Conflict of Interest Guidelines Proposed
Conflicts of interest in biomedical research are gaining increased attention from researchers, universities, and the U.S. government. Both the Journal of the American Medical Association and the New England Journal of Medicine ran articles last fall discussing the issue. And in August, the U.S. Department of Health and Human Services (HHS) hosted a conference on the subject, at which participants were reportedly warned that scientists and universities must reach consensus on conflict-of-interest guidelines or risk increased federal regulations and a loss of public trust.
Conflicts arise when scientists or others involved in research have a financial stake in companies sponsoring the research, or in companies that could profit from it. The likelihood of such conflicts has increased in recent years as the percentage of research funding that comes from industry has grown, especially in medicine, biology, chemistry, and engineering. To date, institutional policies on conflicts have been inconsistent; many focus on disclosure of conflicts rather than on prohibition of them.
Public attention to the issue increased in 1999, following a highly publicized incident at the University of Pennsylvania, in which a teenager died after being injected with genetically engineered viruses as part of a clinical trial. The lead investigator in that trial was a major stockholder in the company that sponsored the research.
This year, the HHS and a group of medical educators are working on guidelines for handling conflicts of interest. In January the HHS issued draft guidelines on dealing with conflicts of interest for researchers, institutions, and the institutional review boards (IRBs) that oversee campus research involving human subjects. The draft recommends that researchers consider any effects their financial relationships with commercial sponsors of scientific studies might have on research outcomes or on human subjects of research. It further suggests that institutions gather information on conflicts of interest, seek to minimize such conflicts on an institutional level and among members of IRBs, and create educational programs on financial conflicts of interest.
Federal rules already require scientists who receive federal health research grants and corporate financing to disclose significant financial interests in corporations that fund or might benefit from their research. But the rules do not prohibit stock ownership by institutions or researchers, and neither would the proposed HHS guidelines.
Defining the exact amount of financial involvement allowable is important, particularly when research involves human subjects, according to a separate group of medical educators that drafted guidelines urging institutions to strengthen their own procedures for handling conflicts of interest. Joseph Martin, dean of the Harvard Medical School, convened the group, which forwarded its guidelines early this semester to the Association of American Medical Colleges (AAMC). The AAMC has itself assembled a task force to study the issue.
The Harvard group means for its recommendations to guide institutions as they develop and review their conflict-of-interest policies. Among other proposals, the group recommends that institutions (a) require that faculty, students, and staff involved in research disclose any financial interests to their campus IRBs; (b) consider setting higher standards for research involving human subjects than for basic laboratory research; (c) clearly outline allowable financial interests, such as participation in mutual funds; and (d) require disclosure to journals considering publishing related research.
The guidelines define financial interests that should be disclosed as any fees, honoraria, or gifts associated with consulting or lectures; equity, including stock options; and payments for directorships or executive roles. Journals are encouraged to require and publish disclosure of financial interests.
"While collaborations between the academy and industry are essential if patients are to benefit from the current biomedical revolution, the integrity of those relationships must be monitored by policies that are clearer and more stringent than is the norm today," says Martin.
For information on the AAUP’s position on this topic, see the "Statement on Corporate Funding of Academic Research" on page 68 of this issue of Academe. For information on IRBs, see "Protecting Human Beings: Institutional Review Boards and Social Science Research," in this issue.
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