized to review research records.
      • If the research includes any risks to fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about the risks for the revocation of clearance, credentials, or other privileged access or duty, and that command or Component guidance should be sought before agreeing to participate.
   2. Limitations on Waivers of Informed Consent- The requirement to obtain consent cannot be waived for any research using DoD funds and meeting the definition of Research Involving a Human Being as an Experimental Subject. This places limitations on research involving deception, decisionally impaired individuals, or research being conducted under emergency conditions where the subject may not be able to provide consent.
      
      • This statute applies only to certain intervention studies. It does not apply to retrospective research involving analysis of data or specimens, observational studies, blood draws, or tissue collection, and does NOT apply to screening of records to identify possible subjects. The IRB may grant a waiver of consent for such activities.
      • The Secretary of Defense may waive this consent requirement for a specific project in order to advance the development of a medical product necessary to the Armed Forces, but only if the research may directly benefit the subject and the research is carried out in accord with all other applicable laws and regulations.
   3. Consent by Legally Authorized Representatives- Informed consent may be provided by a legally authorized representative (LAR) only if: (1) the subjects lack decision-making capacity; and (2) the IRB has determined that the research is intended to be beneficial to the individual subjects.
   4. Subject Injury- For more than minimal risk research, the informed consent document must provide information regarding payment of medical expenses, provision of medical care, or compensation for research-related injuries, consistent with the requirements of the Common Rule.
   5. Emergency Medicine Research- When conducting emergency medicine research, the investigator must obtain approval from the DOHRP on behalf of the Secretary of Defense for a waiver of the advance informed consent provision of 10 USC 980.
6. Research Involving Department of Defense Personnel
   1. Military Participants
      1. Adult Status- All active-duty service members and reserve component members are considered to be adults for the purpose of participating in DoD-conducted or supported research.
      2. Command Approval- Command approval may be required for military personnel to participate in human subjects research as some types of research could impact a soldier’s readiness in the field. Investigators may be asked to provide documentation of Command approval as part of the IRB review.
      3. Protection of Service Members from Undue Influence- Officers and senior non-commissioned officers may not influence the decision of subordinates to participate in human subjects research and may not be present at the time of recruitment. Superior officers must be recruited in a separate session from subordinates.
      4. Appointment of Ombudsman- For more than minimal risk research and where recruitment is conducted in a group setting, an ombudsman must be present to ensure that information is clearly, accurately, and adequately presented and that the voluntary nature of participation is emphasized. The ombudsman must not have a conflict of interest or be part of the study team and should be able to address questions or concerns about participation. For minimal risk studies, the IRB has discretion regarding appointment of an ombudsman.
      5. Large Scale Genomic Data- When research involves large scale genomic data (LSGD) collected on DOD-affiliated personnel, additional protections are required:
         • Additional administrative, technical, and physical safeguards to prevent disclosure of DoD affiliated personnel’s genomic data commensurate with risk (including secondary use or sharing of de-identified data or specimens)
         • The study team will apply for an HHS Certificate of Confidentiality.
         • The research is subject to DoD Component security review and DOHRP approval.
   2. DoD Civilian Personnel - DoD civilian personnel that are recruited into research are afforded the same protections as military personnel.
   3. Limitations on Compensation- Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with Title 5, U.S.C., with particular reference to Subparts G and H, with some exceptions for purposes consistent with Section 30 of Title 24, U.S.C.
      The following limitations on dual compensation for U.S. military personnel apply for DoD funded research:
      1. An individual may not receive pay from more than one position for more than 40 hours of work in one calendar week. This limitation on dual compensation includes temporary, part-time, and intermittent appointments.
      2. On-duty federal personnel including military members:
         • Up to $50 for blood draws;
         • Compensation is not allowed for general research participation.
      3. Off-duty federal personnel including military members:
         • Up to $50 for blood draws;
         • Compensation is allowed for general research participation, as approved by the IRB. Payment many not come directly from a federal source. Payment from a federal contractor or non-federal source is permissible.
      4. Non-federal personnel:
         • Up to $50 for blood draws;
         • Compensation is allowed for general research participation, as approved by the IRB. Payment may come from a federal or non-federal source.
7. Vulnerable Populations
   1. Research with Minors- For purposes of legal capacity to participate in DoD-conducted or supported research involving human subjects, all Service members and all Reserve Component and National Guard members in a Federal duty status are considered for the purpose of DoD Instruction 3216.02 to be adults. If a Service member, Reserve Component or National Guard member in a federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB shall carefully consider the recruitment process and the necessity to include such members as human subjects.
      • The exemption at 45 CFR 46.104 (d) (2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed (See 32 CFR 219.101).
   2. Research with Prisoners
      1. Captured or detained personnel: The DOD Directive 3216.02 (section 3.9) prohibits research involving prisoners of war. This includes any person captured, detained, held, or otherwise under the control of DOD personnel (military and civilian or contractor employees). Such persons include enemy prisoners of war, civilian internees, detained persons, lawful and unlawful enemy combatants. Such persons do not include DOD personnel being held for law enforcement purposes.
         • This prohibition does not apply to research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition.
      2. DoD funded research involving prisoners cannot be expedited.
         
         In addition to the allowable categories of research on prisoners in 45 CFR Part 46, Subpart C, two additional categories are permissible:
         1. Epidemiological research is allowable when 1) The research describes the prevalence or incidence of a disease by identifying all cases or studies the potential risk factor associations for a disease; 2) The research presents no more than minimal risk; 3) The research presents no more than an inconvenience to the participant; 4) Prisoners are not a particular focus of the research.
         2. Human subject research that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB and must meet the requirements in Subpart C of 45 CFR 46
      3. If a participant becomes a prisoner, if the researcher asserts to the IRB that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, the IRB chair may determine that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, until the convened IRB can review this request to approve a change in the research protocol and until the organizational official and DoD component office review the IRB’s approval to change the research protocol.
   3. Pregnant Women
      • For the purposes of applying 45 CFR Part 46, Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.”
      • The applicability of Subpart B is limited to research involving pregnant women in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
8. Reporting Requirements for Investigators and IRBs
   
   Investigators
   1. Investigators conducting DoD funded research must promptly report (within 5 business days of completion of report) to the DoD Human Research Protection Officials (HRPO):
      • any unanticipated problem involving risks to subjects or others
      • suspension or termination of IRB approval
      • any serious or continuing noncompliance pertaining to DoD-supported human subjects research
      • substantiated allegations related to classified HSR
   2. Investigators conducting DoD funded research must promptly report (within 30 days) to the DoD HRPO:
      • The results of the IRB continuing review
      • Change of reviewing IRB
      • Closure of a study
      • Changes to key investigators or institutions
      • Decreased benefit or increased risk to subjects in greater than minimal risk research
      • Transfer of human subject research oversight to a different IRB
      • Addition of vulnerable populations or DoD-affiliated personnel as subjects
      • Change in status when a previously enrolled subject meets the criteria for Subpart B or C and the protocol was not reviewed and approved by the IRB under those Subparts.
   Prompt Reporting Required
   
   The IRB must promptly report (within 5 days) to the DoD research protection officer when they are notified by any Federal department, agency or national organization that any part of the human research protection program is under for cause investigation of a research protocol involving a DoD support. 
   
   Audit Reports
   
   Reports of audits of DoD-conducted or DoD-supported human participants research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government will be promptly reported (within 5 business days of discovering that such an audit report exists) to the DOHRP.
   
   Records Review
   
   Records maintained that document compliance or noncompliance with DoD requirements shall be made accessible for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner as determined by the supporting DoD Component.
9. Chemical or Biological Agents
   
   Human participant research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving HSR can begin, explicit written approval must be obtained from the DoD Office for Human Research Protections (DOHRP).
   
10. Related SOPs
    • Full Board Review Procedures- SOP 5.3
    • IRB Continuing Review of Research- SOP 6.11
11. Responsibilities
    1. IRB Staff: Responsible for reviewing applications to determine if the additional requirements regarding DoD supported research are applicable.
    2. Principal Investigators: Responsible for complying with the additional requirements set forth in DoD regulations and Instructions. Responsible for seeking final approval from the appropriate DoD Component prior to research beginning.
12. Resources
    • 32 CFR 219 Department of Defense Protection of Human Subjects
    • DoD Directive 3216.02
    • Title 10 USC Section 980 Limitation on Use of Humans as Experimental Subjects
    • SECNAV Instruction 3900.39D
    • SECNAV Instruction 5300.8B

The purpose of this SOP is to guide the UNCW IRB to appropriately consider and apply Food and Drug Administration (FDA) regulatory requirements for the review of human research that is regulated by the FDA.

1. General Information
   
   The IRB must ensure that research studies involving clinical trials and medical devices intended for human use are safe and effective, and designed to be in compliance with FDA regulations.
   
   The IRB must ensure that any FDA-regulated study it reviews is planned in a manner that it will comply with 21 CFR Parts 50, 54, 56, 312, 600, and 812.
   
   These procedures supplement the Institutional Review Board Policy (the “Policy”).
2. Definitions
   
   All terms used in these procedures have the same meaning set forth in the Policy unless otherwise defined in these procedures.
   
   1. Clinical trial/Clinical investigation – A subset of human subjects research.
      1. FDA defines clinical investigation as any experiment that involves a test article and one or more human subjects.
      2. NIH defines clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
   2. Premarket approval (PMA) – a review of safety and effectiveness by the FDA before a product can be marketed
   3. Immediately life-threatening disease or condition - a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
   4. Investigational new drug (IND) - a new or biological drug used in a clinical investigation.
   5. Investigational new device (IDE) – a device, including transitional device, is the object of investigation
   6. Medical Device - an instrument, apparatus, implement, machine, contrivance (the thing that causes something to happen), implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
      • Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
      • Intended for the use in the diagnosis of disease or other condition or in the cure, mitigation, treatment, or prevention of disease, or
      • Intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
      • The term “device” does not include software functions excluded pursuant to section 520(o).
        
