Slow Progress on Institutional Conflicts Policies
More than five years after the Association of American Medical Colleges urged its members to adopt policies governing institutional conflicts of interest, progress by medical schools has been decidedly mixed, a new survey co-sponsored by the association shows. While more than two-thirds of the schools now have policies covering financial interests held by top institutional officials, fewer than 4 in 10 medical schools have policies aimed at ensuring that financial interests held by the institution itself don't inappropriately influence research, the study found.
The survey, conducted by researchers at the AAMC and Massachusetts General Hospital and published in this week's issue of the Journal of the American Medical Association (subscription required) , comes at a time of continuing and arguably escalating scrutiny of conflicts of interest in higher education. While that scrutiny has only recently been applied to areas of university operations such as financial aid and study abroad, medical schools have faced it -- or at least wrestled with it -- for more than a decade, given the concerns that potential conflicts of interest in biomedical science might lead researchers to put their own financial interests over those of patients.
It was in that context that the medical college association and the Association of American Universities, which represents the country's leading research institutions, most if not all of which have medical schools, released reports in 2001 and 2002 that urged medical schools to adopt policies and practices aimed at combatting both individual conflicts of interest (those involving scientists and others who are directly involved in research) and institutional conflicts, those involving the financial interests of a college or school itself and of officials there who are not directly involved in research.
A 2004 survey by the medical college association on individual conflicts of interest found that the vast majority of institutions had policies and procedures in place to identify and guard against, or at least manage, financial conflicts of researchers. Susan Ehringhaus, associate general counsel of the AAMC and the author of the 2004 survey, said that association officials had decided to delay a comparable survey of practices surrounding institutional conflicts of interest to give medical colleges more time to carry them out, because "we knew that they were harder."
"With individual conflicts, it's pretty easy to link a particular researcher's disclosed financial interests to his or her research projects," Ehringhaus said in an interview Tuesday. "There's a finite number of research projects, and perhaps certain financial interests like stock or consulting arrangements, and you can make those linkages.
"Contrast that with institutional financial conflicts," she added. "You need to get your arms around all of the financial interests of the institution --- stocks where its endowment are invested, history of giving from pharmaceutical companies, investment in new companies coming out of the university -- and then around the financial interests of all the relevant institutional officials. Then you need to get your arms around all the research being done on the campus, and you have take the huge baskets of interests of the institution and of the officials and link those against the research projects. Mechanically, it's a much, much different endeavor."
The results of the survey released Tuesday show that Ehringhaus and the AAMC were right to think that medical schools would be slower to come to grips with institutional conflicts of interest. Only 30 of 79 medical schools surveyed had to date adopted policies covering possible conflicts of interest between the institution's own financial resources and its research operations. Another 29 reported that they were working on such policies, while 20 others either were not working on such a policy or did not know about their policies. The report also contains details on which kinds of financial entanglements the institutions saw as potential conflicts of interest and which they did not.
The medical schools were much more likely to have adopted policies that covered potential financial conflicts involving institutional officials who in some way oversee research but are not themselves researchers. Two-thirds of the institutions had policies governing trustees, 7 in 10 had policies covering senior and midlevel institutional officials, and 81 percent had policies for members of institutional review boards.
But still, the report notes, that means that "in approximately one-fifth of medical schools, policies are not reported to be in place to govern key financial interests of officials who have responsibilities for managing the research enterprise, and even this may underrepresent the number of institutions without policies because of social desirability bias" -- meaning that respondents may say that they have policies because they know they're supposed to.
The vast majority of medical schools also had embraced practices in which they separated the duties of those at their institutions who oversaw investment management and technology transfer from those who manage their research functions, which was another recommendation made in the medical college association's 2002 report on institutional conflicts.
While Ehringhaus said she and the survey's other authors were heartened by the embrace of administrative practices like that separation of duties, the gaps in policies to govern conflicts troubled them. "The reason the policy figures are important is because we believe policies are the accepted expression of institutional values," Ehringhaus said. "It's important for institutions to have codified expression" of what they think is important.
On that score, she said, "we definitely have more work to do."
Sheldon Krimsky, a professor of urban and environmental policy and planning at Tufts University who has long advocated for stricter research ethics, said he was pleased to see some progress at medical schools and that the institutions are "probably doing more than other schools" within their universities in combatting conflicts of interest.
But Krimsky said that in many ways, policies that seek to identify and manage financial and other conflicts of interest come too little and too late in the process. Medical schools and other research institutions should also be focusing, he said, on reassessing whether their policies "nurture or impede" activities that can lead to conflicts of interest.
"A number of medical institutions have stopped the policy of allowing drug company representatives to enter their campus and get the ear of their medical faculty," Krimsky said. "In addition to worrying about their conflict of interest policies, they should be focusing on institutional policies that feed conflicts of interest."