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医学研究伦理学家应如何应对生物医学研究中的错误观念和治疗误解风险?

How Should a Research Ethicist Combat False Beliefs and Therapeutic Misconception Risk in Biomedical Research?

作者信息

McCormick Jennifer B

机构信息

A member of the Penn State Clinical and Translational Science Institute's program leadership and the American Society of Human Genetics' Social Issues Committee.

出版信息

AMA J Ethics. 2018 Nov 1;20(11):E1100-1106. doi: 10.1001/amajethics.2018.1100.

DOI:10.1001/amajethics.2018.1100
PMID:30499440
Abstract

Therapeutic misconception can be especially challenging at large research-intensive academic medical centers, where boundaries between clinical care and research can become murky. In early stage clinical trials, for example, physicians often encourage patients to enroll in a drug or an intervention study as part of a treatment plan. As a research ethicist, I have found myself having to temper researchers' enthusiasm to prevent their overemphasizing positive benefits to participants. One strategy I've used is to encourage researchers to collaborate with treating physicians and to continually engage participants in assessing risks and benefits. This strategy has been helpful not only in early stage trials but also in translational genomic studies in which research can be used in part as a means of making costly testing available to patients.

摘要

在大型研究密集型学术医疗中心,治疗误解可能尤其具有挑战性,因为在这些地方,临床护理与研究之间的界限可能变得模糊不清。例如,在早期临床试验中,医生常常鼓励患者作为治疗计划的一部分参与药物或干预研究。作为一名研究伦理学家,我发现自己不得不抑制研究人员的热情,以防止他们过度强调对参与者的积极益处。我采用的一种策略是鼓励研究人员与主治医生合作,并持续让参与者参与风险和益处评估。这种策略不仅在早期试验中有所帮助,在转化基因组研究中也很有用,在这类研究中,研究在一定程度上可作为一种让患者能够获得昂贵检测的手段。

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