Sponsored Programs & Research Compliance

Frequently Asked Questions

Institutional Review Board (IRB)

  • How do I submit an application for human subjects research?

    All submissions for human subjects research must be made on the online IRB management system ("IRBIS") found at https://uncw.myresearchonline.org/irb.

    How to create a new study. (PDF)
    How to renew a study. (PDF)
    How to close a study. (PDF)

    Please contact the Research Integrity team at IRB@uncw.edu with any questions.

  • What are the different levels of IRB Review?

    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 and annual renewal of protocol approval. A project may require full 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.

  • Am I doing research as defined by the IRB?

    The chart accessible from the link below may help you determine if you are conducting "research" as defined by IRB regulations. As you view this chart, please note the following definitions: 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.

    Research Decision Chart (PDF)

  • Am I working with human subjects as defined by the IRB?

    The chart accessible with the following link may help you determine if your research involves the use of human subjects. As you review this decision chart, keep in mind the following definition: 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.

    Human Subjects Decision Chart (PDF)

  • What are the IRB training requirements for researchers?

    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.

    Instructions on how to register for the correct CITI training (PDF)

  • What is UNCW's Federalwide Assurance number?

    FWA00001025, Expires 10/22/2023

    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.

  • What if I have more questions?

    Please feel free to contact the Research Integrity team at IRB@uncw.edu if you have other questions about human subjects research.

Animal Care and Use (IACUC)

  • What types of animals fall under IACUC regulation?

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

  • Is IACUC approval required for vertebrate animals used in teaching, or just research?

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

  • Why does my protocol expire after three years even though my grant is continuing?

    PHS Policy and UNCW IACUC policy (PDF) 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.

  • What should I do if I change a procedure, change personnel, or change the species on an approved protocol?

    If you make any change to an approved protocol, please contact IACUC@uncw.edu and provide a complete description of the change. According to UNCW IACUC policy, the research compliance manager and IACUC Chair will determine if the change is minor, moderate or significant. Minor or moderate changes such as the addition or deletion of a student assistant, a minor species change (from one rodent species to another, like mice to rats), or a small increase in the number of animals (less than 5%) can be approved very quickly by the IACUC Chair. Major changes to the protocol such as a major change in the approved activities, a major change in species (such as changing from rats to dogs) or a significant increase in the number of animals used (more than 5% of approved number) require 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.

  • What are the IACUC training requirements for researchers?

    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 research compliance manager.

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

    Instructions on how to register for the correct CITI course (PDF)

  • What is UNCW's OLAW Assurance number?

    A3871-01, EXPIRES 6/30/22

    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.

  • What if I have more questions?

    Please feel free to contact the Research Integrity team at IACUC@uncw.edu if you have other questions about animal care and use.

Conflict of Interest Compliance

  • How do I know if I’m required to submit an Annual disclosure?

    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.

  • I’m a part-time instructor, does this really apply to me?

    Yes, part-time instructors are classified as EHRA employees, and are subject to the disclosure requirement described in the University Conflict of Interest 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.

  • How will I know when to submit my disclosure?

    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.

  • I do not have anything to disclose, am I required to submit a disclosure?

    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.

  • What happens if I answer YES to a question, does this mean that I have a conflict of interest?

    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.

  • I disclosed an ongoing activity last year. Do I need to disclose this every year?

    Yes.

  • If I submit conflict of interest disclosures for research proposals, am I required to submit an Annual disclosure?

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

  • I am unsure how to answer one of the questions, what do I do?

    Please feel free to contact the Research Integrity team at COI@uncw.edu if you are unsure how to answer a question.

  • What is the difference between the Annual disclosure and the external professional activity for pay (EPAP) notification?

    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 appeartance 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).  In some cases, it is appropriate to report a single activity on both an annual COI disclosure form and an "EPAP."  EPAP forms apply to faculty and EHRA staff, must be submitted at least 10 days prior to engaging in an outside activity, 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 the AIR System.

  • What happens if I do not submit an Annual disclosure?

    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.

  • What if I have other questions?

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

Export Control Compliance

  • What are “Export Controls”?

    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.

  • How do these regulations apply to university activities?

    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.

  • Can I take a laptop with me if I’m traveling outside the U.S.?

    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.

  • What is a “deemed export”?

    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.

  • Can I travel to a sanctioned and/or embargoed country?

    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.

  • What happens if we do nothing?

    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.

  • What if I have more questions?

    Please feel free to contact the Research Integrity team at ExportControls@uncw.edu if you have other questions about export control compliance.