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支付临床研究参与者:一所机构研究伦理委员会的观点。

Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective.

作者信息

Ripley Elizabeth B D, Macrina Frank L, Markowitz Monika

机构信息

Virginia Commonwealth University.

出版信息

J Empir Res Hum Res Ethics. 2006 Dec;1(4):37-44. doi: 10.1525/jer.2006.1.4.37.

Abstract

REGULATORY GUIDELINES LEAVE determination of coercion and undue influence of research participants open to interpretation. A web-based survey was conducted of the research ethics committees members at Virginia Commonwealth University (VCU) to evaluate their perspectives on paying participants in clinical research via general questions, as well as 8 short cases involving hypertension placebo-controlled trials, a pilot exercise study, a survey of substance abusers, a healthy-volunteer pharmacokinetic study, a twin study involving DNA samples, and an asthma medication study in children. Research ethics committee members were asked to state what payment they would consider appropriate for a given type of protocol. The results suggest that risk, time required, reimbursement for expenses, and inconvenience were important in determining appropriate payment, while income and funding source were not. The case studies revealed wide variation in recommended payments both within type of study and between studies.

摘要

监管指南对于研究参与者是否受到胁迫和不当影响的判定留有解释空间。弗吉尼亚联邦大学(VCU)对研究伦理委员会成员开展了一项基于网络的调查,通过一般性问题以及8个简短案例来评估他们对临床研究中向参与者支付报酬的看法,这些案例涉及高血压安慰剂对照试验、一项初步运动研究、一项药物滥用者调查、一项健康志愿者药代动力学研究、一项涉及DNA样本的双胞胎研究以及一项儿童哮喘药物研究。研究伦理委员会成员被要求说明他们认为针对某一特定类型的方案支付多少报酬合适。结果表明,风险、所需时间、费用报销和不便程度在确定适当报酬时很重要,而收入和资金来源则并非如此。案例研究显示,无论是在研究类型内部还是不同研究之间,推荐报酬都存在很大差异。

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