FAQs

Research is defined by the federal government as a systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic Investigation is defined by the UNCW IRB as a cohesive approach involving data collection (quantitative or qualitative) from one or more individuals and analysis to address a question or test a hypothesis.

Generalizable knowledge is defined by the UNCW IRB as the results or outcomes gained from systematic investigation that may be published, archived, presented, or viewed in some way as relevant beyond the specific participant population.

Human subject is defined as a living individual, about whom an investigator (whether professional or student) conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.

There are three types of IRB review depending on the level of risk involved in the project: exempt, expedited and full IRB review. Projects that qualify for exempt review are projects having such a low level of risk to subjects that further IRB oversight is not required with the exception of protocol amendments. Amendments are required on exempt studies since a change to the study may alter its exempt status.

Projects qualifying for expedited review are also minimal risk to subjects, but may involve other aspects that require continuing IRB oversight. A project may require full board review for a number of reasons such as the subjects belonging to a potentially vulnerable population or a higher degree of risk to subjects.

According to UNCW IRB policy, researchers may NOT make their own determination as to the appropriate type of review. Only the IRB Chair or designee, can determine which type of review is applicable.

Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the Collaborative Institutional Training Initiative (CITI). The IRB will not review a protocol until training documentation is on file with the Research Integrity team. This requirement includes any faculty, staff, students, or collaborators from other institutions.

The CITI program automatically emails the Research Integrity team when training is completed. Therefore, there is no need to submit hard copies of training certificates to us if you complete training through CITI and identify the University of North Carolina Wilmington as the participating institution.

All submissions for human subjects research must be made on the online OSPREY system.

Please contact the Research Integrity team with any questions.

Yes. Any change to an approved protocol, no matter how small (including personnel changes), must be approved by the IRB prior to the PI making the change. Please log in to the OSPREY system and submit a modification on the study. Your approved protocol is an agreement with the IRB to conduct the study as approved.  Making a change to your methods, procedures or approved forms without IRB approval is a violation of IRB policy.

Please note that approved amendments do not change the original approval dates for a project. In other words, if your protocol was approved in April 2023 and (if subject to continuing review) will expire in April 2024, an amendment to the protocol approved in October 2023 will not extend the expiration date to October 2024.

If there is an unexpected adverse event during your human subjects research, the PI is required to report it to the IRB. Please log in to the OSPREY system and submit an Unanticipated Problem/Adverse Event report. If the problem is very serious, the PI or another responsible person must contact the Leanne Prete, Research Integrity Office director at extension 2-7774.

If the event is less serious, the PI does not have to contact the IRB but must submit an Adverse Event Report within five days. For more information on adverse event reporting, please see the IRB policy posted on the IRB website.

FWA00001025, Expires 10/5/2028

A Federalwide Assurance is an agreement with the United States Department of Health and Human Services (DHHS) to conduct human subject research in accordance with certain principles. UNCW's Assurance agrees to comply with the principles outlined in the Belmont Report and the Code of Federal Regulations Title 45, Part 46 Protection of Human Subjects, Subparts A, B, C and D. UNCW has agreed to follow these regulations for all research involving human subjects, regardless of the funding source. See the DHHS website for more information about assurances.

Please feel free to contact the Research Integrity team if you have other questions about human subjects research.

ALL live, vertebrate animals fall under IACUC regulations. This is stated in UNCW's Assurance of Compliance and in UNCW's IACUC policy.

UNCW IACUC policy requires IACUC approval for vertebrate animals used in research, research training, experimentation, teaching, biological testing or other purposes.

PHS Policy and UNCW IACUC policy require a complete review of ongoing activities at least once every three years. Like many other universities, UNCW requires this complete review to be conducted through the submission of a new protocol form. Therefore, all protocol forms expire after three years regardless of the grant cycle, so that a complete review of animal activities may be conducted.

If you make any change to an approved protocol, please contact the IACUC team and provide a complete description of the change. According to UNCW IACUC policy, the IACUC coordinator and/or IACUC chair will determine if the change is minor, moderate or significant.

