Harvard Medical School is relaxing a conflict-of-interest policy that prohibits some researchers from conducting clinical trials on new treatments when they have a financial stake in the company developing them.
The decision, which Dean Jeffrey Flier announced Thursday afternoon, affects researchers throughout Harvard Med and its teaching hospitals. Flier said the change was made because strict enforcement of the rule threatened to “stifle” the human testing of new drugs and devices.
The school began reviewing its conflict-of-interest rules last year amid complaints by some researchers that the restrictions, which aim to protect scientific research from corporate influence, slow the process of turning laboratory discoveries into treatments. This is the second change the school has made.
“Our goal is to create situations in which we increase the likelihood” that research at the school turns into treatments that help patients, Flier said in an interview in his office Thursday. “One of the ways that that happens is by more interaction between faculty and industry.”
Flier said the school has to balance the benefits of those interactions with the theoretical risks. He said the school will monitor the impact of the rule change and revisit it if need be.
The rule in question, established in 1990, prohibits faculty from conducting clinical trials on a company’s products if they have a certain amount of equity in, or earn at least $10,000 in income from, that company. That’s supposed to prevent researchers from skewing the trial results — and potentially harming people — because they have a financial interest in the outcome.
But there was widespread concern in the Harvard Med community that the school was going too far with this strict prohibition, said Gretchen Brodnicki, dean for faculty and research integrity. She and a faculty ethics committee reviewed policies around the nation and found no other school with a “hard-stop” prohibition like that. Brodnicki said she has heard anecdotes of faculty leaving, or being unable to conduct specific studies, because of the rule, though she said the impact is hard to measure.
As of Thursday, Harvard Med is creating more wiggle room in this rule. First, the school is raising the thresholds: Faculty will have to receive at least $25,000 in income (up from $10,000), or hold $50,000 in equity of a publicly traded company (up from $30,000) to trigger the prohibition on clinical research. Faculty still cannot hold any equity in a privately held company if they want to do clinical trials on that company’s product.
Second, the school will now allow faculty to petition for an exemption if they’re over those thresholds and still want to do the research. If a faculty member applies for an exemption, Harvard Med’s ethics committee will weigh the potential benefits of the research against the risks.
For instance, if a faculty member invents a device or is uniquely qualified to conduct research on it, then it might be in the best interest of patients to allow the faculty member to do the clinical trial, even if he or she owns equity in the company that makes the device, Brodnicki said.
Flier called the change a “small tweak” that brings Harvard Med in line with guidelines from the American Association of Medical Colleges.
Dr. Aaron Kesselheim, an associate professor of medicine at Harvard who studies conflict of interest in medicine, said the new rules “continue to recognize that financial relationships with for-profit companies can influence” research.
But he said “the devil’s in the details.”
“If someone has a legitimate explanation as to why the rules need to be bent in their circumstance,” he said, “then I think that could work out.” But the impact of the changes will depend on “how serious they are about truly making it an exception, and not letting the exceptions swallow the rule.”
Dr. Peter Slavin, president of Massachusetts General Hospital, Harvard’s largest teaching hospital, welcomed the changes.
“I know medical school faculty here at MGH have been concerned that this rule was overly restrictive,” he said. “I presume this modest change in it will be well received.”
“The most important thing we care about when doing clinical research is our integrity, and the safety of patients doing clinical research, but it’s probably not a good idea for the patients if the faculty member cannot do the research because of a modest” financial interest in a company, he added.
“Sometimes there may be a particular faculty member who’s the best person in the world to be involved in that research” — but can’t be involved if they have too much equity in that company, he said.
Slavin said the change may help with a recruitment problem: “Some faculty don’t come because they perceive that Harvard Medical School has rules that are much too restrictive.”
“These changes are relatively modest, but I think they’ll send a signal that we want to encourage these relationships with industry,” Slavin said. “If we don’t do so, we just aren’t going to advance medicine as quickly as we could.”
