Feb. 12, 2008 A minority of U.S. medical schools surveyed have adopted policies on conflicts of interest regarding financial interests held by the institutions, while at least two-thirds have policies applying to financial interests of institutional officials, according to a new study.
Institutional academic-industry relationships exist when academic institutions or their senior officials have a financial relationship with or a financial interest in a public or private company. "Institutional conflicts of interest (ICOI) occur when these financial interests affect or reasonably appear to affect institutional processes. These potential conflicts are a matter of concern because they severely compromise the integrity of the institution and the public's confidence in that integrity," the authors write. They add that these conflicts may also affect research results. The Association of American Universities (AAU) and the Association of American Medical Colleges (AAMC) have recommended policies regarding ICOI.
Federal regulations regarding potential conflicts of interest in government-funded research have been in place since 1995 but specifically address conflicts involving individual investigators. Subsequently the AAMC and the Association of American Universities recommended the adoption of specific policies for institutional conflicts of interest -- defined as financial interests of the institution itself or of major institutional officials that may affect or appear to affect the conduct of research. This study was designed to explore the extent to which institutional conflict of interest policies have been adopted.
Susan H. Ehringhaus, J.D., of the Association of American Medical Colleges, Washington, D.C., and colleagues assessed the extent to which U.S. medical schools have adopted ICOI policies. The authors conducted a national survey of deans of all 125 accredited allopathic medical schools in the U.S., administered between February 2006 and December 2006, and received responses from 86 (69 percent).
The researchers found that 38 percent (30) of survey respondents have adopted an ICOI policy covering financial interests held by the institution, 37 percent (29) are working on adopting an ICOI policy covering financial interests held by the institution, and 25 percent (20) are not working on adopting such a policy or do not know.
"Much higher numbers are reflected for ICOI policies that cover the individual financial interests of officials: with adoption of policies for senior officials (55 [71 percent]), midlevel officials (55 [69 percent]), institutional review board (IRB) members (62 [81 percent]), and governing board members (51 [66 percent]); and with adoption of policies being worked on for senior officials (9 [12 percent]), midlevel officials (12 [15 percent]), IRB members (6 [8 percent]), and governing board members (2 [3 percent])," the authors write.
Most institutions treat as potential ICOI the financial interests held by an institutional research official for a research sponsor (43 [78 percent]) or for a product that is the subject of research (43 [78 percent]). The majority of institutions have adopted organizational structures that separate research responsibility from investment management and from technology transfer responsibility. The researchers add that gaps exist in institutions informing their IRBs of potential ICOI in research projects under review.
"While acknowledging that adoption of ICOI policies is not a simple task and is dependent on, among other factors, highly interactive institutional databases and the active involvement of faculty, administrative officials, and the institution's governing board(s), it is problematic that more schools do not have more comprehensive policies in place," the authors write.
"The gaps in coverage suggest the need for continuing attention by the academic medical community to more consistently and comprehensively address the challenges presented by ICOI."
Journal reference: JAMA. 2008;299:665-671.
Editorial: Academic Medical Centers and Financial Conflicts of Interest
In an accompanying editorial, David J. Rothman, Ph.D., of Columbia University, New York, comments on the findings of Ehringhaus and colleagues.
"It is fair to ask whether it is naive to trust institutions to monitor and discipline their own financial activities, particularly when the financial returns can be substantial. Licensing agreements on patents generate close to $2 billion per year for academic research centers ... At a time when federal research funding is declining and competition for philanthropic gifts is intensifying, universities may not be eager to promulgate policies that would restrict their freedom to maneuver."
"Will government regulation step in to fill the vacuum" Current federal and state interests in industry-academy relationships provide reason to believe so. Congressional hearings are addressing the implications of industry support for continuing medical education, gifts to clinicians, the sale of physician-prescribing data, and pharmaceutical company efforts to intimidate researchers critical of their product(s). Currently, 8 states and the District of Columbia have laws or resolutions affecting marketing of pharmaceuticals," Dr. Rothman writes.
Reference for editorial: JAMA. 2008;299:695-697.
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