© 2004 by Oxford University Press
© 2004 Oxford University Press
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Zerhouni Proposes Major Changes to NIH Ethics Program
In testimony in before the House Oversight and Investigations Subcommittee in late June, National Institutes of Health Director Elias Zerhouni, M.D., outlined "drastic changes" to the ethics program at NIH.The changes are the result of an ongoing internal and external review of ethics policies at the agency, which were prompted in part by the subcommittee's own inquiry into outside activities and consulting arrangements held by top NIH officials. (See News, June 2, Vol. 96, No. 11, p. 819.)
"Today I am announcing that NIH, working with the [Health and Human Services] Office of the Secretary, will seek a major reform of the agency's ethics program by requesting restrictive rules and by seeking to increase the public availability of information related to outside activities with industry," Zerhouni said in his prepared statement. He presented a framework for these changes in terms of four principles of the NIH ethics program.
- Enhancing public trust by restricting financial relationships with outside
organizations: The holding of stock in individual biotechnology and
pharmaceutical companies will be prohibited. All awards given to NIH employees
will have to be pre-screened, and specific awards should be reviewed on a
case-by-case basis. Senior NIH employees will be prohibited from consulting
with industry or institutions for compensation or any other form of
remuneration, and other employees will be able to consult if the arrangement
has been reviewed and approved by NIH's Ethics Advisory Committee. NIH
employees will be prohibited from being members on corporate boards of
pharmaceutical and biotechnology companies, and participation on an industry
scientific advisory board will be allowed, contingent on approval from the
ethics committee. Employees will also be prohibited from accepting
compensation or remuneration for consulting arrangements with grantee
institutions. NIH will also control employee annual compensation for clinical
practice.
- Increasing transparency by requiring public disclosure of financial
relationships: The NIH has increased the number of senior managers who must
publicly disclose their compensated outside activities. Zerhouni said he hopes
to extend the required public disclosure to an additional 508 positions.
Employees will also be required to disclose outside activities with industry
and the amount of compensation earned from those and other outside
activities.
- Balancing NIH's ability to recruit and retain scientific expertise while
expediting the translation of research advances: "In order to encourage
scientific interactions involving the exchange of knowledge and the exercise
of intellectual leadership by NIH scientists, NIH will continue to allow
certain types of outside activities—including teaching and lecturing
opportunities and collaborations with the private sector—but only under
clear, rigorous rules meant to eliminate conflicts of interest,"
Zerhouni said in his prepared statement.
- Establishing effective monitoring and oversight of employee activities:
Supervisors will continue to be required to review proposed outside activities
and monitor the effect that the activity might have on the employee's official
duties. In addition, NIH will develop a system to manage and track approved
activities with outside organizations and will develop a new training method
for employees to update them on changes and updates to ethics rules.
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