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. |