NIH Proposes New Rules on Conflict of Interest

On February 3, 2005, the Department of Health and Human Services (HHS) issued an interim final regulation that will significantly change the ethics standards applicable to all employees of the National Institutes of Health (NIH). The new rules prohibit outside activities of any kind with medical, pharmaceutical, or biotechnology companies; severely limit interactions with any NIH-funded external entity (such as universities and hospitals) and professional organizations such as ASH; and require that all senior employees and many clinicians (and their spouses and dependent children) completely divest their stock holding in any biomedical corporation. (All other NIH employees – and spouses and dependent children – would be required to divest any holding in such companies over $15,000.)

The full text of the interim final regulation, a summary of the regulation, and questions and answers about the regulation are available on the NIH Web site.

Under the leadership of the Government Affairs Committee, ASH has reviewed the new regulation and is deeply concerned about its impact on the NIH, its employees, and on the academic and extramural community for several reasons:

1. The severity of the prohibitions, in particular the stock divestment requirements (which in some ways are more stringent than those applied to employees of the Food & Drug Administration), may affect the ability of NIH to recruit and retain the best scientists for its intramural program.
2. The proposed professional restrictions will limit intramural NIH investigators participation in the wider academic community. While NIH has approved activities with professional societies for some employees, it plans to review employees’ activities on an annual, case-by-case basis and it is already clear that employees’ participation will be restricted. ASH believes that the hematology research community is not well served by a regulation that prohibits NIH employees from participating in ASH meetings or serving on a volunteer basis with ASH or other scientific societies.
3. Extension or application of the rules to those serving on NIH study sections, the Institute boards of scientific councilors or advisory panels, and even NIH grantees in general are of concern to the extramural community. NIH Director Elias Zerhouni has indicated that he is planning a national forum on this issue in the near future.

ASH Comments on NIH Conflict of Interest Rule

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  ASH strongly advocates for safeguards to ensure that personal financial interests do not compromise the design of research, the safety and wellbeing of patients, the collection and interpretation of research data, or funding and contract decisions.
• Strong restrictions on financial interests and protections to avoid conflict of interest are necessary to protect the integrity of science and the public trust in the NIH. However, the new ethics rules proposed for NIH employees go further than necessary to ensure the integrity of NIH grant-making and other activities.
• Enforcement of ethical standards is essential, but ethical restrictions should be tailored to situations where there is a substantial risk of inappropriate influence because of financial interests.
• More carefully crafted and enforced regulations that prohibit actual or perceived financial conflicts of interest – broadly for employees that have decision-making authority for the scientific direction and funding, and in a more focused manner for the vast majority of other scientists – is a better approach. The new NIH ethics rules seem excessive, imposing inappropriate burdens on NIH employees with respect to outside activities and financial interests.
• The nation’s research enterprise depends on a solid core of intramural scientists at NIH, and the new standards threaten recruitment and retention of qualified scientists.
• The new standards are also problematic because they restrict the ability of NIH employees to provide uncompensated volunteer time to non-profit organizations like ASH. Volunteer service to ASH and other non-profit organizations is a public service that should be encouraged rather than prohibited.
• The proposed changes are dramatic and could have a significant impact not just on NIH employees but also on hematology research generally.
• The new regulation should be revised, in consultation with NIH employees and their representatives, and should be published in proposed form with an opportunity for public comment.
  

NIH is accepting public comments on the interim final regulation. Comments are due by April 4, 2005. ASH will be submitting comments, and invites member input on the comments that we develop. We strongly encourage your involvement in this important process.