2018 Common Rule: News and Resources
Investigator Resources
News and Publications
- A Conscious Decoupling of Effective and Compliance Dates (Bloomberg, March 23, 2018)
- Proposed Delay to Research Rule Still Up in the Air (Bloomberg, October 18, 2017)
- Trump Administration Seen Unlikely to Change Human Research Rule (Bloomberg, May 26, 2017)
- Some Social Scientists Are Tired of Asking for Permission (The New York Times, May 22, 2017)
- White House Reviewing Obama-Era Update of Human Research Rule (Bloomberg, May 12, 2017)
- Early Adoption Not an Option for Research Rule Changes (Bloomberg, March 15, 2017)
- Revamping the US Federal Common Rule, Modernizing Human Participant Research (JAMA, April 18, 2017)
- The Common Rule, Updated (New England Journal of Medicine, February 16, 2017)
- Controversial Patient Consent Proposal Left Out of Research-Ethics Reforms (Nature, January 18, 2017)
External Resources
- HHS Q&As about the Revised Common Rule (Last updated: July 24, 2018)
- Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period (Final Rule, June 19, 2018)
- Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period (New NPRM, April 20, 2018)
- Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects (Interim Final Rule, January 22, 2018)
- The Secretary's Advisory Committee on Human Research Protection (all committee recommendations)
- Common Rule Final Rule (January 19, 2017)
- HHS Press Release on the Final Rule (January 18, 2017)
- Common Rule NPRM (September 8, 2015)
- HHS Press Release on the Common Rule NPRM
- National Academies Report, Optimizing the Nation's Investment in Academic Research (2016)
- PRIM&R Common Rule Resources and Tools
- Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations