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 was proposed. The Interim Final Rule delays the effective date and general compliance date to July 19, 2018 for federally funded research. Many research studies are not federally funded and will start noticing changes in the process and reviews starting in January 2018.

We will update this page as information becomes available.

The following are

Key Impacts

on MSU research projects:

Common Rule image
Caption: Common Rules Changes - Major regulation changes
and what to expect at MSU
  • 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).
  • Prospective Agreement Forms: These forms can be used for certain minimal risk research activities with Aduly participants. Check this page out for more details.
  • 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:

Keep checking this website.  We will continue to add new materials and templates in advance of the implementation dates.

MSU IRB Communications on Common Rule:

October Common Rule Email

Common Rule November Communication

ORSP Fall-Winter 2017 Newsletter

December Common Rule Email

 

References and Resources

REVISIONS to IRB P&P Manual

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

Council on Governmental Relations: Common Rule Summary Table