CHICAGO -- 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 Wednesday 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Federal regulations designed to ensure human safety are outdated and limited in reach, the panel said, and review boards at medical centers whose job it is to oversee safety in studies are often undertrained, overburdened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.