NIH Announces New Ethics Rules for Institute Employees

On February 1, 2005, the National Institutes of Health (NIH) issued tough new restrictions for its 18,000 employees on all outside activities, financial holdings, and awards with pharmaceutical, biotechnology, and related companies. The new ban on outside work covers all pharmaceutical interests, health care providers, insurers, trade or professional associations, and supported educational institutions. The regulations take effect when they are published in the Federal Register—probably by the end of the week—and remain in force indefinitely. However, HHS will consider public comments about the new regulations for 60 days following publication.

“Nothing is more important to me than preserving the trust of the public in NIH. It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries. I am confident that these new rules will prevent the recurrence of past abuses and will go a long way in preserving the historic role of NIH as the primary source of unbiased scientific health information for the country,” said NIH Director Elias A. Zerhouni, M.D.

Under the new rules, all NIH employees are prohibited from engaging in certain outside employment with: (1) substantially affected organizations, including pharmaceutical and biotechnology companies; (2) supported research institutions, including NIH grantees; (3) health care providers and insurers; and (4) related trade, professional or similar associations. Investments in organizations substantially affected by NIH, such as the biotechnology and pharmaceutical industries, are also not allowed for those employees who are required to file public and confidential financial disclosure reports, and are restricted for other staff to a $15,000 cap on such holdings. For outside awards, senior NIH employees may not receive gifts with an aggregate market value of more than $200 that were given because of their official position or from a prohibited source.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” said Dr. Zerhouni.

NIH’s conflicts of interest policy is expected to be a major point in discussions on Capitol Hill this year when the House Energy and Commerce Committee begins debate on legislation to reauthorize NIH. After yesterday’s release of the new ethics regulations, Committee Chair Joe Barton (R-TX) praised Dr. Zerhouni for “taking a step that is both difficult and necessary.”

If you have questions, or need more information, please contact ASH Government Affairs Manager Jeff Coughlin at (202) 776-0544.