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Final Revisions to the Common Rule

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies released the final revisions to the Federal Regulations for the Protection of Human Subjects, also known as the Common Rule. The regulations, which have been in place since 1991, govern federally supported research involving human subjects.

Among the changes to the regulations, the most significant include the mandate that a single Institutional Review Board (IRB) review and approve all multi-site research and the extension of the Common Rule to all clinical trials conducted at a U.S. institution that receives federal funding, regardless of funding source. The rule also requires new approaches to the informed consent process such as the publication of informed consent documents.

AAMC Resources

AAMC Webinar on the Final Rule

A call for AAMC-member institutions was held on January 25, 2017, providing an overview of the major changes in the final rule and an update on how the new administration and Congress may affect its implementation (slides with recording) (slides only ). For questions, please contact Daria Grayer at dgrayer@aamc.org or (202) 741-5474.

AAMC Webinar on the Notice of Proposed Rulemaking [archive]

A series of webinars on specific changes proposed in the NPRM. Log into your AAMC account to access the presentations below.

NPRM Overview – September 18, 2015 Slides Recording
Informed Consent – October 13, 2015 Slides Recording
The Categorization and IRB Review of Research – October 14, 2015 Slides Recording
Research with Biospecimens – October 21, 2015 Slides Recording
The Single IRB Mandate – October 22, 2015 Slides Recording

External Resources

Other Resources

For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926.