Tightening conflict-of-interest policies: the impact of 2005 ethics rules at the NIH.

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 institutes' 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%).

RESULTS

Eighty percent of respondents believed the NIH ethics rules were too restrictive. Whereas 45% of respondents believed the rules positively impacted the public's trust in the NIH, 77% believed the rules hindered the NIH's ability to complete its mission. Implementation of the ethics rules significantly decreased self-reported government-industry relationships 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), both of which may be allowed under the new regulations in restricted situations with increased oversight. The policy had limited impact on NIH faculty participation in nonindustrial professional service roles and had no detectable change in publishing behavior (5.29 articles per researcher per year from 2002-2005 versus 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.