Proposed Changes to Human Subjects Regulations

The Office of Science and Technology Policy (OSTP) and the Department of Health and Human Services (HHS) through the Office for Human Research Protections (OHRP) announced that the Advanced Notice of Proposed Rulemaking (ANPRM) on the Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators published in the Federal Register on July 26 and is available on the OHRP website.

The ANPRM is jointly issued by OSTP and HHS/OHRP because it proposes significant changes to Subpart A of 45 CFR 46, the Common Rule used formally by 15 federal agencies and as a framework for private industry and non-profit organization research sponsors.

A series of questions under seven principal categories offers significant insight into the direction for potential changes to the Subpart A of 45 CFR 46:

  • shifting to risk-based protections
  • streamlining multi-site reviews
  • improving informed consent
  • strengthening data protections to minimize information risks
  • creating data collections for oversight of unanticipated events
  • extending the federal regulations to all research conducted at federally funded organizations
  • harmonizing regulations and guidance

The ANPRM comment period closes on September 26. The Council on Governmental Relations (COGR) is developing a response and has invited member institutions to help map out a clear and consistent approach to changes to Subpart A 45 CFR 46 the Common Rule. Comments, suggestions and reactions should be directed to COGR, Carol Blum

Contact: Carol Berdar.


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