Ready or not, single IRB is here.

The requirement to eliminate duplicate Institutional Review Board (IRB) reviews in multisite studies, first made by the National Institutes of Health, now extends to many other federal agencies and is expected to soon apply to some FDA-regulated research. The lofty goal of “single IRB” is to streamline the review and oversight of research involving human participants without sacrificing participants’ protection. How to get to that goal was largely left to the human research protection community to figure out.

Enter SMART IRB (SMART is an acronym for Streamlined, Multisite, Accelerated Resources for Trials), a multi-pronged reliance agreement and web-based platform that more than 1,200 institutions have signed onto. Version 3.0 of the SMART IRB Reliance Agreement  will accommodate the participation of additional  federal agencies  and incorporate feedback from eight years of practical application in the field, including the most recent second round of community comments, which closed Dec. 13

Nichelle Cobb, PhD, CIP, senior advisor for strategic initiatives at the Association for the Accreditation of Human Research Protections Programs (AAHRPP), has been instrumental in developing SMART IRB since its inception in 2016, when she was at the University of Wisconsin, Madison. At that time, she recalls, a “small but mighty” SMART IRB team recruited the Clinical and Translational Award (CTSA) institutions–Harvard and Johns Hopkins medical schools among them–to pioneer a streamlined process for getting reliance agreements in place.  The community has really embraced SMART IRB, she says, driving the agreement’s use across academia and beyond.

We caught up with Cobb, a senior advisor to SMART IRB, to catch up on what’s new.

How does SMART IRB relate to federal efforts to streamline human research protections through the single IRB rule?

These single IRB mandates have been put out there for good reasons, but the federal agencies didn’t provide guidance on how to do this. It’s complicated. When the FDA requirements take effect, a whole new round of institutions will be affected.

“SMART IRB has contributed by providing a roadmap that shows how to make single IRB work. It makes it clear that protecting research participants is still a shared responsibility.”

Some institutions may have been thinking: “Single IRB? Great, it goes to another IRB; we can wash our hands of the study.” Then it’s a big surprise when that’s not at all the case, and that the single IRB process might actually be harder. Relying institutions haven’t lost their responsibilities. They still have to make sure their researchers know what they’re doing and adhere to the terms of the reviewing IRB’s approval. Institutions retain the ethical obligation to make sure that people are protected regardless of whether the IRB review of research is by an internal or external IRB.

SMART IRB has contributed by providing a roadmap that shows how to make single IRB work.  At its heart is the reliance agreement, which spells out what each participating institution has to do, whether it’s reviewing or relying (see definitions of “reviewing” and “relying”). It makes it clear that protecting research participants is still a shared responsibility.

Single IRB has been a long time coming. Is the clinical and translational science world ready?

Well, many smart, dedicated people are working on this, and I think it’s gotten better in many, many cases. Some research teams, IRBs, and relying institutions have gotten really good at single IRB.

What’s missing are metrics on whether single IRB is helping get things done more quickly, which was the whole goal. And did it cost less? We don’t know any of that. I am not aware of anyone collecting systematic data across institutions that would help us know if single IRB reduces time to multisite study activation or reduces cost.

I often hear from folks that single IRB didn’t make the IRB review process better; it made it worse. I hear others say that it has made it better for some things, especially for sponsor-driven clinical research. SMART IRB provides a tremendous amount of resources beyond the reliance agreement to help IRBs, HRPPs, and study teams adapt to single IRB.

How are these single IRB rules changing the landscape of human research protections?

One of the positive outcomes of single IRB is that institutions talk to each other in ways they didn’t before. You really are learning from one another. You’re building relationships. In that sense, single IRB has imposed, or at least encouraged, flexibility and self-reflection. When you see how others do something, you might ask why don’t we do it this way?

“One of the positive outcomes of single IRB is that institutions talk to each other in ways they didn’t before. You really are learning from one another.”

This harmonization is the third leg of the SMART IRB stool, the reliance agreement being the first leg and training and education the second. Harmonization centers on guidance around how to implement best practices as outlined in the agreement.

Adoption of best practices has been slow, but more organizations are doing some things more similarly. One example is the widely divergent rules IRBs have about how personnel changes are reported. The SMART IRB guidance is clear: Very few should be reported to the IRB and the rest should be monitored by the research team. IRBs don’t need to review every single new member of a research team. Changes like that give me optimism that some of the bumps are smoothing out.

Every once in a while, something comes up that makes us say: “Oh they’re still doing that?” Duplicate reviews are a big one, such as when an institution’s local IRB is reviewing the study as though it is the reviewing IRB when in fact it is a relying institution. That approach is not helpful; it’s counterproductive to the goals of single IRB and it can really confuse researchers.

How are researchers’ lives changing with single IRB?

Research teams are no longer working with just one or a few IRBs that they get to know very well. With an investigator-initiated study using an academic IRB as the reviewing IRB, the lead study team has much more responsibility than it ever had in the past. Many reviewing IRBs will primarily communicate with the lead study team only, so that team may be responsible for all participating sites’ applications. It becomes a quasi-coordinating center, getting information from the participating sites to the reviewing IRB and vice versa.

Multiple sources tell us that communication has been a big challenge. People are confused about who needs to do what when, and whose responsibility it is to make sure it’s done. No one’s really taking the lead to say: “You will be responsible for this. These are the duties you have now. Here are the policies and processes you need to know.”

The lesson is that we need to do a better job of communicating, and investigators may need more help to fulfill that role. Some institutions have specialized positions outside the IRB office that help study teams navigate the different steps and communicate with the other researchers and IRBs involved.

The SMART IRB Reliance Agreement Version 3.0 in development is at the stage of reviewing the second round of comments from the community. What’s different about this version and what’s next?

We knew this agreement would need to evolve when we started. Version 2.0 was a minor update to bring in the National Institutes of Health as a partner. Version 3.0 expands its use to other federal agencies, including the Veterans Administration and the Department of Defense. This version also addresses feedback we’ve received over the years about how to make the agreement better.

What’s next is to sign on more than 1,270 institutions who use versions one or two. It’s a good problem to have. It means 1,270 institutions have found this to be a clear roadmap for how to structure a reliance arrangement in the most streamlined way. I’ve never seen such a high level of agreement amongst that many organizations.

Our hope is that many institutions will readily sign on to the new version because their requests have been accommodated. We haven’t had significant pushback on anything that we’ve proposed, so I’m optimistic.

It’s going to take a lot of legwork of course, and we have a wonderful ambassador team that will be helping. Kudos as well to my colleagues Barbara Bierer, Jeremy Levigne, and Polly Goodman, who have worked closely with legal counsel Emily Chi Fogler to get the proposal out, solicit feedback from the community, revise it accordingly, and post it again for a second round of feedback. We are where we are now thanks to them.

Stay tuned for updates on the SMART IRB Reliance Agreement Version 3.0.