A committee recently approved a “points to consider” document that outlines three general areas where exceptions to single IRB oversight can be an option.

The document was approved at the March 13, 2018, meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which has been hammering out guidance documents on the new Common Rule for the Office of Human Research Protections (OHRP).

“We were asked to provide ‘guidance’ on what might be appropriate exceptions to requirements for single IRB review,” said Michele Russell-Einhorn, JD, co-chair of the SACHRP subcommittee that worked on the document. “As the discussion progressed, we decided that having a points-to-consider document seemed to make more sense.”

The document has culminated in a series of discussions in subcommittees, as panel members tried to parse out the exemption categories.

“We ended up with three exemptions,” she said. “One is relating to vulnerable populations. One relates to the number of sites in the study [five or less], and one relates to situations that are politically or otherwise sensitive.”

There was a lot of discussion on all of the options, she said, as the panel wrestled with what a single IRB could provide and what is best handled by a small group of multiple IRBs.

“Why is five sites the magic number?” Russell-Einhorn said, giving examples of the questions raised. “Why vulnerable populations or the needs of special populations? Why are these subject to exceptions when the [single] IRB is supposed to have expertise? Why are political or sensitive situations something that a single IRB couldn’t deal with?”

One can argue for and against the exemption categories, but ultimately these three groups represented the variety of concerns that could be best served by conducting research under several IRBs rather than designating one oversight board, she explained.

“I don’t think any of these three are perfect,” she said. “I think the consensus is that these represent three good ‘buckets’ of situations that would warrant consideration. Remember, this is all about consideration. It isn’t that anybody has to do this and has to have exceptions to single IRB review.”

The approved document cited the following example of an exemption that illustrates both a small number of IRBs involved and a special research population:

“Research involving surgical placement of a deep brain stimulator in patients with OCD who are treatment refractory, who are drawn from a single site and evaluated by psychiatry at the site for capacity to consent, treatment refractoriness, and follow-up, with surgery conducted at a different location. Given the different research activities at different sites, each site IRB may be best suited to conduct its own review. In addition, with only two sites, the logistics of organizing a single IRB may be inefficient and unnecessary for participant protection. Exception for the single IRB review requirement would be acceptable in this context.”

While there is a place for exceptions to the single IRB requirement, it should be remembered that the original idea of streamlining oversight down to a single panel was to improve the review process and better protect research subjects, said Stephen Rosenfeld, MD, MBA, chairman of SACHRP.

“It is counterintuitive for many people why a single IRB would be more protective, but it certainly could be,” he said. “It’s only when those things fail that you should be considering an [exemption] alternative.”

There was a lot of back-and-forth in subcommittee discussions, he added.

“There are always two ways to do this,” Rosenfeld noted. “You can beef up your single IRB to make sure it’s appropriate, or you can go back to individual IRBs. That choice should really be governed by the concerns that drove the single IRB mandate in the first place. Those are efficiencies and protections.”

In the discussion before the vote, board member Sandra H. Berry, MA, asked who would request the exemption from single board review and, perhaps more important, who would approve or deny it.

“Who would make the decision specifically about whether the [requested] exemption will be honored, or whether in fact it will just be a single IRB,” she said. “How does this work in practice?”

Russell-Einkorn said, “My understanding is that it is the agency that is funding it that makes the decision. That said, with a document like this out for public consumption, an investigator [could argue a study should be exempted]. They would submit their grant and their rationale to a federal agency, and they would decide if they want to go along with that or not.”

She added that previous guidance documents had addressed this point in more detail, and the committee approved a motion to amend the document to reference those for more information.

The decision to go to single IRB review for most research has been welcomed by some and condemned by others. In recently submitted comments on the interim final rule, one IRB member found the devil in the lack of details.

“There are fundamental problems with the implementation of single IRBs [in the rule],” wrote Bruce Larsen, co-chair of the Department of Human Services IRB in Utah. “It is a rule without actual procedures for implementation; i.e., a rule that lacks the elements of a rule,” he wrote in comments.1 “It is more like a vision statement that states procedures will be worked out within three years.”

Perhaps the SACHRP document and other committee guidance will help rectify this situation, but Larsen argues that problems with the approach run deep.

“It seems to require IRBs to work out joint agreements, but lacks an appeal mechanism when an agreement can’t be reached,” Larsen commented. “There is no recognition that multiple IRBs may be involved. This rule fails to consider the multiplicity of research that may require researchers to approach multiple IRBs, then wait while the IRBs negotiate new single IRB agreements among themselves.”

REFERENCE

1. HHS, et al. Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects. Fed Reg 83 FR 2885: Jan. 22, 2018. Available at: http://bit.ly/2C50tbp.