Sponsored Programs & Research Compliance

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Animal Research (IACUC)

In order to ensure the humane care and use of live, vertebrate animals, UNCW has its own federally mandated Institutional Animal Care and Use Committee (IACUC). According to UNCW IACUC policy, all research projects conducted by UNCW researchers (including student research) involving live, vertebrate animals must be approved by the IACUC. Animal, as defined by the Public Health Service Policy on Humane Care and Use of Laboratory Animals, is defined as any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purpose. UNCW will not accept funding for this type of research from an external agency without documentation of IACUC approval.

Faculty members from a variety of scientific and non-scientific disciplines and at least one community representative serve on this university committee to review and approve research projects involving live, vertebrate animals. The Research Integrity Office (RIO) is the administrative office that coordinates the activities of the IACUC.

To report concerns about the welfare of animals used in UNCW research, please complete this survey.

Site Contents


IACUC News:

The UNCW IACUC office continues to offer all services virtually and can be reached at iacuc@uncw.edu.  We look forward to assisting you with your research endeavors!

Updates on the status of campus operations related to Covid-19 can be found on UNCW's Coronavirus website and Best for the Nest website.  Other pandemic-related resources for research are posted here.

HEALTH EVALUATION REQUIREMENT for animal researchers:

Researchers who use live vertebrate animals in research are required to obtain certification from a medical professional prior to initiating animal use activities to identify occupational health issues, if any.  This requirement was mandated by the U.S. Office of Laboratory Animal Welfare and has been in effect since Fall 2018.

CHANGE IN PROCEDURE: We have changed the health care provider that faculty and staff must use for their health evaluation!  The new provider is Wilmington Health Associates, and the procedure is similar to what we have used in the past.  The occupational health provider will review forms submitted via email and determine if a personal visit or phone call is needed.  We have updated the health risk assessment form and instructions to include the new Purchase Order number and contact information for Wilmington Health Occupational Medicine.

UNCW-enrolled students who work with research animals may still use the Abrons Student Health Center. The Health Center will not bill students.

The IACUC will require health screenings to be completed prior to final approval of a protocol.

More information about this requirement can be found in this FAQ.

ABRONS STUDENT HEALTH CENTER TIP:  UNCW students may be evaluated at the Abrons Student Health Center.  If you oversee a student who must be evaluated, one of our researchers suggested that you might want to instruct him/her to schedule the appointment first-thing in the morning to avoid delays in getting seen by medical staff.  The appointment should take only about 20 minutes, but some students have waited up to 40 minutes before seeing medical staff.


IACUC Meeting Schedule and Submission Deadlines

The IACUC typically meets twice each semester to review protocols subject to full committee review. Fall meetings are generally held in mid-September and mid-November; Spring meetings are generally held in mid-February and mid-April. Please email IACUC staff at IACUC@uncw.edu if you need assistance.

IACUC submission and meeting dates

INITIAL SUBMISSION DUE

REVISIONS DUE

IACUC MEETING DATE

Monday, August 29, 2022

Tuesday, September 6, 2022

Monday, September 12, 2022

Monday, October 31, 2022

Monday, November 7, 2022

Monday, November 14, 2022

Please note: According to UNCW IACUC policy, when an IACUC protocol is initially submitted, it is forwarded to the attending veterinarian (AV) for review. The AV will send the principal investigator a consultation form within a few days. The researcher should take the AV's comments under consideration and revise the protocol appropriately. If the researcher makes revisions to the protocol, the revised protocol must be submitted by the scheduled revision date to assure review during the desired meeting date. Researchers should plan accordingly to avoid delays. The IACUC hopes this new procedure will allow for smoother reviews during scheduled meetings.

IACUC INSPECTION DATES - Fall 2022

Fall 2022 inspection dates will be scheduled sometime in mid to late October. Facilities will be contacted individually for specific dates and times.

IACUC Forms


We will use the forms below until we transition to the new online research administration portal powered by InfoEd Global, "OSPREY" (Online Sponsored Programs and Research Enterprise sYstem). OSPREY will also be used for grant proposals and management, Conflict of Interest reporting, and human subject research review and approval (IRB). The IACUC module of OSPREY is estimated to be live in early 2023.

All applicants will need the following forms:
Protocol Form - this form includes all possible sections such as diet manipulation, pain and distress, surgery, and/or drug administration.
Animal Chart - the animal chart is now a separate Excel spreadsheet for maximum functionality
Health Surveillance and Risk Assessment Form for Vertebrate Animal Exposure - this is required for all personnel listed as research team members for all study types.

Some applicants may also need:
Additional Personnel Appendix - for use on studies with more than 5 research team members or when modifying a study to add and/or delete personnel
Disaster Plan Form - required for studies that house animals
Peer Review Form for Scientific Merit - required for studies that have not undergone an extramural peer review for scientific merit

PLEASE NOTE: Depending on your browser you may be prompted to download the forms. If the form does not open properly, please check your downloads folder. If you need assistance, please email iacuc@uncw.edu.

IACUC Training Requirements

The online training course, "Working with the IACUC", provided by the Collaborative Institutional Training Initiative (CITI) is required for all members of the research team. Other courses specific to the research may also be recommended. If you experience difficulty using the CITI website, please check to see if you are using a current version (issued within last 3-4 years) of one of the following browsers: Chrome, Firefox, Internet Explorer, or Safari.

We strongly encourage animal researchers to follow these instructions on how to register for IACUC training (PDF) to make sure you register for the correct training course. 

Go to UNCW IACUC Policy

Standard Operating Procedures

    • SOP 5.1 IACUC Membership Procedures
      The purpose of this SOP is to establish procedures for selecting and appointing members to the UNCW Institutional Animal Care and Use Committee (IACUC).

      General Requirements

      UNCW employees who are interested in serving on the IACUC should indicate preference on the Faculty Senate Committee Preference survey each spring. Active membership on the committee is required. IACUC staff will schedule convened meetings at times when the most members are available, and IACUC members are responsible for contacting IACUC staff at the earliest opportunity if the member is unable to attend a meeting due to a conflicting obligation. IACUC members are expected to interact with each other and researchers in a respectful and constructive manner.

      Scope

      This SOP pertains to members serving on the UNCW IACUC.

      Applicable Definitions

      Institutional Official (IO) – The individual who bears ultimate responsibility for the animal research program. The IO provides assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The IO is responsible for resource planning and ensuring alignment of program goals with the university’s mission.

      IACUC Member in Good Standing – a member is ‘in good standing’ if s/he:

      -has not missed three consecutive, regularly scheduled meetings (without a legitimate reason);
      -has completed all required IACUC training;
      -attends meetings fully prepared to contribute to discussions;
      -is in compliance with IACUC policies;
      -and interacts with researchers, other committee members, and IACUC staff in a respectful and constructive manner.

      IACUC Committee Makeup

      Pursuant to the PHS Policy, the IACUC must consist of at least five (5) members and must include:
      -A doctor of veterinary medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program authority and responsibility for activities involving animals at the institution.
      -A practicing scientist experienced in research involving animals.
      -A member whose primary concerns are in a nonscientific area.
      -A member who is not affiliated with the institution in any way other than as a member of the IACUC and is not a member of the immediate family of a person who is affiliated with the institution.
      -An individual who meets more than one of the categories above may fulfill more than one requirement provided membership consists of at least five (5) people.

