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Prohibiting Conflicts of Interest at the NIH

As scientists at the National Institutes of Health, we share the belief of director Elias Zerhouni and others, including Congress and the US public, that any financial conflict of interest at the agency is unacceptable and should be absolutely prohibited by regulations.

May 23, 2005

<p>Conflict of Interest Regulations Proposed by the Assembly of Scientists</p>

As scientists at the National Institutes of Health, we share the belief of director Elias Zerhouni and others, including Congress and the US public, that any financial conflict of interest at the agency is unacceptable and should be absolutely prohibited by regulations. We also recognize that some serious conflict-of-interest abuses have occurred at the NIH, which we find appalling and regrettable. However, we differ on the corrective measures imposed. These measures have gone far beyond conflict-of-interest issues, invaded privacy, and threatened to make the NIH unattractive to the best scientists, who are the foundation of its excellence.

The interim final regulations proposed by the Department of Health and Human Services (HHS) and by the NIH administration rest on two faulty assumptions: first, that every financial interest is a conflict of interest, and second, that comprehensive prohibitions are administratively easier and more efficient. This "ban every financial interest" approach leads to all-inclusive prohibitions in an attempt to eliminate every conceivable financial interest. Far from being efficient, however, this approach requires review of many more employees, activities, and holdings that could not possibly create a conflict of interest.

A closer look at the regulations reveals how intrusive and overreaching they are. First, they apply restrictions to NIH employees who could not possibly have conflicts of interest. For instance, thousands of support staff, including secretaries, janitors, and their spouses, are prohibited from owning more than $15,000 in stock in a biomedically related company such as GE or Proctor and Gamble, technically called "substantially affected organizations." Yet these individuals can have no conflict of interest because their stock ownership could not affect a judgment relevant to research or patient safety; they have no influence on the research that is conducted.

Similarly, NIH investigators and their spouses are prohibited from owning any stock in a substantially affected organization, regardless of whether their research is related to that company's products. Cancer researchers cannot own GE stock, despite their research having nothing to do with medical imaging. An investigator working on the eye's lens is prohibited from owning stock in a biotechnology company devoted to cancer or cardiovascular research.

Second, many activities unrelated to NIH work are prohibited unless scientists and NIH employees specifically obtain approval from NIH. The regulations require that an NIH employee "shall obtain written approval prior to engaging in any outside employment, ... whether or not for compensation, or any self-employed business activity" unless it is "a political, religious, social, fraternal, or recreational organization." Employment is also broadly defined as "any form of non-Federal employment or business relationship involving the provision of personal services by the employee." Indeed, this regulation makes life itself an outside activity subject to NIH approval.

Third, these regulations restrict important collaborations between NIH scientists and professional societies, research institutions, and others that pose no possible conflict. For example, researchers may not serve on the boards of professional societies or be adjunct professors at universities, even when these are unpaid positions.

The ultimate problem with such overbroad and intrusive regulations is that they will make it very difficult for the NIH to recruit and retain talented researchers. Several senior scientists recently have quit the NIH or decided that they should not come to the NIH because of these untenable restrictions.

Almost all professional societies that have commented on the regulations – from the Association of American Medical Colleges to the Federation of American Societies for Experimental Biology – have vigorously criticized them. Similarly, many advocacy groups, such as the Cancer Leadership Council, have said the regulations will be detrimental to the advancement of science and medical treatments.

NIH scientists have proposed an alternative approach that targets actual conflicts of interest, not simply financial interests (see chart). These proposed rules would absolutely prohibit all conflicts of interest because they prohibit stock ownership, consulting, or speaking when they are related to a company with a product or material interest in the on-going research. Where no relationship exists between the research and a product, there would be no conflict of interest, and stock ownership would be permitted, as would consulting, with prior NIH approval.

The regulations we propose are targeted and provide a bright line that allow researchers to know what they can do and allow for easy administration. Properly enforced, this proposal should reassure Congress and the public that conflicts of interest are prohibited, yet they permit the NIH to recruit the best and brightest scientists to maintain its premier research focus.

The NIH scientists have proposed these rules as a simple way to achieve the shared goal of prohibiting all conflicts of interest. We look forward to working collegially and collaboratively with HHS and NIH central administration to expeditiously revise the regulations.

The NIH Assembly of Scientists, comprising tenured and tenure-track investigators, staff scientists, and staff clinicians, has been revived to allow scientists at NIH to have a voice and to express ideas. More information is available at http://homepage.mac.com/assemblyofscientists/Personal1.html

Editor's note: The office of the Director of the NIH declined the opportunity to offer the rationale for their proposed changes.

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