Back in July, universities cheered the Obama administration’s announcement that it would ease rules governing the approval and monitoring of federally financed research involving human subjects.
Now that the institutions have had three months to study the specifics, their tone has turned more cautious, with universities worrying that a key opportunity to lighten the regulatory burden on their research labs may be slipping away.
“We like the intent of many of the proposals,” said Carrie D. Wolinetz, associate vice president for federal relations at the Association of American Universities. “But ultimately,” she said, the extent of university support for the plan will depend upon “the details of the next level of regulation that comes out.”
The federal government provides more than $30-billion a year for research at universities, most of it involving medical care, and the government helps ensure patient safety by requiring that work involving human subjects gains the approval of an ethics panel known as an institutional review board.
The current regulations, known as the “Common Rule,” have been in place since 1991, when most medical trials involved university settings and single locations. The proposed modernization reflects an attempt to match a world in which tests of new drugs and medical devices routinely occur in a variety of places, both public and private.
The suggested changes include making the restrictions on a particular experiment involving human subjects more closely tied to the expected risk, and allowing a single institutional review board to set the policy for all the domestic sites of a single study.
The changes are also being driven by complaints from nonmedical researchers, such as those conducting public-opinion surveys, that their work has been needlessly entangled in a system intended primarily to protect the health of participants.
The proposed revisions were suggested by the Office for Human Research Protections, the division of the Department of Health and Human Services that administers the rules.
Concerns Over Details
“We’re very supportive of the revision of the Common Rule generally,” said Ms. Wolinetz, of the AAU. The association issued its formal response to the government proposal, jointly with the Association of Public and Land-Grant Universities, on Wednesday, the deadline for public comments.
But the AAU and APLU described a series of worries, including over the plan for placing control of a study under a single institutional board. The goal is welcome, but the chain of command is unclear, Ms. Wolinetz said. Universities, she said, could end up getting “all of the responsibility with none of the authority.”
Universities are especially pleased with the proposed language that would exempt from review categories of research that clearly have no effect on human health. But they’re nervous about language in the proposal that would allow for “retrospective audits” of studies in which the institution or its review board has decided to exercise an exemption, Ms. Wolinetz said.
“Institutions really don’t like the idea of retrospective audits,” especially since the proposed rule change doesn’t clearly define how the audits would work and what penalties might be applied in cases in which a federal agency might disagree with an exemption decision, she said.
Altogether the Office for Human Research Protections received more than 600 responses to its request for comments by the deadline, which was extended by one month after groups that included the AAU and APLU said they needed more time to contemplate the list of 74 detailed questions posed in the agency’s outline.
The agency’s director, Jerry A. Menikoff, said he fully anticipated concern among universities. The request for ideas is the initial stage of the rule-making process, and “so by its very nature, many things are vague,” Dr. Menikoff said. “We very much intend to use the input from the public comments to help us” draft the final rules, he said.
Support From Historians
Some of the strongest praise for the proposed changes has come from university historians and social scientists eager to have their work—often oral interviews that have no plausible connection to the participant’s physical or mental health—removed from the oversight of institutional review boards.
And yet even advocates of that change recognize the difficulty of precisely defining when exemptions should be allowed, as endangerment of subjects can’t always be anticipated. The University of California system, in its comments to Dr. Menikoff’s agency, gave an example of how a participant in a study of HIV infection might be intimidated by the police or face other repercussions, especially in some foreign countries, merely as a result of being seen entering or leaving a study site.
Such concerns show that even well-intended changes, that both the universities and government agencies want, may be difficult to write into regulations, said Jeffrey R. Hall, director of research policy development for the University of California system.
As much as possible, Mr. Hall said, the university would like the government to provide institutional review boards with examples of how to handle specific cases rather than with hard rules. “Guidance is better than regulation,” he said.
He quickly acknowledged, however, that the entire point of regulations is to set firm standards in cases in which the judgment of an individual university or researcher might fail to protect a study subject. “All I can say,” he said in reference to his 36-page response to the Office for Human Research Protections, “is that it was a challenging exercise here for us to try to accommodate the different perspectives.”
