Local Versus Central IRBs: What’s the Difference?
What are the differences between working with a local IRB and working with a central one? Since the National Institutes of Health (NIH) and the Common Rule agencies started requiring single institutional review board (IRB) review in multisite research, there have been conferences, workshops, blog posts, and other articles devoted to this topic.
Having worked in a local IRB at an academic medical center (AMC) for over 20 years, and now in my new role as Senior Vice President for IRB review at Advarra, I’m lucky to have gained perspectives on both types of IRBs. And when you come right down to it, I see the differences as minimal.
As IRBs, they both apply the same criteria for approval to the research, they both are responsible for the oversight of the research, and most obviously, and they both exist to protect participants. Thoughtful, dedicated IRB members exist in each and every IRB – local or central – and they both are audited regularly by federal agencies. Additionally, many have moved toward securing accreditation.
However, I do see one big difference: The effect of the single IRB (sIRB) mandate requires little to no real change in the way a central IRB operates, but it has had far more impact on local IRBs.
To examine why the sIRB impact is so great to local IRBs, I return to the 1998 OIG Report on IRBs, which tasked the Institute of Medicine to investigate and provide recommendations for the reform of IRBs. This activity coined the concept of human research protection programs (HRPPs) and lead to robust accreditation standards like those developed by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
As local IRBs began to build their programs to meet the accreditation standards, they took on many roles in addition to IRB review, such as:
- Ancillary reviews (e.g., institutional biosafety committee [IBC] review, radiation for research review, and conflicts of interest [COI] reviews)
- Gatekeeping activities (e.g., review of contract language for participant protections)
These additional responsibilities helped assure research was not initiated until all organizational requirements were met. This trend of expanded roles has resulted in HRPP/IRB offices that vary widely across medical centers, hospitals, and schools.
Today’s sIRB mandates require organizations to extract only the IRB review piece from a HRPP, leading to operational changes within a local IRB’s structure. To confound it further, study teams traditionally used to working with just their local IRB, or working with one central IRB, are now having to adopt processes for working with other local IRBs as well as with other central IRBs. Likewise, IRBs are having to learn to review and rely on other IRBs.
These paradigm shifts have left some local IRBs and their study teams under-resourced to manage working with multiple organizations for one multicenter research project. In this respect, established central IRBs have an advantage and have the resources to continue to review for the many organizations now subject to the single IRB mandate.
The significant shift for local IRBs does not change the actual review requirements or the considerations about how the risk-benefit ratio of the research is evaluated. It does bring to light the difference between IRB review and the many other responsibilities that local IRBs have taken on over the years. In the end, local and central IRBs are not that different – we really are much more the same.