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对参与临床试验的补偿的认知。

Perceptions of reimbursement for clinical trial participation.

作者信息

Breitkopf Carmen Radecki, Loza Melissa, Vincent Kathleen, Moench Thomas, Stanberry Lawrence R, Rosenthal Susan L

机构信息

Health Sciences Research, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.

出版信息

J Empir Res Hum Res Ethics. 2011 Sep;6(3):31-8. doi: 10.1525/jer.2011.6.3.31.

Abstract

A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women's perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women's completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22-45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation.

摘要

更深入地了解参与者对报销的看法,将有助于研究人员规划更有潜力达到目标入组人数的研究,最大限度地提高招募效率,保持科学诚信,并随着时间的推移提高留存率。作为性健康领域一项临床试验的一部分,对健康女性对参与研究报销的看法进行了调查。在女性完成临床试验后,立即进行了半结构化、录音的定性访谈,以实现由参与者主导的对货币报销看法的理解。录音被转录并使用框架分析法进行分析。女性(N = 30)的平均年龄为29.5 ± 5.7岁(范围22 - 45岁)。63%的参与者(n = 19)是非西班牙裔(白人n = 13,黑人n = 4,亚洲人n = 2),其余为西班牙裔(n = 11)。73%(n = 22)的人报告曾参与过研究。总体而言,女性将报销视为参与研究的一项福利,报销金额应反映时间、给研究对象带来的不便以及短期和长期未知风险的可能性。她们认为报销应考虑研究的风险程度,对实验产品的研究应给予更高的报销。女性认为货币报销不太可能迫使个人自愿参与一项涉及她们认为不可接受的程序或要求的研究。本研究结果可用于为那些规划和评估参与研究报销的人提供指导。

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