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临床研究受试者的报酬。

Payment of clinical research subjects.

作者信息

Grady Christine

机构信息

Department of Clinical Bioethics, Clinical Center, NIH, Bethesda, MD, USA.

出版信息

J Clin Invest. 2005 Jul;115(7):1681-7. doi: 10.1172/JCI25694.

Abstract

Offering payment to clinical research subjects, in an effort to enhance recruitment by providing an incentive to take part or enabling subjects to participate without financial sacrifice, is a common yet uneven and contentious practice in the US. Concern exists regarding the potential for payment to unduly influence participation and thus obscure risks, impair judgment, or encourage misrepresentation. Heightening these concerns is the participation not only of adults but also of children in pediatric research trials. Thorough assessment of risks, careful eligibility screening, and attention to a participant's freedom to refuse all serve to reduce the possibility of compensation adversely affecting the individual and/or the study. Institutional review boards currently evaluate payment proposals with minimal guidance from federal regulations. Here, reasons for providing payment, payment models, ethical concerns, and areas for further research are examined.

摘要

向临床研究受试者提供报酬,以通过提供参与激励或使受试者能够在不承担经济损失的情况下参与研究,在美国是一种常见但不均衡且有争议的做法。人们担心报酬可能会过度影响参与,从而掩盖风险、损害判断力或鼓励虚假陈述。不仅成年人参与,儿童也参与儿科研究试验,这加剧了这些担忧。对风险进行全面评估、仔细筛选合格受试者以及关注参与者拒绝的自由,都有助于降低报酬对个人和/或研究产生不利影响的可能性。目前,机构审查委员会在联邦法规的极少指导下评估报酬提议。在此,将探讨提供报酬的原因、报酬模式、伦理问题以及进一步研究的领域。

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