Minor or moderate changes such as but not limited to the addition or deletion of personnel (other than the PI), changing animals within a species (changing from rats to mice), certain increases in the number of animals (depending on the pain category and level of increase) can be approved very quickly by the IACUC chair or IACUC staff.

Significant changes to the protocol such as but not limited to a change in PI, adding new procedures, changing to a higher pain category, changing species, certain increases in the number of animals (depending on the pain category and level of increase) requires a revision to the protocol itself and either designated or full review, depending on the original review received and the nature of the changes requested.

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. The principal investigator of the study may require additional courses for research team members. Other forms of training may be approved on a case-by-case basis by the IACUC chair or IACUC coordinator.

IACUC committee members are required to complete a course specifically for IACUC members in addition to the basic "Working with the IACUC" course.

A3871-01, EXPIRES 6/30/26

An Assurance is an agreement with the Office of Laboratory Animal Welfare to operate an animal care program in accordance with certain policies and principles. UNCW's Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals states that UNCW will follow the USDA Animal Welfare Act and Animal Welfare Regulations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals and the National Research Council's Guide for the Care and Use of Laboratory Animals for ALL live, vertebrate animals.

Please feel free to contact the IACUC by email if you have other questions about animal care and use.

Financial interests include: 

• Payment for services to the covered employee not otherwise included within university salary, such as consulting fees, honoraria, and paid authorships.
• Equity or other ownership interest in a publicly or non-publicly traded entities such as stocks, stock options, or other ownership interests.
• Intellectual property rights and interests upon receipt of income related to such rights and interests, held by the covered employee or members of his or her immediate family.

Following are examples of activities, interests and relationships that subject employees should disclose on their annual disclosure forms. However, please note that this is not an exhaustive list. Please contact us if you have conflict of interest disclosure questions.

• Ownership of stock, options, etc. from any entity during the preceding 12 months, for you and your family members that appears to be related to your institutional responsibilities. 
• Note: Investments in which you do not directly control investment decisions, such as mutual funds or retirement accounts, do not need to be disclosed.

Privately Held or Nonprofit Companies

• Any ownership or equity interest from any entity whose stock is not publicly traded, by you
  and your family members that appears to be related to your institutional responsibilities.

Other Financial Interests

• Any secondary employment that is related to your professional responsibilities at the university. Examples would include: private consulting, serving on a board of directors, speaking engagement, etc.
• Royalties from textbooks or other scholarly works

Intellectual Property Rights

• Intellectual Property (IP) in which you or your family members, have an existing or proposed licensing interest.
• IP rights held (or in negotiation) for a pending or issued patent in which you or your family members are listed as inventors.
• Excluding unlicensed IP held by UNCW.

External Roles

• Paid or unpaid positions of influence, by you or your family members, with an entity in which the interests of the entity appear related to your institutional responsibilities (i.e. CEO, President, Scientific Advisory Board member, etc.).

Student Involvement or Supervisory Roles

• Situations in which an activity could create a potential conflict of interest or commitment with respect to a faculty member’s mentorship responsibility.
• Textbook or course material selection that results in receipt of royalties or other potential financial conflicts of interest.
• Supervising a family member

All EHRA employees are required to submit an Annual disclosure. EHRA employees include:

• All full- and part-time faculty
• All full- and part-time EHRA staff
• Any of the above on leave, when that leave is at least partially paid by UNCW

Any SHRA employee who is serving in an EHRA position on an interim basis, or who teaches a class.

The Provost sends an initial announcement at the beginning of the academic year and sends a reminder prior to the submission deadline. You may also receive reminders from the Research Integrity team and/or your department chair/director.

Yes, even if you have nothing to disclose, you must still submit a disclosure. Submitting a “negative” disclosure documents that you are aware of the annual disclosure requirement and that you have no activities or interests to report.

The Research Integrity team notifies the Provost of any breaches of the Conflict of Interest and Commitment Policy. The Provost will review such cases and take any necessary steps to ensure compliance with university policy.

Not necessarily. All disclosures with at least one “Yes” response are sent to the department chair for review. However, the majority of reported activities and interests are not determined to create an actual conflict of interest.

Yes.

The Annual disclosure is primarily used to identify activities or relationships that in some way relate to your UNCW role and/or responsibilities and therefore could create a bias or impact your ability to act objectively in your UNCW role, or even give the appearance of you having a conflict of interest.

