Common Rule

The Common Rule is the set of federal regulations that regulate research involving human subjects.  Common Rule revisions were announced by the U.S. Department of Health and Human Services on January 18, 2017. Many of the changes were set to be implemented on January 19, 2018, however a delay has been proposed; and is currently under review by the U.S. Office of Management and Budget.

We will update this page as information becomes available.

The following are

Key Impacts

on MSU research projects:

  • Exemptions:  New categories and clarification of existing categories.  Some exemptions may require "limited IRB review" (similar to an expedited review process which would focus on data and privacy).
  • Informed Consent: A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not.
  • Continuing Review: Certain minimal risk studies will no longer require continuing review or renewal submission.  The IRB is currently preparing a simple process for administrative check-ins every two years, which will reduce the burden on PIs.
  • Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020.  

What You Can Do:

  1. Keep checking on this website.  We will continue to add new materials and templates in advance of the implementation dates.
  2. Mark your calendar for our Common Rule training on January 24, 2018. More details coming soon.

MSU IRB Communications on Common Rule:

October Common Rule Email

Common Rule November Communication

ORSP newsletter (pdf coming soon)

References and Resources

Final Revisions to the Common Rule: Notice Issued January 18, 2017

Council on Governmental Relations: Common Rule Summary Table