Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 1, pt. 2, January 2019
Revised Common Rule Updates – Part 2
This is the second part of a two-part newsletter on the revised Common Rule (hereafter revised Rule), which is effective January 21, 2019. Part one of the newsletter covered the impact of the revised Rule on informed consent documents as well as waivers and alterations of informed consent. This part will focus on the other significant impacts of the revised rule.
Transition Plan for Studies Approved or Exempted Before January 21, 2019
In most cases, studies approved or exempted before January 21, 2019 will NOT be transitioned to the revised Rule. The reason is that the only advantage for study teams to transitioning to the revised Rule is potentially qualifying for exception to ongoing continuing review. Even this benefit would likely be offset by changes (e.g., revisions to consent documents) the study team may need to make to bring a study fully in compliance with the revised Rule. Studies already determined to exempt or excepted from continuing review will not be transitioned since study teams would not benefit from transitioning this studies.
To help those interested in possibly transitioning an approved study to the revised Rule, however, the HS IRBs’ has developed a decision tool study teams can complete. After study teams complete the tool, an experienced IRB staff reviewer will then review it and work with the study team to determine whether transitioning to the revised Rule will be beneficial for the study team. NOTE: FDA-regulated studies do not qualify for transition to the revised Rule at this time.
Revisions to Exemption Categories
The revised Rule includes revisions to existing exemption categories as well as adding new categories. UW-Madison has already implemented these revisions under institutional policy for projects not federally funded. After January 21, 2019, the revised exemption categories will apply to all applications for exemption, regardless of funding source. For more information about the revised categories (including a decision tool), please see our Guidance on Exemption Categories under the Revised Common Rule.
Exception to Ongoing Continuing Review
The revised Rule allows studies that qualify for expedited review to be excepted from ongoing continuing review. In addition, the revised Rule permits studies that have reached the point where study activity involving only data analysis or long-term follow-up to no longer require continuing review. UW-Madison has already implemented these revisions under institutional policy for most studies not federally funded or FDA-regulated. After January 21, 2019, the exceptions to continuing review will now apply to federally-funded, non-federally funded studies approved after the implementation date. IRB staff will be reviewing each study to determine whether continuing review is required under the revised Rule.
Single IRB (sIRB) Review
The revised Rule includes a provision requiring single IRB review for all non-exempt studies (this applies only to sites in the United States). While this mandate is already in place for NIH-funded studies, this provision of the revised Rule does not become effective until January 2020. While we encourage study teams to begin thinking about the impact of this provision on their research program now, no action is required at this time. If you have any questions about sIRB, please contact the HS IRBs Reliance Team (firstname.lastname@example.org).