HARVARD CONFLICT-OF-INTEREST POLICY

Executive Summary

HARVARD CONFLICT-OF-INTEREST POLICY that would require researchers to disclose annually their "financial relationships" with industry and would set up a panel to review those relationships was endorsed by the Harvard faculty council on March 22. The guidelines will be reviewed in May by the Harvard Medical Center and, if approved, will serve as the basis for standards governing researcher/industry relationships at all institutions affiliated with the medical school. The Harvard Medical Center is the umbrella group for the 13 hospitals and institutions affiliated with the medical school. The May review will be conducted by the director or chairman of trustees of each of those organizations. A 13-member committee, convened by Dean Daniel Tosteson, has been drafting the guidelines for about a year. Earlier versions contained some more stringent requirements -- while the guidelines now require review of consulting fees paid to a researcher by a company that has financial interest in his or her research, a previous proposal would have barred such fees outright. The Harvard debate has been monitored closely by other organizations considering conflict-of-interest policies. The Harvard decision to come up with an explicit policy was originally sparked by allegations that medical school researcher Scheffer Tseng had violated human safety regulations in a study of vitamin A ophthalmic ointment for treatment of dry eye syndrome, and reportedly had acquired stock in the company that had purchased rights to the ointment. The guidelines would divide researcher activities into three categories, with separate degrees of review required. The categories are: * activities requiring "special attention and specific approval" by the review committee, including participating in a clinical trial while simultaneously serving as a consultant to a company owning the product being tested; receiving research support from a firm in which the researcher has equity interest; making clinical referrals to a lab owned by a full-time faculty member; or presenting research findings without disclosing financial interests in the product studied; * activities that are "with oversight, permitted," including: participating in a clinical trial on a technology invented by a faculty member; assigning post-doctoral fellows to research sponsored by a company in which the faculty member has a financial stake; or serving on the board of directors of a company that helps support the faculty member's research; and, * "more traditional" activities requiring neither approval nor oversight. These include receiving royalties or honoraria for scholarly publications, commissioned papers, or "occasional lectures," or royalties under institutional royalty-sharing policies. Cases of noncompliance will be adjudicated using existing medical school procedures. In a statement on the guidelines, the medical school says that after one year, the school dean, the proposed "Standing Committee on Conflict of Interest and Commitment," and members of the panel that drafted the guidelines will meet to "review the types of activities disclosed and oversight procedures." * National Institutes of Health Acting Director William Raub told the House Appropriations/Labor, Health and Human Services Subcommittee March 12 that revisions to NIH's conflict-of-interest guidelines should be released in the next couple of months.