        
        Examples of medical devices include:
      • Simple items - tongue depressors
      • Complex technologies – pacemakers
      • Diagnostic products - in vitro diagnostic reagents, pregnancy test kits, imaging systems such as magnetic resonance imaging (MRI)
   7. Serious disease or condition - a disease or condition associated with morbidity that has substantial impact on day-to-day functioning.
   8. Significant Risk (SR) – investigational device that:
      • is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
      • is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
      • is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject;
      • otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
   9. Test Article – means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA.
3. Procedures
   1. Review of Initial Submission
      1. IRB staff will conduct a pre-review of all submissions to determine that the IRB receives the necessary information to make all determinations required by FDA regulations and these and other IRB SOPs. Any submission that involves a clinical investigation with one or more human subjects with a test article (e.g., investigational or FDA-approved) will be documented as an FDA-regulated study by the IRB staff.
      2. The following categories of clinical investigations are exempt from the requirements for prior IRB review and approval:
         1. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article is subject to IRB review.
         2. Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
      3. During the IRB pre-review process, IRB staff will ensure that the appropriate regulatory status of any device used in the proposed research is clearly documented in the materials submitted for IRB review (checking if IDE has already been obtained or if N/A, checking if significant risk or not significant risk, etc.).
         1. For FDA-approved devices the device manual will be required.
         2. For investigational device, one of the following will be required:
            1. An approved IDE#, appearing on the sponsor’s protocol, the Device Manual, and/or the IDE letter from FDA.
            2. The sponsor’s or investigator’s (in an investigator-initiated study) letter to the FDA for submission of an IDE application. Regarding this option, final approval of a study cannot be granted by the IRB until 30 days have passed from the date of submission to the FDA, and there has been no notice from FDA of a hold placed on the device.
            3. An explanation and justification from the sponsor/investigator that the device is a Not-Significant Risk device, and an IDE is not required (investigators are strongly encouraged to consult with FDA for an official determination).
   2. Investigational Devices
      1. IRB staff will help the IRB confirm the regulatory status of the device, the potential risks to subjects, and determine if review by the convened IRB is required.
      2. The IRB will determine and document that the use of the device in the study falls into one of the following categories:
         1. Significant Risk (SR) – The sponsor is responsible for making the initial risk determination. The PI should submit a copy of the sponsor’s risk assessment and the rationale used for making the SR/NSR determination. The determination must also be made by the convened IRB, if not previously made by FDA for the indication of the device used in the proposed study.
         2. Non-Significant Risk (NSR) - an investigational device that does not meet the definition of a significant risk device.
      3. Exempt studies (exempt from requirements of 21 CFR 812).
         1. A legally marketed device used in accordance with its labeling.
         2. Diagnostic device studies (g. in vitro diagnostic study) if the testing:
            1. Is noninvasive;
            2. Does not require an invasive sampling procedure that presents significant risk;
            3. Does not by design or intention introduce energy into a subject;
            4. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure;
            5. Consumer preference testing, testing of a modification, or testing of a combination of devices, if all are legally marketed devices;
            6. Device intended solely for veterinary use;
            7. Device shipped solely for research with laboratory animals and contains the label "CAUTION - Device for investigational use in laboratory animals or other tests that do not involve human subjects.
      4. The IRB will complete the IRB Investigational Device Risk Determination checklist during the initial review.
         1. the risk determination will be documented in the IRB meeting minutes.
         2. The risk determination checklist will be filed in OSPREY.
            1. Document the IRB’s reason for its SR or NSR determination.
            2. Document that a copy of the SR IDE approval or conditional approval letter from the FDA was submitted to the IRB or a copy of the NSR letter from FDA or sponsor was provided, as applicable.
      5. If the IRB finds that the device poses an NSR, the sponsor does not need to submit an IDE to the FDA. The FDA considers an NSR study to have an approved IDE after IRB approval and when sponsor meets the abbreviated requirements at 21 CFR 812.2 (b) and informed consent requirements.
      6. Review by the Convened IRB.
         1. If the investigational device is determined to not meet the exemption criteria (and again the research involves the evaluation of the safety and effectiveness of the device) and FDA has not already made an NSR determination, the convened IRB must review the study and determine whether the device is considered to be an SR or an NSR device in accordance with 21 CFR 812 and FDA’s guidance, “ Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies.”
         2. If the convened IRB determines that the device is a significant risk (SR) device, then an IDE must be approved by the FDA before the IRB may proceed with approval of the study (or at least approval of the portion of the study that will involve the device).
         3. If an IDE must be approved by the FDA, the PI will be informed in writing and instructed to inform the sponsor of the SR determination (if applicable).
         4. The review of the device by the convened IRB and the determination of either a SR or NSR device will be documented in the minutes.
         5. These determinations will be made in addition to the overall risk determination of the protocol of minimal risk or greater than minimal risk.
         6. If the IRB determines the device to be an NSR device and the overall risk in the study to be minimal risk, the convened IRB may determine whether the continuing review may be done by expedited If such a determination is made, it will be documented in the meeting minutes.
         7. If the FDA has not made the risk determination or the IRB disagrees with the NSR determination made by the sponsor; the IRB will notify the investigator and where appropriate, the sponsor in writing that the study involves a significant risk device (SR).
         8. If the sponsor or the IRB needs assistance with making the SR/NSR determination, a written determination from the FDA may be obtained.
      7. Other Considerations Involving Clinical Investigations with Devices
         1. The IRB will also review the investigator’s plan on how the device (whether investigational or FDA-approved) will be supplied, stored, utilized in the study, and whether any special handling of the device is required.
            1. The plan must ensure that the integrity, quality, and sterility of the device will not be compromised during the storage process. For example, if temperature controls are needed to maintain the stability of the device, the plan must document how the device will be stored accordingly.
            2. The plan should also describe how device accountability will be maintained (who will be responsible for the storage, distribution, and record-keeping of the device).
         2. If the device is implanted or otherwise requires sterilization and does not come in a sterilized package, the autoclaving of the device (or other sterilization technique that will be used) should be described in the plan.
4. Compliance with Good Clinical Practice (GCP)
   
   All FDA-regulated research and NIH-supported clinical trials involving investigational drugs, devices, or biologics must comply with the International Conference for Harmonization (ICH) E-6 R2 Good Clinical Practice (GCP) Guidelines, to the extent that the GCP standards apply to the research study.
   
   Additionally, it is recommended that all biomedical research complies with these GCP standards to the extent that the standards apply to the research.
   1. In accordance with this guidance, the IRB should obtain the following documents:
      1. Trial protocol(s)/amendment(s);
      2. Written informed consent form(s);
      3. Informed consent form;
      4. Updates that the investigator proposes for use in the trial;
      5. Subject recruitment procedures (e.g., advertisements);
      6. Written information to be provided to subjects;
      7. Investigator’s Brochure (IB);
      8. Available safety information;
      9. Information about payments and compensation available to subjects;
      10. The investigator’s current curriculum vitae and/or other documentation evidencing qualifications and any other documents that the IRB may require to fulfill its responsibilities.
   2. Any investigator conducting an NIH-supported clinical trial must complete GCP training and provide a copy of the certificate to the IRB.
5. Applicable SOPs
   

   Full Board Review of Research- SOP 5.3
   
   Identification and Reporting of Adverse Events and Unanticipated Problems- SOP 6.7
   
   Informed Consent- SOP 6.8

6. Responsbilities
   1. IRB: Responsible for reviewing submissions subject to FDA regulations and determining if device poses significant or not significant risk to subjects.
   2. IRB Staff: Responsible for conducting initial reviews of submissions subject to FDA regulations and guiding researchers on requirements.
   3. Principal Investigator: Responsible for submitting requests for approval on studies subject to FDA approval in accordance with FDA regulations and this SOP.
7. Resources
   • 21 CFR 312.305
   • 21 CFR 312.310
   • 21 CFR 312.315
   • 21 CFR 312.320
   • 21 CFR 56.108 (c)
   • 21 CFR 56.105
   • 21 CFR 50
   • Devices 21 CFR 812.2
   • 21 CFR 814

1. General Requirements
   
   The University of North Carolina Wilmington (UNCW) requires Institutional Review Board (IRB) review and approval of proposed changes in approved research prior to initiation of any changes.
   
   The exception is a change in research necessary to eliminate apparent immediate hazards to a research participant. In cases where changes were made to eliminate apparent immediate hazards, it is the responsibility of the Principal Investigator (PI) to inform the IRB promptly of the change and the IRB must determine if the modified research is consistent with ensuring participants’ continued welfare.
2. Scope
   
   All human subjects research must have IRB approval of any modifications or changes to the research prior to implementation of the modifications/changes, unless the change is to eliminate an immediate hazard to one or more subjects in the research.
   
3. Definitions
   1. Minor Modification, Change, or Amendment - a change in research-related activities that do not significantly affect the risk/benefit ratio of the study and/or do not substantially change the specific aims or design of the study.
   2. Modification, Change, or Amendment – any change or amendment to the IRB-approved study protocol.
   3. Substantive Modification, Change, or Amendment - a change in research-related activities that affects the risk/benefit ratio of the study in a manner that may elevate the risk so that it is greater than minimal risk or substantially changes the specific aims or design of the study.
   4. Qualified IRB member - a voting or alternate voting member who has received training relative to the expedited review categories and possesses the scientific or regulatory expertise needed to review the proposed research.
4. Proedures for Submission of Modifications for IRB Review
   
   Changes in research may encompass amendments, addenda, deletions, or revisions to either the protocol or consent document associated with a protocol. The PI must submit information to allow the IRB to determine if the proposed change may be approved.
   
   1. Investigators must report planned changes in the conduct of a study and receive approval from the IRB prior to implementing these changes except when necessary to avoid an apparent immediate hazard to a subject.
   2. The approval letters sent to investigators of expedited and full board studies notify them of the need to submit any changes in their research projects to the IRB for review and approval. Likewise, the approval letters for exempt studies inform investigators that any changes in the research that affect the exempt status of the research must be submitted for IRB approval.
   3. Modifications may only be initiated without IRB review and approval when necessary to eliminate apparent immediate hazards to the subject(s).
   4. Complete the Modification Request with an explanation of the changes being requested.
      
      1. Edit relevant sections of the application so that the application reflects the requested changes.
      2. Submit two versions of any supporting materials that need to be revised (informed consent/assent/permission documents, recruitment materials (i.e., advertising, flyers, etc.). One version must show tracked changes, and the other must be the revised document without markups.
5. Types of Modifications
   1. Minor modifications/changes/amendments
      
      Examples of minor changes in most situations include but are not limited to:
      
      1. A modest increase or decrease in proposed enrollment target;
      2. Narrowing the range of the inclusion criteria;
      3. Broadening the range of the exclusion criteria;
      4. Alteration in the dosage form of a drug (e.g., tablet or capsule or oral liquid), provided the dose and route of administration remain constant;
      5. Decreasing the number or volume of biological samples collections, provided that such a change does not affect the collection of information related to safety evaluations;
      6. A decrease in the number of study visits, provided that such a decrease does not affect the collection of information related to safety evaluations;
      7. Reduction or minor changes in participant payment or liberalization of the payment schedule with proper justification;
      8. Changes to improve the clarity of statements or to correct typographical errors, provided that such a change does not alter the content or intent of the statement;
      9. The addition or deletion of qualified investigators or study personnel;
      10. The addition of study sites (which may require a Federal Wide Assurance (FWA) and appropriate IRB approval) or the deletion of study sites.
   2. Significant modifications/changes/amendments
      
      Examples of significant changes in most situations include but are not limited to:
      
      1. Broadening the range of inclusion criteria;
      2. Narrowing the range of exclusion criteria;
      3. Add a new subject population (e.g., control group, additional cohort, etc.). However, such a modification/amendment may require review as a new submission if it substantively changes the design of the study;
      4. Addition of research procedures that involve greater than minimal risk to subjects (e.g., collection of sensitive, confidential information such as criminal activity or substance abuse with a potential breach of confidentiality; addition of a new drug to a treatment regimen; addition of invasive procedures; change in route or frequency of drug administration, etc.);
      5. Extending substantially the duration of exposure to the test material or invention;
      6. The deletion of laboratory tests, monitoring procedures, or study visits directed at the collection of information for safety evaluations;
      7. Addition of significant new risks to the protocol and/ or the Informed Consent Document(s);
      8. Changes which, in the opinion of the IRB Chair or his/her designee, do not meet the criteria or intent of a minor modification;
      9. The addition of a qualified investigator with a disclosable conflict of interest.
6. Pre-review of Modifications
   1. The IRB staff will review modifications to determine if the submission is complete and whether the modification is a minor or substantive change.
   2. The IRB staff will contact the investigator if any information is missing from the submission that is necessary to complete the IRB review of the modification.
   3. The IRB staff will inform the IRB Chair that the submission is ready for review.
7. Procedures for Review of Modifications
   1. Materials submitted in support of changes will be distributed to IRB members in accordance with the IRB SOPs. IRBs delegated responsibility for review of changes in research are authorized to conduct the process in accord with federal regulations using either:
      1. An expedited review process (see Expedited Review of Research SOP), which is restricted to review of only minor changes in the research or consent document; or
      2. A convened review process [see Convened IRB Review (Greater than Minimal Risk) SOP] for all substantive changes.
   2. If study modifications reviewed by the expedited review are approved, then information regarding the approval will be presented at the next full board meeting and documented in the meeting minutes.
   3. Substantive changes in research involving drugs, biologics, or Complimentary Alternative Medicines (CAMs) must be reviewed by an appropriately qualified IRB member [e.g., a physician or appropriate health professional serving as an IRB member or consultant] for either an expedited review or a convened review. Changes or modifications reviewed through an expedited review process will be reported to the IRB members on a list as noted in the Expedited Review SOP, and complete files of the research project will be made available to any member upon request for further review.
   4. IRBs conducting a review of changes in research are authorized to alter the approval period for the research based on the degree of risk posed by the change in research or to retain the original approval period granted at the initial review. IRBs have the authority to require revisions to consent documents and notification to enrolled participants of approved changes in research that may affect the participants’ decision to continue.
8. I. Review of Informed Consent Form(s)
   1. Every modification reviewed will consider whether the changes in the research will affect the informed consent form(s)/document(s).
   2. The IRB must determine whether new and/or current subjects must be informed of information related to the study modifications.
      
