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<p> One thing is for certain: Like it or not, the new single IRB mandate from Health and Human Services is here to stay. More from the 2016 AAHRPP conference.</p>

IRBs Eye Single IRB Mandate With Uncertainty, Grudging Acceptance at AAHRPP conference

By Jill Drachenberg, Managing Editor, on site at the 2016 AAHRPP conference

All IRBs will eventually become a relying IRB or will have to rely on a central IRB for multisite studies and must prepare for the eventuality, experts said throughout the Association for the Accreditation of Human Research Protection Programs (AAHRPP) annual conference, held this week in Long Beach, CA.

Last fall's long-awaited Notice of Proposed Rulemaking (NPRM) from the Department of Health and Human Services (HHS) included a mandate that a single IRB of record -- a central IRB -- be used for large, multisite studies. Exceptions to the mandate would be very limited, and the rule has seen serious push-back from IRBs across the U.S.

"A lot more people have spent time thinking and reacting and whining about what is coming down the road [on central IRBs]," said David Strauss, MD, vice chair for research administration, ethics, and policy at the Columbia University Department of Psychiatry in New York City. "When it does come to us, it'll substantially change the way we think about research at our organizations. The shift to single IRB review may solve a lot of problems related [to issues such as] redundancies [in review], but will change the way organizations manage their standards."

For example, IRB policies on things such as the quality of review, and return of results and disclosure of incidental findings to study participants vary between institutions, Strauss added. "We [multisite study IRBs] need to have an agreement on how to handle such things," he said. "It depends largely on how we work together and with AAHRPP on how to form standards."

"Reliance" is becoming the chief buzzword in human research protection programs (HRPPs), added David C. Clark, PhD, director of human research protections at the Medical College of Wisconsin in Milwaukee. Developing master reliance agreements will depend on the protocol and each institution's size and needs, he added.

"The concept is not to create yet one more IRB that will do these multisite reviews -- let's create trusting groups of IRBs that will review and exercise oversight for one another," he said. This is probably best done regionally as familiarity and good communication are critical, he added.

It is also pressure to do a cultural shift at one's organization to rely on a single IRB or to become the relying IRB, said Kathy Lawry, MSSA, CIP, director of reliant review for the Cleveland Clinical and Translational Science Center at Case Western Reserve University. Despite the concerns of IRBs, there are many potential benefits.

"There is decreased burden on relying sites, increases collaboration between institutions, may improve the consistency of IRB review, and encourage best practices through exposure to other institutions' approaches," she says.

Strauss likened the current state of research protection programs in the face of regulatory overhaul to the legend of famed blues musician Robert Johnson, who was said to have made a deal with the devil at a crossroad for his musical abilities. "Like Robert Johnson, we are at a crossroads but we're not sure who the devil is at the moment," he said. Human research protection programs "must respond to political and public pressures and avoid a Faustian bargain," he added.

While there is no firm expected date for the final HHS rule, there is speculation that it may be released in the fall.

Look for more coverage of the AAHRPP annual conference in upcoming issues of IRB Advisor.