While clinical research professionals typically understand what has to be submitted to an institutional review board (IRB), the board’s decision-making processes can seem like a “black box.” A mock IRB meeting can be very illuminating, illustrating how regulatory mandates and ethical principles are reconciled with the realities of current clinical research.
“We’ll be holding a mock IRB meeting at ACRP 2026 in Orlando,” says Robert Romanchuk, CIP, BSHS, Chairperson and Regulatory Director at Univo IRB. “This will demonstrate how IRBs deliberate on topics such as protocols, protocol amendments, reports of noncompliance, and continuing reviews. The mock meeting will show the challenges of ensuring that all members voice opinions, and that a determination can be reached on each question.”
IRBs provide ethical review of research protocols to protect the safety and rights of research subjects. Originating in the 1970s, IRBs are governed by federal legislation, including U.S. Food and Drug Administration guidance and the Common Rule, which apply to all federally sponsored research. IRB membership is dictated by legislation that requires at least five members with varying backgrounds. These include a lay person, a non-scientist, and people with specialist knowledge. IRBs may operate locally, at the health system level, or centrally, covering multiple healthcare organizations. Central IRBs typically cover larger numbers of multisite studies.
“One feature that is unique to central IRBs is the high volume of meetings—some may conduct as many as 20 per week, with five or more items on each agenda,” notes Romanchuk. “Each of these meetings could involve many potential members, depending on the expertise required. It’s easy to see that every panel might reach slightly different conclusions, since regulations and guidances often require interpretation.
“While many terms are clearly defined, concepts such as appropriate protections for vulnerable populations (such as children, pregnant women, prisoners, or someone cognitive impairment) are not so clearly spelled out,” states Romanchuk. “This requires that the IRB determine, for example, when and how a legally authorized representative should be involved in enrollment of a vulnerable patient.”
Behind Closed Doors: The Inner Workings of Institutional Review Boards
Join Robert at ACRP 2026 [April 24-27; Orlando, Fla.] as he informs researchers of the inner workings and deliberations arising from today’s clinical trial proposals and reports as IRBs reconcile regulatory mandates and ethical principles with modern research conundrums. View complete schedule.
Regulations define when a protocol is “minimal risk,” which in turn allows a specific review pathway involving a single delegated reviewer. If the protocol poses greater than minimal risk, the prospect of benefit must be weighed carefully when enrolling vulnerable populations such as children.
“The IRB must attribute the level of risk, which is challenging in placebo-controlled or first-in-human studies where only animal data are available,” concludes Romanchuk, “However, despite the challenges, panels are typically able to make determinations in the interest of protecting research subjects.”
Edited by Jill Dawson