      1. Investigators must provide new information to current subjects if it may alter their study participation, if the new information relates to safety or risks, or if it could otherwise impact subjects’ willingness to continue in the study.
      2. Former subjects must be notified if the study modifications or new information impacts their safety and welfare.
      3. The new information will be given to subjects in a revised consent document (for active participants) or a notification letter (for participants in follow-up).
   3. IRB review of a proposed modification/change during the period for which approval is authorized (not during a continuing review) does not constitute a continuing review.
   4. The review does not extend the date the continuing review must occur (e.g., beyond one year from the effective date of the initial approval or the most recent continuing review approval).
9. Changes Implemented in Order to Avoid Harm
   1. If a change was temporarily implemented without prior IRB approval to avoid immediate harm to subjects, the investigator must notify the IRB within five (5) working days, with submission of a Modification Form, or minimally by email or letter.
      1. Supply all relevant information concerning the modification and potential risks/harms to subjects.
      2. Submit any Unanticipated Problems Involving Risks to Subjects or Others that may have occurred.
      3. The investigator also must submit a Modification Form if long-term implementation of the change is needed, along with revised study documents, as applicable.
10. IRB Determination to Approve or Disapprove the Proposed Changes/ Modifications
    
    1. Possible actions that the IRB can take
       1. Approve the research without any conditions;
       2. Require modification in (to secure approval of);
       3. Disapprove the research - there are significant questions or concerns.
11. IRB Notification /Communication with the Investigator
    
    The PI will receive the corresponding letter for each of the possible actions listed in Section XI above.
    
    1. A letter of approval will be sent to the PI.
       1. 1. A copy of the approval letter will be kept in OSPREY.
          NOTE: Approved modifications do NOT extend the approval period of the protocol.
    2. A letter will be sent to the PI requesting modifications in the research to secure approval.
    3. A letter with the reason for disapproving of the changes in the research will be sent to the PI.
       10.3.1 Disapproval of a study may only be approved by the convened board.
12. References to Other Applicable SOPs
    • Activities not requiring IRB review - SOP 1.1
    • Online Research - SOP 6.2
    • Anonymous Surveys/Questionnaires - SOP 6.3
13. Responsibilities
    • IRB Co-chair: Responsible for determining the level of noncompliance, corresponding with the researcher, and determining if a corrective action plan is acceptable for findings of minor noncompliance.
    • IRB Staff: Responsible for monitoring ongoing studies, ensuring courtesy reminders are sent to PIs, organizing continuing review materials for committee review, ensuring continuing review requests are added to meeting agendas, and stamping consent/assent/permission forms and sending them to PIs when continuing review requests are approved.
    • Research Integrity Office Director (RIO director): Responsible for informing researchers of suspensions and terminations, coordinating investigations, providing guidance to the full board, and coordinating with Sponsored Programs for notifying funding agencies as appropriate.
    • Principal Investigator (PI): Responsible for submitting continuing review requests to the IRB by established deadlines for IRB meetings that occur prior to expiration of IRB approval. Noting any modifications needed for the upcoming approval period, including changes to personnel and/or consent/assent/permission forms as appropriate.
14. Resources
    • 45 CFR 46.110(b)(2)
    • 45 CFR 46.111
    • 45 CFR 46.116
    • 45 CFR 46.117
    • 21 CFR 50.25

1. General Requirements
   
   The University of North Carolina Wilmington (UNCW) Institutional Review Board (IRB) is responsible for conducting a continuing review of the previously approved greater than minimal risk research to ensure the protection of the rights and welfare of human subjects are maintained as originally planned during the initial IRB review, as well as to review the progress of the study.  The IRB must conduct a substantive and meaningful continuing review of greater than minimal risk research, as outlined in this Standard Operating Procedure (SOP), at intervals appropriate to the level of risk, but not less than once per year and prior to the expiration of the one-year approval date. 
2. Scope
   
   This SOP pertains to all human subjects research projects that require continuing review in accordance with 45 CFR 46.109(e) or as determined by the UNCW IRB. 
3. Definitions
   
   All terms used in these procedures have the same meaning set forth in the Policy unless otherwise defined in these procedures. 
   
   1. Accrual - the number of subjects enrolled in the study/trial that have passed a screening phase and are deemed eligible for the study. 
   2. Enrolled – the number of subjects who have provided consent and joined the study and have participated in some portion of the study regardless if they have been deemed eligible for the study.  Therefore, the number of enrolled subjects is at least the number of accrued subjects, as it includes screen failures. 
   3. Expedited Review - review conducted by the IRB Chair or by one or more qualified reviewers designated by the chairperson from among members of the IRB. 
   4. Modification – any change or amendment to the IRB-approved study protocol.
   5. Qualified IRB Member -a voting member or alternate voting member who has received training relative to the expedited review categories and possesses the scientific, clinical, or regulatory expertise needed to review the proposed research. 
4. Procedure
   1. Process for Conducting Continued Review
      1. Continuing Review for all research that is greater than minimal risk (or any study that is minimal risk but the IRB Chair determines would benefit from convened IRB review) takes place during a convened meeting with the majority of IRB members present.  Otherwise, minimal risk research that is not governed by the revised Common Rule qualifies for review under expedited review. 
      2. The IRB will conduct a Continuing Review of research prior to the one-year anniversary of the previous IRB approval date or other date as determined by the IRB. 
      3. The Principal Investigator (PI) is responsible for submitting required materials in an adequate timeframe as defined in this SOP. 
      4. The meeting minutes will be in sufficient detail to show the actions taken by the IRB, the vote on the actions, and a summary of the discussion of controversial issues and their resolution. 
      5. Unless an IRB determines otherwise, continuing review is not required in the following circumstances:
         1. Research eligible for expedited review in accordance with the UNCW policies and procedures and HHS regulations (45 CFR 46).  Minimal risk research governed by FDA regulations (21 CFR 56) must have continuing review at least by expedited review at least once per year; 
         2. Research reviewed by the IRB in accordance with the limited IRB review described in the Exempt Research SOP;
            • Data analysis, including analysis of identifiable private information or identifiable biospecimens, or  
            • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.  Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: 
         3. If the IRB determines that a continuing review will be required for any of the above situations, the IRB will document the rationale/ justification for the requirement of continuing review. 
   2. Submission of Documents to the IRB 
      1. To ensure that the continuing review and re-approval occur prior to the expiration date of the current IRB approval, automated reminders from OSPREY are sent as a courtesy to the PI of the study by email 60, 30, and 10-days prior to the IRB approval expiration date. Submission of the required documents to the IRB is the responsibility of the PI, regardless of a courtesy notice from OSPREY. 
      2. The investigator must submit an Annual Review form in OSPREY containing the following information to the IRB by or before the submission deadline for a convened meeting date scheduled prior to approval expiration:
         1. The number of subjects accrued and enrolled in the study. 
            
            Specifically:
            • Specifically: 
            • The number of subjects included/enrolled to date (i.e., had informed consent obtained); 
            • For clinical trials or studies with intervention, the number of subjects on active treatment; 
            • A summary of any subjects who were withdrawn from the research by the PI since the last IRB review and the reason(s) for withdrawal; 
            • A summary of any subjects who were dropped out from the research on their own accord since the last IRB review and the reason(s) for dropping out.
         2. A brief summary of all amendments to the research approved by the IRB since the IRB’s initial review or the last continuing review; 
         3. Any new and relevant information, published or unpublished, since the last IRB review, especially information about risks associated with the research; 
         4. Any proposed modification/changes to the informed consent, protocol, advertising, and for clinical trials, any changes to the Investigator’s Brochure or Device Manual, if applicable;  
         5. A summary of any unanticipated problems; 
         6. A summary of any adverse events; 
         7. A summary of protocol deviations that occurred during the last approval period. The summary should include protocol deviations that were previously reported, as well as a list of minor deviations that did not meet the prompt reporting requirement; 
         8. A summary of any complaints about the research from the subjects enrolled at the local site since the last IRB review; 
         9. The latest version of the protocol; 
         10. Informed consent form proposed for next review period; 
         11. Current Investigator’s Brochure or Device Manual, as applicable, if not previously submitted; 
         12. If applicable (usually only for clinical trials), a copy of all Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) reports and any communications to and from the DSMB/DMC during the past approval period, if a DSMB or DMC exists for the study.
   3. Expiration of IRB Approval (i.e., a lapse in IRB approval). 
      1. When for any reason, the IRB has not conducted continuing review and re-approved the research before the expiration date of IRB approval, the IRB approval expires automatically. 
         
         1. HHS and FDA regulations offer no provisions for any grace period which permits the conduct of research beyond the expiration date of IRB approval. 
         2. All research activities must immediately stop after IRB approval expires, including screening, recruitment, or enrollment of new subjects; collection or analysis of private identifiable research data, including questionnaires, surveys; any interventions or interactions with subjects, including treatments or therapies that may provide benefit; any monitoring of subjects; or any other research activity for the study. 
         3. In its review of the research upon receipt of a Continuing Review form or request for closure of the study, the IRB should also determine the reason(s) for the lapse in IRB approval occurred, whether any research activities were conducted during the lapse, and if appropriate, any corrective actions that the investigator or the IRB should implement to prevent any future lapse of approval or noncompliance. 
         4. The above determinations will be documented in the IRB meeting minutes. 
         5. OHRP and FDA do not consider an expiration of IRB approval to be a suspension or termination of IRB approval, and such event does not need to be reported to OHRP or FDA. 
         6. If the IRB notes a pattern of noncompliance with the requirements for the continuing review, the IRB should determine whether such a pattern represents serious or continuing noncompliance that needs to be reported to FDA and/or OHRP (e.g., an investigator repeatedly neglects to submit materials for continuing review in a timely fashion or the IRB itself is not meeting the continuing review dates). 
         7. Halting all research activities, especially subject enrollment, due to a lapse in IRB approval would not be considered a suspension of IRB approval that needs to be reported to OHRP or FDA. 
         8. The IRB Chair may approve the request by the simplest and quickest written means (e.g., email, fax, etc.) that permits for a printed copy of the approval for the IRB records. 
         9. If an investigator wants to continue the study, he/she must submit a complete Continuing Review form for the study within 30 days of the approval expiration date, if not already done. The IRB will complete the continuing review as soon as possible. No new screening or enrollment of subjects or continuation of other non-essential research procedures (other than the treatment/intervention and/or safety monitoring) can occur until the full board has approved the Annual Review. The PI may resume human subjects research once the Annual Review approval has been granted by the IRB.
      2. Continuation to Avoid Harm to Subjects 
         
         1. If, due to extenuating circumstances, IRB approval has lapsed on a study and stopping all research activities would cause potential harm to subjects, if the investigator determines that it would be unethical to stop/withhold treatment/ interventions (or withdrawing safety monitoring) because it would pose increased risks/harm to subjects, the investigator must:
            1. immediately notify the IRB Chair and/or IRB Administrator; 
            2. submit a written request to continue those research activities that are deemed unethical to interrupt; 
            3. include a justification for why stopping such activities would cause harm and request approval to continue those activities. 
            4. The written request for approval, along with the justification, must be emailed with high importance to irb@uncw.edu.  The investigator must follow up with the IRB Chair and/or IRB Administrator by phone to ensure receipt and response to the request.  
         2. The IRB Chair may approve the request by the simplest and quickest written means (e.g., email, fax, etc.) that permits for a printed copy of the approval for the IRB records. 
         3. If an investigator wants to continue the study, he/she must submit a complete Annual Review form for the study within 30 days of the approval expiration date, if not already done. The IRB will complete the continuing review as soon as possible. No new screening or enrollment of subjects or continuation of other non-essential research procedures (other than the treatment/intervention and/or safety monitoring) can occur until the full board has approved the Continuing Review. The PI may resume human subjects research once the Continuing Review approval has been granted by the IRB. 
      3. If the investigator intends to continue a study but fails to submit a Continuing Review form within 30 days of expiration of IRB approval, the study is considered closed, and the option to continue the study through the Continuing Review process is no longer applicable.  In addition to the restrictions imposed in C.1.b above to cease all human subjects research activities upon expiration of IRB approval, the investigator must submit an Initial application to conduct human subjects research, which will undergo the same review process as all other initial applications.  
   4. Criteria for IRB Approval of Research
      
      The committee will review the Continuing Review Form to determine if all the following requirements continue to be satisfied prior to recommending approval of the research.  The Continuing Review Form will be discussed at the convened meeting unless the study qualifies for expedited review.  If the study is reviewed by expedited review, the same considerations and review will be conducted by the IRB Chair or designee(s). 
      
