Why do IRBs 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. IRBs were the ultimate result and are in place to ensure research is conducted ethically and in accordance with various sets of regulations.
Where do regulations around human subjects research come from?
At the highest level, they are governed by the United States Department of Health & Human Services' Office of Human Research Protections (OHRP) at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56. 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.
Researchers must also be aware of and adhere to any applicable state, local, and institutional regulations.
FDA regulations differ from OHRP. Please see Is Your Research FDA Regulated? for further guidance.
OHRP has specific definitions of "Research" and "Human Subject"
If your project meets both definitions, you are conducting "Regulated Research" and IRB review is needed.
Click the ovals for the definitions.
With these definitions in mind, there are several possible next steps.
Click the links below to learn more about your study.