NIH Proposes Tougher Rules on Financial Conflicts of Interest

May 20, 2010

The National Institutes of Health, after a year of study driven by Congressional criticism, proposed new regulations on Thursday aimed at reducing financial conflicts of interest in scientific research.

The agency proposed cutting to $5,000 from $10,000 the level at which an NIH-backed researcher must report to his university a payment from an outside company. The new rules also would require universities to give the NIH details of plans to reduce financial conflicts of interest involving their staff members, rather than merely asserting such plans exist.

The recommendations represent "a substantial change in the way in which NIH seeks to oversee potential financial conflicts of interest," the agency's director, Francis S. Collins, said in a briefing. "The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process."

The plan, however, still leaves universities largely in control of key decisions, including letting the institutions determine whether a financial conflict is relevant to a government-financed research project. And the plan contains no new enforcement mechanisms or penalties for violations.

"The NIH has left a lot of this to the institutions," said David J. Rothman, president of the Institute on Medicine as a Profession, a watchdog group based at Columbia University. "One would have hoped it would give them much more explicit guidelines."

Others gave a more cautious response while analyzing the 26-page proposal, which is due to be published on Friday in the Federal Register, triggering a 60-day period in which the NIH is required to collect public comments on the plan before carrying it out.

'An Important Step in the Right Direction'

A leading Congressional critic of the NIH's handling of conflict-of-interest policies, Sen. Charles E. Grassley of Iowa, regarded the proposal as "an important step in the right direction," his office said in a written statement. Mr. Grassley, the top Republican on the Senate Finance Committee, expects to issue specific comments after reviewing the plan, the statement said.

The Association of American Universities, which represents a group of leading research institutions, also needs more time to study the plan, said its spokesman, Barry Toiv. The AAU and the Association of American Medical Colleges jointly issued a set of recommendations last June, when the NIH began studying the matter, that endorsed tougher requirements on researchers to report possible conflicts of interest.

Mr. Grassley has aggressively promoted the notion that the public suffers widespread harm from doctors, many of them university researchers, who are paid secretly by companies to promote drugs and medical devices without sufficient scientific support for the researchers' claims.

He won enactment, as part of this year's health-care overhaul, of a law requiring companies to make quarterly reports to the federal government on payments they make to physicians. Many drug companies and medical-device suppliers, recognizing the coming change, began instituting such policies on their own, leading some researchers to sever their ties with the companies.

Dr. Collins, in outlining the proposed rule changes on Thursday, suggested that problems with financial conflicts were not widespread. "But," he said, "there clearly have been a few examples uncovered in the last few years where investigators were involved in financial conflicts that could be at least perceived as coloring their judgment and perhaps affecting publications that they were involved in."

Either way, the amount of money at stake has grown significantly. Financial support of biomedical research in the United States increased from $37.1-billion in 1994 to $94.3-billion in 2003, with most of that money coming from industry sources, according to an analysis published by the Journal of the American Medical Association. And the number of academic researchers with industry relationships increased from 28 percent in a 1996 survey to 53 percent in a 2007 survey, the NIH reported.

Under current regulations, a researcher needs only to tell his university about payments or stockholdings that exceed $10,000 from a company whose products represent what the researcher considers to be a significant relationship to his work. The university only informs the NIH that a conflict has been managed, and no public disclosures are required.

Under the proposed changes, the trigger level would begin at $5,000, and the university would be responsible for evaluating whether the relationship between the company and the researcher's work is significant. The university also would be required to give the NIH details of how it is managing any such financial conflict, and the university would post details of the payments on a publicly available Web site.

No New Penalties

The NIH began the review process a year ago with an expectation that it would not try to usurp the primary role of universities in guarding against financial conflicts. "We feel it is appropriate that the institutions manage their financial interests," Sally J. Rockey, the NIH's acting deputy director for extramural research, said last May.

The agency stuck to that position, though the new reporting requirements would give the NIH a better position to independently assess how universities are exercising that authority, Ms. Rockey said on Thursday.

The NIH settled on the $5,000 figure out of a belief that a smaller amount would impose large paperwork costs on researchers and universities without a corresponding benefit, Ms. Rockey said.

The AAU and the AAMC, in their joint recommendation, also endorsed the $5,000 figure, even though some universities have imposed no lower limit on reports from their staff. "A zero-disclosure threshold will generate an enormous volume of noise in the system rather than focus on the important signals," the groups said.

The proposed reporting requirement does not apply to payments to faculty members that involve seminars, lectures, teaching, or service on advisory panels that involve government agencies or colleges. The researcher would be responsible for recognizing instances in which an event has underlying financial support from a private company, Ms. Rockey said.

As the proposal includes no new penalties, the ultimate success of the regulations, if enacted, will depend on how seriously colleges consider the threat of NIH enforcement, Mr. Rothman said.

The NIH had success several years ago with new rules on the conduct of experiments involving human beings, Mr. Rothman said, in part because universities were made to fear the loss of financing from the agency, which spends more than $30-billion a year on medical research.

In one high-profile action, the federal government suspended all research financing at the Johns Hopkins University after the 2001 death of a young woman in an asthma study. It lifted the suspension less than a week later.

The regulation of human-research protections was "terribly vague and not good enough," Mr. Rothman said, "but it provoked good changes."