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从研究协调员角度看科研不端行为:一项全国性调查。

Scientific misconduct from the perspective of research coordinators: a national survey.

作者信息

Pryor Erica R, Habermann Barbara, Broome Marion E

机构信息

School of Nursing, University of Alabama at Birmingham, Birmingham, AL 35294-1210, USA.

出版信息

J Med Ethics. 2007 Jun;33(6):365-9. doi: 10.1136/jme.2006.016394.

Abstract

OBJECTIVE

To report results from a national survey of coordinators and managers of clinical research studies in the US on their perceptions of and experiences with scientific misconduct.

METHODS

Data were collected using the Scientific Misconduct Questionnaire-Revised. Eligible responses were received from 1645 of 5302 (31%) surveys sent to members of the Association of Clinical Research Professionals and to subscribers of Research Practitioner, published by the Center for Clinical Research Practice, between February 2004 and January 2005.

FINDINGS

Overall, the perceived frequency of misconduct was low. Differences were noted between workplaces with regard to perceived pressures on investigators and research coordinators, and on the effectiveness of the regulatory environment in reducing misconduct. First-hand experience with an incident of misconduct was reported by 18% of respondents. Those with first-hand knowledge of misconduct were more likely to report working in an academic medical setting, and to report that a typical research coordinator would probably do nothing if aware that a principal investigator or research staff member was involved in an incident of misconduct.

CONCLUSION

These findings expand the knowledge on scientific misconduct by adding new information from the perspective of research coordinators. The findings provide some data supporting the influence of workplace climate on misconduct and also on the perceived effectiveness of institutional policies to reduce scientific misconduct.

摘要

目的

报告一项针对美国临床研究的协调员和管理人员关于科学不端行为的认知及经历的全国性调查结果。

方法

使用修订后的《科学不端行为调查问卷》收集数据。2004年2月至2005年1月期间,向临床研究专业人员协会成员及临床研究实践中心出版的《研究从业者》订阅者发送了5302份调查问卷,收到了来自1645份(31%)符合条件的回复。

结果

总体而言,所察觉到的不端行为发生频率较低。不同工作场所之间在对研究者和研究协调员的感知压力以及监管环境在减少不端行为方面的有效性上存在差异。18%的受访者报告有过不端行为事件的第一手经历。那些了解不端行为第一手情况的人更有可能报告在学术医疗环境中工作,并且报告称,如果一名典型的研究协调员意识到主要研究者或研究工作人员参与了不端行为事件,他们可能什么都不会做。

结论

这些发现从研究协调员的角度增加了新信息,从而扩展了关于科学不端行为的知识。这些发现提供了一些数据,支持工作场所氛围对不端行为的影响,以及对机构政策在减少科学不端行为方面的感知有效性的影响。

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