• 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

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