Classifications of Research Involving Human Subjects

45 CFR 46 refers to the Department of Health and Human Services regulations on protecting human subjects in research. Specifically, 45 CFR 46 includes five subparts. The Common Rule (also known as Subpart A) was revised and put into effect in January 2019. The revision includes an expanded list of protections for human subjects. Subparts B, C, and D include additional protections for certain populations included in research studies. A complete list is found in the document below, Federal Regulations & Policy for Research Subjects Subparts A, B, C, D, E. For questions about Exempt Research, please see the attached document, Educational Settings Exempt Research Subpart A.