Changes to the Common Rule and some NIH policies have been delayed

New forms, guidance documents, and templates have been posted. However, there are key provisions from the Revised Rule that cannot be included because they conflict with the current regulations. Return to the HRPP website for current versions of documents and instructions prior to each submission.

Changes to the DHHS Policy for Protection of Human Research Subjects (aka “Common Rule”)

  • June 18, 2018: Final rule to delay Revised Rule until January 19, 2019
  • April 19, 2018: NPRM to further delay Revised Rule until January 19, 2019
  • January 19, 2018: Effective and compliance date of Final Rule [Delayed]
  • 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

Reliable resources for learning more about the potential changes to the Common Rule

Recent Changes to NIH Policies Relevant to Research with Human Subjects

  • 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