Dear Investigators,
The revised Common Rule updating regulations regarding the protection of human subjects in federally funded/supported research goes into effect on January 21, 2019. All new studies submitted on or after that date will be subject to the revised Common Rule. Over the next few weeks, the Institutional Review Board (IRB) will be distributing additional notices explaining aspects of these changes in more detail.
Major Regulation Changes
- Continuing Review - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. Research that is regulated by the FDA is still subject to annual review.
- Exemptions - New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process).
- 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.
- Waiver of Informed Consent - New criteria must be addressed when requesting a waiver/alteration of consent.
What to Expect
- New studies - All new applications, regardless of funding source, submitted on or after January 21, 2019 must use the revised Consent Template.
- Existing Federally-funded studies - All existing federally funded studies will be transitioned to the Revised Common Rule at the time of Annual Continuation, with the goal of transitioning all federally funded studies by February 2020. This will require completion of the Continuation/Transition Checklist, and may require updated consent documents using the Consent Template as determined by the Checklist.
- All other existing studies - All other existing studies will be considered for transition to the Revised Common Rule at the time of Annual Continuation with the goal of transitioning by February 2021. This will require completion of the Continuation/Transition Checklist, and may require updated consent documents using the Consent Template as determined by the Checklist.
UConn-Storrs Actions
- Updated business processes to incorporate the Revised Common Rule
- Revised reminder notices to assist researchers in meeting the requirements of the Revised Common Rule
- Updated Consent Template that includes the updated waiver criteria
- New Continuation/Transition Checklist to assist researchers in meeting the requirements of the Revised Common Rule
If you have additional questions regarding the revised regulations and what, if any, action is needed on your part, please contact an IRB Staff member:
Doug Bradway: 860-486-0986, doug.bradway@uconn.edu
Jerry McMurray: 860-486-5736, jerome.mcmurray@uconn.edu
Diane Sainsbury: 860-486-5944, diane.sainsbury@uconn.edu
For more information, contact: Karen Moré/ Research Compliance Services at 860-486-2459/ karen.more@uconn.edu