On November 11th, FASEB submitted proposed changes to the Department of Health and Human Services (HHS) Federal Policy for the Protection of Human Subjects. The agency issued the modifications in an effort to better protect those who participate in research studies while simultaneously easing oversight and administrative requirements for scientists. HHS also addressed digital privacy and security concerns that have emerged since the regulations—known as the “Common Rule”—were introduced in 1991.

In general, FASEB approved of HHS’s proposed revisions, including:

• Mandating use of a single Institutional Review Board of record for multisite research studies  
• Extending protections for human research participants to all clinical trials 
• Ensuring appropriate digital privacy and security protections 
• Eliminating continuing review requirements under certain circumstances. 

The biggest proposed change is the extension of the definition of “human subject” to include non-identified biospecimens. FASEB member societies did not reach consensus and FASEB therefore did not comment on this specific proposal.

The Federation supported the proposed use of broad consent for obtaining authorization to store and use subjects’ biospecimens or identifiable private information for secondary research purposes. However, FASEB recommended making such a system opt-out rather than opt-in to limit administrative burden imposed on investigators and staff and opposed the proposed 10-year limit on such specimens and data because tracking and re-collecting participant consent responses could add cost and hinder work on chronic conditions.

Last updated: December 7, 2015