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NIH Issues Conflict of Interest Rules for Intramural Scientists
On February 1, 2005, the Department of Health and Human Services (HHS) issued an Interim Final Rule on ethical conduct and financial disclosure requirements for its employees including those at NIH. The new regulations are intended to restore public trust in the wake of recent disclosures of potential financial conflicts of interest involving senior NIH scientists. To avoid any real or perceived conflicts of interest, the newly issued rules broadly limit interactions between NIH employees and outside organizations. Under the new regulations:
- NIH employees may no longer engage in certain compensated or uncompensated activities with biotechnology and pharmaceutical companies, health research organizations (including professional and trade associations), educational institutions that receive NIH funding, health care providers, and health care insurers.
- Senior NIH employees are prohibited from owning stock in biotechnology and pharmaceutical companies, and other employees are limited to holding no more than $15,000 worth of stock in such companies.
- NIH employees are required to obtain prior approval for accepting awards, and in most cases may not receive awards with greater than $200 market value.
The new regulations have prompted concerns about how NIH investigators will maintain meaningful relationships with non-NIH scientists and professional organizations. While the rules are intentionally broad, a number of exceptions are expected so that intramural investigators can continue important professional interactions such as teaching, speaking, writing and editing. NIH officials have said they will issue further guidance in the coming weeks.
The Interim Final Rule was published in the Federal Register on February 3, 2005, and comments will be accepted until April 4, 2005. The complete rule and related documents are available at: http://www.nih.gov/about/ethics_COI.htm. NIH has indicated that it will also monitor the new Rule's effect on retention and recruitment of intramural scientists throughout the next year.
It is important to note that while the regulations issued on February 1 apply only to intramural NIH employees, there has been speculation that these policies might also be extended to NIH reviewers and grantees in the future.
For APS comments on the new NIH conflict of interest, click here.
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