      Member Selection and Appointment Procedures Qualification of Members

      The IACUC at this Institution is properly appointed according to PHS Policy IV.A.3.a. and is qualified through the experience and expertise of its members to oversee the Institution's animal care and use program and facilities.

      The IACUC consists of at least 5 members, and its membership meets the composition requirements of PHS Policy IV.A.3.b. UNCW faculty who are interested in serving on the IACUC should indicate preference on the Faculty Senate Committee Preference survey each spring.

      The Institutional Official (IO) Appointment

      The associate provost for Research and Innovation serves as the IO and is appointed by the chancellor. The IO considers recommendations from IACUC staff and chair and submits a recommended roster to the chancellor for consideration and has the authority to appoint individuals as IACUC chair/vice-chair.

      IACUC Chair Appointment

      The IO appoints a tenured or advanced tenure-track faculty as chair for an agreed-upon term with the option of reappointment. The IACUC chair should be an experienced animal researcher and current or former IACUC member.

      IACUC Vice-Chair Appointment

      The IO may appoint a tenured or tenure-track faculty as vice-chair for a one-year term with the option of reappointment. The IACUC vice-chair should be an experienced animal researcher and current or former IACUC member.

      Selection and Appointment of IACUC Members

      Regular IACUC Members IACUC staff review the results of the annual Faculty Senate Committee Preference survey, consult with the committee chair, and make recommendations to the IO based on committee needs. The IO submits a proposed roster to the chancellor’s office for consideration. The chancellor appoints IACUC members for a two-year term.

      Alternate IACUC Members

      Alternate members are selected in the same manner as regular members and have the same responsibilities as regular members. Alternate members typically attend meetings only when needed to vote in place of a regular member of the same classification (scientist, non-scientist, attending veterinarian, unaffiliated). If an alternate member attends a meeting when all similarly classified regular members are present, the alternate member’s vote is not counted. Alternate members in good standing may be offered full member terms as openings become available.

      Member Resignations/Termination Procedures

      Resignation of Member

      If a member needs to resign from the committee before the end of the member’s term, the member must provide written notice to the IACUC 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.

      Member Termination

      IACUC staff, in consultation with the IACUC chair, may recommend to the IO in the best interest of the committee that any member of the committee who has completed an appointment term not be reappointed.

      -If a member who is mid-term is not in good standing as defined above, and IACUC staff have conducted a good-faith effort to return the member to good standing, IACUC staff, in consultation with the IACUC chair, may recommend to the IO in the best interest of the committee to remove the member from the committee.
      -The IO will send the member a written notice of membership termination with reasons for the termination.
      -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 so that committee contributions are properly accounted for.
      -If needed in order to maintain composition and minimum number requirements of PHS Policy IV.A.3.b., the IO may recommend to the chancellor a new member to replace the terminated member.

      Chair Termination

      If a member has serious concerns about the effectiveness of the chair, the member should inform IACUC staff or the IO of the concerns. A serious concern is either:
      -a single action by the chair that resulted in programmatic non-compliance or otherwise jeopardized the integrity of the IACUC program;
      -a series of ineffective behaviors by the chair that impacted the ability of the committee to properly conduct business, or
      -an inability of the chair to fulfill the IACUC chair responsibilities outlined in IACUC policy and SOPs.

      If the concern(s) are not resolved to the satisfaction of the concerned member after IACUC staff and/or the IO conduct an intervention with the chair to correct the problem, the concern(s) will be raised through the proper chain of command until resolved or until the determination is made that the chair must be terminated.
      If such a determination is made, the IO will send written notice to the chair with reasons for the termination. The IO will copy the chancellor and the chair’s supervisor so that committee contributions are properly accounted for. The IO may appoint an interim chair until a new chair can be appointed.
    • SOP 6.1 IACUC Meeting and Minutes
      The purpose of this SOP is to establish guidelines for convening IACUC meetings, list the steps involved in the distribution of protocols in advance of meetings and other materials prior to meetings and outline PHS-requirements for meeting minutes.

      General Requirements

      The UNCW IACUC will convene meetings for the following:

      1) to conduct full committee review of a proposed/new project or ongoing research that the committee has requested to review at a convened meeting;

      2) to review amendments to previously-approved studies if the proposed changes are considered to be significant; and

      3) to suspend an activity.

      The IACUC chair may also call a full committee meeting to determine appropriate action for major offenses/noncompliance.

      IACUC meetings will be scheduled at times when the most members are available. The dates of these standing meetings will be announced on the IACUC website.

      Scope

      This SOP pertains to UNCW IACUC meetings and the minutes compiled from those meetings in compliance with PHS Policy and UNCW’s Assurance. The Institutional Official (IO) is notified of protocol review and approval activities through the IACUC minutes.

      Applicable Definitions

      Assurance – an agreement with the Office of Laboratory Animal Welfare (OLAW) to operate an animal care program in accordance with certain policies and principles. UNCW's OLAW Assurance # is D16-00502(A3871-01).

      Attending Veterinarian (AV) – the AV has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals. The AV reports to the IACUC chair and directly to the IO if any violations of the AWA are discovered.

      Backup Veterinarian – if the AV is unavailable, the Backup AV provides veterinarian services and has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals.

      IACUC staff – Research Integrity Office director or research compliance specialist assigned to oversee the UNCW IACUC program.

      Institutional Official (IO) – the individual who bears ultimate responsibility for the Animal Welfare Assurance Program and is responsible for resource planning and ensuring alignment of program goals with the university’s mission.

      Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI.

      Quorum – a majority of members of the IACUC.

      Convened Meeting Procedures

      Meeting Preparation

      Upon receiving revised applications by the second submission deadline, IACUC staff organize meeting materials, specifically:

      1) create an activity report summarizing all amendments and annual reviews conducted since the previous meeting;

      2) create an agenda showing submissions under review; and

      3) transmit the agenda, activity report, finalized minutes from the previous meeting, and agenda items electronically to all IACUC members.

      Any member of the IACUC may obtain, upon request, detailed information about any amendment or annual review listed on the activity report.

      Meeting Procedures

      IACUC staff must ensure:

      1) A majority of the members of the IACUC (a quorum) are present. (Approval of research is by a majority vote of this quorum.)

      2) No actions or votes occur if the quorum fails during a meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures).

      3) The minutes of the meeting reflect if/when the quorum fails and if/when quorum is restored.

      A member may count toward a quorum when the member cannot physically attend a meeting but can be present by speakerphone or videoconference, provided the member can hear all discussion and interject comments and concerns as needed.

      IACUC members who are also researchers on projects under review may not participate in the review or approval of their own research except to provide information requested by the IACUC and may not be present when the vote takes place. IACUC members may not participate in the vote when the IACUC reviews research in which they have a conflicting interest, and such should be noted in the IACUC meeting minutes.

