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Steps to modernize how nearly 20 federal agencies oversee human research will primarily kick in next year, under a major rule issued by the Obama administration two days before it leaves the White House.
The Jan. 18 release of the human subject protection regulations known as the Common Rule ( RIN:0937-AA02) culminates an initiative from the early days of President Barack Obama’s administration. The regulations issued in 1991 were developed around a very different model than the one scientists use today. The first-ever update to the rule accounts for the shift away from a single-lab, single-site model and toward a global research enterprise incorporating rapidly advancing technologies in mobile health and genomics.
“We think overall these are good changes and that implementing them will both improve protections for research subjects and reduce inappropriate burdens,” Jerry Menikoff, director of the Office for Human Research Protections in the Department of Heath and Human Services, told Bloomberg BNA.
The rule goes into effect Jan. 19, 2018, except for the single institutional review board requirements, which will take effect Jan. 20, 2020. The final rule appears to address many objections to the proposed version, eliminating the most controversial provision to reclassify all biospecimens as human subjects—whether or not they can be identified—with limited ability to waive consent requirements.
“It does appear they were responsive to many of the concerns that we raised,” Lisa Nichols, director of research and regulatory reform for the Council on Governmental Relations, told Bloomberg BNA.
Menikoff, whose office administers the Common Rule (45 C.F.R. 56), acknowledged the proposed rule elicited a wide variety of opinions. “You shouldn’t always be waiting for perfection,” he said in a Jan. 18 interview.
Michael Carome, who before joining Public Citizen‘s health research group spent 13 years as the OHRP’s associate director of regulatory affairs, said the final rule is much clearer than the proposed rule, in part because it eliminates entire sections from the proposal released in September 2015. “The rule is much more understandable and really is really much less dramatic in what it seeks,” he said.
But it is unclear what will happen to the 543-page final rule once President-elect Donald Trump takes office; the House Freedom Caucus listed the Common Rule among more than 200 regulations to be reexamined and possibly revoked.
“It is possible that the new Administration may rescind the revised final rule, as suggested with many other late regulatory publications, but withsupport for many of the revised final rule’s provisions so varied, the new Administration may find rescission very contentious,” T. Howard Stone, deputy director of the Army Human Research Protections Office, told Bloomberg BNA in an e-mail.
Ezekiel Emanuel, who started the Common Rule revision process as a White House adviser in 2009, told Bloomberg BNA the final rule is definitely a step in the right direction. “I do think it will improve the efficiency of the system.”
Emanuel, now a bioethicist at the University of Pennsylvania, said he’s not worried the Trump administration will rescind the rule because it’s right in line with the president-elect’s goal to reduce regulatory oversight. “This makes the review process less onerous,” Emanuel said.
The final rule kept the requirement for shorter, clearer informed consent forms that put the most important information at the top, based on a reasonable person standard.
Informed consent, Menikoff said, is “at the core of the system for protecting subjects. The bottom line is: what would a person want to know, what would a person find most important in making a decision about whether or not they should or shouldn’t be in the trial?” he said. “Let’s put that up front, and that’s basically what it does.” It dropped a provision to put all the extraneous information in an appendix.
Consent forms for certain federally funded clinical trials also must be posted on a public website under the new rule.
Heather Pierce, senior director of science policy and regulatory counsel for the Association of American Medical Colleges, expressed concern such a requirement would hinder researchers from adopting more innovative, multimedia approaches to consent that don’t rely strictly on a paper document.
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.
New exempt categories are 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.
But the rule also retained a requirement to require single IRBs for studies that take place at multiple institutions, which falls in line with a similar policy the National Institutes of Health adopted last summer. While investigators embraced a single IRB mandate as removing a cumbersome roadblock that stalls science, groups including the AAMC, the Council on Governmental Relations and Public Citizen all oppose such a mandate.
