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Executive Summary

NIH SHOULD REQUIRE DISCLOSURE BY EXTRAMURAL RESEARCHERS of financial ties that may be seen as conflicts of interest, rather than institute a new set of guidelines, several universities maintained in recent comments to the institute. The comments were submitted in response to a notice that the National Institutes for Health is developing guidelines for NIH-funded investigators regarding their relationships with companies that use drugs or other products in clinical trials. The notice, published in the Jan 20 NIH Guide for Grants and Contracts, states that "NIH expects" that investigators and consultants in projects funded by NIH extramural awards "will not have financial interests in organizations or entities that produce drugs, devices, or other interventions studied in a controlled clinical trial." Among the comments, K. W. Heathington, University of Tennessee, asserted that NIH's guidelines should "be concerned with public disclosures rather than developing guidelines that might prohibit activities. Prohibition in transferring technology does not necessarily work to anyone's advantage." Heathington maintained that restrictive policies would "allow technology to die in the lab," while full disclosure would insure that the research in question "will be more closely scrutinized than that of other individuals not connected with commercial ventures." The University of Rochester's D. K. Hess commented that public disclosure would be the only "guidance that is 'enforceable,' and which is ethically sound." He warned, however, that NIH and the investigator's institution should defend that person "vigorously from those who would question their integrity or motives when they are deserving." Like Heathington, Hess maintained that blanket guidelines would lead to researchers and faculty dropping out of federally funded research activities and migrating to industry. According to Hess, "NIH should be willing to enlist principal investigators under full disclosure who possess critical scientific skills and experience despite apparent conflicts of interest." Bernard Babior, Scripps Clinic, made similar remarks, adding that "present mechanisms for dealing with fraud and related behaviors are adequate to address such problems." He said that the addition of more regulations would lead to financial and administrative costs that would exceed any possible gain from the promulgations. NIH's conflict of interest standards might differ from individual state guidelines, another factor that will further complicate the ability of an institution to enforce the NIH guidelines, according to Virginia Commonwealth University's Herbert Chermside. La Jolla, California attorney T. Knox Bell suggested that any NIH guideline should be consistent with what the individual states have adopted. Several schools, however, concurred with NIH's proposed rule. Stanford's David Korn, who is also chairman of the National Cancer Advisory Board, said the guidelines were "appropriate and necessary." The medical centers at both Louisiana State University and the University of Michigan also support the regulations. The University of Michigan's William Kelley added, however, that the policy "should apply essentially equally to intramural as to extramural investigators." NIH has scheduled a conference on the subject on June 27-28 in Masur Auditorium. A final guideline is expected shortly thereafter.

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