      Members of the IACUC who vote to disapprove a protocol shall convey their reasons verbally or in writing to the IACUC chair within 7 days of the meeting.

      PIs may be invited to meetings to explain projects and answer questions. PIs may not be present when the IACUC votes on projects. If an IACUC member wishes to ask a PI to address specific journal findings during a convened meeting, the IACUC member must provide the PI and the other committee members with a PDF copy of the journal citation at least 2 days prior to the meeting.

      Each protocol will be fully discussed until there are no more concerns expressed by the members. Any member may make a motion to approve, approve with modifications, table for a future meeting or deny the protocol. After a motion has been made and seconded, the committee chair calls for a vote on the motion.

      The IACUC staff records the anonymous results of the vote. Voting results may be:

      Protocol Approval:

      When the IACUC votes to approve a protocol, the IACUC chair signs the original protocol, the IACUC staff prepares an approval memo for the IACUC chair’s signature and sends a complete copy of the approved/signed protocol to the PI with the memo stating the effective dates of the protocol. IACUC staff retain an electronic copy of the approved/signed protocol in the electronic IACUC files.

      Modifications Required to Obtain Protocol Approval:

      When the IACUC votes to approve a protocol pending minor modifications, the PI must provide the additional information before an approval memo can be issued. If the committee determines that the changes are substantive, the committee may vote to authorize the Designated Member Review Subsequent to Full Review process described below.

      Designated Member Review:

      All members of the IACUC have signed a written agreement that allows a unanimous vote of the convened quorum to refer a protocol to Designated Member Review if it is determined during the meeting that the protocol cannot be approved without substantial modifications. The IACUC chair designates one or more reviewers to complete the review process in accordance with the Designated Member Review procedures specified in SOP 6.2.

      Deny or Withhold Approval:

      When the IACUC votes to deny, withhold or table a protocol, IACUC staff prepares a memo for the IACUC chair’s signature stating the reasons for denial. The researcher is given the opportunity to respond. Approval may only be withheld after full IACUC review. Any minority views (dissensions on protocol approvals or denials) will be included in the minutes of meetings in which they are expressed. Dissenting members may also provide written explanations of their minority views. These should be submitted to the IACUC staff within seven (7) days of the meeting in which the protocol was considered. Minority views will be filed with the appropriate protocol in the IACUC files.

      Meeting Minutes Procedures

      IACUC staff compile the minutes of IACUC meetings which, per PHS Policy and UNCW’s Assurance, capture the following information:

      1) members who attended the meeting;

      2) actions taken at the meeting;

      3) the outcome of the vote on research protocols including the numbers of members voting for or against approval and abstaining;

      4) the basis for requiring any modifications or revisions in research procedures;

      5) documentation of any specific findings required by the federal regulations; and

      6) a summary of the discussion. Meeting minutes are distributed electronically to all IACUC members for review and final approval. IACUC staff retain finalized meeting minutes for three years after the meeting is conducted.
    • SOP 6.2 Protocol Review Process

      The purpose of this SOP is to establish the process for processing and reviewing research or education protocols that involve the use of live, vertebrate animals and amendments to previously approved projects.

      General Requirements

      Per PHS Policy IV.B.6-8 and UNCW policy, the IACUC shall review research and teaching protocols involving the use of live, vertebrate animals to determine that the proposed research project is in accordance with PHS Policy and is consistent with the Guide for the Care and Use of Laboratory Animals unless acceptable justification for a departure is presented, and conforms with the UNCW Assurance. The IACUC may approve, require modifications in (to secure approval), or withhold approval of activities related to the care and use of animals according to PHS Policy IV.C.1-3.

      Scope

      This SOP pertains to studies involving the use of animals as defined below.

      Applicable Definitions

      Animal – any live, vertebrate animal used or intended for use in research, research training (including teaching), experimentation, or biological testing or for related purposes. Only animals approved by the UNCW IACUC are permitted in animal housing or experimentation areas. This definition excludes:
      1) Free-living wild animals observed in their natural habitat during field studies, provided the field study activity is not likely to materially alter or influence the activity of the study animal or other species in the study area and does not have the potential to cause harm (does not involve trapping, capturing, physical/chemical restraint, handling and/or invasive procedures). A field study will materially alter or influence the activity of a study animal if the methods to detect the animal reduce the animal’s chance at survival, the ability to reproduce and/or impacts their migration.
      2) Animals used for display purposes only, such as fish tanks/exhibition aquaria where the animals are not research subjects.
      3) Pets, meaning domestic or tamed animals owned by an individual, whether UNCW employee, student, or community member, kept for that individual’s companionship or personal enjoyment, provided they are not used as research subjects.
      4) Animals that meet the definition of service or emotional support animals per UNCW policy 05.360 Service Animals, Emotional Support Animals, and Pets.

      Assurance – an agreement with the Office of Laboratory Animal Welfare (OLAW) to operate an animal care program in accordance with certain policies and principles. UNCW's OLAW Assurance # is D16-00502(A3871-01).

      Attending Veterinarian (AV) – the AV has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals. The AV reports to the IACUC chair and directly to the institutional official (IO) if any violations of the AWA are discovered.

      Backup Veterinarian – if the AV is unavailable, the Backup AV provides veterinarian services and has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals.

      Designated Member Review (DMR) – a review method where written descriptions of activities involving live vertebrate animals are made available to all IACUC members, and members may request review at a convened meeting for any reason. If no member of the committee requests review at a convened meeting, the IACUC chair designates one or more reviewers who are qualified to conduct the review and have the authority to approve, require modifications (to secure approval), or request full committee review of the activities. Designated reviewers do not have the authority to deny approval. The DMR process in no way implies that the quality of the review is less stringent than a protocol reviewed by the full committee.

      IACUC staff – Research Integrity Office director or research compliance specialist assigned to oversee the UNCW IACUC program.

      Pet – a domestic or tamed animal owned by an individual, whether UNCW employee, student, or community member, kept for that individual’s companionship or personal enjoyment.

      Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI.

      Quorum – a majority of members of the IACUC.

      The Three Rs – a widely accepted concept referring to three ways of reducing distress to research animals and encouraging the use of alternatives. The Three Rs, reduction, refinement and replacement, are defined as:
      1) Replacement - substituting other systems for whole animal use. Examples include human and animal cell, tissue, and organ cultures; chemical systems; blood products; computer simulations; and plastic organ models.
      2) Reduction - decreasing the number of animals to the minimum needed to yield accurate test results.
      3) Refinement - using modern medicine to minimize or eliminate pain and distress and employing housing and husbandry techniques to enrich the captive environment to reduce boredom and promote natural behavior.

      Protocol Processing Procedures for Initial and Replacement Submissions

      Upon receipt of a protocol to use live, vertebrate animals for research or education, IACUC staff are responsible for the following:
      1) assigning a protocol number;
      2) entering protocol information in the IACUC database;
      3) saving an electronic copy of the submission in appropriate folder; and
      4) conducting an initial administrative review to ensure all relevant questions on the form have been completed, any necessary appendices have been included, and basic compliance requirements have been met, such as training requirements and the health evaluation requirements described in SOP 7.1 Health Surveillance and Risk Assessment for Vertebrate Animal Exposure (a.k.a. Health Screening Questionnaire).

