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The HHS agency charged with protecting human research subjects is on track to post a record low number of enforcement findings this year.
The Office for Human Research Protections in the Department of Health and Human Services just issued Dec. 1 its first determination letter of the calendar year, which offered two minor recommendations but no noncompliance findings. At its peak, the OHRP issued 146 letters in 2002, but that number has dwindled for a number of reasons ranging from staffing to regulatory and process changes.
The office is experiencing a truly historic year, with finalization of the first-ever major revisions to the human subject protection regulations known as the Common Rule ( 45 C.F.R. 46). But such a dramatic drop in public enforcement activity by an agency whose jurisdiction includes billions of federal research dollars raises questions about what is happening in the OHRP’s enforcement arena.
There are currently 16 compliance cases under review at the OHRP, which indicates more determination letters are coming down the pike, an HHS spokesperson told Bloomberg Law in a Dec. 1 email. “OHRP hopes to close more cases by the end of the year, but cannot predict the timing with certainty,” the spokesperson said.
OHRP determination letters are similar to warning letters issued by the Food and Drug Administration. They detail findings of inspections of institutions’ human research protection programs that often stem from noncompliance allegations received by the OHRP, but also can be conducted without a specific cause in mind.
Research attorneys and compliance consultants in Nov. 30 comments cited a number of potential reasons for the lack of determination letters, including preoccupation with implementing the Common Rule revisions that are scheduled to take effect in Jan. 19. The OHRP hadn’t issued a single determination letter in 2017 when Bloomberg Law received comments.
F. Lisa Murtha, senior managing director of Ankura Consulting Group based in Philadelphia, who has three decades of research compliance experience, noted that while the revisions are set to take effect Jan. 19, there’s a proposed rule under review by the White House Office of Management and Budget that would delay most of those revisions by a year. “Given this uncertainty, I suspect that OHRP does not want to publish compliance letters that may contradict with anything in the ‘final’ revised Common Rule,” she said in an email.
Mark Barnes, an attorney with Ropes & Gray LLP in Boston who is co-chairman of an HHS advisory panel on subject protection regulatory harmonization, said he believes the OHRP has decided its resources are best devoted to the rulemaking process and public education and outreach about the new Common Rule. “I fully expect, though, that in 2018, we will see an uptick in compliance and enforcement, especially if some or all of the new Common Rule becomes effective during 2018,” he said in an email.
Kate Gallin Heffernan, an attorney with Verrill Dana LLP in Boston, said, “OHRP has had a lot going on with the impending regulatory changes; however, one wouldn’t expect that to justify a decrease in appropriate enforcement activity.” She noted the OHRP may be enforcing the regulations through means other than formal determination letters, such as working behind the scenes with institutions on voluntarily compliance strategies when institutions self-disclose as opposed to issuing determination letters. “I just flag the possibility that zero determination letters doesn’t necessarily mean that OHRP is not responding in some fashion to identified concerns within certain [human research protection programs],” she said. “There may be more nuanced explanations for that number.”
The HHS spokesperson confirmed to Bloomberg Law they are doing exactly that. “It is important to note that, in recent years, OHRP has been using other approaches to dealing with concerns raised before automatically opening a case and issuing a determination letter,” such as working more closely with complainants and institutions to address some of the concerns, the spokesperson said. “We find that oftentimes this approach is able to resolve concerns without opening a compliance case.”
Gary L. Chadwick, a senior consultant with HRP Consulting Group in Lake Success, N.Y., noted fewer institutions are opting to have all their research, regardless of the funding source, subject to the Common Rule—which is known as “checking the box” on the Federalwide Assurance agreement to follow the regulations. This means there are fewer studies over which the OHRP has jurisdiction. The OHRP has mentioned in the past it is referring more cases to the FDA, which has a much larger inspection program, when studies are subject to both the OHRP’s and the FDA’s similar but not identical sets of rules.
There are also staffing issues, Chadwick noted, particularly as the OHRP lost Kristina Borror, its longtime compliance oversight director. Borror became the director of policy and education in the Veterans Health Administration’s Office of Research Oversight this summer after 15 years with the OHRP, she confirmed in a Dec. 5 email to Bloomberg Law. There are now three people out of the OHRP’s total staff of about 20 running its compliance division. “OHRP is woefully understaffed,” Chadwick said in his Nov. 30 email.
Both Chadwick and Barnes said institutions also may be doing a better job complying with the rules. “The advent of accreditation through AAHRPP and better industry sponsor monitoring of studies, as well as improved internal compliance at medical centers, have all contributed to a general improvement in human research practices over the past few years,” Barnes said. AAHRPP refers to the Association for the Accreditation of Human Research Protection Programs, Inc., which reviews and accredits subject protection programs that meet its standards. Public Responsibility in Medicine & Research now also offers individual certifications for institutional review board professionals, Chadwick said.
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OHRP’s determination letters are available at https://www.hhs.gov/ohrp/compliance-and-reporting/determination-letters/index.html.
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