      The committee will consider if: 
      1. Risks to subjects are minimized; 
      2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects; and the importance of the knowledge that may be expected to result; 
      3. Selection of subjects is equitable; 
      4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative and appropriately documented; 
      5. Where appropriate, the research plan adequately provides for monitoring the data collected to ensure the safety of subjects; 
      6. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; 
      7. Appropriate additional safeguards are included to protect vulnerable subjects; and, 
      8. Where the study involves vulnerable subjects, the research complies with the UNCW IRB Policies and SOPs. 
   5. IRB Continuing Review and Approval 
      
      The IRB has the authority to disapprove or require modifications in research activity that does not meet the Criteria for IRB Approval of Research. 
      
      
      1. The IRB should focus on whether there is any new information provided by the investigatorr or information available to the IRB, would alter the IRB’s prior determination, especially the IRB’s prior determination of the potential benefits or risks to the subjects.  
      2. The IRB should assess whether any new information (since the initial approval or last continuing review, whichever occurred last) that would necessitate revision of the protocol and/or the informed consent. 
      3. The IRB should pay particular attention to the following areas:
         1. Risk assessment; 
         2. Adequacy of informed consent;  
         3. Local issues for all sites at which research is conducted under the auspices of UNCW; and, 
         4. Progress of the study from the prospective of protection of human subjects from research risks, the ethical conduct of the research, and based on available information to the IRB, the integrity of the study is maintained. 
         5. Verification from Sources other than the Investigator that no Material Changes Occurred 
      4. When concerns are raised regarding the conduct of the study or potential risks to subjects that may have changed that the IRB cannot satisfactorily resolve with the investigator, the IRB may verify whether or not material changes may have occurred in the conduct of the research since the last review by the IRB.  
      5. The IRB may verify such concerns by reviewing the audit report that may have been conducted by an external entity or requesting additional information from sources other than the investigator (e.g., the sponsor) that may address the concerns.
      6. The IRB may request an audit of the research. The reason(s) for on-site review may include, for example:
         1. Random selection; 
         2. Complex projects involving unusual levels or types of risks to participants; 
         3. Projects conducted by an investigator who previously failed to comply with IRB determinations, or 
         4. Projects where continuing review or reports from other sources have indicated that changes without IRB approval may have occurred. 
      7. The IRB may decide to conduct an on-site review that may include:  
         1. Requests for progress reports from investigators; 
         2. Examinations of research records, including signed informed consent documents, protocol amendments, and serious and/or unexpected adverse experience report(s); or, 
         3. Contacts with research participants.
      8. The IRB has the authority to observe the informed consent process. Examples of when observation of the consent process could occur include:
         
         1. The full board IRB determines during review of a project that a conflict of interest, potential noncompliance, or other concerns that may affect the consent process exists such that the informed consent process should be observed by a neutral party; 
         2. The IRB is made aware of a complaint or concern with regard to the informed consent process; or   
         3. The IRB determines as a result of the monitoring process or an audit that the consent process is insufficient, and education/training is required for conduct of consent. 
      9. A written record of any monitoring activities performed by the IRB is maintained in the IRB records.
   6. Continuing Review Decision
      1. Approve the ongoing research study without any conditions. 
      2. Approve the ongoing research study or with conditions (also referred to as “conditional approval or contingent approval”);
         1. The IRB may require an investigator make specific changes to the protocol or informed consent; 
         2. IRB may require an investigator to submit additional documents, after which:
            1. the IRB Chair or other designated IRB members (with expertise or qualifications) may review materials submitted from the investigator and determine that the conditions have been satisfied; 
            2. further review by the IRB at a subsequent convened meeting would not be necessary; 
            3. The IRB should specify whether any conditions need to be satisfied before an investigator can continue particular research activities (e.g., research activities involving currently enrolled subjects may continue, but no new subjects may be enrolled until a designated IRB member reviews a revised protocol). 
      3. Requiring modifications for re-review by the full board to secure IRB approval - Defer or Table the study for further review at a future date after the required modifications are submitted by the investigator.  Note: this may cause a lapse in IRB approval (see above and below sections). 
      4. Suspension or termination of IRB approval - The IRB has the authority to suspend or terminate approval of research involving human participants that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants.
   7. Determining Frequency of Continuing Review
      
      Continuing review is typically conducted annually unless decided otherwise by the IRB.
      1. IRB must conduct continuing review of research at intervals appropriate to the degree of risk posed to subjects, but not less than once a year.  
      2. Continuing review more frequently than once a year is appropriate when the risks to subjects warrant more frequent assessment.
      3. When the IRB finds that it is necessary to conduct review more frequently than annually, the IRB will consider the following factors to determine an appropriate interval for continuing review:
         1. The nature of any risks posed by the research; 
         2. The degree of uncertainty regarding the risks involved; 
         3. The vulnerability of the subject population; 
         4. The experience of the investigator conducting the research; 
         5. The IRB’s previous experience with the investigator (e.g., compliance history, prior complaints from subjects about the investigator, previous problems with the investigator obtaining informed consent); 
         6. The projected rate of enrollment; and, 
         7. Whether the research project involves novel interventions (new or unusual approach of treatment).
      4. When the IRB determines it is necessary to review a study more frequently than annually, the approval period will be documented in the meeting minutes.
   8. Dates for Continuing Review 
      1. When there is no need to conduct continuing review more frequently than annually, the expiration date of approval and the date by which the first continuing review must occur may be as late as the anniversary of the initial approval date. 
      2. If a researcher request continuing review no more than 30-days in advance of the approval expiration date, the anniversary date of continuing review will remain the same as the original approval date. 
      3. If a researcher requests continuing review more than 30 days in advance of the approval expiration date, the continuing review approval date will change to the date the IRB finalizes the continuing review request.
      4. When the IRB determines that continuing review is needed more frequently than annually, the IRB will determine the approval expiration date and will notify the PI, accordingly, as described below. 
   9. Notification of IRB Continuing Review Determination to the Investigator
      
      After the IRB completes the continuing review, the IRB must provide a written notification informing the investigator of the IRB’s determination.
      1. For studies approved to continue – a clear statement will be provided to when the approval is effective, the period of time for which the study is approved, and the next continuing review date. 
      2. For studies approved with conditions – notification should state whether any conditions need to be satisfied before an investigator can continue particular research activities.  
      3. For suspended or terminated research – provide a written statement of the reason(s) for the IRB decision and give the investigator an opportunity to respond in person or in writing.
         1. A copy of the notification letter will be kept in OSPREY.
      4. The approved informed consent/assent/permission document(s) will be released with the IRB approval letter and will be stamped with the IRB number, date of approval, and the date approval expires.
5. Other Applicable SOPs
   • Full Board Review Procedures  - SOP 5.3
   • Adverse Event, Unanticipated Problem Reporting Procedures - SOP 6.7
   • Recruitment and Informed Consent - SOP 6.8
   • Findings of Noncompliance - SOP 11.1
6. Responsibilities
   1. IRB Members : Responsible for reviewing continuing review requests as described in this SOP. 
   2. IRB Staff : Responsible for monitoring ongoing studies, ensuring courtesy reminders are sent to PIs, organizing continuing review materials for committee review, ensuring continuing review requests are added to meeting agendas, and stamping consent/assent/permission forms and sending them to PIs when continuing review requests are approved. 
   3. Principal Investigator: Responsible for submitting continuing review requests to the IRB by established deadlines for IRB meetings that occur prior to expiration of IRB approval.  Noting any modifications needed for the upcoming approval period, including changes to personnel and/or consent/assent/permission forms as appropriate.
7. Resources
   • U.S. Department of Health & Human Services, Office of Human Research Protections Informed Consent FAQs
   • UNCW IRB Website 
   • U.S. Department of Health & Human Services, Office of Human Research Protections website
   • 45 CFR 46 (“Common Rule”)
   • Belmont Report

The purpose of this SOP is to outline the procedures for submission and review by the IRB of completion/closure of a study or the processes for managing expiration of IRB approval.

1. General Requirements
   
   The completion or termination of the study is a change in activity and must be reported to the IRB. IRB oversight of a research protocol is required as long as the activities conducted continue to involve human subjects.
   
   These procedures supplement the Institutional Review Board Policy (the “Policy”).
2. Scope
   
   The SOP pertains to all human subjects research conducted approved by the UNCW IRB, including studies that qualified for exemption.
3. Applicable Definitions
   1. Identifiable private information (or specimens) are considered to be individually identifiable when they can be linked to specific individuals (i.e., the identity of the subject is or may readily be ascertained) by the investigator(s) either directly or indirectly through coding systems.
   2. Screened refers to all procedures performed to determine whether a potential participant is eligible to take part in the study.
   3. Enrolled participants/enrolled subjects are individuals who are eligible for participation (i.e., meet the inclusion criteria for the study), have given informed consent and participated in some or all the study procedures.
4. Procedures
   
   A study closure report is required for all human research studies. The closure report updates the IRB on the conduct and outcomes of the study, any new risks, safety issues, or problems that may have arisen since the last study renewal, and informs the IRB of the final disposition of research records and data.
   1. Completion or Permanent Closure
      1. When a study is closed or permanently discontinued for any reason, a Closure form in OSPREY must be completed by the principal investigator (PI) and submitted to the IRB within thirty (30) days.
      2. The Closure form serves as notification to the IRB that all research activities for the given study have been completed and (when applicable) the continuing review of the study is no longer required.
      3. The IRB will review all reports of study completion and, if needed, request additional information from the PI when necessary.
      4. Once a Closure form has been received by the IRB, no further data collection may occur. Therefore, if an investigator is still collecting follow-up data about participants (either directly from participants or indirectly from existing records), the project must remain open until all data have been collected, even if new participants are no longer being enrolled.
      5. Once the IRB approves study closure, the study is considered to be closed on the day the IRB approved closure of the study.
         1. A letter confirming IRB approval for permanently closing the study will be sent to the PI. The letter will be kept in the study’s electronic record.
         2. Records shall be retained for at least three years after completion of the research, and the records shall be accessible for inspection.
   2. Criteria for Closing a Study
      1. The project was not conducted or otherwise has been permanently discontinued OR
      2. The PI is leaving UNCW and will transfer the study to the oversight of another institution IRB OR
      3. The project was conducted and completed. Project completion is when ALL the following have occurred:
         1. Screening and enrollment is permanently closed, AND
         2. Research-related interventions, procedures, and interactions with human subjects have ended, including follow-up care, AND
         3. No individually identifiable private information (data), including follow-up data, is being collected or used, AND
         4. Data analysis involving the use of directly or indirectly identifiable data is completed. (Data analysis on fully de-identified data may continue after study closure.)
   3. Administrative Closure for Lapse in IRB Approval in Applicable Studies
      1. When IRB-approved studies have approval expiration dates (those subject to full board review or otherwise assigned a specific expiration), the researcher’s approval to conduct the study ends on the IRB approval expiration date. This may occur if a PI fails to secure continuing review approval prior to the expiration date for the study.
      2. No human subject research activity may take place (e.g., enrollment, follow-up, data collection, etc.) upon expiration of IRB approval until approval is reinstated.
      3. If study approval has been expired for more than thirty (30) days, the IRB will consider this study closed, and the PI may only reinstate IRB approval by submitting an Initial application subject to the IRB process appropriate for the necessary level of review.
   4. Principal Investigator Leaving UNCW
      1. The PI is responsible for ensuring that their research-related duties are appropriately transitioned or completed before officially exiting their position at UNCW.
      2. Prior to leaving UNCW, the PI must submit a modification form to transfer the study to an alternate but equally qualified PI or submit a Closure form if the study meets the above criteria for closure.
         • If subjects are still participating in the research study, the IRB recommends that the PI provide the subjects with a letter to notify them of the change in PI or closure of the study and, when applicable, update them regarding changes in relevant telephone numbers (e.g., for study-related questions) and addresses (e.g., to withdraw authorization).
      3. All changes must be reviewed and approved by the IRB prior to the change(s) being implemented (except to eliminate hazards to subjects).
      4. If the study is funded, the PI must notify the Sponsor of the change in status.
      5. All study-related records will remain at UNCW unless specifically approved by UNCW.
5. Responsibilities
   • IRB: Responsible for reviewing and formally closing completed studies.
   • Principal Investigatorr: Rresponsible for Ensuring that all research-related activities, interventions, or interactions with human subjects have been completed prior to submitting the Closure Form to the IRB, rretaining research records for at least three years after completion of the study, depending on the applicable regulations, and mmaintaining confidentiality and data security for retained records.
6. Resources
   • UNCW IRB Website 
   • 45 CFR 46 (“Common Rule”)
   • Belmont Report

1. General Requirements
   
   These procedures support the University’s efforts to protect human subjects and UNCW researchers while minimizing institutional risk in conducting blood draws for research purposes.
2. Scope
   
   This SOP pertains to all human subjects research projects that involve blood draws. These procedures apply to any blood draws occurring on the UNCW campus or conducted by UNCW’s staff, students, and faculty.
   
