The Obama administration announced on Tuesday the final form of new rules governing financial conflicts of interest in federally sponsored medical research, saying it hoped to boost public confidence after years of scandals tied to corporate influence.
The rule changes, the first in 16 years, bring new standards for universities to evaluate financial ties between their researchers and companies, for the researchers to disclose them, and for the public and government agencies to understand them.
"It's time for the rules governing those relationships to be modernized," Francis S. Collins, director of the National Institutes of Health, said in announcing the regulations after more than two years of development.
Dr. Collins said he recognized that the changes would place some additional burdens on universities. The changes, however, still leave universities largely responsible for ensuring that the integrity of the science underpinning the quality of U.S. medical care is not diminished by the universities' own multimillion-dollar ties to corporate partners.
The final form of the changes falls short of some of the more aggressive regulations suggested by Dr. Collins and the NIH. In particular, the rules do not require universities to post online details of the specific financial conflicts involving their scientists. Instead, universities are required only to respond to individual requests for such information.
And, despite the fact that the rule-making process was halted a year ago following revelations that a prominent psychiatrist had escaped NIH sanctions by moving to a new university, the final language does nothing new to specifically prevent such a maneuver.
The new rules will be formally published Thursday in the Federal Register and will take effect one year after that, replacing the current guidelines established in 1995.
No New Enforcement
Among the changes, researchers will be required to report to their universities a financial relationship with a company when the amount exceeds $5,000 a year, rather than $10,000 under current rules. The threshold will also be applied to all payments and stock benefits, including options, with fewer exceptions for nonprofit entities. The requirement also will apply to all corporate payments, not just those the researcher considers related to his government-sponsored work.
Universities will also be required to provide the federal sponsoring agency, such as the NIH, with details of any financial conflict and their strategy for resolving the conflict, rather than merely stating the conflict exists and has been handled.
But the federal government is getting no new enforcement powers, and Sally J. Rockey, deputy director for extramural research at the NIH, acknowledged that the agency has never suspended a research grant because of a financial conflict of interest.
Dr. Collins halted the rule-making process a year ago after The Chronicle reported that Thomas R. Insel, who was helping to lead the review, was also helping a tainted researcher, Charles B. Nemeroff, land a new job at the University of Miami.
Dr. Nemeroff, while chairman of the psychiatry department at Emory University, was one of several high-profile doctors found to have given speeches or written articles in medical journals extolling drugs or products made by companies that had paid them money or stock benefits that they did not report to their universities. Emory agreed to make Dr. Nemeroff ineligible for NIH grant money for two years. But after moving to Miami with the assistance of Dr. Insel, the director of the NIH's National Institute of Mental Health, Dr. Nemeroff was receiving NIH money before the two-year ban expired.
Addressing the NIH's advisory board after Dr. Insel's assistance to Dr. Nemeroff was revealed, Dr. Collins said he would delay the process of putting the rules in place to consider additional changes. In particular, he said the rules might need to be changed to ensure that any penalties or sanctions against a researcher remain in effect if the researcher moves to another institution.
Asked Tuesday why the final version of the rules included no such changes, Dr. Rockey said the NIH was confident any such problems could be handled by the additional new requirements for public disclosure of researcher activities.
University groups, in responding to the final form of the regulations, suggested they saw little reason to expect major changes in their institutions' dealings with the NIH, the world's largest source of financing for medical research.
The Association of American Universities said in a written statement that while the administration "has not incorporated all the recommendations AAU made," it was pleased with the NIH's efforts and especially gratified that universities will not be required to post financial-disclosure information from their researchers on publicly available Web sites.
Dr. Rockey, in the NIH briefing with reporters, said the administration accepted that request in part because it recognized that some institutions that accept federal research money may not have Web sites.
The Association of American Medical Colleges, in a written statement, said the new rules are "an important step forward" in ensuring the integrity of biomedical research.