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Research institutions may get another year to implement revisions to the research oversight regulation known as the Common Rule, potentially alleviating concerns about the current deadline.
The White House is reviewing a proposed rule to delay the implementation date of the Common Rule by one year, according to a posting dated Oct. 7 on the Reginfo.gov website. The proposed rule from the Department of Health and Human Services Office for Human Research Protections would provide more breathing room by moving the date to Jan. 19, 2019. These changes affect nearly 20 federal agencies that fund billions of dollars of research involving human subjects.
With the original date now less than four months away, regulated institutions likely would embrace a delay, but the posting also leaves a trail of unanswered questions. There is no actual proposed rule, so there is no text beyond the title, Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.
“It’s sort of a combination of added uncertainty but increasing hope that maybe the effective date will be pushed back a little bit,” Holly Fernandez Lynch, medical ethicist at the University of Pennsylvania who is also a member of the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP), told Blooomberg BNA Oct. 10. “It’s still just a proposed rule under review, and we are only a couple of months out from the general implementation date. And we don’t yet know whether institutions are going to have to implement the revised rule.”
It is HHS policy not to discuss the details of such proposals before they appear in the Federal Register for public comment, an HHS spokesperson told Bloomberg BNA in an Oct. 10 email. “The rule is now under review at the Office of Management and Budget’s Office of Information and Regulatory Affairs.”
Released in January, the revised Common Rule (45 C.F.R. 46) marked the first-ever update to the regulation designed to protect study volunteers from undue harm. The HHS intended to provide a year to adopt the changes. But President Donald Trump’s administration imposed a regulatory freeze shortly thereafter to review all last-minute rules from President Barack Obama’s administration. The review of the Common Rule started in May, which meant the OHRP couldn’t move forward with guidance or other efforts to assist those who must follow the rule.
“The request to delay compliance with the revised Common Rule reflects the reality that the changes require guidance from the government in order to ensure an appropriate implementation of these important, and in some cases complex, regulatory changes,” Michele Russell-Einhorn wrote in an Oct. 10 email. She is vice president for human research protection services and institutional official for Schulman IRB, a commercial institutional review board based in Cincinnati. She is also a member of Bloomberg BNA’s health-care editorial advisory board and co-chairwoman of a SACHRP subcommittee.
Many new parts of the Common Rule would benefit from guidance that could be developed over the next year in a way that makes sense, Heather H. Pierce, the Association of American Medical Colleges’ senior director of science policy and regulatory counsel for scientific affairs, told Bloomberg BNA. “It seems this is really about a delay, and it certainly doesn’t look like it’s about any substantial changes to the rule itself,” Pierce said Oct. 10. “This is something that the higher education associations were really hoping would happen.”
Section 3023 of 21st Century Cures ( Pub. L. 114-255), the biomedical innovation law to spur new drugs and devices, requires the HHS and the Food and Drug Administration to harmonize differences between their human subject protection rules by December 2019. The FDA already agreed to update its similar but separate human subject protection regulations to align with the revised Common Rule.
“This delay provides at least some time for FDA to draft and propose regulatory provisions that will harmonize requirements adding to streamlining, efficiency and better protections for human subjects in research,” Russell-Einhorn said.
The revised Common Rule released in January mentions both an effective date and a compliance date of Jan. 19, 2018. The proposed rule submitted to the OMB mentions an “implementation” date, so it isn’t entirely clear if the proposed delay would affect just one or both of these dates. This is important because Laura M. Odwazny, the HHS senior attorney who provides counsel on the Common Rule, has said repeatedly that institutions cannot start following the revised regulations until the new effective date.
“A delay in the compliance date as requested by COGR and other higher education associations would have provided institutions with greater flexibility in implementing the rule,” Lisa Nichols, director of research and regulatory reform for the Council on Governmental Relations, told Bloomberg BNA. “A delay in the effective date would nonetheless be well-received by many institutions. We look forward to seeing details on the three burden reducing provisions that could be implemented during the proposed delay period.”
The proposed rule also mentions allowances for “three burden-reducing provisions during the delay year,” but it doesn’t specify what they are. However, the one-year delay lines up with a letter the AAMC, the COGR, and other higher education organizations submitted in June asking for a one-year delay to the compliance date. In that letter, they also asked for permission to move forward with reducing burden and named three areas:
“Those continuing reviews by IRBs of research that may have huge data sets and take many years to analyze but aren’t actually involving human subjects any more take up a lot of IRB time and that was a welcome change from the community pretty universally,” Pierce said.
The proposed delay will come up at the next SACHRP meeting, set for Oct. 17. “If it doesn’t come up, I will ask about or somebody else will ask about it,” Fernandez Lynch said. “Everybody is just aflutter with what is going on here.”
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
The OMB posting is available at https://www.reginfo.gov/public/do/eoDetails?rrid=127614#.
The revised Common Rule is available at http://bit.ly/2hzC5Gs.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
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