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The White House is reviewing a major human research rule the Obama administration finalized one day before exiting the White House.
The so-called Common Rule (45 C.F.R. 46; RIN:0937-AA02) governs research such as clinical studies funded by the National Institutes of Health to protect people from undue harm. The Jan. 18 final rule culminated a multiyear modernization of regulations that affect nearly 20 different agencies and billions of dollars of federally funded research.
The review of the Common Rule is part of a governmentwide regulatory freeze to allow President Donald Trump’s administration to review any regulatory actions in the final days of President Barack Obama’s administration. The rule doesn’t take effect until January 2018, and the administration started with rules that have more pressing deadlines, according to Ivor Pritchard, senior adviser to the director of the Health and Human Services Office for Human Research Protections, which administers the Common Rule.
“They’re just now getting around to reviewing the regulation,” Pritchard said at the Association for the Accreditation of Human Research Protection Programs’ annual conference in Detroit.
“We are basically in a holding pattern,” Pritchard said, “until they’ve had a chance to understand the provisions of the newly revised rule and recognize where there is latitude for new policy making.”
Pritchard acknowledged there are a number of areas in the 543-page final rule that will require additional interpretation to understand how new requirements will be applied.
While the effective and implementation dates are both set for next January, Pritchard said the White House is considering pushing back the implementation date.
“Our interest is not to play gotcha,” he said. “Our interest is to enable the protection of human subjects in a reasonable sort of way.”
The OHRP originally expected institutions to have a year to come into compliance with the new rule, and Pritchard said setting both the effective and implementation dates at the same time was designed to make it easier for them.
That timeline is much shorter now, since it’s already May and the White House is just now undertaking a review. But the OHRP doesn’t have enforcement discretion simply to grant an extension.
“We can’t say we’re going to give people a free pass for another three months,” he said. “At the same time, we understand the predicament that you’re in.”
The Trump administration is aware of the situation, Pritchard said, but it hasn’t confirmed any delays in implementation, “particularly since it has not yet been decided whether they want to go forward with the rule at all.”
The first-ever update to the Common Rule accounts for the shift away from a single-lab, single-site model for research in 1991 and toward a global research enterprise incorporating rapidly advancing technologies in mobile health and genomics.
The final rule requires shorter, clearer informed consent forms that apply a “reasonable person standard” to put the most important information at the top. This new requirement addresses concerns that informed consent has evolved into use of lengthy documents designed to protect the research institution, instead of protecting the subject.
The final rule also allows for broad consent—authorization to use someone’s data or biospecimen for unknown, future research—as an alternative to seeking institutional review board approval to waive the consent requirement. As under the current rule, researchers still won’t have to obtain consent for studies on nonidentified stored data or biospecimens.
There are also new exemption categories designed to allow IRBs to spend more time reviewing riskier studies, and review boards can skip annual review of studies that pose minimal risk and were approved under an expedited process.
The final rule also requires studies that take place in multiple locations to use the same IRB. But this provision doesn’t take effect until 2020 out of a recognition of the complexity involved in its implementation.
To contact the reporter on this story: Jeannie Baumann in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
More information on the AAHRPP conference is available at http://www.aahrpp.org/grow/aahrpp-learning-opportunities/annual-conference. The final new Common Rule is available at https://www.gpo.gov/fdsys/pkg/FR-2009-03-05/html/E9-4628.htm.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
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