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Nov. 17— A major revision of the regulations designed to protect research subjects is still on track for release before the Obama administration exits the White House Jan. 20.
“It is the goal of this administration to come out with a final rule,” Jerry Menikoff, director of the Health and Human Services Office for Human Research Protections, said Nov. 14.
OHRP Deputy Director Julie Kaneshiro added, “We could certainly decide not to move forward with some of the things being proposed” in response to the public comments about the proposed new Common Rule . The final rule also could have different effective dates for different provisions, Menikoff said. Both Kaneshiro and Menikoff were part of a “Dialogue with OHRP” session Nov. 14 at Public Responsibility in Medicine and Research’s Advancing Ethical Research conference in Anaheim, Calif.
The Obama administration has been working since its early stages to revise the federal regulations governing human subjects research (45 C.F.R. 46), which have remained largely untouched since they went into effect in 1991.
“The Obama administration appears to be hastening to release this massive and very controversial revision by the end of this calendar year,” Mark Barnes, a research attorney with Ropes & Gray, told Bloomberg BNA in an Nov. 16 e-mail. “[B]ut many, myself included, are expecting that a Trump administration will re-evaluate the revision, listening intently to the views of the research community and organized medicine, which has been largely hostile to the Obama administration proposals in this area.”
Released as an initial set of questions in 2011 and a proposed rule in 2015, the changes are an effort to account for major changes in the research enterprise, including: biobanking; the explosion of genetic and genomic research; and the move from a one-site, one-investigator model to multisite clinical trials.
But the proposed rule has received major pushback. Two influential panels—the HHS Secretary’s Advisory Committee on Human Research Protections and a National Academies committee studying research regulations—have called for scrapping the proposed rule and starting over, saying the changes are unclear. Menikoff also said in May the OHRP staff didn’t agree with all the provisions that moved forward in the proposed rule, but higher officials within the department overruled them ().
Neither Menikoff nor Kaneshiro referred to any specific provisions in the 519-page rule. But most of the pushback in the comments focused on the proposed changes to rules governing research involving biospecimens.
In a related development, one week after Donald Trump became the president-elect, Republican leaders in the House asked all of President Barack Obama’s Cabinet and agency leaders not to finalize any pending rules or regulations in the administration’s final days. “By refraining from acting with undue haste, you will ensure that agency staff may fully assess the costs and benefits of rules,” the Nov. 15 House Republican letter said.
The HHS referred an inquiry of how this letter may affect the final Common Rule to the Office of Management and Budget. An OMB spokesperson responded with a Nov. 16 statement that the “Administration will continue to be guided by the same rigorous practices and principles used to develop and review regulations that have been upheld throughout the entirety of this Administration and previous Administrations.”
“This means that rules will be drafted with the careful consideration they are due under relevant statutes, applicable executive orders, and related guidance, in addition to benefiting from adequate public scrutiny and interagency review,” the OMB statement said.
Barnes told Bloomberg BNA, “Especially given this call by Republican leadership, we may end up as we did with the HIPAA Privacy Rule,” referring to the privacy rule under the Health Insurance Portability and Accountability Act, which went out Dec. 28, 2000, less than a month before Bill Clinton’s term as president ended.
The privacy rule was “hastily issued,” Barnes said, “only to be re-evaluated and revised extensively by the [George W.] Bush administration during 2001.”
“Assuming that the Obama administration will not honor the Republican call for a regulatory moratorium, then HHS would be well served to issue only those limited revisions that had widespread public, industry and academic support,” Barnes said. “Because otherwise, the revision will be discredited and withdrawn by the Trump HHS Secretary.”
The OMB continues to include the Common Rule revision in its regulatory agenda. The latest version of the agenda released Nov. 17 lists this December as the release date for the final rule.
The Common Rule entry in the OMB’s regulatory agenda includes a new “risk” sentence: “If this regulation is not published, the rules overseeing federally funded or conducted human subjects research will not be modernized, strengthened or made more effective.”
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
The regulatory agenda is available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0937-AA02.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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