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NIH FINALIZES ETHICAL STANDARDS

The National Institutes of Health (NIH) has announced finalized 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, in close collaboration with the NIH, with the concurrence of the Office of Government Ethics, the federal agency that proscribes executive branch-wide ethics standards. The August 25 announcement came following a careful review of all comments submitted by NIH staff, the public, and scientific organizations.

The NIH followed three principles in designing the rules. First, the public must be assured that research decisions made at the NIH are based on scientific evidence and not inappropriately influenced. Second, senior management and people with an important role in research decisions must meet a higher standard of disclosure and divestiture than people who are not decision makers. However, 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 opportunities for teaching.

The final rules will enable NIH employees to support and conduct medical research while maintaining the highest ethical standards. Remaining unchanged is 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. All senior NIH employees and their spouses and minor children must divest all holdings in substantially affected organizations in excess of $15,000 per company. All other employees may be required to divest if, after review, a potential conflict might impede their ability to do their government job. Receipt of monetary awards from outside sources will continue to be contingent on prior approval and is limited to awards that have been determined to be bona fide through a prescreening …

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