Three Approaches to Accommodate the Single IRB Policy for Multi-Site Research
The new NIH Policy on the Use of Single Institutional Review Board for Multi-Site Research went into effect on January 25, 2018. The goal of the policy is to streamline the IRB Review process by eliminating duplicative IRB review.
While the policy is well-defined, IRBs are now faced with how best to comply. For it to work, IRBs must tackle several difficult questions. One such question is the following:
How is information shared and maintained between the single IRB of record and each participating site?
"How is information shared and maintained between the single IRB of record and each participating site?"
There are many people that play a critical role in the oversight of multi-site research. At a high level, we can consider these people come from the following groups:
- Lead principal investigator and study team
- Single IRB of record
- Participating site principal investigator and study team
- Participating site IRB
It’s clear that each group has a role to play in the submission and review process, but how can this be accommodated when there are multiple institutions involved, each with their own IRB system? There are three fundamental approaches:
- Direct Access: Allow parties from other institutions to access your IRB system to provide required information and participate in the review. While this approach may sound simple, there are hidden costs related to a constant need to manage user accounts for a steady stream of new users, and, perhaps even more challenging, providing training to all these infrequent users on how to properly use your IRB system. Many institutions also have security concerns when providing access to individuals who are not employees of the organization.
- Human Proxy: Rather than dealing with the complexities of infrequent users, task dedicated staff with acting on their behalf within the IRB system. In this model, local staff works with each external party to ensure the proper information is recorded into the local IRB system. While this certainly avoids the need to provision numerous user accounts and constantly train new and infrequent users, it does require additional staff that must scale as the number of participating sites increases.
- System-to-System Integration: To address the concerns inherent in the other two approaches, Huron developed the IRB Exchange, which allows each user to work with their own IRB system, eliminating the need to learn many systems while automatically sharing information among IRB systems. This allows each IRB to maintain a consistent experience across all active research while adhering to the new NIH policy of single IRB review. Huron IRB Exchange is based on open-application programming interfaces (APIs), so any IRB solution can connect and share information with their partners.
Learn more about how the Huron IRB Exchange is currently helping leading research institutions in their compliance efforts.