On January 19, 2017, years of discussion and debate coalesced into a new Common Rule to govern the protection of people who join clinical trials. The Department of Health of Human Services and the other 14 federal agencies that follow Common Rule guidelines have until January 2018 to implement all but one of the changes. The change that will become official in 2018 relates to cooperative IRB review; the Common Rule gives the research community until 2020 to start relying on one IRB for all of the investigative sites in most multisite, federally funded research.
Single IRB Mandate in the New Common Rule
- §__.114 (b)(1)Cooperative research. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States
The new Common Rule requires that (with some exceptions) federally funded studies with more than one investigator must use a single IRB (sIRB). This suggestion appeared in the draft of the rule too, (known as the Notice of Proposed Rulemaking, or NPRM), which was open to public comment. According to the Common Rule’s preamble, this section received some of the highest numbers of comments. And opinion split pretty much down the middle, with 130 commenters for the idea and 140 against. In the end, the agencies stuck with the supporters and made it official policy.
Those 130 opposing comments did not go unheeded, however; the final policy does have some significant changes from what was in the NPRM.
- The effective date of 2020 was a tip of the hat to concerns over the complexity of implementation.
- To ease concerns that investigators and institutions could be held accountable for decisions made by an external IRB, the regulations now state that any IRB-related enforcement action will be attached to the IRB of record, not necessarily the location of the research.
- The regulations endorse coordination between the funding agency and the lead investigator in selecting an IRB. This approach resembles the NIH’s version of the sIRB policy, which takes effect May 25, 2017.
- Funding agencies will have the authority to determine that a single IRB review is inappropriate for certain types of research.
- The Common Rule acknowledges that single IRB review is not possible when the law prohibits it. One specific application is for research on tribal lands, where central IRB review is typically prohibited.
How Will this Work? SMART IRB Could be a Smart Choice
The text of the new Common matches closely the NIH’s single IRB requirement from late 2015. The NIH’s rules become effective in May, and the ramp up to that date could show how the community will absorb the broader application of the Common Rule. One developing trend is that institutions are bolstering their HRPP programs to serve as a single IRB as necessary. This is not completely new; IRBs in large research centers such as the Fred Hutchison Research Center here in Seattle and Partners Healthcare in Boston often serve as central IRBs already.
Other innovations are showing up, too. Quorum recently signed on with the NIH-backed initiative SMART IRB, which is seeking to make cooperative review easier for its members. SMART IRB provides a kind of umbrella authority under which research institutions can accept reviews from other members. SMART IRB members must show they have undergone an external quality assessment, and agree to certain standard procedures. Quorum is excited about joining SMART IRB and hopes leads to a strong, flexible network of IRB cooperation.