Healthy Skepticism Library item: 13582

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Publication type: news

Harris S.
Medical Schools Wrestle with Conflict of Interest Policies
AAMC Reporter (Association of American Medical Colleges) 2008 Apr
http://www.aamc.org/newsroom/reporter/april08/coi.htm

Notes:

See AAMC site for internal links

Full text:

Many medical schools and major research universities are facing challenges on several fronts as they develop or refine financial conflict of interest (COI) policies in research. In order to assist research institutions in overcoming these challenges, the AAMC and the Association of American Universities (AAU) recently released a report, titled Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research, that recommends implementing institutional conflict of interest policies within two years and provides a detailed “roadmap” to assist medical schools and major research universities in reaching not only that goal but also other refinements in their individual and institutional COI policies. The 21-member committee was co-chaired by Robert R. Rich, M.D., senior vice president for medicine and dean of the University of Alabama at Birmingham School of Medicine, and Mark S. Wrighton, Ph.D., chancellor of Washington University in St. Louis.

“There is keen interest in the relationships between academic medical research and the companies that sponsor that research,” said AAMC Chief Scientific Officer David Korn, M.D., who helped develop the AAMC-AAU guidelines. “The objectivity of biomedical scientists and their trustworthiness are both eroded by the perception that their research and their interpretation of that research may be biased by these relationships and the information received from a manufacturer, rather than the patient’s best interest. We need to manage these relationships in ways that do not undermine the integrity of science or the practice of medicine.”

In 2001 and 2002, an AAMC task force issued reports that addressed, respectively, individual and institutional financial conflicts of interest in human subjects research. In 2006, a joint AAMC-AAU advisory committee was formed to update and amplify these recommendations following well-publicized cases of improper financial relationships between research entities and companies that could stand to profit in some way from their research.

According to the results of a survey undertaken by the AAMC and Massachusetts General Hospital and published in the Feb. 13 Journal of the American Medical Association, only 38 percent of responding medical schools have adopted policies covering institutional COI involving financial interests of an institution. (This figure contrasts with the 71 percent of medical schools with COI policies covering the financial interests of its senior officials, another kind of potential institutional COI.)

Most institutions have relatively well-established individual COI policies. But schools have struggled with putting into effect institutional COI policies. For institutional COI in particular, implementation is complicated by the fact that many medical schools are components of parent universities and may not have the authority to independently adopt such policies. Serious obstacles also lie in compiling,managing, and evaluating the financial information necessary to prevent potential COI.

Successfully managing COI may be an especially pressing concern given the current funding climate for biomedical research-a potential Catch-22 in which a generally downward trend in inflation-adjusted public research dollars means that more private funds are needed to bridge the gaps. Academic leaders readily acknowledge the importance of industry in the nation’s research enterprise, but said that if private relationships are not managed effectively, public funding could be at further risk, possibly creating even larger gaps.

“We’re in an era of very tight funding. So we are all seeking new sources of support, and industry is one important source of that support,” said Julie D. Gottlieb, M.A., assistant dean for policy coordination at Johns Hopkins University School of Medicine.“One of our missions is to get research discoveries to the bedside as quickly as possible, so as we use our research institutions as the creative engine, we need industry to get it to the market. We just need to do it in a credible way. This is not the time to play fast and loose with the public trust.”

Not surprisingly, technology is increasingly central to putting these policies intomotion.One of the most important parts is an online database that catalogues financial relationships and research projects, among other things, to determine where conflicts may exist. However, such a tool requires considerable staff time and other resources to develop and maintain, officials said.

After a full year of work and several “false starts,“Gottlieb said Johns Hopkins School of Medicine recently launched an online transaction database that ties together several facets of the school’s research entity.

“We deliberately chose a platform that the Institutional Review Board was already using, so that we could all be in sync,“Gottlieb said.“We also have a close working relationship with the tech transfer office and have electronically integrated our sponsored project database into this to ensure that financial interests are disclosed during the grant application process.”

The database is helping to streamline transaction tracking, Gottlieb said, but so too are the personal collaborations established while the system was in development.

“One of the important outgrowths of our database project is a much closer relationship between conflict of interest review and the Institutional Review Board,” she said.“We have good, old-fashioned, staff-to-staff communication, and there are now standard operating procedures that have been agreed upon by all sides.”

Officials at Duke University School of Medicine, tentatively set to release its institutional COI policy this spring, emphasized the importance of the COI committee and its makeup. “We recommend having an independent conflict of interest committee and,where possible, including members of the public to help promote transparency and bring about a measure of public trust,” said Ross E. McKinney,M.D., Duke’s vice dean for research.

According to school officials, institutional leadership that is supportive of a credible COI program is essential. “For an institution to be at the forefront of innovation, it has to be trustworthy,” said Guy M. Chisolm, Ph.D., M.S., vice chairman of the Lerner Research Institute at the Cleveland Clinic Foundation. “It’s important to have leadership that will commit resources to this, and commit to being at that forefront.”

As part of their institutional COI policies, some schools have created rules for those leaders and officials who represent the institution. For example, some institutions prohibit officials from serving on the boards of companies sponsoring research at their institution if they have oversight responsibility for research.

It is not uncommon for university leaders to serve on corporate boards. According to the American Council on Education, 88 percent of 2,148 college and university presidents surveyed in 2007 said they served on at least one external board. Among those who serve on external boards, each president served on an average of 1.6 corporate boards (this average increased to two for doctorate-granting institutions), 1.7 other college or university boards, and 3.5 boards of non-profit organizations.

“If a vice president of medicine or a dean or a chief executive is on a board that does business with his or her own institution, it is up to that person and their institution to make sure it does not distort decision making,” Korn said. “But that doesn’t mean there’s anything inherently wrong with it. Some would argue that this kind of relationship sets a bad example. Fundamentally, I think it has to be a combination of an individual decision and something that is approved by the governance of that institution.”

Some researchers have expressed concern that COI policies hamper the scientific process with extra layers of bureaucracy. Gottlieb said that the Hopkins policy was designed to minimize time and effort. Fax machines were eliminated from the process, and extra phone calls and e-mails are avoided.

“We wanted to make the process as easy as possible,” she said. “We did a lot of testing with faculty beforehand. On average, it takes maybe nine minutes to complete one of our disclosure forms, and it’s all online. There is a lot less paper flying around.”

Korn said that both individual and institutional COI policies and programs are critical, and achievable, parts of the future of biomedical research.

“These interactions with industry are critically important if discoveries are to be translated into public benefit. That’s the system in our country,” Korn said. “We just want to make sure these relationships are credible and withstand intense public scrutiny. That’s the bottom line. And I believe it’s very possible to do that.”

For more information, visit Financial Conflicts of Interest in Clinical Research.

To read or download “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research,” visit AAMC Publications.