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 amendment forms. Amendment forms 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 designate, 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.
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 University of Miami's Collaborative Institutional Training Initiative (CITI). The IRB will not review a protocol until training documentation is on file at ORS. This requirement includes any faculty, staff, students, or collaborators from other institutions.
The CITI program automatically emails ORSSP when training is completed. You are no longer required to submit hard copies of training certificates to ORS if you complete training through CITI and identify the University of North Carolina Wilmington as the participating institution.
What is UNCW's Federalwide Assurance number?
FWA00001025, Expires 6/30/2014
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 (PDF). 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.
Where do I get the forms? Where do I send my completed forms?
If you are unable to retrieve the forms below, all forms can be obtained by contacting the regulatory compliance officer in ORS (910-962-7774 or email@example.com). Researchers must submit to the IRB Chair a signed hard copy along with any supporting documentation (surveys, consent forms, etc.).
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 (FAQ #6 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 submit something in writing explaining the change to the regulatory compliance officer (e-mail requests are acceptable, firstname.lastname@example.org). According to UNCW IACUC policy (PDF), the regulatory compliance officer 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 University of Miami's Collaborative Institutional Training Initiative (CITI) is required for all members of the research team. Other forms of training may be approved on a case-by-case basis by the IACUC chair or regulatory compliance officer.
IACUC committee members are required to complete a course specifically for IACUC members in addition to the basic "Working with the IACUC" course.
What is UNCW's OLAW Assurance number?
A3871-01, EXPIRES 6/30/14
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 (PDF) 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. The Assurance also sets out the organization of the UNCW IACUC and lists certain procedures and policies of the IACUC.
Where do I get the forms? Where do I send completed forms?
There are now two versions of the main application form - a long form and a short form. If your activities include surgery, drug administration, dietary manipulation, pain and/or distress or prolonged restraint, you should use the long form. If your activities include none of those things or just one you should use the short form and attach an appendix if needed. Please submit an electronic copy of the completed form to the regulatory compliance officer (email@example.com) by the initial submission deadline posted on the IACUC homepage. All protocols submitted will be forwarded to the attending veterinarian (AV) for consultation. The AV will complete a consultation form and forward it to the principal investigator (PI) within a few days. The PI should take the comments under consideration and revise the protocol if appropriate. Please go to the IACUC home page for specific submission deadlines. Submit the fully revised, signed hard copy to: Regulatory Compliance Officer, Office of Research Services and Sponsored Programs, Hoggard Hall, Room 180 or Campus Mail box 5973