HHS Proposing Rule to Increase Protection for Human Study Subjects

Proposed changes include new data security and information protection standards to reduce the potential for violations of privacy and confidentiality.

The U.S. Department of Health and Human Services is updating the regulations that govern research on people who participate in research. Current regulations have been in place since 1991, are followed by 18 federal agencies, and are often referred to as the Common Rule. "They were developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at a single site," according to the HHS announcement. "The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participatory model of research has also emerged, with individuals looking for more active engagement with the research enterprise."

The agency's proposed rule follows an Advance Notice of Proposed Rulemaking issued in July 2011 to get public input on updating the Common Rule.

Proposed changes include:

  • Stronger informed consent provisions to ensure individuals have a clearer understanding of the study's scope, its risks and benefits, and alternatives to participating in the study.
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research.
  • New data security and information protection standards to reduce the potential for violations of privacy and confidentiality.
  • Requirements for written consent for use of an individual's biological samples (e.g., blood or urine) for research, with the option to consent to their future use for unspecified studies.
  • A 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 U.S. institution that receives funding for research involving human participants from a Common Rule agency. HHS is taking public comments on it for 90 days beginning Sept. 8.

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