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Experts say human safeguards in medical studies are inadequate CHICAGO (December 10, 1998 09:21 a.m. EST <http://www.nandotimes.com>) -- People in medical studies are inadequately protected from risks, with hazards often poorly explained and scientists often in conflicts of interest, a panel of experts reported Thursday in The Journal of the American Medical Association. Federal regulations designed to ensure human safety are outdated and limited in reach, the panel said, and review boards at medical centers whose job it is to oversee safety in studies are often undertrained, overburdened and swamped with paperwork. "The current system is straining and in danger of falling apart," said Arthur Caplan, a co-author and director of the Center for Bioethics at the University of Pennsylvania Health System. "It costs too much, is too bureaucratic and doesn't give the kind of protection to subjects that people have a right to expect," he said. 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 center 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 Copyright 1998 Nando Media Copyright 1998 The Associated Press janet paterson - 51 now /41 dx /37 onset - almonte/ontario/canada [log in to unmask]