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September 2, 2015
Contact: HHS Press Office

HHS announces proposal to update rules governing research on study participants

Proposed changes enhance protections for individuals involved in research, while modernizing rules and improving efficiency

The U.S. Department of Health and Human Services today announced proposed revisions to the regulations that govern research on individuals who participate in research.

The current regulations that protect individuals who participate in research, which 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. 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.

In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public’s input on updating the Common Rule. The Notice of Proposed Rulemaking (NPRM) issued today reflects that input and requests comments for HHS to consider as it drafts the final rule.

The protection of research participants is of paramount importance. Medical advances would not be possible without individuals who volunteer to participate in research. This NPRM proposes to modernize the current regulations by enhancing the ability of individuals to make informed decisions about participating in research, while reducing unnecessary burdens by streamlining the regulatory requirements for low-risk research.

Changes proposed in the NPRM issued today 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 U.S. institution that receives funding for research involving human participants from a Common Rule agency.

To view the NPRM, click here. HHS will take public comment on this NPRM for 90 days, beginning Sept. 8.

Note: All HHS press releases, fact sheets and other news materials are available at https://www.hhs.gov/news.
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Last revised: September 2, 2015

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