      IACUC staff complete relevant sections of the Veterinary Consultation form and transmit a copy of each submitted protocol to the AV and/or back-up AV. The AV and/or back-up AV conduct a veterinary consultation of the study and send comments and recommendations to the PI. The PI may revise and resubmit the protocol based on the AV's comments.

      The PI must return the revised protocol to IACUC staff by or before the second submission deadline posted on the IACUC website.

      IACUC staff organizes meeting materials in accordance with SOP 6.1 IACUC Meetings and Minutes.

      Protocol Review Procedures for Initial and Replacement Submissions

      Full IACUC Review

      Submissions are normally placed on regularly scheduled convened meeting agendas, and PIs are expected to plan in advance so that no special approval arrangements are necessary to accommodate the researcher's needs.

      Full board meetings are conducted in accordance with SOP 6.1 IACUC Meetings and Minutes.

      The IACUC will conduct its review of submissions in accordance with PHS Policy IV.C and will specifically consider the Three Rs (see Definitions), personnel qualifications, and personnel safety.

      Designated Member Review (DMR)

      If designated review is authorized by the members, the IACUC chair or designee appoints a member, a team of members, or him/herself to conduct the review. The designated reviewer or review team (reviewer) has the authority to approve or require modifications to the protocol. When the reviewer decides to approve a protocol, the reviewer notifies the IACUC staff and the IACUC staff prepares an approval memo for the IACUC chair’s or designee’s signature.

      When the reviewer determines that modifications are needed in order for the PI to secure approval, the reviewer may contact the PI by phone, e-mail or in person to discuss the protocol and the modifications required. In all instances, the reviewer must notify the IACUC staff of the information being requested from the PI. The modifications are communicated in writing to the PI by the IACUC staff and that communication/exchange becomes part of the electronic protocol file for the proposed study.

      When the revised protocol is submitted and the PI’s responses to the required modifications are found to be acceptable, approval procedures stated above are followed.

      The reviewer does not have the authority to deny an application for animal use. If the reviewer is unable to approve a protocol with or without changes, the reviewer must withhold approval and request full review of the protocol.

      When the reviewer decides to withhold approval of the protocol, the reviewer e-mails justification for his/her decision to the IACUC staff. IACUC staff prepares a memo for the IACUC chair’s or designee’s signature and includes the justification in the memo. The memo may also include the date of the next IACUC meeting, if known, and other instructions to the PI. IACUC staff send the memo to the PI.

      An electronic copy of the approved/signed protocol is placed in the IACUC files.

      Procedures for Processing and Reviewing Modifications to Approved Protocols

      PIs are responsible for submitting requests to change any aspect of an approved protocol, including changes to personnel, funding sources, types or numbers of animals used, etc. in accordance with SOP 7.2 Protocol Development, Submission and Modification Requirements.

      PIs must submit these requests in writing to iacuc@uncw.edu.

      Upon receiving a request to modify a study, IACUC staff review the information provided, determine if additional information is needed in order to properly direct the request, and acknowledge receipt of the request to the PI and if necessary, request clarifications.

      Minor changes may be handled administratively by IACUC staff. These changes are documented in the electronic protocol file and include:
      1) correcting typographical errors;
      2) correcting grammar;
      3) updating contact information;
      4) changing personnel, other than the PI, if it can be documented that all such personnel are appropriately identified, adequately trained and qualified, enrolled in applicable occupational health and safety programs, and meet other criteria as required by the IACUC;
      5) adding or removing experimental rooms or housing areas in buildings already approved by the IACUC for those purposes; and/or
      6) proposing an increase in the total number of animals needed for animal groups that will experience Pain Category B, provided appropriate justification is provided.

      Moderate changes require review by either the IACUC chair or an IACUC member appointed by the chair in order to receive approval. Once approved, these changes are documented in the electronic protocol file. Examples of moderate changes include but are not limited to:
      1) harvesting additional tissues if it requires additional procedures and/or substantially lengthens anesthesia or captivity length;
      2) taking additional measurements;
      3) altering the operant schedule (e.g. fixed ratio to variable interval);
      4) altering a surgical approach;
      5) using a different gender animal;
      6) making a minor change in species (rat to mouse); and/or
      7) proposing an increase in the total number of animals needed for animal groups that will experience Pain Categories C or D, or proposing a 10% increase or less of animal groups that will experience Pain Category E, provided the animal group does not include endangered or threatened species at state or federal level, and appropriate justification is given.

      Significant changes in ongoing research projects are those that either have, or have the potential to have, a negative impact on animal welfare, or those that indicate a substantial difference in the conduct of the study. Significant changes require the PI to submit a revised protocol and, as determined by the IACUC chair or designee, may require review by the full committee for designated member review or review at a convened meeting, depending on the nature of the request. Once approved, the revised protocol becomes part of the original protocol electronic file. Examples of significant changes include but are not limited to:
      1) changing the objective of a study;
      2) changing from non-survival to survival surgery;
      3) changing the degree of invasiveness of a procedure or discomfort to an animal;
      4) making a substantive change in species;
      5) changing the principal investigator of the study;
      6) changing the anesthetic agent(s) or the use or withholding of analgesics;
      7) changing the approved method of euthanasia;
      8) changing the duration, frequency, or number of procedures performed on an animal; and/or
      9) proposing more than a 10% increase in the total number of animals needed for animal groups that will experience Pain Category E or that include threatened or endangered species at the state or federal level.

      Procedures for Continuing Review of On-Going Research Projects

      The IACUC will conduct continuing review of each previously approved, on-going activity at appropriate intervals as determined by the IACUC, including a complete de novo review at least once every 3 years according to PHS Policy IV.C.1.-5. Continuing review is conducted at least annually. The IACUC may determine that some protocols require continuing review more often than annually, based on the type of animals used or procedures involved.

      Principal Investigator Notification

      The IACUC must notify the PI in writing as soon as possible of the results of the review.
    • SOP 6.3 IACUC Semi-annual Inspection Procedures


      The purpose of this SOP is to establish procedures for conducting animal facility inspections.

      General Requirements

      The UNCW IACUC is required to conduct animal facility inspections at least once every six months. All IACUC members are invited to serve on a team to conduct inspections of all the Institution's animal facilities, including satellite facilities and animal surgical sites, using the Guide and OLAW guidelines.

      Scope

      This SOP pertains to the UNCW IACUC and principal investigators who house live, vertebrate animals for periods of more than twenty-four (24) hours.

      Applicable Definitions

      Animal – any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes (PHS Policy). Only animals approved by the UNCW IACUC are permitted in animal housing or experimentation areas.

