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Medical News & Perspectives
August 11, 1999

Protecting Subjects of Clinical Research

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JAMA. 1999;282(6):516-517. doi:10.1001/jama.282.6.516-JMN0811-3-1

Washington—The system that attempts to protect subjects in clinical research is heading for a major overhaul. Its purported protections are insufficient and irregularly applied. It's time for a change, says a preliminary report from the National Bioethics Advisory Commission.

As an initial step, pressure is mounting within and outside the commission to give the Office of Protection From Research Risks (OPRR), which is currently located in the National Institutes of Health (NIH), a more prominent role in monitoring clinical research by elevating it to a position within the Department of Health and Human Services (DHHS). Moves are also in the offing to create a "national office of human subjects in research" that would effectively ensure that everyone participating in clinical research—not just those in federally funded studies—is properly protected. At least half the clinical research studies in the United States are funded by private sources, industry or nonprofit, that may or may not conduct ethically appropriate research.