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As the new normal becomes single IRB review for multisite studies, some researchers are wary that this system may undermine the vital role of local IRBs to protect research subjects in their community.
In an attempt to answer and resolve these issues, researchers asked central IRBs about their perceived needs for local knowledge and input.1 In a description that suggests single and local IRBs are going to have to work together through better and worse, lead author Robert Klitzman, MD, tells IRB Advisor, “It’s like a marriage.”
Klitzman, a psychiatrist and director of the Master of Science in Bioethics Program at Columbia University in New York City, says, “It’s sort of a division of labor, and these kinds of things need to be worked out. There are still issues — if something goes wrong, who is responsible? There are levels of trust, and local IRBs may feel it is important that certain local information be communicated to the single IRB.”
In the study, Klitzman and colleagues interviewed IRB members from boards that have served as central IRBs for multisite studies. Local knowledge identified as potentially important to single IRBs included culture and linguistics issues, geography, socioeconomics, and researchers.
“Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs’ reviews and interactions with researchers,” the authors noted. “While a recent, commonly used, standardized single IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.”
IRB Advisor asked Klitzman to comment on these findings in further detail in the following interview, which has been edited for length and clarity.
IRB Advisor: The move to single IRB oversight of multisite studies has not been universally embraced, with some seeing it as trading off one set of problems for another. Do you think it was a mistake to adopt a single IRB system?
Klitzman: I wouldn’t say it was a mistake. I do think there are a lot of details about how it is actually going to work that have not yet been thought out. It’s one thing to say there will be single IRBs that use local IRBs. What are the unintended consequences that have not been thought through? What are the kinds of details that need to go along with that? The single IRB policy was made from sort of a 30,000-foot level. There are a lot of issues about how all of this is going to play out on the ground.
IRB Advisor: In the context of institutional challenges, you note that single IRBs will need the requisite organizational skills and resources to manage research across multiple sites. You suggest those that decide to do it for the first time may face a learning curve.
Klitzman: When you decide to become the single IRB, you may need someone to manage 60 IRBs in 30 different states. That’s a different experience [from a local IRB]. An IRB administrator who is just used to looking at reviews and protocols may not have the experience to deal with all these different IRBs and make spreadsheets to keep track of them. People are trainable, but you need someone who is good at that kind of management.
IRB Advisor: You found that issues that single IRBs should be aware of are cultural restrictions and language barriers in research subjects, which will be better known by the local IRB.
Klitzman: I think it is important to drill down. What percentage of potential participants is English not their primary language? Someone at the single IRB may not think of that — 3% of the population speaks Vietnamese.
IRB Advisor: You also raise questions about the cost of living and ability to get to clinic sites in various locales reporting to a single IRB.
Klitzman: In some places, it is a three-hour drive to a hospital. Somebody else in the same study might just take the subway. That is a big burden to participants. Those are relevant concerns.
IRB Advisor: What can local IRBs tell central IRBs about researchers they may not have worked with before?
Klitzman: Local IRBs know if a researcher has some problems, has been overextended, or they have to keep an eye on him. It is not bad intentions, necessarily. Maybe he is busy in China half the time and is just not around.
IRB Advisor: What about the challenges for local IRBs in this new system?
Klitzman: There are still going to be local human subject programs and there will be challenges. For example, local institutions will have to come up with reliance agreements to work with the single IRBs, and that poses a number of challenges because they are giving up certain responsibilities and functions to the single IRB. Local IRBs and local human subject protection programs will presumably retain several important functions, such as conflicts of interest assessments, monitoring and management, responsible conduct of research, research integrity, and compliance issues.
1. Klitzman R, Pivovarova E, Murray A, et al. Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions. Ethics Human Research 2019;(41)1: 22-31.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.