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.
January 2020 Update
Effective January 20, 2020, NIH-funded multi-site studies being conducted at more than one domestic site and supported by career development (K) and fellowship (F) awards that obtain initial institutional review board (IRB) approval on or after January 20, 2020 will be subject to the requirements of 45 CFR 46.114. For more details, see this webpage: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-058.html
For MSU NIH funded researchers, please reach out to the IRB Office for more information.
January 2019 Update
Federally the New Rule was delayed in implementation till January 21, 2019. Montclair State adopted the New Rule regulations for all non-federally funded studies in January 2018, and for all studies on January 21, 2019.
The Office of Human Research Protections has added a FAQ section specifically addressing New Rule questions. View the section – “Companion Q&As about the Revised Common Rule”.
The following are Key Impacts on University 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).
- Prospective Agreement Forms: These forms can be used for certain minimal risk research activities with adult participants.
- 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). The sIRB NIH policy that applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site non-exempt human subjects research is now in effect. For other federal funders, the requirement starts 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.
University IRB Communications on Common Rule:
- October Common Rule Email
- Common Rule November Communication
- ORSP Fall-Winter 2017 Newsletter
- December Common Rule Email