Wayne State University

Common Rule Changes

The Office of Human Research Protections (OHRP) has announced changes to federal regulations that protect the rights and welfare of human research participants, known as the Common Rule.  The Common Rule changes seek to modernize, strengthen and make more effective the federal policies for the protection of human research participants. The Common Rule changes are tentatively set to be effective January 19, 2018 and are expected to be applied to any study approved on or after January 19, 2018.

Some changes to the Common Rule will include:

  • Expanding the definition of "human subject" and "research"
  • Improvements to informed consent and additional informed consent elements
  • Implementation of a single IRB review of multi-site research (effective date January 20, 2020)
  • Elimination of continuing review for certain minimal risk studies with annual PI check ins with the IRB
  • Posting of consent forms for clinical trials supported by federal funding
  • Creation of a new "exclusions" category of study activities that are excluded from the Common Rule (i.e. clarifying research activities that are not human subjects research)
  • Revision of and new exempt research categories

WSU's Institutional Review Board is actively reviewing all applicable policies, procedures and forms to comply with the new Common Rule by the effective date. This includes an in-depth review by the HRP Consulting Group. The revised Common Rule can be viewed at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

Proposed delay for new Common Rule

The U.S. Department of Health and Human Services has proposed a one-year delay of the general implementation date for the revised Common Rule.  The proposed delay is currently under review by the U.S. Office of Management and Budget. More information to come as available.