Tightening Conflict-of-Interest Policies: The Impact of 2005 Ethics Rules at the NIH

Abstract

Purpose To determine both the intended and unintended effects of the National Institutes of Health (NIH) 2005 ethics rules by examining changes in publishing rates and the frequency of external relationships among NIH scientists. Method After identifying eligible intramural scientists and administrators from institute’s web pages and central directories, a mailed survey was administered to 900 NIH research faculty between October 2008 and January 2009 (response rate 70.1%).A Results Eighty percent of respondents believed the NIH ethics rules were too restrictive. While nearly half (45%) of respondents believed the rules positively impacted the public’s trust in the NIH, over three-quarters (77%) believed the rules hindered the NIH’s ability to complete its mission. Implementation of the ethics rules significantly decreased self-reported GIRs among NIH faculty (from 51.8% to 33.2%, P<.01), including significant drops in consulting (33.1% to 7.8%, P<.01) and scientific advisory board membership (31.5% to 16.0%, P<.01). The policy had limited impact on NIH faculty participation in non-industrial professional service roles and had no detectable change in publishing behavior (5.29 articles per researcher per year from 2002–2005 vs. 5.26 from 2005–2008, P = .88). Conclusions The NIH ethics rules accomplished much of what they were intended to do, limiting relationships with industry while maintaining NIH researchers’ association with external scientific and professional organizations. However, the rules negatively affected personnel morale and the perceived progress of research.

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