Revised Rules on Financial Conflicts

U.S. issues final regulations to increase requirements on researchers and universities to report and eliminate conflicts of interest; standards eased slightly from 2010 proposal.
August 24, 2011

WASHINGTON -- For the first time since 1995, the federal government has revised its policies governing researchers' financial conflicts of interest, in ways that federal officials said would build public trust in the integrity of biomedical research by strengthening transparency and oversight.

Like a draft of the rules that the Department of Health and Human Services and the National Institutes of Health issued in May 2010, the final regulations the agencies unveiled Tuesday keep largely intact the basic structure and design of the existing system for regulating financial conflicts of interest, in which universities, based on information disclosed to them by the researchers who work for them, are primarily responsible for ensuring compliance with the conflict of interest regulations, and the NIH and other Public Health Service agencies would remain responsible for overseeing the institutions' compliance.

But following a two-year review, the rules significantly alter the nature and extent of the information that researchers must report to their employers and that institutions must report to the government, as well as the extent to which the public will be made aware of possible conflicts of interest (though the public disclosure requirements were eased in the final version of the rules).

Most significantly, the rules would require individual recipients of federal research grant money to report to their universities not just about how their financial interests in a company or other entity might affect a particular federal project or grant, but how it might affect all of their "institutional responsibilities," including research, consulting, teaching, and membership on university committees -- a change designed to "provide institutions with a better understanding of the totality of an investigator's interests."

The rules, which will be published in Thursday's Federal Register and will take effect a year from that day, also drop to $5,000 -- from the current $10,000 -- the minimum level at which researchers would have to report money they had received in the previous year or equity they own in companies whose products are related to their work. The May 2010 proposed rules would have excluded from the reporting requirements payments from universities and governments for lectures or other forms of teaching; the final regulations released Tuesday expanded that exemption to payments from academic teaching hospitals and research institutes affiliated with universities.

The new regulatory scheme aims to ramp up the reporting that researchers do to the universities that employ them, and that those institutions do to the government and to the public, with the goal of building the public's trust through transparency, Francis S. Collins, the NIH's director, said during a telephone news conference with reporters.

Under the new rules, for instance, before receiving any federal money for a particular grant, an institution will have to submit a conflict of interest report "regarding any [significant financial interest] found by the institution to be conflicting and to ensure that the institution has implemented a management plan in accordance with the regulations."

The volume and breadth of information universities would have to report would also increase, to be much more explicit about the dollar value of the financial interest in question (in $5,000 ranges up to $20,000, $20,000 ranges up to $100,000, and $50,000 increments above $100,000), the nature of the conflict, and the key elements of the management plan.

The agencies will also require institutions to make that information public. But in a major change from the proposed rules released last year, and in response to complaints about regulatory burden, the government has decided not to require universities and others to publish the information "on a publicly accessible website." Instead, to give institutions more "flexibility," said Sally Rockey, the NIH's deputy director for extramural research, they can also choose to make the information available within five business days upon request. "The chosen approach promotes such transparency without imposing undue burdens," the agencies said in the document laying out the regulations.

The Association of American Universities cited this change in particular in praising the agencies for responding to issues raised by those who commented on the proposed regulations. "Although the final rule has not incorporated all the recommendations AAU made in our comments, we greatly appreciate the process of consultation on this important set of regulations," association officials said in a prepared statement.

Some experts on conflicts of interest said they did not believe the government's changes would meaningfully address some of the underlying problems in the oversight of research conflicts of interest.

"Providing more 'flexibility' on policy is precisely the root of many conflict of interest problems," Jane Robbins, senior lecturer in innovation, entrepreneurship and institutional leadership at the University of Arizona, said via e-mail. "Similarly, enforcement of conflict of interest policy is an area that has been consistently found to be lacking by researchers; enforcement methods are a wide range of 'options' and have no teeth." The new NIH policies do not significantly strengthen the government's stance in those areas, she said.

Collins, the NIH director, challenged that view. To ensure public trust in scientific research, "the system needs an additional layer of careful oversight," which the new rules provide, he said. "This is an insurance plan against potential trouble."


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