      This definition excludes:
      Free-living wild animals observed in their natural habitat during field studies, provided the field study activity is not likely to materially alter or influence the activity of the study animal or other species in the study area and does not have the potential to cause harm (does not involve trapping, capturing, physical/chemical restraint, handling and/or invasive procedures). A field study will materially alter or influence the activity of a study animal if the methods to detect the animal reduce the animal’s chance at survival, the ability to reproduce and/or impacts their migration. Animals used for display purposes only, such as fish tanks/exhibition aquaria where the animals are not research subjects.
      Pets, meaning domestic or tamed animals owned by an individual, whether UNCW employee, student, or community member, kept for that individual’s companionship or personal enjoyment, provided they are not used as research subjects.
      Animals that meet the definition of service or emotional support animals per UNCW policy 05.360 Service Animals, Emotional Support Animals, and Pets.

      Animal Facility – any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal (as defined above) confinement, transport, maintenance, breeding, or experiments, inclusive of surgical manipulation. A satellite facility is any containment outside of a core facility or centrally designated or managed are in which animals are housed for more than 24 hours (PHS Policy).

      Institutional Official (IO) – the individual who bears ultimate responsibility for the Animal Welfare Assurance Program and is responsible for resource planning and ensuring alignment of program goals with the university’s mission. Minor Deficiency – a problem for which an immediate solution is not necessary to protect the health or safety of animals in the judgement of the IACUC.

      Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI.

      Significant Deficiency – an unapproved departure from regulatory standards that, in the judgement of the IACUC, could cause injury, death, or severe distress to animals or people. Significant deficiencies that impact animal wellbeing must be reported to OLAW if the study is funded by a PHS agency.

      Inspection Procedures

      During the first meeting of the fall and spring semesters, or thereabout, IACUC staff consult with IACUC members to establish dates to conduct animal facility inspections. Once dates are established, IACUC staff publish them on the IACUC website. IACUC staff notify PIs who house live, vertebrate animals for more than 24 hours, of inspection dates by email at least one week prior to scheduled inspection dates and provide PIs with an estimated arrival schedule.

      PIs must ensure that the inspection team can access animal facilities they oversee. PIs must arrange to have a knowledgeable research team member present to answer any questions the inspection team may have or notify IACUC staff if no research team member is available at the scheduled time.

      IACUC staff organize resources for the inspection team’s use, such as lists of active protocols that house animals, previous inspection reports, guidelines to conduct inspections, and maps of buildings.

      Inspection teams typically consist of at least two voting members of the IACUC who have no conflicting interests regarding the facility scheduled for inspection. If deemed appropriate by the IACUC when scheduling inspections, inspections may be conducted by one unconflicted voting committee member and/or conducted virtually if necessary due to extenuating circumstances, such as restrictions on access to buildings.

      The IACUC subcommittee will evaluate animal facilities based on OLAW guidelines, the Guide, known best practices for appropriate animal husbandry and maintenance of experimental areas, and methods approved by the IACUC.

      IACUC staff will record any concerns and/or deficiencies identified by the inspection subcommittee and enter observations onto a report that is sent to the PI, the PI’s supervisor, the IACUC, and the IO.

      Significant deficiencies that impact animal wellbeing must be reported to OLAW if the study is funded by a PHS agency. PIs must correct deficiencies identified or address concerns by the date established by the IACUC.

      IACUC staff ensure corrections have been made and if necessary, arrange for a voting IACUC member to confirm with a follow-up visit. IACUC staff record inspection dates, any reported deviations or minority opinions on the Semi-annual report to the IO and Annual Report to OLAW.
    • SOP 6.4 Procedures for Investigating Allegations and Incidents of Noncompliance and/or Concerns for Animal Welfare


      The purpose of this SOP is to outline the steps for evaluating and investigating a report of noncompliance or concern for animal welfare in a live, vertebrate animal research study or educational activity.

      General Information

      Researchers conducting research, training or educational activities with live, vertebrate animals are required to conduct the activity in a humane, ethical and responsible manner, in accordance with the methods and procedures approved by the UNCW Institutional Animal Care and Use Committee (IACUC). Failing to follow the approved methods and procedures is a violation of UNCW IACUC policy.

      Scope

      The SOP pertains to all live, vertebrate animal research, teaching and training activities conducted by UNCW faculty, staff and students, or external researchers collaborating with UNCW faculty, staff or students on research approved by the UNCW IACUC.

      Applicable Definitions

      Allegation of Noncompliance – an unproven assertion of noncompliance.

      Attending Veterinarian (AV) – the AV has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals. The AV reports to the IACUC chair and directly to the institutional official (IO) if any violations of the AWA are discovered.

      Continuing Noncompliance – repeated instances of noncompliance by the same investigator. “Repeated instances” can mean a noncompliant activity occurring multiple times within the same study, or a noncompliant activity occurring once in multiple studies. Such repetition if unaddressed may affect the humane care and use of live, vertebrate animals.

      Institutional Official (IO) – the individual who bears ultimate responsibility for the Animal Welfare Assurance Program and is responsible for resource planning and ensuring alignment of program goals with the university’s mission.

      Minor Noncompliance – noncompliance that does not increase risk to animals, such as an administrative inconsistency from the methods and procedures approved by the IACUC. Examples of minor noncompliance include but are not limited to:
      Failing to submit annual review information within a reasonable time following the due date.
      Failure to notify the IACUC when appropriately trained personnel were added to the research team;
      Using a location not listed on the approved protocol for approved activities.

      Noncompliance – failure to comply with federal regulations, state laws, or UNCW policies or SOPs related to the humane care and use of live, vertebrate animals, and/or the requirements or determinations of the IACUC, or provisions of the approved research, education or training study.

      Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI.

      Research Misconduct – fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion. Noncompliance of IACUC policies and/or SOPs generally does not constitute research misconduct.

      Serious Noncompliance – instances of noncompliance that pose an actual or potential increased risk to the wellbeing of live, vertebrate animals or UNCW research team members working on animal research. Examples of serious noncompliance include but are not limited to:
      Conducting research, education or training activities involving live, vertebrate animals without UNCW IACUC review and approval;
      Continuing use of animals after study approval has lapsed;
      Changing the PI of the study without IACUC approval;
      Allowing untrained or inappropriately trained individuals to work with animals;
      Not providing anesthetics or analgesics as required by the approved protocol;
      Performing unapproved surgical procedures;
      Using an unapproved euthanasia method;
      Other major deviations from approved methods and procedures that may place animals or research team members at risk; and/or
      A combination of continuing and/or minor incidents of noncompliance or concerns of inhumane treatment of animals.

      Whistleblower – a person who informs on an individual or an organization engaged in an unethical or illegal activity.

      General Procedures

      Retaliation and/or discrimination against any individual who acts as a whistleblower by reporting a concern regarding animal welfare is strictly prohibited and actionable. Retaliation and/or discrimination may result in a disciplinary action up to and including dismissal from employment or expulsion from the university, in accordance with procedures established by university policies.

      Any individual who identifies a concern regarding animal welfare or who identifies a possible incident of noncompliance should report the matter to IACUC staff, the IACUC chair, or the IO. The Research Integrity Office (RIO) also maintains a reporting system on its website to accept anonymous complaints or concerns.

      The recipient of the concern, if not the RIO director, will notify the RIO director of the concern at the earliest opportunity.

