Institutional Review Boards must adhere to federal regulations found in the Code of Federal Regulations (45 CFR Part 46, Protection of Human Subjects). Learning about these regulations begins with some basic questions and 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 risks of harm.
Informed consent helps assure that prospective human subjects will understand the nature of the research and can knowledgably 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. Refer to informed consent guidelines.
Getting Help Making Decisions
The Office for Human Research Protections at the Department of Health and Human Services provides a decision tree to help you decide, e.g. “Does my research activity have to be reviewed by the IRB?” Can the review go through the expedited process?” “Can informed consent be waived?”
Code of Federal Regulations (45 CFR Part 46)
National Science Foundation Common Rule
(45 CFR Part 690)