At the third in a series of Congressional hearing on conflicts of interest at the National Institutes of Health (NIH), NIH Director Dr. Elias A. Zerhouni last week announced further changes to strengthen agency ethics policies. Speaking before the House Energy and Commerce Subcommittee on Oversight and Investigations, Dr. Zerhouni explained that the changes are rooted in four principles: enhancing the public trust, increasing transparency, recruiting and retaining the best scientific expertise while expediting the translation of research advances, and establishing effective monitoring and oversight mechanisms.

The announcement followed NIH's continued review of its ethics program and policies, as well as findings from an investigation by the subcommittee of more than 100 consulting or other arrangements between industry and NIH scientists that had not been reported to NIH ethics officials.

"I have reached the regrettable conclusion that drastic changes are needed," Dr. Zerhouni said. "In retrospect, there was not sufficient safeguard against the perception of conflict of interest."

Among the proposed changes to the NIH ethics policy is a total ban on paid consulting arrangements between senior NIH officials and industry, a ban on the receipt of stock or stock options by all NIH employees as compensation from industry, a limit on consulting fees that certain NIH scientists can receive from industry and on the number of hours they can spend working on such arrangements, and a ban on all NIH employees receiving any form of payment from any institutions that receive NIH funding for research. The creation of a centralized database that contains all outside collaborations for NIH employees is also being considered, Dr. Zerhouni explained.

Some subcommittee members suggested that a total prohibition on outside consulting activities may be the only way to truly eliminate any perception of a conflict of interest at NIH. Such a move, Dr. Zerhouni responded, would have a detrimental effect on the NIH and its employees.

Three NCI senior staff participated in the hearing: Dr. J. Carl Barrett, director of the Center for Cancer Research; Dr. Anna D. Barker, deputy director for advanced technology and strategic partnerships; and Dr. Maureen O. Wilson, assistant director and deputy ethics counselor.

The subcommittee sought additional information on an NCI scientist's consulting arrangement with a California-based life sciences company from the NCI officials who had approved the activity. The witnesses responded to questions about the approval process and suggested that reforms to the system, such as those proposed by Dr. Zerhouni, are likely to prevent future conflicts. NCI has committed to taking the necessary steps to support the highest standards of ethics and recognized standards of scientific excellence. Dr. Wilson has noted that efforts are underway to educate NCI staff on their responsibilities as federal employees in order to avoid any real or apparent conflicts of interest in the future.

In a message to staff last week, NCI Director Dr. Andrew C. von Eschenbach said he shares Dr. Zerhouni's "concern about the potential erosion of public trust" brought on by these hearings and that he strongly endorsed transparency.

"Along with NIH, NCI will take actions to clarify its rules and policies and look at ways to improve our ethics program as it relates to federal employees' relationships with outside organizations," he said.

NCI is in the process of linking its many databases so that proposed outside activities by NCI staff can be cross-referenced easily against any grant, contract, or other agreement that the institute may have with an outside organization. Local briefing sessions with NCI staff will also be held, Dr. von Eschenbach said, to explain and discuss ethics rules and policies.