The US Department of Health and Human Services has issued revised regulations governing human subject research protections that go into effect January 21, 2019.

Impact on Review of Applications at OSU

Application Status

Old Regulations Apply

Revised Regulations Apply

Approved before Jan. 21

  

Submitted before but approved on or after Jan. 21

Changes to application may be required to ensure compliance with revised regulations and/or to migrate into iRIS

Submitted on or after Jan. 21

  

Summary of Key Revisions to the Common Rule

There are new elements of consent, as well as changes to how and when consent information is presented. These changes are reflected in the updated consent form templates and guidance and have been incorporated into the application and protocol form.

In most cases, minimal risk studies approved on or after January 21, 2019 will be given a 5-year, non-renewable determination and will no longer require continuing review. This change will be reflected in the expiration date for each study and will not apply to FDA-regulated studies. Researchers must continue to submit reports of unanticipated events, requests for project revisions, and final reports. Refer to the additional requirements and guidance provided for Post Approval activities.

There are new and revised categories of exemption. Restrictions have been added to some categories, while others have been expanded or replaced. The changes have been incorporated into the application and protocol form available through iRIS in January 2019.

Regulatory Resources and History of Changes

  • January 21, 2019: Final Rule in effect
  • December 13, 2018: FDA issues proposed rule to harmonize FDA regulations for the Protection of Human Subjects and Institutional Review Boards to harmonize with the revised Common Rule
  • December 6, 2018: EPA issues proposed rule to harmonize the EPA-specific regulations with revisions to the Common Rule in order to resolve discrepancies
  • June 18, 2018: Final rule to delay Revised Rule until January 21, 2019
  • April 19, 2018: NPRM to further delay Revised Rule until January 19, 2019
  • January 19, 2018: Effective and compliance date of Final Rule
  • January 17, 2018: Interim Final Rule to delay the Revised Rule until July 19, 2018
  • January 19, 2017: Final Rule to revise the Common Rule
  • September 2, 2015: Notice of Proposed Rule Making to revise the Common Rule
  • July 26, 2011: Advanced Notice of Proposed Rule Making to revise the Common Rule
  • June 18, 1991: Common Rule adopted

  • March 22, 2018: Congress directs NIH to delay new clinical trials policy
  • January 16, 2018: New definition of “clinical trial” [Delayed]
  • October 11, 2017: Single IRB required for multi-site trials
  • September 1, 2017: Certificates of Confidentiality “deemed issued” [retroactive to December 13, 2016]
  • January 18, 2017: Registration with clinicaltrials.gov required for all NIH funded clinical trials
  • September 16, 2016: GCP training required for researchers conducting clinical trials