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human safety in medical research inadequate



Experts call human safety in medical research inadequate

The Associated Press - Chicago, December 8, 1998

People in medical studies are inadequately protected from risks, with
hazards often poorly explained and scientists often snared in conflicts of
interest, a panel of experts says.

Federal regulations designed to ensure human subjects' safety are outdated
and limited in reach, the panel said in Wednesday's edition of The Journal
of the American Medical Association.

Further, the review boards at medical centers whose job it is to oversee
human safety in studies are often undertrained, overburdened and swamped
with paperwork, according to the panel from the Center for Bioethics at the
University of Pennsylvania Health System.

"The current system is straining and in danger of falling apart," said
Arthur L. Caplan, a co-author and director of the center. "It costs too
much, is too bureaucratic and doesn't give the kind of protection to
subjects that people have a right to expect."

Caplan said the first step should be to gather data on what happens to
research subjects and on how review boards do their work of overseeing
patient safety, Caplan said in a telephone interview Tuesday.

Then, steps need to be taken -- including possible federal legislation --
to streamline the system under which research is conducted and to
strengthen the rules that govern it, Caplan and his colleagues wrote.

Currently, the only regulations are the ones developed 17 years ago by the
Department of Health and Human Services and the Food and Drug
Administration, and they only apply to government-funded research.

"If you're privately funded, you can ignore all those rules, and that's a
major problem," Caplan said.

Medical centers increasingly get funding from drug companies and other
for-profit entities rather than the federal government, the ethicists
wrote. Concerns have mounted that researchers may be paid by the number of
subjects they enroll, which gives them an incentive to put the sponsor's
interest ahead of the subjects' interests, they said.

Also, the forms used to obtain subjects' consent to be studied have "become
vehicles for reducing legal liability for researchers and institutions,
rather than empowering subjects to make good choices about being in
research," Caplan said.

"They're also too long, too technical, and most importantly too abstract,"
he said. "If no one reads it, or if there's no intent to talk to subjects
about what really happens in research, there's a problem."

He said people who serve on institutional review boards need to get out of
board rooms and talk with study subjects, a goal that their heavy
bureaucratic workloads may currently make impossible.

By BRENDA C. COLEMAN, AP Medical Writer