Human Research and IRB (Institutional Review Board)
All research involving human subjects is subject to review by the Wilmington College Institutional Review Board (IRB). Documents should be submitted to the Office of Academic Affairs. All projects that meet the definition of research with human subjects (45 CRF 46.102) must be reviewed and approved by an IRB, or receive an IRB exempt determination, prior to beginning the research.
Definition of Human Subjects Research:
- A systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge
Why do Institutional Review Boards exist?
Simply stated, egregious human experimentation such as that conducted by Nazis during World War II and during the Tuskegee Syphilis Study resulted in the creation of regulatory and ethical safeguards designed to protect the rights and dignity of participants in clinical trials and research studies.
Where do regulations of human subjects’ research come from?
They are governed by the US Department of Health & Human Services Office of Human Research Protections (OHRP) at 45CFR part 46 and the Food and Drug Administrations’ regulations at 21CFR part 50 and 21 CFR part 56. Additional state, local and institutional regulations must also be adhered to.
The Belmont Report sets forth guidelines to be followed by researchers, based on three fundamental ethical principles:
- Respect for persons: Protect autonomy, ensure respect, and allow for informed consent without deception.
- Beneficence: “Do no harm” while maximizing research benefits and minimizing participant risks.
- Justice: Ensure reasonable, non-exploitative, and well-considered procedures involve the fair and equal distribution of costs and benefits to potential research participants.
IRB Membership
A minimum of 5 people with diverse backgrounds, ensuring varied perspectives on research involving human subjects. Members must include at least on scientist and one non-scientist, along with at least one person not affiliated with the institution conduct the research. Consideration should be given to balance in terms of race, gender, cultural backgrounds, and sensitivity to community attitudes. The Academic Dean/Dean of Facutly serves as the clear of the IRB.