Scrutinizing Human Research

New medical treatments can be lifesaving-if they work. But for a volunteer in the experiments necessary to evaluate those hoped-for cures, the new treatments can be risky, even deadly. In the last few years, in fact, a number of research institutions have come under fire for not adequately protecting the health and rights of volunteers. Part of the problem, critics say, is that the federally mandated review boards whose responsibility it is to oversee human research at their respective institutions are often overburdened and lacking in the necessary expertise.

“Things get overlooked, short cuts are taken,” says David Korn, a senior vice president of the nonprofit Association of American Medical Colleges. So this year Korn’s group joined with six other nonprofit medical and research outfits to set standards for all U.S. institutions conducting human research and to promote those standards through a voluntary accreditation process. In contrast to federal inspectors, who tend to focus on record keeping, this new group will check that review boards have the experts to scrutinize complex studies, that the consent process for volunteers is ethical and that each study’s risks are fully explained to volunteers.

Not everyone sees accreditation as the best route to cleaning up the mess. “It should be up to the government to enforce the rules and give more money to federal inspection agencies,” says Leonard Glantz, associate dean of Boston University’s School of Public Health. When the government shuts down a lab, Glantz says, the effect is much greater than when an institution loses its accreditation. Indeed, since 1998, the federal government has shut down, suspended or restricted research at over a dozen institutions. But officials at the U.S. Department of Health and Human Services say accreditation would send an important message about an institution’s practices. And they welcome the help. “There’s no way we can be all places at all times,” says Bonnie Lee, a health issues analyst with the U.S. Food and Drug Administration. Accreditation may allow the FDA to concentrate less on random inspections of institutions, Lee says, and more on site visits in response to reports of misconduct.

Representatives of the biotech and pharmaceutical industries have also embraced the idea of accreditation, recognizing that their very survival depends on a public that perceives human research to be ethical and safe and is therefore willing to participate in it. The thousands of people who volunteer each year in the name of science are likely to welcome the new measure of safety too.