Background on Institutional Review Boards
IRBs must adhere to federal regulations found in the Code of Federal Regulations (Title 45 Part 46, Protection of Human Subjects). Learning about these regulations begins with some basic definitions: Is my project considered research?Does my project involve human subjects?
Does my project involve only minimal risk?
Why is risk level important? According to federal regulations, principal investigators have an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
Informed consent helps assure that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Consent forms tell subjects they are free to withdraw from participation at any time, as well as convey other critical information; see informed consent guidelines.
Get help making decisionsThe Office for Human Research Protections of the Department of Health and Human Services provides a decision tree to help you decide: Does my research activity have to be reviewed by the IRB? Can the review go through the expedited process? Can informed consent be waived?
Important LinksThe online version of the Code of Federal Regulations, (45 CFR Part 46) is user-friendly and allows you to search for particular topics.
Another indispensible online resource is the webpage of the Department of Health and Human Services Office for Human Research Protections. The National Science Foundation, and 16 other federal agencies, adhere to federal regulations called the Common Rule for the Protection of Human Subjects is 45 CFR Part 690.