BMJ  2005;331:472 (3 September), doi:10.1136/bmj.331.7515.472-b

News

US National Institutes of Health issue new ethics guidelines

New York

Elias Zerhouni, director of the US National Institutes of Health (NIH), announced new guidelines on ethics for staff members last week, addressing concerns initially made public in December 2003 by the Los Angeles Times about staff members who had lucrative consulting arrangements with drug and biotechnology companies ( BMJ 2004;329: 10[Free Full Text]).

The new rules are tougher than some NIH staff members had wanted but more lenient than some critics had demanded. Dr Zerhouni said the new rules are "the most restrictive we know about."

The rules went into effect last week. Scientists who must sell investments under the new rules have until 30 January to do so.

In a teleconference with journalists Dr Zerhouni reiterated earlier preliminary rules: all NIH staff members are prohibited from consulting work with pharmaceutical and biotechnology companies, makers of medical devices, healthcare providers such as insurance companies, and research institutions receiving major support from the NIH.

Senior staff members, such as heads of institutes and their deputies, as well as their spouses and any children who are minors, are prohibited from having any holdings in such companies. Dr Zerhouni said that about 200 staff members were in this category. Such senior employees—and their spouses and minor children—are prohibited from holding investments of more than $50 000 (£28 000; 41 000) in funds that invest in pharmaceutical and biotechnology industries.

Other staff members—about 6000 people—and their families may hold up to $15 000 in pharmaceutical and biotechnology companies, makers of medical devices, health providers, and research institutions who get major funds from the NIH.

Disclosure rules mean that more NIH employees will have to report their holdings, some of which disclosures are public. Clinical researchers at the NIH may also be required to report their holdings. Some decisions about financial holdings, Dr Zerhouni said, will be made on a case by case basis.

The new rules allow NIH scientists to teach courses at universities, write textbooks, perform journal reviews, and lecture to doctors, if the funding that comes from industry sources is "an unrestricted grant." NIH scientists may also receive awards, such as the Nobel prize or the Lasker awards.

NIH scientists may also serve as officers of scientific societies, even if those societies receive substantial funding from drug companies. Such participation, Dr Zerhouni said, "is a service to the public," and scientists "benefit from the interaction."

Prior approval will be needed for some educational and society activities.

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