NIH to act on conflicts within 1 year

The National Institutes of Health may change its regulations for managing financial conflict of interest among extramural grantees within 12 months, the acting director of the NIH said today (Dec. 5). "In roughly six months to a year, we're going to have action on this," NIH's acting director linkurl:Raynard Kington;http://www.nih.gov/about/director/directorbio.htm told an linkurl:advisory committee,;http://acd.od.nih.gov/ adding that there may be legislative action forcing the NIH to alter its conflict of interest policies before then. Kington, responding to questions from a blue-ribbon panel of researchers and administrators, said that an advanced notification of proposed rule making (ANPRM) that is meant to elicit public comment on the value of the NIH's current financial conflict regulation (which is technically a regulation of the Public Health Service) is at the Office of Management and Budget and will be published in the Federal Register within 90 days. Kington said during the meeting, which was linkurl:webcast;http://videocast.nih.gov/ live, that releasing the ANPRM to the public "triggers a thoughtful, step-wise process to consider change in a regulation." linkurl:Sally Rockey,;http://www.nih.gov/about/almanac/historical/deputy_directors.htm#rockey the NIH's acting deputy director for extramural research, said during the meeting that the ANPRM will ask the extramural community what the NIH should do to better manage financial conflicts among grantees. The current regulation largely absolves the NIH of direct responsibility for managing conflicts among NIH grantees, stating that the researchers and their home institution are responsible for disclosing "significant financial interests" -- including 5% stock ownership or $10,000 worth of income or equity from companies that might appear to have a stake in research outcomes -- that relate to NIH-funded research. "We have oversight, and the institutions manage," Rockey said of the current regulation. The ANPRM will include questions on managing institutional (rather than individual) conflicts, encouraging more thorough disclosure, and whether or not the NIH should assume a larger role in managing, rather than just overseeing, financial conflicts among extramural researchers. Rockey did admit, however, that once conflicts were uncovered -- e.g., several recent, high-profile cases involving NIH-funded psychiatrists who failed to disclose or underreported pharma company remuneration -- the NIH does have the power to take drastic action. "If we feel that there is a problem that cannot be resolved," Rockey said, "we may suspend funding until the matter is resolved." The NIH did freeze a multi-million dollar grant to Emory University this October over failures by PI and prominent psychiatrist linkurl:Charles Nemeroff;http://www.psychiatry.emory.edu/NeuropsychopharmacologyLaboratory/Charles%20Nemeroff.htm to disclose hundreds of thousands of dollars in payouts from GlaxoSmithKline. Rockey added that in the past year, the NIH has reviewed 20 cases where NIH-funded researchers seemed to run afoul of the agency's conflict of interest regulation. In only one of these cases, she said, did the NIH discern a serious issue of "institutional non-compliance" with the current regulation. Kington said that after the Office of Management and Budget approves the ANPRM, it will appear in the Federal Register and be open to public comment for 60 days. Then it will return to the NIH, and the comments will be considered in crafting the proposed rule, which will return to the Federal Register for further public comment before a final rule is drafted and enacted. **__Related stories:__** *linkurl:Conflict probe turns to Stanford;http://www.the-scientist.com/blog/display/54771/ [25th June 2008]*linkurl: Grassley to APA:Open your books;http://www.the-scientist.com/blog/display/54832/ [14th July 2008]*linkurl:NIH $ frozen amid conflict probe;http://www.the-scientist.com/blog/display/55088/ [14th October 2008]

NIH to act on conflicts within 1 year

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