The EPAP form is used to identify externally-paid activities that, while relating to your professional expertise, only impact your UNCW role and responsibilities in terms of time-commitment (conflict of commitment). EPAP forms apply to faculty and EHRA staff, must be submitted at least 10 days prior to engaging in an outside activity, and must be approved by your supervisor prior to engaging in that activity. EPAP forms are routed directly to your unit head/supervisor (usually a department chair) for review, whereas Annual disclosures are only routed to the department chair if a potential conflict is identified.

Both forms are completed electronically through OSPREY.

Yes. Research disclosures are separate, and in addition to, the Annual disclosure. Research disclosures are narrower in scope than the Annual disclosure.

Yes, you must disclose anything you or a family member received of monetary value from a non-UNCW entity that is related or potentially related to your responsibilities at the university unless the travel is reimbursed or sponsored by the following: 

• a federal, state, or local government agency,  
• an Institution of higher education as defined at 20 U.S.C. 1001(a),  
• an academic teaching hospital,  
• a medical center, or  
• a research institute that is affiliated with an Institution of higher education. 

Yes, part-time instructors are classified as EHRA employees, and are subject to the disclosure requirement described in the UNCW Conflict of Interest and Commitment Policy. However, part-time instructors are only expected to disclose activities and interests that directly relate to their duties as an instructor.

Examples include: outside employment where you may supervise or work closely with students that you concurrently teach at UNCW, requiring your students to purchase instructional materials when you will personally receive royalties or other financial compensation from those sales, etc.

Please feel free to contact the Research Integrity team if you are unsure how to answer a question.

Please feel free to contact the Research Integrity team if you have other questions about conflict of interest compliance.

The term “export controls” refers to a set of federal laws that regulate the transfer of items, information, and services from the US to foreign countries, entities, and/or persons (including transfers to foreign persons within the US). There are some exclusions to export control laws that permit unrestricted sharing of information that exists, or is intended to be placed, in the public domain. These exclusions apply to information that is published and is generally accessible to the public.

At UNCW, most educational, research, and administrative activities fall under “fundamental research” and public domain exclusions of the export control laws. However, these exclusions do not apply when carrying or shipping physical equipment to foreign destinations, and they do not apply to travel to sanctioned countries.

While most research conducted at UNCW is considered “fundamental” research (intended to be shared broadly within the scientific community), this exclusion may not be applicable if a researcher accepts restrictions in a contract on how the results can be distributed or the nationalities of those employed on the project.

Probably yes. Laptops themselves generally do not require licenses to export to most countries. However, the software installed on the laptops may contain encryption technology that is controlled for exporting to some destinations, or data stored on the laptop may include a controlled technology.

For this reason, it is important to make individual determinations to ensure compliance. Usually, a temporary license exception can be applied to travel with a university laptop, provided travel is not to a sanctioned destination. A baggage license exception can typically be applied to travel with a personally-owned laptop.

The export control regulations may apply if someone shares a controlled technology with a foreign national, even if the communication occurs in the U.S. This is called a “deemed” export. For this reason, it is important to notify SPARC's Research Integrity team if a foreign national will visit or work at the university, particularly if they will have access to technical data or equipment. Deemed exports can occur through verbal, visual, or written transmission of controlled information.

Probably, but some activities may require a license and you might be required to document your activities. Broad, country-based sanctions and/or embargoes exist for Cuba, Iran, North Korea, Sudan and Syria. Specific activities conducted in these locations can be permissible under certain General Licenses issued by the Office of Foreign Asset Control in the US Department of Treasury.

Other sanction programs are in place for numerous other countries and entities. Exporting equipment to these destinations could likely require an export license. Please notify the Research Integrity team as far in advance as possible for any activities involving a sanctioned or embargoed country, as export control licenses can take several months to obtain.

Penalties for violations can be more than six figures and include jail time. These are assessed against the individual, and the university could be penalized as well by being barred from accepting federal funding. Educating our faculty and staff is the best protection against violations.

Please feel free to contact the Research Integrity team if you have other questions about export control compliance.