“We don’t oppose central IRB review for research when it’s appropriate but we don’t think that should be imposed as a regulatory requirement,” Public Citizen’s Carome said. “Institutions should have the authority to decide for the patients and subjects that might come into their facility.”
“It seems that the most ‘controversial’ of the sections that was in fact adopted includes the requirement for use of a single IRB for certain multi-site studies,” F. Lisa Murtha, who leads the clinical research and compliance practice at FTI Consulting, said in an e-mail. “This will no doubt cause considerable discussion among IRB members nationwide.”
The OHRP’s Menikoff said the final language provides more flexibility on single IRBs than the proposed version. “At its broadest, it could be that all the studies that a particular Common Rule agency funds could be determined to be inappropriate to be subjected to this rule,” he said. The rule also extends the compliance date to three years for the single IRB language, whereas every other provision takes effect in 2018. “We appreciate infrastructure has to be built. We need communications among the different institutions that will be working together,” he said.
The HHS said the final rule is far more flexible in areas like single IRBs and potentially on posting consent forms, Pierce said. “It’s not clear from the language of the rule itself how much flexibility will actually be allowed. So the single IRB is still of great concern,” she said.
In a Federal Register notice to be published Jan. 19, the HHS said it isn’t moving forward with six provisions, three of which involved biospecimens, which Menikoff said was a direct response to the public comments. “Pretty much every major group of commenters did not like that provision and their analysis in general was this is going to be harmful to the research enterprise for a variety of reasons if we went forward with it,” Menikoff said. “And the flip side of it was that many people said, ‘Look it doesn’t harm particularly much if you go ahead and do research on my biospecimen without even knowing who I am. That’s okay.’”
The final rule also nixed a proposal to expand the jurisdiction of the rule beyond just federally funded research to cover all clinical trials regardless of whether federal dollars paid for the study. Carome expressed disappointment the revised Common Rule didn’t adopt this change. “We think that if you’re a human subject in research conducted in this country, you deserve the same protections regardless of who’s funding it,” he said.
The final rule also got rid of a whole set of “excluded” activities that would have been separate from an existing but expanded set of “exempt” activities. “We recognized people felt the proposal was too complex,” Menikoff said. “So we eliminated the whole notion of exclusions.” The final rule either incorporated the exclusions into the existing exemption categories, carved them out so those activities didn’t meet the definition of research and therefore weren’t subject to the Common Rule or dropped them altogether.
Mark Barnes, a research attorney with Ropes & Gray, told Bloomberg BNA it is gratifying that the HHS appears to have listened to and been swayed by the vigorous opposition to the proposal to treat all biospecimens as though they were identified subjects. “What has emerged here after five years of sustained debate is useful and deserves the strong support of the national research community. Especially appealing are the provisions allowing broad consent and relaxing some requirements for minimal risk research,” Barnes wrote in an e-mail.
Public Responsibility in Medicine & Research also applauded a rule that is “in many ways much more modest in its scope than the proposed rule. “While we have yet to review the entire 540+ page document, and so must stop short of endorsing the new rule in its entirety, the rule also appears to increase flexibility for institutions and IRBs but not, as the [proposed rule] did, shift responsibility away from the entities best equipped to ensure the ethical conduct of research. This is certainly welcome and appropriate.”
FTI Consulting’s Murtha said research sites and sponsors will need to modify their IRB policies and procedures and conduct training with IRB members and researchers alike to ensure their understanding of the updated Common Rule. “Well, we have been waiting a long time and it all seems a bit anticlimactic,” she said.
Eliminating these provisions also dramatically cut the cost of implementing the rule. HHS spokeswoman Diane Gianelli said the proposed rule had a net cost of more than $10 billion, whereas the final rule will show a savings of more than $1 billion.
Menikoff said the OHRP will be communicating with stakeholders and determine what parts of the new rule merit additional guidance.
“Our goal is to work with the regulated community, with institutions, with researchers to help them have a smooth transition,” he said.
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 final rule is available at http://src.bna.com/lur.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
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