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According to a new survey, fewer than half of the U.S. medical schools queried have policies in place to safeguard against improper financial links with drug companies. And it is not clear whether those with such safeguards actually enforce them. The findings come from the first national survey to examine the potential for what are called institutional conflicts of interest (ICOI) between pharmaceutical manufacturers or other for-profit groups and academic medical research centers that oversee drug testing on human subjects.
There is no data on whether the lack of oversight is damaging research, but "it's another potential source of at least apparent conflict, if not real," says study co-author Susan Ehringhaus, assistant general counsel for the Association of American Medical Colleges (AAMC) in Washington, D.C. "The protection of the integrity of research, the protection of human subjects—these are fundamental values. Anything that would call them into question suggests the need for systematic and serious response."
Ehringhaus, working with colleagues from the AAMC as well as Massachusetts General Hospital and the University of Michigan at Ann Arbor, sent surveys to the deans of 125 medical schools, both public and private, questioning them about the scope and nature of their ICOI policies.
Of the 86 schools (69 percent) that responded, 30 (38 percent) said they had procedures for evaluating sources of income such as royalties on patents, stocks and large contributions that fill their schools' coffers. Some said they also kept tabs on officials involved in drug testing: 55 schools (70 percent) reported monitoring senior and mid-level officials responsible for hiring and firing, and 62 of them (81 percent) said they kept an eye on members of so-called institutional review boards, who approve human research proposals.
Congress in 1980 passed a law called the Bayh–Dole Act, designed to speed commercialization of publicly funded research by making it easier for universities to patent and license their research as well as partner with for-profit companies.
The AAMC in 2001 recommended a set of specific guidelines to prevent ICOI, including separating the staffs that supervise human research from those that manage investments and license technology. Nearly all the 77 schools (74, or 94 percent) reported that they were following this guideline by assuring no single individual was responsible for both supervising research and approving financial investments.