SIGNIFICANT CHANGES PROPOSED FOR HUMAN SUBJECTS RESEARCH REGULATIONS Created by on 08/02/2011
FASEB is planning to provide comments on an Advance Notice of Proposed Rulemaking (ANPRM) recently issued by the U.S. Office of Science and Technology Policy (OSTP) and the Department of Health and Human Services (HHS) entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. The ANPRM requests input on to how modernize current regulations for protecting human research subjects. Arising from concerns that the Common Rule (the framework under which most federally funded human subjects research is regulated) requires institutions and investigators to implement burdensome and costly procedures that do little to protect research participants, particularly those involved in low risk studies, the ANPRM proposes changes in seven broad areas. These include ensuring risk-based protections, streamlining IRB review of multisite studies, improving consent forms and the consent process, strengthening data protection to minimize information risks, improving data collection to enhance system oversight, extending federal regulations to all research studies conducted by institutions that receive federal funding, and clarifying and harmonizing regulatory requirements. Comments on the ANPRM are due on September 26, 2011.