Trump Administration Seen Unlikely to Change Human Research Rule

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Jeannie Baumann

President Donald Trump’s administration is reviewing the Common Rule revisions as part of a routine process but hasn’t flagged the human research regulations for any changes, a key regulatory official said.

President Barack Obama’s administration pushed through the first-ever revision of the Common Rule on its last day in office. Top officials in the Department of Health and Human Services under Trump are reviewing all so-called midnight rules issued during the final weeks of the previous administration, including the Common Rule.

The 543-page final rule released Jan. 19 culminates a multi-year—and at times controversial—effort to rewrite the regulations that protect research subjects from undue harm. Once effective, these changes will impact nearly 20 federal agencies, along with the universities and other institutions that receive billions of dollars in federal research grants.

“I want to make it clear, there is no implication that anybody has any particular reason to be concerned about this rule in any way at all,” Jerry Menikoff, director of the HHS Office for Human Research Protections, told an HHS advisory committee May 25. “We have not heard anything about specific changes to be made.”

Possible New Effective Date

If anything, he said, the HHS may decide to push back the rule’s Jan. 19, 2018, effective date to give research institutions more time to comply with the changes.

But pushing back an effective date could take some time. Menikoff said he expects all the federal agencies that have agreed to follow the Common Rule also would have to sign off on any changes to the effective date.

Holding Pattern

The regulatory review has put the OHRP in a holding pattern in moving forward on the new rule. The effective date was set to give institutions a year to come into compliance with all but one of the new requirements. But now almost half that time has lapsed.

Holly Fernandez Lynch, a member of the HHS Secretary’s Advisory Committee on Human Research Protections and a bioethicist at the University of Pennsylvania, told Menikoff information about time frames would be helpful.

“The community is trying to figure out the extent to which they should start shifting systems over and making changes,” she said.

Menikoff replied, “We will not hesitate at all to get the information out there immediately, once we have an answer in terms of what the time frame is.”

The goal throughout the process of revising the Common Rule has been to reduce administrative burdens, “and I think it’s true of the new administration too,” Menikoff said.

The Final Rule

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 unidentified 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 jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

More information on the SACHRP meeting is at http://src.bna.com/peF.

The final rule is at http://src.bna.com/peG.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

Request Health Care on Bloomberg Law