You may recall that in January, the federal Department of Health and Human Services (HHS) announced a 6-month delay in the implementation of the Revised Common Rule. Part of the intent of that delay was to allow stakeholders to formally request a longer delay.
Well, we’re now one step closer to that longer delay period. HHS and other federal agencies under the rule have released a new Notice of Proposed Rulemaking (NPRM), seeking comment on a proposal to move the implementation date to January 21, 2019, instead of the current July 2018 date. The comment period for the NPRM runs through May 20.
The NPRM also proposes allowing institutions to implement three aspects of the revised rule during the delay period, because these changes are considered burden-reducing. Those three changes are:**
- use of the revised definition of “research,” which deems four categories of activities as not research (not much will change for UAMS/ACH researchers in this regard, as these four categories don’t really apply to what we do here)
- allowance for no annual continuing review for certain categories of research (fingers crossed — many PIs may like the idea of not having annual continuing however)
- elimination of the requirement for IRB review of grant applications for research (this would mean one less thing to upload in the CLARA file and one less thing for the IRB to review).
**Please note that changes 1 and 3 would have only minimal impact on researchers’ IRB interactions, and we’re not sure yet if we’re going to entirely do away with annual continuing review for low-risk non-exempt studies. Institutions can add requirements in addition to what the Common Rule specifies, and there may be institutional reasons to keep some sort of regular check-in with investigators on the table. Institutions may also have the option of continuing under the current rule until the new rule is fully implemented.
And yes, this on-again, off-again revision of the Common Rule is driving us all a little crazy. The joke in the IRB office is that we should comment that we hope the final implementation of the rule is delayed until after we’re all retired. It has taken years to get us this far, so why not add a few more more years to the wait, right? Please read this blog item on the Public Responsibility in Medicine and Research website for more information on what its author calls “the rather tortured path” of the revised rule.