      If the IACUC chair has a conflicting interest in the matter, the RIO director will ask the IO to designate an IACUC member without a conflicting interest to oversee the IACUC’s response to the concern.

      If the report is made by a complainant whose identity is known, and the complainant wishes to maintain confidentiality of his/her identity, the RIO director will not divulge the complainant’s name unless it is ultimately found that the complainant provided inaccurate information in bad faith. If so, the RIO director will share the complainant’s identity to appropriate authorities such as the IO and/or General Counsel’s office for possible disciplinary or legal action.

      At the conclusion of the review or investigation, the RIO director will communicate the IACUC’s findings to the reporting individual, if their identity is known.

      Within one day of being notified of the concern, the IACUC chair or designee will determine the appropriate initial response based on whether the concern:

      Places animal welfare or safety at risk If the concern describes conditions that threaten animal welfare, the IACUC chair or designee will immediately:
      Notify the AV and request a site visit. If the site visit reveals a deviation from regulation, policy or protocol that poses a serious threat to animal welfare, the IACUC chair/designee and/or AV have authority to temporarily halt research activities until the full committee convenes to determine appropriate action.
      Notify the IO

      Places staff safety at risk:
      If the concern describes conditions that create unsafe conditions for research team members, the IACUC chair or designee will immediately:
      Notify the UNCW Environmental Health & Safety office and request a site visit.
      Notify the IO

      Involves research misconduct

      If the concern describes research misconduct, the IACUC chair/designee will advise the RIO director to refer the matter to appropriate institutional officials in accordance with UNCW’s Research Misconduct policy.

      Involves noncompliance with IACUC policy that does not impact animal welfare.

      Upon determining the appropriate initial response, the chair/designee will instruct IACUC staff to send an inquiry to the PI of the study on behalf of the chair/designee to notify the PI that a concern regarding animal welfare and/or possible noncompliance has been identified, and instruct the PI to respond to the concern within two days.

      IACUC staff will retain a copy of the notification in electronic format.

      IACUC staff will place the concern on the next regularly scheduled convened IACUC meeting for evaluation and will provide the committee with a summary of the concern and the PI’s response. If the PI fails to respond, IACUC staff will advise the committee of the PI’s failure to respond.

      If necessary, based on the nature of the concern, the IACUC chair may call a special meeting to review the matter.

      Only a quorum of convened IACUC members may determine if a concern or complaint warrants a full investigation.

      Minor Noncompliance

      When the IACUC determines that a concern or complaint constitutes an incidence of minor noncompliance, the IACUC may direct the chair/designee, a subcommittee, or IACUC staff to instruct the PI to develop a corrective action plan to address the problem, establish the due date of the corrective action plan, and who will review it to determine if it is acceptable.

      Serious Noncompliance

      If the IACUC determines that an incident of noncompliance is serious, or if the IACUC finds a significant number or repeated minor infractions the IACUC can vote to require any of the following actions or combination of actions:
      Take no action – When the IACUC votes to take no action, the PI, his/her immediate supervisor, and the IO will be notified in writing. IACUC staff will file a report in electronic format.
      Open an in-depth investigation - When the IACUC votes to open an in-depth investigation, the IACUC 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 chair/designee to conduct the investigation under the coordination of the RIO director.
      Suspend the protocol – When the IACUC 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 IACUC of the date the suspension must commence. When a protocol is suspended, no new animals can be collected. The researcher may also be required to safely return animals to the collection location if collected from the field, or if possible, transfer animals to another approved study conducted by a researcher not involved with the incident of noncompliance. The IACUC may instruct the PI to provide the IACUC with a plan to phase out the use of animals, which must be accepted by the IACUC, and must contact the IACUC when all animals have been phased out. The study may resume only when the IACUC votes to lift the suspension of the protocol.
      Terminate the protocol – When the IACUC votes to terminate the protocol, the RIO director will notify the PI, the PI’s immediate supervisor, and the IO in writing on behalf of the IACUC of the date the termination must commence. When a protocol is terminated, all research activities related to the protocol must cease. The IACUC may direct the PI as to how to terminate the protocol. Typically, the PI may not collect new animals and must submit a plan to the IACUC describing how existing animals will be cared for until they are able to be transferred to other approved studies conducted by researchers not involved in the incident of noncompliance, safely returned to the collection site if collected from the field, or other humane method of ceasing use of the animals. The study may not resume until the IACUC votes to lift the termination of the protocol or to allow some parts of the study to continue.
      Prevent the researcher/PI from conducting research at UNCW - In extreme cases, the IACUC may decide to no longer permit a researcher to conduct research at UNCW. When the IACUC votes to prevent a researcher from conducting research, the RIO director notifies the PI, the PI’s immediate supervisor, and the IO in writing on behalf of the IACUC. When the IACUC votes to prevent a researcher from conducting research at UNCW, all relevant research activities must cease.

      In addition to or in lieu of the above-mentioned actions, the IACUC can vote to require the researcher to complete additional training in the humane care and use of animals, require more frequent than annual review of protocols, place a researcher on temporary probation from conducting animal research, require the researcher to destroy data already collected, or take any similar disciplinary action appropriate to the magnitude of the noncompliance.

      The IACUC or IO 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 animals or research team members.

      Procedures for Conducting an In-Depth Investigation

      When the IACUC determines that an in-depth investigation is required to obtain detailed information regarding the conduct of a live, vertebrate animal study, the investigation team may:
      Conduct interviews of knowledgeable sources, including but not limited to the principal investigator (PI), research team members, and animal housing staff;
      Request from the PI a written response to questions;
      Observe the methods and processes used; and
      Collect and review any related documentation, including but not limited to correspondence, feeding and husbandry logs, or other study materials.

      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 IACUC chair/designee 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.

      Upon conclusion of the investigation, the investigation team shall prepare a written report to the IACUC 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:
      Require no further action;
      Accept and approve a proposed corrective action plan provided by the PI or the Institution;
      Require that the PI modify the protocol to minimize risk, such as modifying the feeding or husbandry procedures or revising other methods and procedures;
      Require the interval at which continuing review is conducted to be modified to less than one year as appropriate to the degree of risk;
      Require observation of the research;
      Require submission of status reports on a defined set schedule to the IACUC;
      Require additional education and training for the PI and/or other research team members;
      Require that random audits be performed of studies conducted by the PI to ensure study procedures are followed as approved by the IACUC;
      Replace the PI of the study with an experienced animal researcher with a clean research compliance record, selected by the IACUC;
      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 noncompliant individual was a student), dean, provost, institutional official, or other administrator;
      Require the PI to destroy or decommission data collected by noncompliant methods or during a lapse in IACUC approval;
      Refer the PI or all of the research team to another University entity (i.e., IO, Sponsored Programs and Research Compliance, Institutional Risk Management, Human Resources);
      Refer the matter to the appropriate UNCW office(s) that handle(s) research misconduct and/or whistleblowing activities;
      Suspend any or all components of the research (i.e., new animal collection, specific experiments, and data analysis) until a corrective action plan can be developed and implemented or until additional review can occur;
      Terminate the research; and/or
      Revoke the privilege of the PI and/or members of the research team to conduct live, vertebrate animal research or education activities.