   Please note, if the research blood draws will occur at off-site locations that are not owned or leased by UNCW (such as hospitals or other healthcare facilities or private physician offices), with their own venipuncture or equivalent policy, then that site’s policy supersedes these procedures. If UNCW faculty, staff, or students conduct blood draws at those sites, they must follow the site’s policy. If the site is contracted by a UNCW principal investigator (PI) to conduct blood draws for research, the off-site personnel must follow the site’s policy.
3. Definitions
   
   All terms used in these procedures have the same meaning set forth in the Policy unless otherwise defined in these procedures.
   
   1. Children – as defined in the HHS regulations "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
   2. Expedited Review - review conducted by the IRB Chair or by one or more qualified reviewers designated by the chairperson from among members of the IRB.
   3. Finger stick means a type of blood draw where the finger is pricked with a lancet to obtain a small amount of capillary blood.
   4. Intravenous (IV) lines means a thin tube or cannula that is inserted into a vein, typically to administer drug, blood, or fluid products directly into the bloodstream.
   5. Phlebotomy/Venipuncture means a type of blood draw in which a needle is used to take blood from a vein. Multiple tubes may be collected; however, it is considered a single blood draw “stick” and the needle is taken out and a bandage used.
4. Blood Draws Qualifying for Expedited Review
   1. Expedited Review of Blood Collection
      
      The federal regulations 45 CFR 46.110 and 21 CFR 56.110 allow research activities that present no more than minimal risk to human subjects and involve only procedures listed in an expedited review category may be reviewed by the IRB through the expedited review. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture is an activity that is included in Expedited Review Category 2 provided the following requirements are met:
      
      1. The collection is from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
      2. The collection is from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
   2. All Other Blood Collection
      
      If the criteria for Expedited Category 2 cannot be met, studies involving blood collection will be reviewed by the full board.
      
      
5. Blood Draw Considerations
   1. Personnel Qualifications
      
      All blood draws must be performed by personnel who are proficient in both phlebotomy and safe handling of blood and human tissues. The PI must justify on the IRB application that the individual(s) who will perform the blood collection will do so within their scope of practice and are credentialed appropriately. Examples of appropriate credentials include but are not limited to:
      
      • Medical or Nursing license
      • Medical Technologist license or certification
      • Phlebotomist license or certification
      • Advanced EMS certification
   2. Volume
      
      Blood samples must not exceed the minimal amount necessary for analysis. This amount must be documented in the IRB application and approved by the IRB. Justification for the amount must comply with federal guidelines and the scope/purpose of the study.
      
      
   3. Subject Screening
      
      There must be no contraindications for blood withdrawal that would injure the subject or contraindications that would undermine the research goals. The PI or designee must create and submit for approval appropriate screening tools to identify contraindications. The IRB will consider factors including but not limited to the following when assessing the risks and benefits of blood collection:
      1. Health status of the subject population
         
         1. Blood clotting conditions
         2. Receiving chemotherapy
         3. Vascular grafts, hematoma
      2. Volume of blood the researcher proposes to collect
      3. If opportunities exist to collect blood at the same time as a clinical visit
   4. Special Informed Consent Requirements
      
      Subjects must be informed through an appropriate informed consent process of the potential risks of blood collection, which may include:
      1. Bruising
      2. Hematomas
      3. Infection at the blood collection site
      4. Allergies (e.g. latex, betadine, bandage/tape)
      5. Less common risks such as nerve damage or extensive bleeding
6. Safety Considerations
   1. UNCW Environmental Health & Safety Requirements
      
      Researchers collecting or handling blood from human subjects must contact UNCW’s Environmental Health & Safety Office (EH&S) and follow bloodborne pathogen standard requirements including but not limited to annual training, completion of an exposure control plan, and the opportunity to receive a Hepatitis B vaccine.
      
      The PI or designee of the study must upload the completed Bloodborne Pathogen Exposure Control Plan in the Supporting Documents section of the IRB application as documentation of having engaged EH&S.
      
      If a third-party contractor is used to collect blood, the PI must ensure that the contractor has appropriate safety protocols in place and is properly trained and credentialed.
   2. Location
      
      When blood draws are conducted on UNCW premises, they must be conducted in an appropriate location inspected by UNCW EH&S prior to final approval by the IRB:
      1. Floors must not be carpeted. If the only option is a carpeted space, plastic or other impervious and cleanable material must be used to cover the carpet.
      2. One or more comfortable chairs must be available. Chair covers must be non-porous. If a chair with a nonporous cover is not available, a cleanable and impervious cover must be used on the chair. Chairs must be used for the subject. When research involves the collection of blood mid-exercise, a chair must be available in case the exercise subject becomes light-headed.
      3. Space should have a curtain or door for privacy if possible.
      4. Space must not be used for eating or drinking.
   3. Infection Prevention
      
      Per WHO guidance, proper procedures must be followed to prevent infection:
      
      1. The researcher conducting the blood draw must first wash his/her hands, wrists, and in-between fingers with soap and water or alcohol rub for at least 30 seconds.
      2. Personal Protective Equipment must be available and used. Avoid using latex gloves in case the subject or researcher is allergic to latex.
      3. Single-use gloves must be worn during all blood withdrawal procedures. Hands must be washed, and gloves must be changed between subjects.
      4. Tourniquets must be single-use or cleaned before the next use.
      5. Only single-use/one-hand cap devices must be used for blood withdrawal.
      6. Each subject’s skin must be disinfected prior to blood draw.
      7. A sharps container must be no more than four (4) feet from where the blood draw is conducted.
      8. Work surfaces must be decontaminated/disinfected for the appropriate contact time immediately after work is complete. Suitable disinfectants include:
         1. A 1:10 dilution of 5.25%-6.15% sodium hypochlorite (i.e., household bleach) for 10 min contact time. NOTE: A dilution of 70% Ethanol may be used to remove chlorine residue following disinfection to reduce the wear on metal surfaces.
         2. An EPA–registered tuberculocidal disinfectant, used for contact time listed on the disinfectant.
      9. Blood samples that are to be transported outside the building must be sealed in appropriately labeled, leak-proof primary tubes/flasks/containers and disinfected on the outside before being placed into a durable, leak-proof secondary transport container. Specimens must be transported at an acceptable temperature based on the type of specimen. A biohazard symbol will be placed on the primary container. The secondary container will be disinfected and secured for transport.

1. General Information
   1. Legal Counsel
      
      When appropriate, the UNCW IRB will consult legal counsel (not to suggest that legal counsel serves as an IRB member) regarding the details and status of the applicable federal and State regulations in regard to biomedical and behavioral research proposals submitted to the IRB in which the study subjects are prisoners, fetuses, children, or pregnant women, and to require the principal and participating investigators to comply with the applicable provisions for proposed studies involving any of the aforementioned special subjects. Additionally, procedures found in the following sections, III. Children as Research Subjects, IV. Protections Pertaining to Research Involving Fetuses, Pregnant Women, and Human In-Vitro Fertilization; and V., Prisoners as Research Subjects, shall be followed.
   2. Selection of Subjects
      
      In compliance with 45 CFR 46, the IRB shall determine that adequate consideration has been given to the manner in which potential subjects who are prisoners, fetuses, children, or pregnant women will be selected and that adequate provision has been made by the applicant/investigator(s) for monitoring the actual informed consent process. In this regard, the IRB may elect a member or an advocate to participate in:
      1. Overseeing the actual process by which individual consents required by federal and State regulations are secured either by approving induction of each individual into the activity or verifying, perhaps through sampling, that approved procedures for induction of individuals into the research study are being followed, and;
      2. Monitoring the progress of the research and intervening as necessary through such steps as visits to the study site and continuing evaluation to determine if any unanticipated risks have arisen.
2. Review of Research Involving Children (45 CFR 46, Subpart D)
   
   Children, like other potential vulnerable populations, require additional protections when they are research subjects. At the same time, children should not be denied the opportunity to enroll or the prospective benefits of participating in research. There are federal regulations in 45 CFR 46 Subpart D that provide additional protections for children when they are research subjects.
   
   Federal guidelines require that children be included in certain research activities unless there is a justification for excluding them, while federal regulations require that additional precautions be taken when children are research subjects, depending on the degree of risk involved in the research. NIH policy, which guides the conduct of much human research due to funding relationships, has similar requirements.
   
   The regulations also set forth requirements for obtaining parental permission and, where appropriate, assent by the children themselves. The IRB will review research that involves children in consideration of Subpart D of the applicable HHS and FDA regulations, North Carolina state law, and institutional policy. When appropriate, requirements for involvement of minors in research postulated by the North Carolina Department of Child Protective Services (DCPS), and/or Department of Public Instruction, are also considered.
   
   Information provided by the investigator regarding level of risk, prospect of direct benefit (when applicable), assent and parental permission, and inclusion of wards/foster children is evaluated by the IRB, which may concur with the investigator’s determinations, make alternative determinations, or impose additional requirements.
   
   1. Determination of Risk/Benefit Category
      
      When the IRB (or qualified reviewer for research that is eligible for expedited review) reviews research involving children, it will be determined which of the risk/benefit categories described in 45 CFR 46 (Subpart D) and 21 CFR 56 (Subpart D) the research fits into, whether assent will be required, the manner in which assent will be obtained, if required, the requirements for parental permission or approval of waiver thereof, and the appropriateness of the inclusion of wards/foster children if their involvement is proposed for research that involves greater than minimal risk with no prospect of direct benefit. The IRB will consider information provided by the research team in the submission.
      
      • If full Board review is indicated, the IRB’s determinations will be entered into the minutes for the meeting at which the research was reviewed.
      • For research that is eligible for expedited review, the IRB chair’s/designee’s determinations are indicated in the IRB record.
      • Any concern with the information provided by the researchers should be included in the documentation of Subpart D findings.
        
        The IRB may approve research involving children only if it meets the criteria in one of the four following categories:
      1. 45 CFR 46.404; 21 CFR 50.51: Research not involving greater than  minimal risk.
         • “Minimal Risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
         • The IRB, or designated expedited reviewer, will provide the basis for the determination of minimal risk.
         • If permission of the parent is required, the UNCW IRB, or designated expedited reviewer, will almost always require that the permission of only one parent is necessary for research in this category and will determine whether assent is required for some or all minors. However, the IRB has the discretion to require that the permission of both parents must be obtained.
      2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (45 CFR 46.405; 21 CFR 50.52):
         • For research to be approved under this category, the convened IRB must find that:
           • the risk is justified by the anticipated benefits to the subjects; and
           • the relation of the anticipated benefit to the risk must be at least as favorable to the subjects as that presented by available alternative approaches.
         • The IRB, at a convened meeting, will provide the basis for the determinations of greater than minimal risk and prospect of direct benefit.
         • The IRB may determine that the permission of one or both parents is required for research in this category and will determine whether assent for some or all minors is required.
      3. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition (45 CFR 46.406; 21 CFR 50.53):
         
         For research to be approved under this category, the Board must find that it meets the requirements of 45 CFR 46.406 and 21 CFR 50.53, as follows:
         1. The risk represents a minor increase over minimal risk;
         2. The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
         3. The intervention or procedure is likely to yield generalizable knowledge about the subject’s disorder or condition which is of vital importance for the understanding or amelioration of the subject’s disorder or condition;
         4. Adequate provisions are made for soliciting and documenting assent of the children; and
         5. Adequate provisions are made for soliciting the permission of both parents of each child unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. (45 CFR 46.407 and 408).
            
