Revised Common Rule (45 CFR 46, Subpart A)

On January 18, 2017, the Department of Health and Human Services issued the final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The effective date for most provisions is January 19, 2018*. 

Summary of major changes effective January 19, 2018: 

• Improvements to the informed consent process and documents.
• Posting of consent documents to public website for applicable trials. (E.g. ClinicalTrials.gov website)
• Continuing Review for some minimal risk research may no longer be required.
• Clarification and addition of new categories of exempt research. 

Summary of major changes effective January 20, 2020: 

• Single IRB of Record (sIRB) requirements for certain cooperative research. 
  [NOTE: the NIH sIRB Policy effective date is January 25, 2018.]

The revised Common Rule allows for other changes such as "broad consent", but will not be implemented at OUHSC at this time. 

Other resources for the revised Common Rule can be found at:

• https://www.hhs.gov/ohrp/news/announcements-and-news-releases/2017/revisions-to-the-common-rule.html
• https://www.reginfo.gov/public/do/eoDetails?rrid=1276
• https://about.citiprogram.org/en/final-rule-resources/ 
• https://www.primr.org/commonrule/regulatory/ 

Please check the HRPP website regularly for updates.

*On October 7, 2017, HHS proposed a one-year delay of the implementation date of the revised Common Rule. The proposed delay is currently pending review.