August 24, 2011

The U.S. Department of Health and Human Services announced earlier this summer that the Federal Government is contemplating various ways to enhance the regulations governing research on human subjects.

Before making changes to the regulations, the Government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration are in an Advance Notice of Proposed Rulemaking (ANPRM), “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” published in the July 25, 2011, Federal Register.

International investigators supported by the U.S. Federal Government may be affected by the proposed changes as they relate to Institutional Review Board assessments of multisite studies, informed consent, and clarifying and harmonizing regulatory requirements and agency guidance, among other issues.