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为何研究伦理应纳入回顾性审查。

Why research ethics should add retrospective review.

作者信息

Dawson Angus, Lignou Sapfo, Siriwardhana Chesmal, O'Mathúna Dónal P

机构信息

University of Sydney, Sydney, Australia.

University of Oxford, Oxford, UK.

出版信息

BMC Med Ethics. 2019 Oct 10;20(1):68. doi: 10.1186/s12910-019-0399-1.

Abstract

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a 'tick box' exercise to get over the 'hurdle' of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people's capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project's ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others' perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

摘要

研究伦理是研究不可或缺的一部分,尤其是涉及人类受试者的研究。然而,有人担心研究伦理已被视为一个程序问题,侧重于研究人员为获得伦理批准以开始研究而需要解决的一些既定的伦理问题。虽然对研究进行这种前瞻性审查很重要,但我们认为这不足以解决研究伦理的所有方面。我们建议进行回顾性审查,作为前瞻性审查的重要补充。我们提出两个论据来支持我们关于前瞻性审查不足的主张。首先,按照目前的做法,研究伦理对一些人来说已成为一种“打勾”练习,以越过伦理批准的“障碍”。这未能抓住伦理中许多重要的东西,也没有促进对所涉及的伦理问题进行仔细思考。其次,当前的方法往往基于规则,我们认为研究伦理应超越这一点,培养人们对其研究的相关道德特征、伦理决策技能和诚信的敏感度。对一个项目的伦理问题及其解决方式进行回顾性审查,有助于更好地实现这些目标。我们认为,广泛的利益相关者应参与这种回顾性审查,包括伦理委员会的代表、参与的社区以及参与研究的人员。然后,所有利益相关者都可以从他人的观点和经验中学习。对研究进行公开透明的评估有助于促进利益相关者之间的信任和理解,以及确定一致和分歧的领域,以及如何在此基础上进行建设或解决。回顾性审查还有可能促进对伦理的批判性思考,并有助于在研究团队中培养伦理敏感度和诚信。要证明这一点需要实证证据,我们建议任何此类举措都应伴随着对其有效性的研究。我们的文章最后讨论了对我们提议可能提出的一些反对意见,并邀请进一步的辩论和讨论。

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