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.
Review the set of infographics Protecting Research Volunteers (https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/index.html) to get an overview of the Federal system of protections. These provide an easy-to-follow introduction to human subjects’ research protections that covers topics such as why we have regulations to protect human research participants and the framework for protecting human research participants in the U.S.
Watch the video Evolving Concern: Protection for Human Subjects (https://www.youtube.com/watch?v=_8Ku4b1fW18) to understand the historical events that provoked public concerns and led to the development of regulations and policies to protect human research participants in the U.S
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.