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August 21, 2000
law

Human medical research weighted with financial conflicts, reforms may be coming

The current environment of human medical research is heavily conflicted because of the influence for-profit companies have with those institutions and individuals conducting research, and new, more restrictive national standards may be coming, the New York Times reports.

Speaking during a recent conference on medical research conflicts of interest, Dr. Greg Koski -- the new head of the Office for Human Research Protections (OHRP) -- told attendees that financial ties between private industry and researchers testing medical devices, drugs and procedures were "very real, very serious and a threat to our entire endeavor."

The OHRP, part of the U.S. Department of Health and Human Services, oversees safety and other standards of any medical research done on people in the U.S.

Koski's predecessor had been fired after shutting down research programs at eight universities and hospitals which failed to disclose the risks to patients and their organization's financial ties to specific companies.

Patient-rights advocates speculated that the next OHRP head would tone down future actions, but Koski stated he was quite serious about new standards, particularly in light of reports that such financial conflicts of interest are far more common than previously believed.

"I want to make it unmistakably clear that institutions and individuals who fail to accept this responsibility should not be permitted to engage in this endeavor (human trails," he told conference attendees.

Koski also said current ethical guidelines may be so out of date that an entirely new set of standards may need to be imposed, the newspaper reports.

The doctor also wasn't afraid to use the carrot-and-stick approach: Koski praised the American Society of Gene Therapy for a new policy requiring its members be "free from conflicts caused by significant financial involvement with the commercial sponsors" of any medical trial or study.

At the same time, he urged other groups such as the Biotechnology Industry Organization to adopt similar guidelines, the newspaper reports.

Free registration may be required to view this article:
http://www.nytimes.com/library/national/science
/health/081700hth-research-ethics.html



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