Changes To The Common Rule

An Application to BYU Human Subject Research

Changes to the Common Rule, the primary rule regulating human subjects research, has a planned implementation date of January 19, 2018. The purpose of these changes is to reduce administrative burden and to better protect subjects in the modern research context.

However, the Department of Health and Human Services proposed a one-year delay of the implementation date. The proposal is currently under review. When (or if) the status of the Common Rule effective date changes, or the proposed revisions change, BYU researchers will be updated. Please visit this website for the most current news.

  1. Expanding the defination of "human subject" and "research"
  2. Improvements to informed consent and additional informed consent elements
  3. Implementation of a single IRB review of multi-site research (effective date January 20, 2020)
  4. Elimination of continuing review for certain minimal risk studies with annual PI check ins with the IRB
  5. Posting of consent forms for clinical trials supported by federal funding
  6. Clarification of research activites that are not human subjects research
  7. Revision of and new exempt research categories