Clinical Center Department of Bioethics.
J Law Med Ethics. 2013 Summer;41(2):397-410. doi: 10.1111/jlme.12051.
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.
《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。