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Memorandum on Ethics Rules
The following memorandum was sent to all NIH staff on August 25, 2005 from NIH Director Elias A. Zerhouni, M.D.
MEMORANDUM
August 25, 2005
Topic: Ethics Rules Announcement
Today we are announcing final regulations regarding reporting of certain financial interests, stock divestiture, outside activities, and awards. The regulations were developed by the Department of Health and Human Services (HHS), in close collaboration with NIH, with the concurrence of the Office of Government Ethics (OGE), the Federal agency that prescribes executive branch-wide ethics standards.
Appropriate adjustments were made to the interim final rules, based on a careful review of all comments about those regulations submitted by NIH staff, the public, and scientific organizations. We believe these final rules protect the integrity of NIH and its ability to provide the American public with an unbiased and trusted source of scientific and health information, while preserving our ability to recruit and retain world class scientists and staff.
Three principles guided the crafting of the rules:
- The public must be assured that research decisions made at NIH are based on scientific evidence and not by inappropriate influences.
- Senior management and people who play an important role in research decisions must meet a higher standard of disclosure and divestiture than people who are not decision-makers.
- To advance the science and stay on the cutting edge of research, NIH employees must be allowed interaction with professional associations, participation in public health activities, and genuine teaching opportunities.
The major features of the final rules announced today are:
- The basic prohibition on outside consulting by NIH staff with substantially affected organizations, such as pharmaceutical, biotechnology or medical device manufacturing companies, health care providers or insurers, and supported research institutions remains unchanged.
- Divestiture of all holdings in substantially affected organizations in excess of $15,000 per company will be required for all senior NIH employees and their spouses and minor children. As defined by the final regulations, these senior employees include the NIH Director and Deputy Director; all direct reports to the NIH Director; all Institute/Center (IC) Directors, Deputy Directors, Scientific Directors, and Clinical Directors; extramural program officials who report directly to an IC Director; and other employees designated as senior because they possess equivalent levels of decision-making responsibility. All other employees may be required to divest if, after review, a potential conflict resulting from their holdings or those of their spouses and minor children would impede their ability to do their government job.
- The receipt of monetary awards from outside sources will continue to be contingent upon prior approval, and be limited to awards that have been determined through a pre-screening process to be bona fide. The revised regulations will bar senior employees from receiving the cash component of pre-screened awards offered by donors who have matters pending under their official responsibility.
- Employees who file either a public (SF 278) or a confidential (OGE 450) financial disclosure report, and those non-filers who serve as clinical investigators identified on an NIH clinical study, are required to report their interests in substantially affected organizations, as well as those of their spouse and minor children, and to indicate the amount held in such investments.
- To facilitate academic and scientific interactions, these final regulations will allow, subject to prior approval and review by ethics officials, outside activities with professional and scientific organizations, service on data and safety monitoring boards, Grand Rounds lectures, and scientific grant review.
- The regulations maintain current provisions that permit NIH scientists, to the extent allowed under existing government-wide rules and with prior approval, to engage in compensated academic outside activities, such as teaching courses at universities, writing general textbooks, performing scientific journal reviews or editing, and providing general lectures to physicians and scientists as part of a continuing professional education program. NIH scientists can also engage in the practice of medicine and other health professions with prior approval and in accordance with existing rules. Outside activities that involve hobbies, sports, civic organizations or interests unrelated to the NIH mission are permissible, generally without prior approval.
As before, these regulations apply in addition to existing statutes and the OGE Standards of Ethical Conduct. The NIH Ethics Office is developing procedures and information systems to implement the final regulations and will hold extensive training sessions with staff over the coming months. If you have immediate questions about these rules, please contact your Institute/Center Deputy Ethics Counselor.
Over the past months, I have greatly appreciated your thoughtful and candid input. I received more than a thousand emails about the interim regulations, and they were invaluable in helping us to arrive at a resolution that I believe is fair and balanced. I encourage you to continue sending me your comments and opinions at director@nih.gov.
This has been a difficult time for NIH. I appreciate your patience, and most of all, your commitment to outstanding science that is conducted in a manner that is above reproach.
For more information, go to: http://www.nih.gov/about/ethics_COI.htm.
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