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外包伦理义务:修订后的通用规则是否应涉及调查员和赞助商的责任?

Outsourcing ethical obligations: should the revised common rule address the responsibilities of investigators and sponsors?

机构信息

Clinical Center Department of Bioethics.

出版信息

J Law Med Ethics. 2013 Summer;41(2):397-410. doi: 10.1111/jlme.12051.

Abstract

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.

摘要

《通用规则》在研究中划分了道德劳动。它意味着调查人员和赞助商可以将其道德义务外包给 IRB 和参与者,从而培养一种合规文化,而不是责任文化。拟议的《通用规则》修订版可能会使这个问题更加严重。为了利用法律的表达力,我建议对《通用规则》进行修订,纳入调查人员和赞助商的道德责任。

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