NIH Expects Multisite Research Trials to Stick with Single IRB

The National Institutes of Health (NIH) just issued a policy statement to the effect that it expects all sites participating in multisite studies funded by NIH and involving non-exempt human subjects research to use a single institutional review board (IRB) to conduct the ethics review to ensure the protection of participants.

The stated policy, years in the making and consistent with long-time NIH thinking, is designed to enhance and streamline the process of IRB review and reduce inefficiencies, the agency says. “We’ve been hearing for years, and the scientific evidence bears this out, that the use of [multiple] IRBs can slow research without a consummate increase in protection,” says Carrie Wolinetz, PhD, NIH’s associate director for science policy.

If anything, there are sometimes so many chefs in the kitchen that no one notices when the pan’s on fire.

While patient groups have broadly cheered the measure, others, including some research institutions, have expressed wariness, Wolinetz admits. “They know they have a lot of work to do to get their [information technology] systems in order,” she notes. NIH will offer ideas, FAQs, and other tools to help research institutions meet these and other new challenges associated with the new policy edict, she adds.

The new policy applies to the domestic sites of NIH-funded multisite studies where each site will conduct the same protocol involving non-emempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. However, it does not apply to career development, research training, or fellowship awards.

Resources

Check out our White Paper, Considerations for AMCs When Debating the Use of a Central IRB, to learn more about the main points of maintaining local IRB review and oversight of multisite trials versus outsourcing to a commercial IRB as the IRB of record.