FDA’s Proposed Single IRB Mandate Could Streamline Clinical Trials

Institutions that take steps now to comply with the Food and Drug Administration’s (FDA) proposed rule aligning FDA institutional review board (IRB) regulations with the Common Rule will likely see benefits in terms of streamlined processes and improved activation timelines, experts said.

Sandy Smith, senior vice president, clinical solutions and strategic partnerships at WCG, told a webinar audience that FDA’s proposed changes—released along with a second notice of proposed rulemaking (NPRM) on the same day in 2022[1] —will require institutions to make some changes but ultimately, those changes will be positive enough to warrant institutions moving forward prior to the rules being finalized.[2] WCG is a consulting firm that can be contracted to serve as a single IRB; it also offers related clinical trial services.

“We know that it will make it much easier for the [trial] sponsor, but we also believe it’s going to be easier for the sites as well,” said Smith, who has stood up and managed local IRBs both for community hospitals and a large site management organization. “Overall, we do believe that this will add efficiencies; it will reduce activation timelines and hopefully be easier for your team members. But there’s work in working out all of the workflows.”

The May 2 WCG webinar covered two FDA NPRMs: the NPRM on “cooperative research”—known as the single IRB requirement—and the NPRM on the protection of human subjects and IRBs. On the protection of human subjects NPRM, WCG speakers specifically focused on the part that deals with informed consent.

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