NIH Promotes ‘Sea Change’ in Multi-Site Study Framework

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Calling the National Institutes of Health’s (NIH’s) new multi-site clinical trial strategy a “sea change,” Lyric Jorgenson, PhD, deputy director for the Office of Science Policy at NIH, said the regulatory body believes its new initiatives should help avoid redundant institutional review board (IRB) reviews—saving time and money and speeding products to market.

“We heard you all loud and clear—you are excited but want more information on implementation,” she told attendees of NIH’s “Single IRB Review for Multi-Site Research: Resource and Infrastructure Development Workshop” event held on September 12 in Rockville, Md.

The “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research” establishes the expectation that the domestic sites of all NIH-funded, multi-site studies involving non-exempt human subjects research will use a single IRB. As described in a January 2018 blog, NIH said it has heard a great deal of positive feedback in support of the policy and believes that streamlining IRB review for multi-site studies will reduce unnecessary delays and costs caused by duplicative review.

However, NIH also heard concerns from institutions about the resources that would be required to amend business practices, make system changes, and develop other tools necessary to facilitate single IRB review.

In an effort to mitigate some of these concerns, NIH funded seven administrative supplements that provided one year of support to develop widely applicable approaches for modifying and enhancing institutional IRB infrastructure and related resources to allow for efficient and effective single IRB review of multi-site studies.

The lessons learned and insights gleaned from case studies were shared by a number of presenters at the September 12 workshop, including Ann Johnson, PhD, IRB director at the University of Utah. For example, fresh off a trial with 25 sites, she told attendees it’s critical to separate site reviews and study reviews rather than allowing them to overlap. “Otherwise, your risk stalling” a multi-site trial, she noted.

It’s not easy, though the rewards are great, Johnson said. “Within eIRB systems, it can be difficult to manage the activities of multiple sites,” she said. “Many eIRB applications are set up to collect site-level information in the study level application.” However, delays are almost inevitable because various pieces of information are rarely ready at the same time, she added.

Johnson advocated a new framework separating site and study reviews. “To maximize flexibility, study-level information and site-level information can be collected either in tandem, or sequentially, though the review process for each remain separate,” she said.

At the University of Utah, Johnson and her team implemented a framework using the Huron RX version of the Click Portal eIRB system. “The system can be used to enhance any modifiable eIRB system,” she said.

Public comments on NIH’s IRB policy can be submitted to SciencePolicy@od.nih.gov.

Author: Michael Causey