HHS proposes updated rules governing research on study participants

The US Department of Health and Human Services (HHS) announced proposed revisions to the regulations that govern research on individuals who participate in research. The current regulations, referred to as the Common Rule, have been in place since 1991 and are followed by 18 federal agencies. With the expansion of research into new scientific disciplines (e.g., genomics), significant advances in technology, more participatory models of research, and an increase in multisite studies, HHS is seeking to modernize this regulatory framework. According to an HHS press release, specific changes proposed in the Notice of Proposed Rulemaking include:

  • Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study.
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research, thus increasing efficiency.
  • New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.
  • Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies.
  • Requirement, in most cases, to use a single institutional review board for multisite research studies.
  • The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted in a US institution that receives funding for research involving human participants from a Common Rule agency.

HHS will take public comment on this proposal for 90 days, effective September 8, 2015.

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