Leading medical schools agree on new guidelines

Stressing the protection of research subjects supercedes any other concerns, the leaders of eight of the nation’s top medical schools and another six nationally prominent leaders in academic medicine have drafted a set of guidelines that would strengthen most research institutions’ policies for dealing with financial conflicts of interest that can arise from collaborations between faculty and industry.

Harvard Medical School dean Joseph Martin, MD, convened the group. He says it is impossible to avoid collaborations between medical school faculty and outside industry, but the guidelines can reduce the risk of improper influences. "While academic-industry collaborations 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," Martin says.

Filling in the gaps

The group’s recommendations address inconsistencies and gaps in policies described in a series of four articles in the Nov. 1, 2000, Journal of the American Medical Association and the Nov. 30, 2000, New England Journal of Medicine. The group met recently in Washington, DC, to review the articles and discuss possible improvements in the system. Guidelines developed by the group were submitted to the Association of American Medical Colleges, which has formed a committee to review financial conflicts-of-interest policies for medical schools and teaching hospitals nationally.

Martin says the proposals are designed to guide individual institutions as they review their own conflict-of-interest policies, and were drafted with an eye to refining some of the weaknesses and gaps cited in the journal articles. The group recommends these actions:

  • Require disclosure of financial interests to the institutional review boards that approve clinical research trials, something only around 1% of institutions do now.
  • Apply required disclosure of financial ties to anyone involved in research — faculty, students, and staff — and require that disclosure should be both on a set periodic basis as well as in real time if their situation changes.
  • Consider a higher standard for clinical research than for basic laboratory research.

The guidelines state: "Individuals directly involved in the conduct, design, or reporting of research involving human subjects should not have more than a clearly defined minimal personal financial interest in a company that sponsors the research or owns the technology being studied."

The guidelines also define financial interests that should be disclosed to include any fees, honoraria, or gifts associated with consulting or lectures, equity including stock options, and payments for directorships or executive roles. To make an institution’s policy as specific as possible, the guidelines suggest that key terms, such as "family" be clearly defined and that there be a clear delineation of any allowable financial interest, such as mutual funds.

For research published in medical journals, the group recommends the journals require disclosure when the article is submitted, something only 7% of institutions do now. The group also encourages all biomedical science journals to require and publish disclosure of financial interests, something only 43% do now.

Martin says the guidelines were developed after much national debate on the topic, sparked by Harvard Medical School’s announcement that it would retain its strict conflict policies.