      The IACUC will review the investigation report at the next scheduled full board meeting and will consider the recommendations made by the investigation team. If the investigation is completed in-between regularly scheduled IACUC meetings, the IACUC may decide if an additional meeting should be scheduled to consider the recommendations.

      The IACUC chair/designee 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.

      Appeals and Reporting Procedures

      Appeal

      The PI may appeal any action by the IACUC in writing to the IO within 10 business days of receiving notification of the decision. The IACUC’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 IACUC’s decision is due to inadequate, or inaccurate information, or noncompliance with university policy, state law or federal regulation. Mere disagreement with the IACUC’s decision does not constitute grounds for an appeal.

      The RIO director will report the IO’s decision to the IACUC at the next scheduled meeting and will record the decision in the meeting minutes.

      Reporting to Federal Agencies

      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.

      In accordance with UNCW’s Assurance to the Office of Laboratory Animal Welfare (OLAW), Part VI.B., the IACUC must report to OLAW when the following occurs on animal research supported by a Public Health Service agency or the National Science Foundation:
      Any serious or continuing noncompliance with the PHS Policy
      Any serious deviations from the provisions of the Guide
      Any suspension of an activity by the IACUC.
    • SOP 7.1 Health Surveillance and Risk Assessment for Vertebrate Animal Exposure


      The purpose of this SOP is to establish procedures for ensuring all research team members complete an assessment for health risks associated with conducting research on live, vertebrate animals.

      General Requirements

      In June 2018, the Office of Laboratory Animal Welfare (OLAW) added an occupational health screening requirement to UNCW’s animal care and use program. The UNCW IACUC’s position on the new requirement is that the conduct of research with vertebrate animals is a privilege, and it is important for UNCW to hold its animal researchers to a standard other than those held by other industries that interact with animals. Best practices identified by various regulatory and advisory organizations such as OLAW and the National Research Council include monitoring and protection of health for those who work in animal laboratories or field settings where the daily care of, or frequent and/or independent contact with, animals exists.

      Scope

      This SOP applies to all individuals listed in or added to the research team member section of protocols submitted to and approved by the IACUC. All activities that require approval by the IACUC are subject to this requirement. There are no exclusions to the Health Surveillance and Risk Assessment for certain types of activities, such as netting fish or other field work, and there are no exclusions for certain species.

      Applicable Definitions

      Animal – any live, vertebrate animal used or intended for use in research, research training (including teaching), experimentation, or biological testing or for related purposes. Only animals approved by the UNCW IACUC are permitted in animal housing or experimentation areas. This definition excludes:
      Free-living wild animals observed in their natural habitat during field studies, provided the field study activity is not likely to materially alter or influence the activity of the study animal or other species in the study area and does not have the potential to cause harm (does not involve trapping, capturing, physical/chemical restraint, handling and/or invasive procedures). A field study will materially alter or influence the activity of a study animal if the methods to detect the animal reduce the animal’s chance at survival, the ability to reproduce and/or impacts their migration.
      Animals used for display purposes only, such as fish tanks/exhibition aquaria where the animals are not research subjects.
      Pets, meaning domestic or tamed animals owned by an individual, whether UNCW employee, student, or community member, kept for that individual’s companionship or personal enjoyment, provided they are not used as research subjects.
      Animals that meet the definition of service or emotional support animals per UNCW policy 05.360 Service Animals, Emotional Support Animals, and Pets.

      Health Evaluation for Researchers – an assessment conducted by a medical professional to determine health risks associated with the use of live vertebrate animals used in research (U.S. Office of Laboratory Animal Welfare, 2018).

      Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI. Researcher – any member of a research team.

      Procedures

      Procedures for Students Listed as Research Team Members on Animal Research Protocols

      Students complete the risk assessment form approved by the IACUC and available on the IACUC website. Students make an appointment at the Abrons Student Health Center for evaluation. Health center leadership has agreed to provide this evaluation at no charge to students. Students bring the completed risk assessment form with them to meet with a healthcare professional, who will review the information on the form with the student.

      The healthcare professional will complete the Healthcare Provider Clearance Form (page 3 of the risk assessment survey) and provide a signed copy to the student.

      The student submits the Healthcare Provider Clearance Form to the PI of the animal research study. If the student is a member of multiple research teams, the Healthcare Provider Clearance form can cover multiple studies.

      The student should also discuss any health-related concerns noted on the Healthcare Provider Clearance Form with the PI to see if any additional protective gear or accommodations are needed to ensure the health of the student.

      This process is the same for undergraduate, graduate and post-doctoral students.

      Procedures for UNCW Faculty and Staff Listed as Research Team Members on Animal Research Protocols

      Faculty/staff researchers complete the risk assessment form approved by the IACUC and available on the IACUC website.

      Faculty/staff researchers submit the completed risk assessment form by email to Wilmington Health Associates at occmed@wilmingtonhealth.com. An occupational healthcare provider at Wilmington Health will review the risk assessment form email Healthcare Provider Clearance Forms to the requestor.

      If a health condition is indicated on the form that warrants a conversation or examination, the physician will determine if an in-person exam is needed or if an evaluation can be performed over the phone.

      Wilmington Health will invoice the Research Integrity Office for risk assessments they conduct.

      If faculty/staff prefer to use their own personal physicians to conduct this evaluation, they must first check to make sure that the university will not have to pay more than what it would be charged by Wilmington Health for the service. After confirming this, faculty/staff must pay out-of-pocket for the evaluation and submit a receipt to RIO for reimbursement.

      Faculty/staff research team members submit their Healthcare Provider Clearance Forms to the PI of the animal research study. If the employee is a member of multiple research teams, the Healthcare Provider Clearance form can cover multiple studies.

      Faculty/staff research team members should also discuss any health-related concerns noted on the Healthcare Provider Clearance Form with the PI to see if any additional protective gear or accommodations are needed to ensure the health of the employee.

      If the faculty/staff member is the PI, s/he submits the Healthcare Provider Clearance Form to the IACUC at iacuc@uncw.edu and notes the date of completion on all protocols forms submitted to the IACUC for approval.

      Procedures for PIs of Animal Research Studies

      If the PI needs to add new personnel to a study after receiving IACUC approval, the PI must ensure that new personnel meet this requirement (along with the usual required online training) prior to submitting the individual’s name to the IACUC to request approval to amend the study.

      The PI should discuss with research team members any health-related concerns noted on the Healthcare Provider Clearance Form to see if any additional protective gear or accommodations are needed to ensure the safety and well-being of researchers.

      The PI must retain the Healthcare Provider Clearance Form (page 3 only of the questionnaire) for all research team members in a secure location and make a note of the date clearance was provided.

      The PI must provide the date of the health evaluation on any new or replacement protocol or modification request to add personnel submitted for approval to the IACUC.

      The PI must also send a copy of the Healthcare Provider Clearance Form to IACUC at IACUC@uncw.edu.

      Certification of clearance must be provided to the IACUC prior to protocol approval.
    • SOP 7.2 Protocol Development, Submission, and Modification Requirements


      The purpose of this SOP is to establish the requirements for research protocol development and submission to the IACUC for review.

