3 October 2002 18:00 EST

by Tabitha M. Powledge

It's generally assumed that adequate protection for human research subjects will require more money, more regulation, more bureaucracy, more paperwork, and more time. But some of what the Institute of Medicine is recommending in its new report released today - Responsible Research: A Systems Approach to Protecting Research Participants - could be accomplished tomorrow for free, says Daniel Federman of Harvard Medical School, who chaired the study committee.

Protection of research participants, says Federman, just requires an attitude adjustment - what the report calls an "unequivocal" commitment. The right attitude must emanate from the top levels of a research organization, he said, creating "an institutional culture that facilitates and improves the ethical and scientific quality of research."

Rather than generate a blizzard of new paperwork, Federman argues, some of the report's recommendations should reduce the administrative load on individual researchers. One example: more resources to implement a robust system of protection, meaning additional space, equipment, support personnel, and research assistants. "Most have been on a shoestring in the past," he told BioMedNet News.

The report has advice for each actor - federal agencies, research organizations, sponsors, institutional review boards (IRBs), investigators, and even the research subjects themselves - in the human research enterprise. Congress, for example, was urged to require that federal protections apply to all human research, regardless of funding source.

Among the report's major recommendations aimed at investigators: "Revitalize informed consent." The optimum consent process, it maintains, should be an "ongoing, interactive dialogue" between staff and research subjects in which the risks and unknowns are explained and participants' concerns aired. The report also calls for consent forms that focus on informing and protecting participants rather than on protecting institutions - a change that the institutions' attorneys will be reluctant to embrace.

"Who cares about the lawyers?" Doris T. Zallen retorted. Zallen, of Virginia Tech in Blacksburg, wrote the National Institutes of Health guidelines on informed consent as a member of the NIH-Recombinant DNA Advisory Committee. She says she felt betrayed when investigations into the 1999 death of gene-therapy patient Jesse Gelsinger at the University of Pennsylvania revealed that informed-consent guidelines had been violated in the research.

Young Gelsinger's death was a major stimulus for the new IOM report. "If investigators are too pressed for time to conduct the consent process properly or to recontact if adverse events occur, it is likely that they will be too busy to notice adverse events and respond appropriately. In the long run, when the consent process is conducted properly, everyone is protected," Zellen told BioMedNet News. "Everyone," she notes, includes not only the subjects but the institutions and even the lawyers.

But not everyone agrees that protection could be so universally achieved. "It is true that institutions may have language which is put into the consent form to fulfill requirements by the institutions' legal staff, but I don't think it likely that this language can be entirely removed," said Stephen Bernard, of the University of North Carolina at Chapel Hill, who conducts clinical research and chairs the medical school's IRB. "The reality is that there is legal liablity for an institution, and increasingly this reponsibility is being recognized by the courts. Consent forms that we see from other institutions also seem to recognize these issues, so I am not certain where the IOM is coming from."

The report also called for "refocusing" the mission of the IRB on ethics: It should serve as the principal representative of the interests of potential research participants, and it should concentrate primarily on ethical aspects of protection issues. Community or research-participant representatives should comprise at least 25% of membership and protocols should be approved by at least 75% of voting members, the report recommended. The point, it said, is to keep IRBs from being dominated by the scientific perspective, a common complaint.

"I think that most boards try to put scientific members on who can get beyond the box and think of the broader questions, but perhaps I am naïve," he told BioMedNet News. Still, Bernard sees an enlarged role for community members as useful, creating a critical mass that will encourage nonscientists to feel freer to speak up at IRB meetings.

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