HMS Revises Conflict of Interest Policy

Harvard Medical School (HMS) announced in May revisions to its 13-year-old conflict of interest (COI) policy for faculty. The revised policy would apply to more HMS researchers while clarifying and updating some specific provisions, especially faculty ties to businesses.

The changes, which were presented to the HMS faculty in May and subsequently adopted by Dean Joseph B. Martin, will take effect this fall during the faculty’s mandatory annual disclosure of outside ties.

Kuhn Professor of Biological Chemistry and Molecular Pharmacology Christopher T. Walsh, who chaired the group on basic research, called the newest changes “fine tuning,” noting that the review found that the previous regulations had largely been effective.

“I don’t think there will be major changes in the relationships of HMS faculty with companies,” he wrote in an e-mail.

But he added that it continues to be important to avert conflicts of interest stemming from researcher ties with outside companies.

“We re-emphasized the basic tenets that investigators cannot conduct sponsored research if there is an equity interest in a privately held company,” he wrote.

The new policy will now cover faculty who design and author studies, while the previous policy only applied to faculty who recruited patients for clinical trials. It explicitly bars full-time faculty from holding positions of fiduciary responsibility like Chief Medical Officer or Chief Scientific Officer in outside biomedical companies. Before, faculty could hold such positions after review by the school or hospital they work for.

The new regulations also make clear that companies for which faculty serve on the board of directors or in other executive positions cannot sponsor work in that faculty member’s lab, although this does not apply to faculty serving on scientific advisory boards.

And the new rules make clear that the end of a project—at which point faculty are permitted to own related stock—is at publication, not the end of research.

The suggested changes come from the recommendations of two committees—one on clinical research and one on basic research—which completed their work last summer and presented their conclusions to Martin.

He then consulted with an advisory committee and with department chairs before presenting the proposals to the faculty.

At each stage of consultation, Martin “found strong concurrence with the recommendations of the committee,” including at the May faculty meeting, according to a press release.

HMS Associate Dean Margaret L. Dale said that given the age of the current regulations on conflicts of interest, the time had come to ensure that they were still serving their purpose well.

“There was not a particular impetus for the most recent revision,” wrote Dale in an e-mail. “Instead, the policy is reviewed periodically as a matter of course to keep pace with the advancement of science and to ensure strong safeguards in the relationships between faculty and industry.”

The policy has previously been revised in 1993, 1995 and 2000.

Another new aspect of the policy stipulates that only income post-marketing is exempt from licensing royalties, noting that pre-marketing income like stock options is not exempt.

Rules requiring faculty to disclose their financial ties to students, postdoctoral fellows and other faculty now also require that they disclose such relationships to prospective students, fellows and faculty.

At the same time, some minor liberalizations of the current conflict-of interest regulations were also adopted.

The maximum amount of stock a faculty member may hold in a publicly traded company doing research in a field related to that faculty’s work was raised from $20,000 to $30,000 in recognition of the time that has passed since the $20,000 limit was set. Faculty still may not hold equity in privately-held companies doing research related to their research.

And the maximum amount of fees for consulting and other non-equity purposes a faculty member may receive was raised from $10,000 from each business per year to $20,000 per business annually.

The changes come under a central administration—led by University President Lawrence H. Summers and Provost Steven E. Hyman—that has made “tech transfer,” the transfer of intellectual property from academia to industry, a high priority.

Summers and Hyman have encouraged the practice because they say it expedites the movement of important discoveries into mainstream usage.

Walsh said that the new rules are consistent with the HMS mission of turning discoveries into useable therapies and medicines.

“I think the HMS COI guidelines continue to encourage and enable investigators who have made significant discoveries to get technologies patented and licensed, while protecting the inventors from conflict,” he wrote.

—Staff writer Stephen M. Marks can be reached at marks@fas.harvard.edu.