BETHESDA, MD — This summer, HHS announced a proposal to improve the rules governing the protection of human research subjects — a system usually referred to as the Common Rule, which has been in place since 1991. While the proposed changes are wide-ranging, some critics question whether the revisions go far enough or do anything to better protect human subjects.
In July, a notice of proposed rulemaking (ANPRM) was published
in the Federal Register, laying out proposed changes and soliciting comments from the research community. Those proposals, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” included revisions to risk-based protection rules.
HHS is proposing to no longer keep Institutional Review Board (IRB) reviews going once a study has reached the data-examination phase. Also, while there now are categories of studies, such as surveys that are exempt from a review, HHS is proposing those studies be held to a data-protection standard and officially tracked by the agency.
The ANPRM also targets informed consent forms, which have been heavily criticized as being too technical, too lengthy and with no highlighting of the important points that a research subject should know. HHS is proposing to prescribe appropriate content as well as dictate appropriate length, because some consent forms can be as long as 50 pages.
HHS also proposes an overhaul of how multisite studies are reviewed. Currently, a domestic multisite study could be reviewed by dozens or hundreds of IRBs, with no clear evidence that more IRB reviews bring added protection. HHS proposes to have a single IRB of record for all domestic, multisite studies.
The agency also proposes that all federally funded human research fall under the Common Rule. Six categories of research currently are exempt: research in education settings involving educational practices; research involving educational tests if the subjects are elected officials and if federal status requires confidentiality; research involving the collection of existing data; research designed to study public benefit or service programs; and taste and food quality evaluation and consumer acceptance studies.
All such studies that receive federal funding would be held to Common Rule regulations if the proposal becomes law.
The proposal also tackles “regulatory harmonization.” After the Common Rule was adopted in 1991, each federal agency was allowed to create its own set of additional guidance regarding human subject protection. Consequently, each federal agency has differing guidelines, which sometimes conflict with each other. The ANPRM would require consistency of regulations across the federal government.Do HHS Proposed Changes to Common Rule Go Far Enough, Critics Ask Cont.
Does It Go Far Enough?
As the first director of the HHS Office of Human Research Protection (OHRP), Greg Koski has seen the evolution and impact of the Common Rule since its inception. “It began the year the regulations were adopted. Recommendations for changes have been coming out over and over again from different groups,” Koski told a roomful of researchers recently on the campuses of NIH. “The [problems with the system already were] there. And the number of reports and concerns reflect that this is a complicated set of issues.”
However, none of those reports resulted in any major changes to the current system, and Koski said he does not have much confidence that this new initiative will achieve anything different.
“It seems that the proposal focuses mostly [on] inefficiencies and redundancies in the system, and that a spin-off of fixing that would be improving human subject protection,” Koski said.
Those proposed system changes are mainly good ones, he noted, but are not thought out far enough. “Obviously we ought to be streamlining multisite studies. It’s a silly waste of time and resources. But if there’s only going to be one IRB review, we have to make certain it’s a very good one, because everyone else will be depending on it. And we don’t have a really good mechanism for determining if an IRB is any good in the first place.”
Koski also questioned whether there was any way to prevent researchers from shopping around for the most lenient IRB.
“ ‘Harmonizing,’ in my mind, is a euphemism for ‘failure to standardize.’ If we want to avoid ambiguity, we just need to standardize across the board,” Koski said. “I’ve examined this process for 30 years from virtually every side of it — IRB chair, university administrator, OHRP investigator. I think it’s time to simply say, ‘What we have is not working the way we want it to. Let’s scrap it.’ I think we should have a single federal office for the oversight of human research. Not in any one agency, but somewhere else, where it is not subordinate to any one agency.”
Koski argued that the way to protect subjects is not to focus on improving the research regulations but on improving the researchers. “The way we protect human subjects is having people doing the research that understand it, that are committed to it and are going to act responsibility,” he said. “If the behavior we’re looking for is centered around regulations, then we missed the boat. The behavior we want is for investigators to understand their responsibilities, and make a commitment to fulfilling those responsibilities.”
“We have bred a new generation of investigators that are not coming from the same place as in 1978. Tuskegee was a long time ago. So was Guatemala. How many people really believe that, in today’s climate, we would actually have a recurrence of the kinds of unethical research that led to the creation of this system,” Koski said, referring to notorious research projects in the past. “The system that we have was imposed on a generation of scientists, and many of them resented it. I think that scientists today are more responsible. They’re certainly better educated and more sensitized to the issues around human research.”
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