By Ray Tobey, Chief Medical Officer on May 2, 2018 9:00:00 AMWith the expanding number of human clinical trials and multi-trial sites, the need for organized, fast turn-around, and efficient Institutional Review Board (IRB) processes are needed more than ever. In the last few years, there have been a range of proposals to improve these processes and rules protecting human subjects in clinical trials. One proposal, emphasizes that IRB processes should be held at central locations because of the increasing need for efficient oversight of trials taking place at multiple sites. It is thought that, generally speaking, local IRBs lack resources and infrastructure, yet, they are thought to be critical in understanding the values and attitudes of the local population participating in a study.
We wanted to break down the pros and cons of adopting a central IRB processes so you can understand how this may affect your organization. The FDA also provides a lengthy guidance on this topic if you’d like to dig a little deeper.
- The FDA allows and, in some cases, suggests that an IRB is held at a different location from the research. This will ultimately promote a more ethical review.
- A larger set of resources, such as access to experts and information systems, that allows for faster and more efficient oversight of trials taking place at multiple sites.
- Well-trained personnel with less turn over than local teams.
- Consistency and predictability with associated processes and forms.
- There may be a lack of understanding about the local context and/or community values that may undermine the study.
- There is a possibility of lost interaction with investigators which may present fewer opportunities to initiate corrective actions.