HHS Proposes Changes to Human Research Protection Regulations

July 27, 2011

by Paula Skedsvold

The federal government is seeking comments on how to improve protections for human research participants, while also facilitating research and reducing burdens on investigators. According to the Advance Notice of Proposed Rulemaking (Federal Register, July 26, 2011), the regulations governing human research protections have been in place since 1991, and although changes have occurred over the years, the regulations “have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of human services research, research in the social and behavioral sciences, and research involving databases, the internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.”

The proposed revisions address seven concerns about the “Common Rule” (45 CFR 46, Subpart A of the federal regulations) that have been raised in various reports and academic papers. These areas are:

  • Calibrating the review process to the risk of research
  • Streamlining IRB review of multi-site studies
  • Improving the informed consent process and forms
  • Strengthening data protections to minimize “information” risks (e.g., medical records, genetic information)
  • Improving the monitoring and evaluation of the research oversight system
  • Extending federal regulatory protections to all research conducted at U.S. institutions that receive federal funding from a Common Rule agency
  • Harmonizing federal regulations and guidance across agencies

HHS is seeking public input before making any changes to the regulations. All comments must be received by 5pm on September 26, 2011.

View the Federal Register Notice »