The National Institutes of Health (NIH) announced today a new supplemental ethics regulation that addresses the concerns raised by the activities of some of its employees, particularly regarding outside consulting with the pharmaceutical and biotechnology industries. The regulation was developed by the Department of Health and Human Services (HHS), with the concurrence of the Office of Government Ethics (OGE), the federal agency that prescribes executive branch-wide ethics standards.

"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.

The new regulation focuses on outside activities, financial holdings, and awards for all NIH employees.

Over the past year, the NIH has been addressing the ethics issues raised by the outside consulting activities of several of its employees. The NIH conducted thorough reviews of these activities, established an NIH central review committee, convened a Blue Ribbon Panel to help develop NIH-wide policy, responded to Congressional inquiries and testified at public hearings in the House and Senate. It was clear that NIH needed a substantially expanded system of oversight to ensure that conflicts of interest — even the appearance of conflicts — were prevented.

This is an interim final regulation, which means that it goes into effect once it is published in the Federal Register, which is expected in the next few days, and remains in effect unless changed by subsequent regulations. As noted in the new regulation, HHS intends to evaluate certain provisions in the rule, including those regarding outside activities and financial holdings, within the next year. HHS will consider public comments about the regulation — which will be accepted for 60 days once the Federal Register notice is published — and the knowledge gained from the first year of implementation when deciding, which, if any, provisions to revise.

During this period, HHS also will complete a review of existing outside activities that is presently ongoing, develop and test more effective oversight systems, overhaul its administrative capabilities for the management of its ethics program, implement improved training and evaluate the impact of this regulation. NIH scientists will continue to be able to conduct academic activities such as teaching courses at universities, writing general textbooks, performing scientific journal reviews, participating in scientific meetings and providing general lectures to physicians and scientists at continuing professional education and similar events, as well as practicing medicine as appropriate, provided that the activities are otherwise in accordance with existing law and adhere strictly to the conditions specified in the new rules.

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 the 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.

"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 leadership is developing procedures to implement the regulation and will hold training sessions as soon as possible to explain the full impact of these new rules to employees.

For further information, visit:
NIH Conflict of Interest Information and Resources (http://www.nih.gov/about/ethics_COI.htm)
Federal Register (http://www.archives.gov/federal_register/index.html)

The National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services, is the Nation's medical research agency for conducting and supporting basic, clinical, and translational medical research. NIH comprises the Office of the Director and 27 institutes and centers and investigates the causes, treatments, and cures for both common and rare diseases.