            The IRB, at a convened meeting, will provide the basis for the determinations of greater than minimal risk and no prospect of direct benefit.
            
            The permission of both parents is required for research in this category, unless one parent cannot reasonably provide permission, as allowed per Subpart D. The assent of the minors involved is required unless the Board determines that some or all are not capable of providing assent.
      4. Research not fitting into the aforementioned categories which presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (45 CFR 46.407; 21 CFR 50.54):
         
         The IRB, at a convened meeting, will provide the basis for its determinations regarding risk level and potential for direct benefit.
         
         If the research is supported by HHS jurisdiction, and falls in this category, it cannot be performed without review by the Secretary of the HHS as outlined in 45 CFR 46.407.
         Research under FDA jurisdiction that falls in this category cannot be performed without review by the Commissioner of Food and Drugs as outlined in 21 CFR 50.54.
         If the research is HHS-supported or under FDA jurisdiction, the IRB staff will prepare a request for panel review promptly after the IRB review and will provide such to the Director of the IRB. The Director, or designee, will prepare a report for submission to OHRP to request a panel review as described in 45 CFR 46.407 or 21 CFR 50.54, as applicable.
         Research in this category that is not federally funded and does not involve FDA-regulated products will be reviewed by a special panel convened by the UNCW IRB office to make the determinations that would be otherwise be made by HHS or FDA when evaluating research in this category.
         The permission of both parents is required for research in this category, unless one parent cannot reasonably provide permission, as allowed per Subpart The assent of the minors involved is required unless the Board determines that some or all are not capable of providing assent.
   2. Assent Determination
      
      After the Board makes the risk/benefit determination, they must consider the issue of child assent, as described in 45 CFR 46.408(a) (Subpart D). The Board must decide whether assent is necessary and also whether and how it will be documented if it is necessary. Among the formats the Board may consider are the following:
      1. 1. 1. waiver of assent;
            2. determination that the children lack the ability to provide assent;
            3. verbal assent, without documentation;
            4. verbal assent, with documentation by the investigator and/or the legally authorized representative(s);
            5. written assent form, with subject signature; or
            6. subject signature block on consent form (for older children only).
            The federal regulations do not require that assent be sought from children starting at a specific age, but that their assent should be sought when, in the judgment of the IRB, the children are capable of providing their assent. IRBs are to take into account the ages, maturity, and psychological state of the children involved (see 45 CFR 46.408(a)).
      
      
      
      1. When the research offers the child the possibility of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research, the IRB may determine that the assent of the child is not necessary (45 CFR 46.408(a)).
   3. Inclusion of Wards in Research
      
      Special protections must be considered whenever children who are wards of the state or any other institution, agency, or entity are considered for inclusion in research that is greater than minimal risk with no prospect of direct benefit. Of primary concern are consent issues, i.e., who has authority to enroll a child who is a ward in research. Responsibility for ensuring that appropriate individuals provide permission rests with the PI and must be in compliance with applicable statutes and the process described in the protocol that was approved by the IRB.
      
      Federal regulations do not require special provisions for wards enrolled in research that is either minimal risk or greater than minimal risk with the prospect of direct benefit. However, the IRB may impose additional requirements if the research and/or status of the child(ren) warrant additional safeguards. North Carolina state laws and the North Carolina DCPS policies will be considered during review of research that involves wards.
      
      Wards may only be included in research that is greater than minimal risk and does not offer the prospect of direct benefit (45 CFR 46.406 or 45 CFR 46.406) when such research is either related to their status as wards or conducted in a facility at which most of the children are not wards.
      
      If it is proposed that wards will be enrolled in research that is greater than minimal risk and does not offer the prospect of direct benefit, an advocate or advocates who will serve to ensure the best interests of each child are being upheld must be appointed, in addition to obtaining permission from any other individual acting on behalf of the child, e.g., as guardian or in loco parentis. One individual may serve as an advocate for more than one child.
3. Review of Research Involving Pregnant Women, Human Fetuses, or Neonates (45 CFR 46, Subpart B
   
   Pregnant women/fetuses/neonates like other potential vulnerable populations require additional protections when they are research subjects. At the same time, they should not be denied the opportunity to enroll or the prospective benefits of participating in research. There are federal regulations in 45 CFR 46 Subpart B that provide additional protections for pregnant women/fetuses/ neonates when they are research subjects.
   
   Distinction should be made between studies that are designed to study pregnant women or the characteristics of the pregnant woman and/or fetuses/ neonates (i.e., the inclusion criteria is geared to enroll pregnant women, fetuses, and/or neonates in the research), and studies for which pregnant women may enroll by chance. With regards to the latter, Subpart B requirements need not be met although when studies pose potential risks to pregnant women, neonates, or fetuses appropriate safeguards should be considered for women of child-bearing potential.
   
   The IRB will ensure that the requirements of Subpart B are appropriately satisfied prior to granting approval of any study designed to study pregnant women, fetuses, or neonates. In addition to the considerations made by the IRB in the scope of its review (in accordance with Section VIII.A), the IRB will also consider the following:
   • there is adequate expertise on the IRB to evaluate the risks and benefits related to the inclusion of pregnant women, fetuses and neonates. When additional expertise is needed the IRB will consider adding an appropriate consultant(s);
   • the determinations required by Subpart B are documented appropriately in the IRB records (in the IRB minutes for reviews conducted by the convened IRB or in the documentation for review for expedited reviews); any involvement of pregnant women or fetuses meets all requirements as stated in 45 CFR 46.204;
   • any involvement of neonates meets all requirements as stated in 45 CFR 46.205;
   • any research involving, after delivery, the placenta, the dead, macerated fetal material, or organs excised from a dead fetus will be conducted in accordance with 45 CFR 46.206, federal, state, or local laws and regulations;
   • proposals that are supported by HHS and for which the inclusion of pregnant women, neonates, or fetuses is not approvable per Subpart B will be referred to the HHS Secretary for review. For other such proposals, the IRB will establish a separate panel composed of individuals with appropriate expertise to determine whether the research meets ethical and regulatory standards and whether the research should be approved. If the research is supported by another federal agency or sponsor, their requirements must be considered during this process;
   • informed consent is obtained per provisions of Subpart B for pregnant women who have reached the age of majority or are legally emancipated;
   • informed consent is obtained per provisions of Subparts B and D for pregnant minors (where research is related to prenatal care, consent of the pregnant minor may be acceptable);
   • consent documents contain information regarding risks of breastfeeding, when risks to the pregnant woman or neonate is determined to be greater than minimal;
   • consideration is given to excluding women of child-bearing potential when the woman’s reproductive status is not relevant to the research and risks to the pregnant woman or fetus is determined to be greater than minimal.
4. Review of Research Involving Prisoners (45 CFR 46, Subpart C)
   1. Justification to Use Prisoners
      
      A prisoner is defined by the federal regulations as any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures, which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Prisoners, like other potential vulnerable populations, require additional protections when they are research subjects. Although prisoners should not be denied the opportunity to enroll in research that provides potential benefits, the submission for IRB review and approval should include a justification for the inclusion of prisoners as subjects in the study, particularly if the research will be conducted solely on prisoners.
      
      There are federal regulations in 45 CFR 46 Subpart C that provide additional protections for prisoners when they are research subjects. The IRB shall ensure that the North Carolina Penal Code limitations on experiments involving prisoners in North Carolina are met for research conducted at UNCW.
   2. Review Level for Research Involving Prisoners
      
      Per UNCW IRB policy, all research involving prisoner studies requires review by the convened IRB, with the designated prisoner representative involved in the review of the study. The IRB will not meet quorum on such agenda items without the prisoner representative member present.
   3. Requirements to Consider Research Involving Prisoners
      
      In addition to other considerations in this SOP, the IRB will only approve federally-supported or -conducted research involving prisoners if it finds that the study meets all the requirements of 45 CFR 46.300 (Subpart C).
      
      The IRB may proceed and approve the study if it determines that the research under review represents one of the following minimal risk categories in category 1 or 2 below. If the IRB determines that the research falls under category 3 or 4 below and the research is federally supported or conducted, the research must be submitted to OHRP for review by a panel.
      1. Study of the possible causes, effects, or processes of incarceration and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to subjects; or,
      2. Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risks, and no more than inconvenience to the subjects. If the IRB finds that the study involves one of the following categories and it is federally supported or conducted, then the IRB must forward the protocol (along with documentation of its review) to OHRP:
      3. Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may proceed only after the Secretary (i.e., HHS) has consulted with appropriate experts including experts in penology medicine and ethics, and published notice in the Federal Register, of its intent to approve such research; or
      4. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary (i.e., HHS) has consulted with appropriate experts including experts in penology medicine and ethics, and published notice in the Federal Register, of its intent to approve such research.
5. Related SOPs
   • Full Board Review Procedures- SOP 5.3
   • Recruitment and Informed Consent Procedures- SOP 9.1
   • Adverse Event, Unanticipated Problem Reporting Procedures- SOP 6.7
6. Responsibilities
   • IRB: Responsible for ensuring vulnerable subjects are included in research studies in accordance with federal regulations and best practices.
   • IRB Staff: Responsible for processing and assisting the IRB reviewer with studies being conducted with vulnerable populations.
   • Principal Investigator: Responsible for fully documenting the need to include vulnerable subjects in research, providing requested information to the IRB to aid their review of research involving vulnerable subjects, and conducting research involving vulnerable subjects as approved by the IRB.
7. Resources
   • 21 CFR 56
   • 45 CFR 46
   • Protections Pertaining to Research Involving Fetuses, Pregnant Women, and Human In-Vitro Fertilization
   • Prisoners as Research Subjects
   • Children as Research Subjects

The purpose of this SOP is to explain how real or perceived conflicts of interest in human subjects research will be evaluated and managed by the IRB.

