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Human Research Rule Revisions Enter Final Compliance Countdown

Dec. 21, 2018, 6:39 PM

Medical research institutions can finally see the finish line for adopting major changes to human research protection regulations after almost six years of anticipation and two false starts.

Revisions to the Common Rule, a set of regulations to protect research volunteers from undue harm, take effect on Jan. 21 (41 C.F.R. 46). Unless there’s an unlikely third delay to the start date, institutions have one month to implement the first substantial changes in the requirements since they were first issued in 1991.

Research institutions and institutional review boards (IRBs)—ethics panels that review studies to ensure compliance with the Common Rule—are ready. At the very least, they’re ready to move on from the uncertainty that’s been surrounding the rules for the last two years.

“The rulemaking process that brought us to this point has been an interesting odyssey, but it will be good to have it behind us,” David Borasky told Bloomberg Law. Borasky is vice president of IRB compliance for WIRB-Copernicus Group, a large, commercial IRB headquartered in Princeton, N.J.

Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania who primarily focuses on human subjects research ethics and regulation, told Bloomberg Law, “My sense is that while there is some anxiety, everyone is feeling pretty ready to just be done with the transition period.”

No Formal HHS Guidance

To date, there are no final guidance documents on the rule changes from the Health and Human Services Office for Human Research Protections (OHRP), although there are four draft documents. The revisions include a new requirement that all “key information” a prospective volunteer might want to know before enrolling appears at the top of a consent form. There are also new exemption categories designed to allow IRBs to spend more time reviewing riskier studies. But the draft guidance documents don’t address these areas.

“There’s no doubt that it’s harder in the absence of guidance related to key information in informed consent, and some of the new exemption categories,” said Elisa A. Hurley, executive director of Public Responsibility in Medicine & Research, which is an organization for human research professionals. Institutions are sharing resources and making the best of it, she said.

“If new guidance should appear from OHRP, I hope that it will be straightforward,” Borasky said. “If we continue to operate in a guidance vacuum, then we will look to the recommendations” that have been issued by an HHS advisory panel where additional clarity might be desired.

Institutions will generally be ready on Jan. 21, as there’s a lot of focus right now on educating investigators and IRB members on what they need to know, Hurley said. Likewise, Borasky said he’s confident the WIRB-Copernicus IRBs are ready to implement the revisions.

Released Jan. 19, 2017, the revised Common Rule culminated more than six years of work to modernize the regulations, which hadn’t been changed significantly since they were first issued in 1991. Many of the changes are designed to accommodate a transition over that time from single investigators conducting research at one institution to a more global, collaborative approach involving many investigators at multiple institutions.

A Trump administration review and two compliance date extensions by the OHRP delayed the effective date of the revisions from January 2018 until Jan. 21, 2019.

Next Steps

On Jan. 21, institutions can choose to migrate ongoing studies to comply with the new revised rule or keep them following the old rule, which means institutions will likely have different studies following different versions of the Common Rule at the same time. “It will be hard for a while,” Fernandez Lynch said. She expects to hear about about kinks in the new rule that need to be resolved, which can’t be fully predicted until studies start running under the new requirements.

Additional complications may arise for research that’s also subject to separate Food and Drug Administration human research regulations that are more consistent with the old Common Rule. The FDA plans to issue new rules that line up with the Common Rule revisions and has issued guidance to address studies that must follow both the FDA regulations and the Common Rule.

“The next adventure will revolve around the FDA approach to harmonization under the new rule,” Borasky said. “I hope that the timeline for those rule changes will be shorter.”

As research institutions have devoted “tons of resources to getting this right,” Fernandez Lynch said she also hopes they evaluate the impact of the revisions. “Are things faster? Are investigators happier? Are subjects better protected? Those were the goals—now we need to figure out whether they will actually be realized.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Randy Kubetin at rkubetin@bloomberglaw.com