健康研究人员对新西兰伦理委员会运作情况的看法。

Health researchers' views of ethics committee functioning in New Zealand.

作者信息

Paul C

机构信息

Department of Preventive and Social Medicine, University of Otago Medical School, Dunedin.

出版信息

N Z Med J. 2000 Jun 9;113(1111):210-4.

PMID:10909934

Abstract

AIMS

To find out, from the perspective of researchers, how ethics committees are dealing with matters of ethical concern in research on humans and to seek the views of researchers on their role in thinking through the ethical issues in research.

METHODS

A sample of researchers was selected from the Health Research Council database of grant recipients. Information was sought, using a mailed questionnaire, in relation to essential elements of concern to ethics committees according to the 1996 National Standard, types of study undertaken, codes of practice, national application forms, multicentre review, aspects of committee function and the role of researchers.

RESULTS

The response rate was 35/40 (87.5%). Approximately half the respondents commented favourably on most aspects of ethics committee functioning. Major criticisms were directed at the assessment of risks and benefits, scientific validity and handling of consent procedures. Consistent weaknesses in multicentre review, quality of advice and the composition of committees were noted. Positive aspects were: availability of chairpersons for discussion, the protection of vulnerable participants, the handling of the Health Information Privacy Code and the introduction of a national application form. Most researchers expected to take a major role in thinking through the ethical issues in their work. Half reported occasions where ethics committees had unnecessarily impeded research.

CONCLUSIONS

The high level of commitment of researchers to ethics should be acknowledged by involving them more in guideline development and education. Perceived deficiencies in the range of expertise on ethics committees, particularly expertise to judge potential harms in experimental research, should be further investigated and addressed. Recommendations to improve the quality of ethical review include reducing the overload on committees by identifying categories of research which might not require full ethics committee review.

摘要

目的

从研究人员的角度了解伦理委员会如何处理人体研究中的伦理问题，并征求研究人员对其在思考研究伦理问题中所起作用的看法。

方法

从健康研究委员会资助获得者数据库中选取研究人员样本。通过邮寄问卷，收集与1996年国家标准中伦理委员会关注的基本要素、所进行研究的类型、实践规范、国家申请表、多中心审查、委员会职能方面以及研究人员的作用相关的信息。

结果

回复率为35/40（87.5%）。约一半的受访者对伦理委员会运作的大多数方面给予好评。主要批评集中在风险和益处评估、科学有效性以及同意程序的处理上。多中心审查、建议质量和委员会组成方面存在持续的薄弱环节也被指出。积极方面包括：主席可随时进行讨论、对弱势参与者的保护、对《健康信息隐私法》的处理以及国家申请表的引入。大多数研究人员期望在思考其工作中的伦理问题时发挥主要作用。一半的人报告称存在伦理委员会不必要地阻碍研究的情况。