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Executive Summary

REP. DINGELL's SCIENTIFIC MISCONDUCT PROPOSAL would establish an office of scientific review within the office of the HHS assistant secretary for health. Lesley Russell, a staff member on Dingell's (D-Mich.) Energy & Commerce Committee, discussed the draft legislation at the American Association for the Advancement of Sciences annual colloquium on science and technology policy, April 14. Russell said the office would be located within HHS rather than NIH to avoid conflict of interest at NIH and to have a central site to oversee all research funded by the Public Health Service. A name for the office has not been chosen, she added. HHS and NIH have already established review offices. In March, the department formed the Office of Scientific Integrity Review, and NIH formed the Office of Scientific Integrity. When asked why legislation would be needed to establish an office similar to those just formed, Russell pointed out that it is easier for something authorized by Congress to get funding. Reportedly, Sen. Kennedy (D-Mass.) is interested in a companion Senate bill. The Dingell bill would also require institutions to have guidelines in place to prevent misconduct and handle allegations in order to obtain NIH funding. Russell said the bill would exempt research conducted at FDA. Last September PHS announced a proposed rule on scientific misconduct that also requires institutions to have such guidelines. NIH's Janet Newburgh, Office of Extramural Research, told the AAAS session that the proposal was submitted for Office of Management and Budget review 10 days ago. Newburgh noted that the PHS regulation "reflects the conviction that the primary responsibility for investigation continues to be placed with the grantee institutions." She said the regulation also spells out much more clearly than in the past "the characteristics of an appropriate investigation." Newburgh added that NIH staff will work with the assistant secretary for health to develop a compendium of "successful approaches to formal curriculum development in the ethics of biomedical and behavioral research.

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