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Harvard Medical amends policies

Rules for faculty on conflicts may become a model

Harvard Medical School has increased the amount of stock faculty members can own in firms utilizing their research, but placed stricter limits on their involvement in the management of such firms, under a new policy that could influence commercial ties at hospitals and medical schools nationwide.

The policy, which also allows faculty to get higher consulting and other fees from companies, is the first revision of the medical school's conflict-of-interest rules in more than a decade. Much has changed in that time: Once-sequestered academics now frequently work with pharmaceutical and biotechnology firms housed in corporate offices often blocks from local hospitals and labs.

Advocates of these ties say they give professors incentives to be entrepreneurial and to quickly turn their research findings into treatments and diagnostic tests. But critics worry that scientists chasing financial rewards will be tempted to skew their research or neglect to adequately protect patients in medical experiments.

The changes at Harvard were slight, said experts, and indicated that the medical school sought to maintain its traditionally cautious view of industry links while acknowledging such collaborations were now a fact of life in modern medicine.

''What's at play here is a very delicate balancing act: to protect the integrity of science and [human test] subjects, but also to ensure the discoveries get translated into useful products and services," said Dr. Jordan Cohen, president of the Association of American Medical Colleges. ''Harvard is an important pace setter."

Harvard spent more than a year crafting the policy, which takes effect this fall, covering more than 9,000 researchers at the medical school and its 18 affiliated hospitals and research institutions. Harvard officials said about 7 percent of the faculty are involved in industry collaborations affected by the policy, which was finalized at a faculty meeting this week.

Under the policy, Harvard faculty cannot own more than $30,000 in stock from public companies that benefit from their research, a $10,000 increase from the previous limit. They cannot have any stock from companies with which they have ongoing research collaborations. In addition, faculty members cannot own stock in private companies related to their research. But faculty can receive up to $20,000 in consulting fees from companies tied to their research, also a $10,000 increase from the previous limit.

Harvard counts on faculty researchers to disclose their financial dealings, with medical school officials reporting 100 percent disclosure in recent years.

Until now, faculty could not hold upper management jobs in firms. The new policy extends this prohibition to include the positions of chief scientific officer and chief medical officer, slots Harvard faculty occasionally accept.

The new policy was crafted by Harvard medical dean Dr. Joseph B. Martin, in consultation with several faculty committees. He noted that some faculty members argued for looser rules that would foster increased interaction with Boston's vibrant biotechnology and pharmaceutical communities.

''The issues that some individuals raised were set aside for two reasons: that we need to protect human subjects in research . . . and that there not be any perception of bias in research work," he said.

But of faculty collaborations with industry, Martin said: ''We encourage it in every possible way." The increase in the stock and consulting limits, said Martin, reflected what he thought ''responsible people ought to be able to take in."

Some Harvard faculty and outside critics argued that faculty should not be able to own any stock from companies that benefit from their research.

''Why not just do away with that? Do they really need that money? The notion that that's not a conflict seems questionable to people," said Boston University medical ethicist George Annas.

But Annas said overall, Harvard's new policy ''is moving in the right direction."

''This comes at a very important time," he said.

The Association of American Medical Colleges found in a recent survey that a majority of US medical schools were considering changes to their conflict of interest policies. Harvard's new policy closely mirrors a model designed by the association last year.

''It's quite consistent with what is emerging as a national consensus of a clear and unambiguous monitoring of these relationships," said Cohen.

While setting certain limits, the policy also makes clear that a faculty researcher can benefit financially from his work. Royalties from marketed products that make use of faculty members' work are exempt from the $30,000 limit.

If a faculty member sits on a corporate board, according to the new policy, that company cannot fund projects in the faculty member's laboratory. And faculty must tell not only students and colleagues about financial ties, but also potential students and colleagues applying for jobs there.

Raja Mishra can be reached at rmishra@globe.com.

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