More attention needed to conflicts presented by institutional relationships

Study suggests that some medical schools’ policies are incomplete

BOSTON - February, 2008 - A new study indicates that many U.S. medical schools do not have policies that govern conflicts of interest related to financial relationships the institutions have with public or private companies. In the Feb. 13 Journal of the American Medical Association, researchers from Massachusetts General Hospital (MGH) and the Association of American Medical Colleges (AAMC) report that, while about 70 percent of responding medical schools have policies related to the financial interests of key institutional officials, only about than a third have policies addressing the interests held by the institution itself.

“Thirty eight percent of schools have implemented policies covering potential conflicts arising from their own financial interests in research, but almost two thirds still have not.” says Eric G. Campbell, PhD, of the MGH Institute for Health Policy, the study’s principal investigator. “This raises questions about the potential impact of institutional conflicts of interests on the missions of academic medical centers.”

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.

The researchers note that some recent reports have suggested the process of developing and implementing these policies has been difficult, given the complexity of many types of institutional relationships. The current study is the first systematic national examination of the adoption and scope of medical schools’ institutional conflict of interest policies. During 2006 the team sent questionnaires regarding such policies to the deans of 125 U.S. medical schools. Representatives from 86 schools completed and returned the surveys, a response rate of 69 percent.

Among responding medical schools, 38 percent reported having an institutional conflict of interest policy, and 37 percent reported that such policies were in development. About 70 percent reported having policies addressing the interests of senior or mid-level institutional officers. More than 80 percent have policies addressing the interests of members of Institutional Review Boards (IRBs), which are charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines; and two-thirds have policies related to the institution’s governing boards.

More than 90 percent of responding medical schools have organizational structures that separate the handling of the institution’s investment portfolio from management responsibility for the research program. The majority of respondents also restrict investment officials from serving on IRBs or evaluating potential conflicts of interest.

“The survey’s results raise questions about whether the national associations have given enough attention to the mechanics and complexity of implementing these policies,” says Susan Ehringhaus, JD, of the AAMC, the report’s lead author. “The results also suggest that institutions may need some additional support in addressing this issue in the future and that institutional conflicts of interest have not received the emphasis and attention given to individual financial conflicts.”

Campbell adds, “The next step is to figure out how effective are the policies that have been put into place - whether some work better than others - and what impact, if any, the lack of these policies has on the research, educational and patient care mission of academic health centers.” Additional co-authors of the report - which was funded by the Greenwall Foundation - are Joel S. Weissman, PhD, and Sandra Feibelmann, MPH, MGH-IHP; Jacqueline Sears, MPH, AAMC; and Susan Dorr Goold, MD, University of Michigan.

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.

Media Contacts: Sue McGreevey, MGH Public Affairs