Schneider Institutes for Health Policy, Heller School of Social Policy and Management, Brandeis University, Waltham, Massachusetts 02454, USA.
Acad Med. 2010 Nov;85(11):1685-91. doi: 10.1097/ACM.0b013e3181f578b2.
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.
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%).
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).
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.
通过考察 NIH 科学家出版率和外部关系频率的变化，确定 NIH 2005 年伦理规则的预期和非预期影响。
在确定了各研究所网页和中央目录中符合条件的院内科学家和管理人员后，于 2008 年 10 月至 2009 年 1 月期间向 900 名 NIH 研究人员邮寄了调查问卷（回复率为 70.1%）。
80%的受访者认为 NIH 伦理规则过于严格。尽管有 45%的受访者认为这些规则对公众对 NIH 的信任产生了积极影响，但 77%的受访者认为这些规则阻碍了 NIH 完成其使命的能力。伦理规则的实施显著降低了 NIH 教师自我报告的政府-产业关系（从 51.8%降至 33.2%，P<.01），包括咨询（从 33.1%降至 7.8%，P<.01）和科学顾问委员会成员（从 31.5%降至 16.0%，P<.01）的显著下降，而这些都可能在新规定下允许在增加监督的限制情况下发生。该政策对 NIH 教师参与非工业专业服务角色的影响有限，对出版行为也没有明显改变（2002-2005 年每位研究人员每年发表 5.29 篇文章，2005-2008 年为 5.26 篇，P=.88）。
NIH 伦理规则完成了它们预期的大部分工作，限制了与产业的关系，同时保持了 NIH 研究人员与外部科学和专业组织的联系。然而，这些规则对人员士气和研究进展产生了负面影响。