1. General Requirements
   
   The regulations protecting human research subjects are based on the ethical principles described in the Belmont Report: respect for persons, beneficence, and justice. Researchers conducting human subjects research should not compromise Belmont Report principles by financial interests or other relationships that may create real or perceived conflicts of interest. The bias such conflicts may impart can affect many human subject research activities, including decisions about who serves on the research team, where supplies or equipment are purchased, how data is collected, analyzed, and interpreted, and which statistical methods are used. Openness and honesty are indicators of respect for persons, which promote ethical research and can only strengthen the research process.
2. Scope
   
   This SOP pertains to all human subjects research reviewed by the UNCW Institutional Review Board (IRB).
3. Applicable Definitions
   1. Conflict of Interest: Relates to situations in which financial or other personal considerations, circumstances, or relationships may compromise, may involve the potential for compromising, or may have the appearance of compromising a researcher’s objectivity in conducting human subjects research.
   2. Belmont Report : A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
4. Procedures
   1. IRB Member Conflicts
      
      IRB members may not vote on agenda items if doing so creates a real or perceived conflict of interest.
      1. When sending meeting agendas to IRB members, IRB staff include a statement asking IRB members to notify IRB staff of any real or perceived conflict of interest in reviewing or voting on agenda items.
      2. If concerned, the Research Integrity Office director (RIO director) may inquire during meeting proceedings if any members have real or perceived conflicts of interest on agenda items.
      3. IRB members must recuse themselves from review and approval of studies in which they have a conflicting interest.
   2. Investigator Conflicts
      1. The IRB will not approve an application if any personnel on the study subject to the UNCW Conflict of Interest or Commitment policy (UNCW Policy 03.230) do not have current annual conflict of interest disclosures on file in the AIR system.
      2. The RIO director will confirm that research team members subject to UNCW Policy 03.230 either do not have conflicts relevant to the study under review or that there is a current management plan for the conflict on file in the department or in Academic Affairs.
      3. If the RIO director is unable to clear the application due to potential conflicts of interest, the RCM will notify the IRB co-chairs and the Institutional Official (IO). If the co-chairs and IO concur that a potential conflict exists with no appropriate management plan in place, the RIO director will coordinate conflict management plan meetings between the investigator, his or her supervisor, and General Counsel’s office, as appropriate to determine how or if the conflict can be managed.
      4. As indicated in UNCW Policy 03.230, examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to:
         1. Public disclosure of significant financial interests;
         2. Monitoring of research by independent reviewers;
         3. Modification of the research plan;
         4. Disqualification from participation in all or a portion of the research;
         5. Divestiture of significant financial interests; or
         6. Severance of relationships that create actual or potential conflicts.
5. Responsibilities
   • IRB Members: Responsible for notifying IRB staff at the earliest opportunity if the review of any agenda item or expedited study creates a real or perceived conflict of interest.
   • IRB Staff: Responsible for reminding IRB members of their obligation to recuse themselves if a real or perceived conflict of interest exists as a result of their review of human subjects research.
   • RIO Director: Responsible for determining if personnel listed in OSPREY applications under review have outstanding annual conflict of interest disclosures and notifying them that approval may not occur until disclosures are submitted. Responsible for coordinating meetings to develop management plans for investigators.
   • Investigators: Responsible for cooperating with IRB staff in resolving or managing conflicts of interest prior to conducting human subjects research.
6. Resources
   • UNCW IRB Website
   • UNCW Conflict of Interest Website
   • U.S. Department of Health & Human Services, Office of Human Research Protections Guidance on Financial Conflict of Interest
   • 45 CFR 46
   • Belmont Report

The purpose of this SOP is to provide detail on the conditions and steps for conducting an audit of human subjects research.

1. General Requirements
   
   At times, audits of ongoing studies are necessary to confirm compliance with approved procedures, to ensure subject safety, and/or to ensure that subject privacy is protected. The full IRB or the IRB chair may request an audit of any activity that is subject to or appears to be subject to UNCW IRB oversight. The UNCW Internal Audit office or the chancellor may also initiate an audit randomly, as part of an investigation, or for any other reason.
   
   The IRB can use the following to determine which projects need verification from sources other than the principal investigator that no material changes have occurred since previous IRB review, that the study is being conducted as approved by the IRB, and/or the study is subject or not subject to IRB oversight.
   
   The regulations protecting human research subjects are based on the ethical principles described in the Belmont Report: respect for persons, beneficence, and justice. Researchers conducting human subjects research should not compromise Belmont Report principles by financial interests or other relationships that may create real or perceived conflicts of interest. The bias such conflicts may impart can affect many human subject research activities, including decisions about who serves on the research team, where supplies or equipment are purchased, how data is collected, analyzed, and interpreted, and which statistical methods are used. Openness and honesty are indicators of respect for persons, which promote ethical research and can only strengthen the research process.
   1. randomly selected projects
   2. complex projects involving unusual levels or types of risk to subjects,
   3. projects conducted by principal investigators who previously have failed to comply with UNCW policies, SOPs or federal regulations, or
   4. projects where concerns have been raised during the continuing review process or other sources about conducting human subjects research without IRB approval, making material changes to approved human subjects research without IRB approval, or other concerns.
2. Scope
   
   This SOP can be applied to any activity that has either been reviewed and/or approved by the UNCW IRB as human subjects research at any level of review, or any other activity conducted by UNCW faculty, staff and/or students that appears to be subject to UNCW IRB policies, SOPs and related federal regulations.
   
3. Applicable Definitions
   1. Audit
      
      For the purposes of this SOP, an audit is a review conducted by one or more objective parties designated by the IRB, Office of Internal Audit, or chancellor, for the purpose ofconfirming compliance with applicable policies and regulations and ensuring subject safety and protection.
   2. Conflict of Interest
      
      Relates to situations in which financial or other personal considerations, circumstances, or relationships may compromise, may involve the potential for compromising, or may have the appearance of compromising IRB staff or an IRB member’s objectivity in conducting an audit of a human subjects research study.
   3. Noncompliance
      
      Failure to comply with applicable regulations, laws, UNCW policies, UNCW IRB SOPs, and/or the requirements or determinations of the IRB or provisions of the approved research study.
   4. Serious Noncompliance
      
      Instances of noncompliance that pose an actual or potential increased risk to the safety, rights and/or welfare of human research subjects. Examples of serious noncompliance include but are not limited to:
      
      • Conducting human subjects research without UNCW IRB review, a determination of exemption and/or approval;
      • Enrollment of subjects that fail to meet the inclusion or exclusion criteria of the approved study;
      • Enrollment of subjects while study approval has lapsed;
      • Failing to provide all relevant sections of the informed consent form to subjects;
      • Major deviations from approved methods and procedures that may place subjects at risk from the research.
4. Procedures
   1. Appointment of an IRB Audit Team
      1. When the IRB determines that an audit of one or more human subjects research studies is necessary, the research compliance manager will conduct the audit with one or more IRB members.
      2. An IRB co-chair will appoint the audit team for all studies other than those reviewed at the full board level.
      3. The full board will appoint the audit team for studies reviewed at the full board level.
      4. The IRB co-chair or full board must refrain from appointing IRB members who may have a real or perceived conflict of interest related to the audited study or studies.
   2. Cooperating with Audit
      
      All members of the research team must fully cooperate with the IRB audit team, Internal Audit staff, or a chancellor-assigned audit team.
   3. Audit Procedures
      
      When conducting an audit of one or more human subject research studies, the audit team:
      
      1. may conduct interviews of knowledgeable sources, including but not limited to the principal investigator, research team members, and subjects;
      2. may observe the methods and processes used;
      3. may review any related research documentation, including but not limited to consent forms, survey instruments, subject identification logs, or other study materials;
      4. shall ensure that the audit procedures used are limited to those that are deemed reasonable and necessary in order to produce relevant, reliable, and sufficient detail that will enable the IRB chair or full board to determine if the study has been conducted in a compliant manner; and
      5. shall make a recommendation based on the documentation collected.
   4. Findings of Serious Noncompliance
      
      If at any time an auditor finds a serious noncompliance or practice that may jeopardize the welfare of human subjects or others, the auditor must notify the IRB at the earliest possible opportunity upon identifying the problem.
   5. Audit Report
      
      Following audit, the audit team will write a report based on the documentation collected that includes recommendations as to whether the study or studies were found to be operating in compliance. The audit team will provide the report to:
      1. the principal investigator of the study;
      2. the IRB co-chair or full board, depending on the review level of the study; and
      3. the Director of Sponsored Programs, if the study received external funding.
   6. Determination of Compliance or Non-compliance
      
      For all activities other than those reviewed by the full board, an IRB co-chair will review the recommendations contained in the report to determine if the audit team found the study to be compliant. The full board will make this determination for studies reviewed at the full board level. If the co-chair or full board determines that the study was found to be non-compliant, the co-chair or full board will refer to SOP 11.1, Findings of Noncompliance.
5. Other Applicable SOPs
   • Expedited Review Procedures- SOP 5.2
   • Full Board Review Procedures- SOP 5.3
   • Conflict of Interest Evaluation Procedures- SOP 9.1
   • Findings of Noncompliance- SOP 11.1
6. Responsibilities
   • Full Board: Responsible for designating audit team members for studies originally approved by the full board. Responsible for reviewing the recommendations included in the audit report and making a determination as to whether the audited study has been conducted in accordance with UNCW IRB policies, SOPs, and related federal regulations.
   • IRB Co-chair: Responsible for designating audit team members for studies originally approved by the full board. Responsible for reviewing the recommendations included in the audit report and making a determination as to whether the audited study has been conducted in accordance with UNCW IRB policies, SOPs and related federal regulations.
   • RIO Director: Responsible for leading audit teams designated by an IRB co-chair or the full board.
   • Audit Team Members: Responsible for conducting audits in a fair, unbiased, and timely manner. Responsible for making recommendations based on audit findings to assist an IRB co-chair or full board in determining if the audited study has been conducted in accordance with UNCW IRB policies, SOPs and related federal regulations.
   • Principal Investigator: Responsible for conducting human subjects research in accordance with IRB policies, SOPs and related federal regulations. Responsible for cooperating fully with audit teams.
   • Research Team Members: Responsible for conducting human subjects research in accordance with IRB policies, SOPs and related federal regulations. Responsible for cooperating fully with audit teams.
7. Resources
   • UNCW IRB Website
   • U.S. Department of Health & Human Services, Office of Human Research Protections Guidance on Institutional Official Responsibilities
   • 45 CFR 46 (“Common Rule”)
   • Belmont Report
   • UNCW Conflict of Interest Website
   • UNCW Office of Internal Audit Website

The purpose of this SOP is to outline the steps for evaluating and investigating a report of noncompliance in a human subjects study.

1. General Information
   
   Researchers conducting human subjects research are required to conduct the research in an ethical and responsible manner, in accordance with the methods and procedures approved by the UNCW Institutional Review Board (IRB). Failing to follow the approved methods and procedures is a violation of UNCW IRB policy.
2. Scope
   
   The SOP pertains to all human subjects research conducted by UNCW faculty, staff and students, or external researchers collaborating with UNCW faculty, staff or students on research approved by the UNCW IRB.
3. Applicable Definitions
   1. Allegation of Noncompliance - An unproven assertion of noncompliance.
   2. Continuing Noncompliance - Any incident of noncompliance that has been:
      1. previously identified during an audit, investigation, or other IRB activity,
      2. confirmed by the IRB or an external authority (e.g., OHRP, FDA, sponsor, etc.) as noncompliance,
      3. communicated in writing to the investigator or research team and
      4. the incident(s) of noncompliance occur again.
   3. Minor Noncompliance
      
      Noncompliance that does not increase risk to subjects and/or violate the research subject’s rights and/or welfare, such as an administrative inconsistency from the methods and procedures approved by the IRB. Examples of minor noncompliance include but are not limited to:
      • Failing to use the official stamped consent form but using a version otherwise identical to the official stamped version.
      • Failing to submit continuing review forms prior to lapse in IRB approval when study was otherwise inactive.
   4. Noncompliance
      
      Failure to comply with the IRB-approved protocol/study (including the requirements or determinations of the IRB), federal regulations, state laws, or UNCW policies or SOPs related to the protection of human subjects.
   5. Protocol Violation
      
      A protocol change or modification (commonly referred to as a protocol deviation) that was not approved by the IRB and is identified by the research team after the change was implemented.
   6. Research Misconduct
      
      Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results. It does not include honest errors or differences of opinion. Noncompliance with IRB policies and/or SOPs generally does not constitute research misconduct.
   7. Serious Noncompliance
      
      Instances of noncompliance that pose an actual or potential increased risk to subjects or violate the safety, rights, and/or welfare of human research subjects.
      
