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研究不当行为与偶然发现问题

Research malpractice and the issue of incidental findings.

作者信息

Milstein Alan C

机构信息

Sherman Silverstein Kohl Rose & Podolsky, Pennsauken, NJ, USA.

出版信息

J Law Med Ethics. 2008 Summer;36(2):356-60, 214. doi: 10.1111/j.1748-720X.2008.00280.x.

DOI:10.1111/j.1748-720X.2008.00280.x
PMID:18547205
Abstract

Human subject research involving brain imaging is likely to reveal significant incidental findings of abnormal brain morphology. Because of this fact and because of the fiduciary relationship between researcher and subject, board-certified or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental findings may be revealed and what consequences will follow. In the event such findings are revealed, qualified physicians should explain to the subject the significance of the findings and the alternatives available.

摘要

涉及脑成像的人体研究很可能会揭示出大脑形态异常的重大偶然发现。鉴于这一事实以及研究者与受试者之间的信托关系,具备委员会认证资格或符合委员会认证条件的放射科医生应审查扫描结果以查找任何异常情况,扫描应按照用于评估全脑临床状况的标准医疗实践进行,并且知情同意过程应披露可能揭示偶然发现的可能性以及随之而来的后果。如果揭示出此类发现,合格的医生应向受试者解释这些发现的意义以及可供选择的方案。

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