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Panel Addresses Financial Conflicts in Clinical Trials

http://www.medscape.com/viewarticle/442067

Sept 25, 2002
By Karen Pallarito
Reuters Health
NEW YORK

Academic institutions must establish policies for assuring that their financial interests do not compromise the well-being of human subjects in the clinical trials they conduct, an expert panel said this week.

Weak conflict of interest policies may pose a risk to the safety and welfare of human subjects and threaten public faith in the research enterprise, according to the latest report from the Association of American Medical Colleges' (AAMC's) task force on financial conflicts of interest.

The report highlights certain financial relationships that warrant close scrutiny - for example, situations in which an institution controls more than a $100,000 stake in a publicly traded sponsor of a trial through a licensing pact or similar agreement. But it doesn't recommend prohibiting any particular arrangement.

"We weren't out to ban anything," said Dr. David Korn, senior vice president in the division of biomedical and health sciences research at the AAMC. Each situation should be examined case-by-case, he said. "This is not cookie-cutter stuff."

To prevent competing interests, the panel called for a distinct separation of financial and research management functions. Deans, department heads, IRB chairs and others with direct responsibility for overseeing human-subject research, for example, should not be involved in managing an institution's investments or technology transfer program, it said.

It called for full disclosure of any financial interest that conflicts or appears to conflict with an institution's human-subject research.

If the appearance of conflict is impossible to avoid even if steps are taken to separate investment and research duties, the institution should not conduct the research, the panel said.

The report is the second from the Task Force on Financial Conflicts of Interest in Clinical Research. The AAMC appointed the panel to review conflict-of-interest policies at the nation's medical schools and teaching hospitals.

Its first report, issued last December, focused on individuals' financial interests in their own research.

"I would argue that these reports are really very stringent and they do raise the bar," Korn said. Although the recommendations do not carry the force of regulation, "we do have a very big bully pulpit," he said, and the AAMC intends to review compliance with the recommendations sometime in the future.
 

© 2002 Reuters Ltd