      Examples of serious noncompliance include but are not limited to:
      • Conducting human subjects research without UNCW IRB review, a determination of exemption and/or approval;
      • Enrollment of subjects that fail to meet the inclusion or exclusion criteria of the approved study;
      • Enrollment of subjects while study approval has lapsed;
      • Failing to obtain informed consent from subjects or not providing all relevant sections of the informed consent form to subjects;
      • Major deviations from approved methods and procedures that may place subjects at risk from the research.
      • Failing to promptly report serious unanticipated problems involving risks to subjects or others or noncompliance in the conduct of the study to the UNCW IRB.
   8. Suspension (of research) – a temporary or permanent halt to some or all research procedures short of a termination until the IRB determines whether the research may recommence (with or without modifications to the research) or whether the research must be terminated.
   9. Termination (of research) – a permanent cessation of IRB approval prior to study expiration that includes permanent halt in the enrollment of new subjects, approved activities for previously enrolled subjects and all research activities.
4. Procedures for Reporting of Noncompliance
   1. Any protocol violation and/or alleged noncompliance must be reported by the PI, research staff, or any employee aware of the alleged noncompliance.
      1. The alleged noncompliance must be reported promptly to the IRB chair and/or IRB staff, but no later than five working days, of learning about the noncompliance.
      2. The report of the alleged noncompliance should include all known details of the alleged noncompliance including all individuals involved and the location where the alleged noncompliance occurred.
      3. The report should be preferably submitted in writing to the IRB Office). If the individual(s) reporting the alleged noncompliance is not able or comfortable reporting the alleged noncompliance in writing, then the report may be made verbally to the IRB chair and/or IRB staff.
   2. UNCW, the UNCW IRB, the IRB chair, all IRB members and staff will protect the confidentiality of the person(s) submitting the allegation to the extent allowed by law and the UNCW policies/SOPs.
5. Procedures for IRB Review of Noncompliance
   1. Preliminary brief inquiry
      
      The RIO director, IRB coordinator, and/or the IRB chair or designee will conduct a preliminary brief inquiry to determine whether the allegation involves a current approved study, whether the study is sponsored and, if yes, by whom, and whether the study is overseen by other research committees/units.
      
      If the study is also under the oversight of other committees or research administrative units, the allegation will be reported to the Director/Head/ Chair of the other unit(s)/committee(s).
      
      The IRB will determine, based on the information collected to date, whether the safety, rights, and welfare of subjects are at immediate harm. In such instances, the chair or designee will contact the PI in order to establish an appropriate interim measure (e.g., suspend all new subject enrollment) to be taken to protect subjects until such a time that the full committee can review the study.
      
      If the PI refuses to cooperate with the interim measure, the matter is referred to the IO.
      
      If the study is suspended or any interim action is taken to mitigate or eliminate any risk or harm to subjects, the suspension/interim action will be reported to the IRB at the next available convened meeting.
   2. Magnitude of Noncompliance
      
      Upon finding that a PI or any member of the research team has not complied with federal regulations, state laws, or institutional policies and/or SOPs regarding the protection of human subjects, IRB staff will ask an IRB chair or designee to determine whether the violation is minor or serious.
      1. Minor Noncompliance: If the chair or designee determines that an incident of noncompliance is minor, and it is the first noncompliance by a PI or research team member, IRB staff will send a notification of the minor noncompliance to the PI and/or researcher (if different from the PI). IRB staff will retain a copy of the notification in electronic format.
         1. The researcher and/or PI will be asked to respond within a specified time period and provide the IRB with a plan to correct the noncompliance.
         2. The IRB chair or designee will promptly conduct a review of the researcher’s response and of the corrective action taken.
         3. If the IRB chair or designee finds that the researcher’s response is acceptable, the IRB chair or designee will send the researcher an acknowledgment. IRB staff will retain the researcher’s response and IRB chair’s or designee’s acknowledgment in electronic format.
         4. If the chair or designee finds that the researcher has not adequately addressed the noncompliance, or if the researcher fails to respond within the specified time period, the chair or designee may:
            1. Order the researcher to suspend research activities, if warranted;
            2. Notify the applicable department chair or other immediate supervisor of the researcher, and/or;
            3. Instruct the researcher to submit a plan to correct the noncompliance within a specified time period.
               • The IRB chair or designee will acknowledge the researcher’s corrective action plan when found to be acceptable.
               • If the researcher fails to respond or submits an inadequate response, the IRB chair or designee may treat the incident as serious noncompliance as outlined below.
      2. Serious Noncompliance:If the chair or designee determines that an incident of noncompliance is serious, or if the IRB finds a continuing noncompliance (or significant number or repeated minor infractions), such activities will be reported promptly to the Institutional Official (IO) and forwarded to the full IRB for action.
   3. Possible IRB Actions
      
      The IRB can vote to require any of the following actions or combination of actions:
      1. Open an in-depth investigation- When the IRB votes to open an in-depth investigation, the IRB will designate two or more members of the committee who do not have conflicting interests in the study and are not in the role of lead chair to conduct the investigation under the coordination of the Research Integrity Office director (RIO director). The investigation will be conducted according to the procedures outlined in section D below.
      2. Suspend the protocol- When the IRB votes to suspend the protocol, the RIO director will notify the PI, his/her immediate supervisor, and the IO in writing on behalf of the IRB of the date the suspension must commence. When a protocol is suspended, no new subjects can be recruited or enrolled in the study. The researcher may also be required to phase out existing enrolled subjects. The IRB may instruct the PI to provide the IRB with a plan to phase out subjects, which must be accepted by the IRB, and must contact the IRB when all subjects have been phased out. The study may resume only when the IRB votes to lift the suspension of the protocol.
      3. Terminate the protocol- When the IRB votes to terminate the protocol, the RIO director will notify the PI/researcher, the PI’s immediate supervisor, and the IO in writing on behalf of the IRB of the date the termination must commence. When a protocol is terminated, all research activities related to the protocol must cease. The IRB may direct the PI as to how to terminate the protocol. Typically, the PI may not recruit or enroll new subjects into the study, must notify all enrolled subjects of the termination of the project, and must cease all data collection, analysis, and dissemination. The study may not resume until the IRB votes to lift the termination of the protocol or to allow some parts of the study to continue.
      4. Make recommendation to IO- In extreme cases, the IRB may decide to recommend to the IO that a researcher should no longer be permitted to conduct research at UNCW. When the IRB votes to make this recommendation, the RIO director notifies the IO in writing on behalf of the IRB.
      5. Take no action- The IRB may choose to take no action if the committee determines that the PI has already taken all appropriate actions to correct the noncompliance and has provided adequate assurance to the committee that a plan is in place to avoid the same problem in the future. When the IRB votes to take no action, the PI/researcher, his/her immediate supervisor, and the IO will be notified in writing. IRB staff will file a report in electronic format.
      6. Other Remedies- In addition to or in lieu of the above-mentioned actions, the IRB can vote to require the researcher to complete additional training in the protection of human subjects, require more frequent than annual review of protocols, place a researcher on temporary probation from conducting human subjects research, require the researcher to destroy data already collected, or take any similar disciplinary action appropriate to the magnitude of the noncompliance.
      7. The IRB, IO or Chancellor may take any of the above actions when it is determined a research protocol is not being conducted according to federal or local regulations or UNCW policies and procedures, has deviated from its approved protocol, or raises concerns about the risks to human subjects.
   4. Conducting an In-Depth Investigation
      1. When the IRB determines that an in-depth investigation is required to obtain detailed information regarding the conduct of a human subjects research study, the investigation team may:
         1. Conduct interviews of knowledgeable sources, including but not limited to the principal investigator (PI), research team members, and subjects;
         2. Request from the PI a written response to questions;
         3. Observe the methods and processes used; and
         4. Collect and review any related documentation, including but not limited to correspondence, consent forms, completed survey instruments, subject identification logs, or other study materials.
      2. The investigation team shall ensure that the investigation is conducted in a timely manner, is thorough, and the procedures used are limited to those that are deemed reasonable and necessary in order to produce relevant, reliable, and sufficient detail that will enable the IRB chair or full board to determine further actions needed, if any. They should establish and communicate deadlines for interviews, responses, and document collection and make available extensions for good cause.
      3. Upon conclusion of the investigation, the investigation team shall prepare a written report to the IRB detailing the investigation process, the investigation findings, and the investigative team’s recommendations for further actions to be taken, which may include, but are not limited to:
         1. Require no further action;
         2. Accept and approve a proposed corrective action plan provided by the PI or the Institution;
         3. Require that the PI modify the protocol to minimize risk, such as modifying the recruitment and/or consent procedures or revising the consent document;
         4. Require the interval at which continuing review is conducted to be modified to less than one year as appropriate to the degree of risk;
         5. Require observation of the research or the consent process;
         6. Require submission of status reports on a defined set schedule to the IRB;
         7. Require additional education and training for the PI and/or other research team members;
         8. Require that random audits be performed of studies conducted by the PI to ensure study procedures are followed as approved by the IRB;
         9. Require that previously and/or currently enrolled subjects be notified of the noncompliance and reconsented with the additional relevant information, if applicable, such as information that may relate to a subject’s willingness to continue participation in the research;
         10. Replace the PI of the study with an experienced human subject investigator with a clean research compliance record, selected by the IRB;
         11. Issue a letter of reprimand to the PI and/or other research team member(s) and copying as appropriate the department chair, faculty advisor (if a student PI), dean, provost, institutional official, or other administrator;
         12. Require the PI to destroy or decommission data collected by noncompliant methods or during a lapse in IRB approval;
         13. Refer the PI or all of the researcher team to another University entity (i.e., Institutional Official, Sponsored Programs and Research Compliance, Institutional Risk Management, Human Resources);
         14. Refer the matter to the appropriate UNCW office(s) that handle(s) research misconduct and/or whistleblowing activities.
         15. Suspend any or all components of the research (i.e., new enrollment, treatment, follow-up and data analysis) until a corrective action plan can be developed and implemented or until additional review can occur;
         16. Terminate the research; and/or
         17. Revoke the privilege of the PI and/or members of the research team to conduct human subjects research or serve as a faculty advisor on a human subjects research study.
      4. The IRB will review the investigation report at the next scheduled full board meeting and will consider the recommendations made by the investigation team. The IRB chair will issue a final determination letter to the PI to convey the final decisions of the board. The letter shall also describe the PI’s appeal rights.
   5. Appeals and Reporting Procedures
      1. Appeal- The PI may appeal any action by the IRB in writing to the IO within 10 business days of receiving notification of the decision. The IRB’s decision will stand until the appeal can be properly evaluated. The IO’s decision is final. The only grounds for requesting an appeal are if the researcher believes that the IRB’s decision is due to inadequate or inaccurate information or noncompliance with university policy, state law, or federal regulation. Mere disagreement with the IRB’s decision does not constitute grounds for an appeal. The RIO director will report the IO’s decision to the IRB at the next scheduled meeting and will record the decision in the meeting minutes.
      2. Reporting to Federal Agencies
         1. As required by applicable law, regulation or UNCW policies, the IO shall report, in writing, the finding of serious or continuing noncompliance and the action(s) taken by UNCW to address such noncompliance to regulatory agencies, the study sponsor, and UNCW officials as appropriate.
         2. In accordance with 45 CFR 46.103(a) and (b)(5) and UNCW’s Assurance to the Office of Human Research Protections (OHRP), the IRB must report to OHRP when the following occurs on human subjects research supported by any agency that has adopted the Common Rule:
            1. Any unanticipated problems involving risks to subjects or others that result in changes to the protocol and/or informed consent form;
            2. Any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and
            3. Any suspension or termination of IRB approval.
   6. Findings of Research Misconduct
      
      If the IRB co-chair or full board determines that the incident of noncompliance involves research misconduct, the IRB co-chair will advise the RIO director, who will refer the matter to appropriate institutional officials in accordance with UNCW’s Research Misconduct policy.
6. Responsibilities
   • Full Board: Responsible for taking action on findings of serious noncompliance, for reviewing investigation reports, and for making final decisions on the investigation team’s recommendations.
   • IRB Co-chair: Responsible for determining the level of noncompliance, corresponding with the researcher, and determining if a corrective action plan is acceptable for findings of minor noncompliance.
   • IRB Staff: Responsible for assisting co-chairs with policy and SOP interpretation, drafting correspondence on behalf of co-chairs, providing relevant information to the full board, and retaining correspondence related to noncompliance.
   • RIO Director: Responsible for informing researchers of suspensions and terminations, coordinating investigations, providing guidance to the full board, and coordinating with Sponsored Programs for notifying funding agencies as appropriate.
     Principal Investigator: Responsible for conducting human subjects research in compliance with federal regulations, state laws, and UNCW policies and SOPs, cooperating with IRB instructions on submitting corrective action plans, and complying with suspensions, terminations or other determinations by the full board.
7. Resources
   • UNCW IRB Website
   • UNCW Research Misconduct Policy
   • U.S. Department of Health & Human Services, Office of Human Research Protections, Guidance on Reporting Incidents to OHRP
   • 45 CFR 46
   • Belmont Report