In the world of ethical review of human research, a salient trend emerged in 2015: more calls to centralize ethical review. Over the past eighteen months numerous sources have moved towards preferring or even requiring a central ethical review board (Institutional Review Boards, or IRBs) whenever a study has more than one research site:
- In July, the National Institutes of Health (NIH) proposed a rule that would mandate a central IRB for multi-site studies with NIH funding.
- Also in July, the House of Representatives passed its version of the 21st Century Cures Act, which endorsed the NIH’s proposal as well as allowing for central IRB review of device research.
- Industry sponsors of research – several pharmaceutical companies and contract research organizations alike – began to require central IRB review as a condition for participating in multi-site studies.
- In September 2015, the U.S. Department of Health and Human Services released for comment a range of proposals to improve rules protecting human research subjects (Notice of Proposed Rule Making). The NPRM, as released, included a requirement that federally funded, multi-site studies, use central IRBs.
If this trend continues, or if these proposed rules take effect, many research institutions will need to broaden their use of central IRBs, including independent IRBs such as Quorum. And many IRB administrators or Chairs may be wondering, what would that transition be like? How could a transition to central IRB review affect our operations?
To help consider these questions, I asked one of our IRB members, Dr. Lynn Borgatta, to compare her experience on local IRBs with independent IRBs. Lynn served on Boston University’s IRB for many years, including as Chair, and she was a member of another independent IRB before joining Quorum. Lynn shared her thoughts about differences between these ethical review boards.
Q: In academic research, have you noticed a trend toward or away from the use of central IRBs?
Universities are considering independent IRBs more readily because they want faster turnaround times for pharmaceutical studies. But it’s not always a straightforward decision. At Boston University, the IRB office would look over the protocol before agreeing to transfer jurisdiction to another IRB.
Q: What differences have you noticed between local and central IRB review? What are some things a research institution might give up when transferring jurisdiction to a central IRB?
With centrals / independents, you really can lose that interaction with the investigator. A local IRB knows investigators, and it knows the facilities. It understands the capacity and capabilities of researchers, and can appreciate whether a particular protocol is a reasonable undertaking.
One IRB would have the researchers come into the meeting to answer questions, or respond to suggestions about changing protocols. Or we could ask them to be available, to respond to concerns, rather than approaching them formally. This contrasts with the experience at an independent IRB, which I’ve noticed tends to either accept or reject a proposal without less formal discussions.
For anything at a particular site, or with a specific investigator, an independent IRB doesn’t have the same leverage to suggest corrective actions. There is less opportunity for direct performance improvement. Sending a formal letter doesn’t always invite a conversation.
Q: How about some advantages? What benefits might an institution see from using a central IRB for some or all protocols?
The Chairs of independent IRBs consistently know the protocols at the meeting. In contrast, most academic Chairs are part-time and voluntary. An academic’s Chair doesn’t necessarily have technical expertise, and is less likely to have as detailed knowledge of the protocols at a meeting.
The independent IRBs are fast and predictable. You know who to contact with questions, there’s a process, and you know how long it will take to turn things around. That’s missing from a lot of local IRBs.
The investigators certainly liked that central IRB review tended to be efficient. Of course, the administrative staff on a research team still had to engage with the local IRB office, outside of a particular protocol.
In my experience, turnover in the staff at local IRBs was high. And it could take a long time to get someone new up to speed. It could take one year to train someone, and at the local level you can’t proactively hire for turnover in the IRB office.
Another big difference is attention to the consent form. The consent form editor structure (at Quorum) is incredibly detailed, and they are aware of the extensive guidelines for protection of participants. In local IRBs, the consent falls largely to the assigned reviewer, so there can be inconsistency. Having a separate operation that concentrates on consent forms is wonderful.