Institutional Review Boards (IRBs) are required to create and follow written Standard Operating Procedures (SOPs) under US regulations. Each IRB created SOPs it deemed necessary to bring it into compliance with the lab. But is that enough for the FDA? Apparently, there were concerns about the adequacy of SOPs at the IRBs as the FDA released two guidance documents yesterday on this topic, one giving the list of SOPs and the other answering many common questions about IRBs.
IRBs, sometimes also called Independent Review Boards, are the key regulatory bodies for all clinical trials, even the ones not directly regulated by the FDA. The first IRB was established in the US in July 1974 with the passage of the National Research Act, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, effectively initiating the modern IRB system for regulating human subject research. Currently, there are 2300 IRBs registered with the Office of Human Research Protection (OHRP) of which 1800 are affiliated with specific institutions while about 500, it seems, are not affiliated with any specific institution and hence operate as “Central” IRBs. The rules for SOPs are the same for all IRBs in the US, i.e., they need to register with OHRP and work per their SOPs.
But IRBs come in all sizes and scopes, from small institution-affiliated IRBs that review very few clinical trials, meet a few times a year, and are run on shoe-string budgets, to large central IRBs that each oversee hundreds of clinical trials, have elaborate processes, and run like efficient businesses with significant resources. Hence, there is a variability in the SOPs at these organizations. To help standardize the processes across all IRBs in the US, the FDA’s latest guidance document gives a list of 55 SOPs that an IRB should have to cover all its operations. The list describes, at a high level, the scope of each SOP. A companion webpage on the FDA’s website, written in a Q&A format, answers 66 common questions in 7 areas of IRB responsibilities along with some general topics, to help IRBs formulate their practices.
For IRBs in operation for longer than 10 years, most of the information in the guidance document and the Q&A should confirm the existing practices. There are probably a few SOPs that almost all IRBs would either revise or create to meet the FDA list but those will likely not be about major operational aspects of these IRBs. For the new IRBs or the ones that have been operating in the shadows, the new advice from the FDA could be the one they needed to be fully compliant.
For sponsors, the next time you pick an IRB to supervise your trial, ask them: do you have the 55 SOPs required per the FDA guidance document of 2025?
