NIH Releases Final Ethics Rules

Ban on Outside Consulting with Industry Remains in Force

Last week, the National Institutes of Health (NIH) announced final regulations regarding reporting of certain financial interests, stock divestiture, outside activities, and awards. The announcement came following a careful review of all comments about the interim ethics regulation submitted by NIH staff, the public, and scientific organizations. The changes, considered sweeping by most media reports and policy analysts, were first proposed in early February (see the Feb. 7, 2005 issue of the Digest.).

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.

Following those principles will change the way NIH scientists and researchers do business with private companies, however. The major features of the final rules are:

1. 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.

2. 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 in each IC; extramural program officials who report directly to an IC Director; and other employees designated as such 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.

3. 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 final 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.

4. 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.

5. To facilitate academic and scientific interactions, the final regulations will allow, subject to prior approval and review by ethics officials, outside activities with professional or scientific organizations, service on data and safety monitoring boards, Grand Rounds lectures, and scientific grant review.

6. 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 also can 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.

More information is available at: http://www.nih.gov/about/ethics_COI.htm.