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Executive Summary

The National Institutes of Health's proposed conflict of interest guidelines, originally published in the Sept. 15 issue of the NIH Guide to Grants and Contracts, are to be revised and re-issued as proposed regulations, HHS Secretary Sullivan has announced. In a Dec. 29 statement, Sullivan said he had directed NIH to submit "options for addressing potential conflicts of interest that properly treat potential abuse while keeping the research process free of unnecessary burdens and disincentives." NIH is currently in the process of revising the guidelines for Sullivan's approval. In his end-of-the-year announcement, Sullivan said it is his "intention to implement all changes through a formal regulatory procedure, involving at the minimum the publication of a Notice of Proposed Rulemaking, a specified comment period, and publication of final rules with additional opportunity for comment before the rules become effective." Under the formal rules procedure, the notice will be published in the Federal Register. Sullivan's decision was influenced by widespread criticism of the proposed guidelines from academia, industry and NIH officials. Those opposed to the guidelines argue that they are too broad and would result in the severing of ties between the academic community and private industry. For example, the PMA contended that the guidelines "would be devastating to companies with strong ties to the academic research community" ("The Pink Sheet" Jan. 1, p. 8). PMA said, more specifically, that it opposed the severity of the prohibitions against researchers holding equity positions in companies that might be affected by the outcome of the research. The association advised that the guidelines be redrafted and issued for public comment. In separate comments, the Industrial Biotechnology Association recommended that NIH redraft the guidelines into "voluntary points to consider." IBA also urged that honoraria might have a "threshold level," or specific dollar amount that would constitute conflict of interest, specified in the guidelines. As currently written, the guidelines would prohibit investigators funded by NIH or Alcohol, Drug Abuse and Mental Health Administration from having personal equity holdings or options in any company that could be affected by the outcome of the research. In addition, investigators would be prohibited from receiving honoraria or a position from companies that are involved "in an NIH- or ADAMHA-supported project that is evaluating or testing a product of the source." According to the guidelines, institutional conflict of interest reviews "need to be particularly careful to ensure that private companies are not in a position to influence the research plan, results, or the reporting or interpretation of results of NIH- or ADAMHA-supported research." A National Institute of Allergy and Infectious Diseases' AIDS Clinical Trial Group (ACTG) committee also strongly objected to the proposal. The committee commented in a Dec. 5 letter to NIH Deputy Director for Extramural Research Katherine Bick, that "it is possible" NIH's ACTG program "would collapse because of investigator withdrawal and lack of pharmaceutical industry participation." NIAID Director Anthony Fauci agreed with the committee's viewpoint, commenting at a Dec. 11 AIDS Program Advisory Committee meeting that the proposed guidelines represent a "potential disaster" that could destroy the institute's AIDS program.

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