Harvard COI Policies Being Revised

With new impending implementation of federal regulations on conflict of interest, each of Harvard’s schools is underway with drafting a respective set of policies to judge conflict of interest that is also in compliance with University policies approved in 2010.

Harvard schools must draft their policies and have them approved by the late August 2012 federal deadline, according to Mark Barnes, a senior associate provost and co-chair of the University Standing Committee on Financial Conflicts of Interest.

“The federal government encourages us—in fact, requires us, through the Bayh-Dole Act—to commercialize faculty inventions that were produced with federal research funds,” Barnes said. “We want to protect faculty by having schools analyze issues related to inventions and external financial interests, upfront, before anyone can say that something went wrong.”

In many cases, faculty members face conflict of interest allegations when they receive funding for academic research that is directly related to their personal financial interests.

But conflict of interest can take on different forms depending upon the discipline—thus necessitating school-specific policies.

The Standing Committee has been meeting every six weeks to vet proposed policies. Each school is expected to define what it considers a “significant financial interest,” and present protocol by which potential conflicts of interest can be resolved, Barnes said.

Thus far, policies at Harvard Medical School and Harvard Law School have received preliminary approval.

The Faculty of Arts and Sciences will also propose its own implementation policy later this spring.

“I would say FAS is more complex because it’s larger and there’s a greater variety of funding sources,” Barnes added.

The FAS task force is on track to finish on time, according to Molecular and Cellular Biology professor Alexander F Schier, who is chair of the FAS Committee on Research Policy that is working to draft the policy.

Harvard’s re-evaluation of conflict of interest policies has been a two-year process aimed at standardizing disclosure practices across the University.

Revised U.S. Public Health Service regulations affect faculty members who receive grants from the National Institutes of Health and the Centers for Disease Control among others, mandating annual disclosure of all outside interests. According to Barnes, Harvard receives about 60 percent of its external research funding from PHS.

In a shift from regulations that have been in place since 1995, universities, rather than individual professors, must judge all potential conflicts of interest.

While professors acknowledge that change in a system can yield temporary inconvenience, most agree that a standardized protocol for avoiding conflict of interest situations is necessary.

John Y. Campbell, chair of the Economics department, said that he and other members of the department have always tried to be “conscientious” about disclosure, for example, by displaying outside interests on their websites. But he pointed out that this use of Harvard websites could be seen as a misuse of the Harvard name.

“I think it’s mostly a matter of deciding on a common protocol,” he said. “It’s helpful if norms develop so that people know the appropriate thing to do.”

—Staff writer Radhika Jain can be reached at radhikajain@college.harvard.edu.

—Staff writer Kevin J. Wu can be reached at kwu@college.harvard.edu.