      General Requirements

      Researchers are responsible for designing and implementing research and educational activities consistent with the Three Rs (see Definitions) so that animals receive the most humane treatment possible. They must also comply with all applicable sections of the Guide for the Care and Use of Laboratory Animals (“the Guide”) and other applicable guidelines (see Resources section below) as well as all applicable UNCW policies and procedures, and IACUC decisions, conditions, and requirements.

      PIs should refer to their protocols by UNCW protocol number in all communication with the IACUC and IACUC staff.

      Scope

      This SOP pertains to the development of protocol applications for the use of animals in research at UNCW and includes a list of items/concerns that the IACUC takes into consideration during review of the protocol application.

      Principal Investigators (PIs) should use this SOP as a guide during the development, submission and modification of protocols involving live, vertebrate animals.

      Applicable Definitions

      Animal – any live, vertebrate animal used or intended for use in research, research training (including teaching), experimentation, or biological testing or for related purposes. Only animals approved by the UNCW IACUC are permitted in animal housing or experimentation areas. This definition excludes:
      Free-living wild animals observed in their natural habitat during field studies, provided the field study activity is not likely to materially alter or influence the activity of the study animal or other species in the study area and does not have the potential to cause harm (does not involve trapping, capturing, physical/chemical restraint, handling and/or invasive procedures). A field study will materially alter or influence the activity of a study animal if the methods to detect the animal reduce the animal’s chance at survival, the ability to reproduce and/or impacts their migration.
      Animals used for display purposes only, such as fish tanks/exhibition aquaria where the animals are not research subjects.
      Pets, meaning domestic or tamed animals owned by an individual, whether UNCW employee, student, or community member, kept for that individual’s companionship or personal enjoyment, provided they are not used as research subjects.
      Animals that meet the definition of service or emotional support animals per UNCW policy 05.360 Service Animals, Emotional Support Animals, and Pets.

      Assurance – an agreement with the Office of Laboratory Animal Welfare (OLAW) to operate an animal care program in accordance with certain policies and principles. UNCW's OLAW Assurance # is D16-00502(A3871-01).

      Attending Veterinarian (AV) – the AV has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals. The AV reports to the IACUC chair and directly to the institutional official (IO) if any violations of the AWA are discovered.

      Backup Veterinarian – if the AV is unavailable, the Backup AV provides veterinarian services and has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals.

      IACUC staff – Research Integrity Office director or research compliance specialist assigned to oversee the UNCW IACUC program.

      Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI. Quorum – a majority of members of the IACUC.

      Researcher – any member of a research team.

      The Three Rs – a widely accepted concept referring to three ways of reducing distress to research animals and encouraging the use of alternatives. The Three Rs, reduction, refinement and replacement, are defined as:
      Replacement - substituting other systems for whole animal use. Examples include human and animal cell, tissue, and organ cultures; chemical systems; blood products; computer simulations; and plastic organ models.
      Reduction - decreasing the number of animals to the minimum needed to yield accurate test results.
      Refinement - using modern medicine to minimize or eliminate pain and distress and employing housing and husbandry techniques to enrich the captive environment to reduce boredom and promote natural behavior.

      Protocol Submission Procedures

      The Principal Investigator (PI) must submit protocol(s) to IACUC staff using the most current electronic forms available on the IACUC website. PIs from other institutions may submit their institutional forms if they have already obtained IACUC approval from their home institution and the form required by the home institution provides substantially the same information as the UNCW form.

      PIs from other institutions must receive written UNCW IACUC approval before starting any activities using UNCW animals or facilities.

      If a PI desires review at a specific IACUC meeting, the PI must submit all necessary forms electronically by the submission deadlines posted on the IACUC website. The IACUC cannot ensure placement of a protocol on a meeting agenda if submitted after the corresponding deadline.

      Protocol Development Procedures

      It is the responsibility of the PI to ensure that research personnel have completed required online training and health screening requirements as specified by IACUC policy and SOP 7.1 Health Surveillance and Risk Assessment Form for Vertebrate Animal Exposure.

      Dates of completion for training and health screening must be indicated on the protocol form in the designated section. PIs must either demonstrate the scientific/technical merit of a study by either:
      Obtaining determinations to that effect from two appropriately qualified UNCW scientists who do not have conflicting interests in confirming the scientific merit of the study. When the study is associated with an academic course, one of the internal reviewers must be the department chair/director to certify approval to use departmental resources for the purposes described in the application; or
      Indicating on the protocol form that external funding has been awarded for the study and the study has undergone review for scientific merit by the external funding agency.

      PI develops the protocol with the following components in mind to ensure that the proposed research will be conducted in accordance with the three Rs (see Definitions), relevant guidance (see Resources below), and the Guide unless acceptable justification for a departure is presented. Components to be considered:
      Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
      Species to be used is identified;
      Number of animals to be used;
      Justification for involving live, vertebrate animals, for the appropriateness of the species, and for the numbers to be used; and
      Complete description of the proposed use of the animals.

      Animal Housing

      When animals will be housed for a period exceeding twelve (12) hours, PIs must develop an emergency, disaster or continuity of operations plan to ensure that animal wellbeing will be maintained in the event of unforeseen environmental or staffing circumstances.

      The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals meets the approval of the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.

      Only animals approved by the IACUC are permitted in animal housing or experimentation areas.

      Medical care for animals will be available and provided as necessary by a qualified veterinarian.

      Procedures involving discomfort, pain and/or distress Procedures are designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator.

      Humane endpoints via euthanasia are chosen to minimize or terminate the pain or distress of animals that cannot be relieved.

      Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.

      Protocol Modification Procedures

      The PI must notify the IACUC of any/all proposed changes to approved personnel, species, number of animals, methods and procedures. Changes may not be implemented until IACUC approval is received.

      Amendments must be fully described and submitted in writing to the IACUC by email to iacuc@uncw.edu.

      Significant changes to approved procedures may require resubmission of the full protocol form.

      Emergency deviations from an approved protocol made to prevent harm to animals or research team members must be reported to the IACUC as soon as possible. The PI must provide justification for the deviation.

      Periodic Review of Approved Protocols

      PIs are responsible for responding promptly to IACUC requests for updates on ongoing studies in accordance with IACUC policy 03.390 VII.I.1.


IACUC Contact Information:

IACUC@uncw.edu or 910-962-3056

To report concerns about the welfare of animals used in UNCW research, please contact the IACUC by email or phone (see above) and/or complete this survey.

Tell the IACUC team in the Research Integrity Office (RIO) how we're doing on this quick, 4-question survey, which you can also access by scanning this QR code!

RIO_Satisfaction_Survey_QR_Code_2021.jpeg

Additionally, please be aware that the Office of Internal Audit at UNCW maintains an anonymous reporting tool to facilitate reporting of allegations of fraud, waste, abuse, or mismanagement of funds. Concerns about ethical practices may also be reported anonymously to the State Auditor’s Fraud and Abuse Hotline by calling 1-800-730-8477 or filing a complaint online at https://www.ncauditor.net/HotTips/.