September 8, 2015

The U.S. Department of Health and Human Services (HHS) has announced proposed revisions to what is generally referred to as the Common Rule. The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies. The purpose of the proposed revisions to the Common Rule are to modernize and improve the current regulations which have not been updated since 1991.

HHS began seeking comments on the proposed revisions to the Common Rule on September 8, 2015. The comment period will remain open for 90 days.

NINR encourages stakeholders to read and comment on the Notice of Proposed Rulemaking (NPRM) located at https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects.

The proposed changes to the Common Rule 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.

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