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权衡开放科学与研究参与负担在知情同意:一个随机试点研究

Renata Iskander¹, Patrick Kane¹, Madeleine Sharp²

¹Department of Equity, Ethics and Policy, McGill University, Montreal, Canada.

Journal of empirical research on human research ethics : JERHRE

|October 10, 2025

概括

对于临床研究中的帕金森病患者来说,较少的试验访问显著增加了参与意愿,超过了开放科学偏好. 这凸显了访问负担在患者决策中的重要性.

科学领域:

神经学神经学
临床研究方法论临床研究方法论
健康决策科学健康科学

背景情况:

患者参与临床研究涉及评估复杂的试验特征.
了解影响患者招募的因素对于推进帕金森病研究至关重要.

研究的目的:

评估临床试验特征,特别是访问量和开放数据共享对帕金森病患者参与意愿的影响.
确定试验信息的呈现方式 (联合或单独) 如何影响患者的决策.

主要方法:

一项涉及帕金森病患者的调查研究,随机选择评估一个或两个临床试验场景.
参与意愿的定量分析得分基于试验特征和信息呈现格式.

主要成果:

评估这两项试验的患者表现出更愿意参与更少访问的方案 (平均差异为-0.48).
在两项试验中,与仅评估这项研究的患者相比,患者不太愿意参加更高访问率的研究 (平均差异为1.02).
减少访问负担的偏好强烈影响了决策,即使开放科学观点是有利的.

结论:

访问频率是帕金森病临床试验参与决策的主要因素.
单独呈现复杂的信息,如开放科学和访问负担,阻碍了患者的评估和决策.
优化试验设计以尽量减少访问负担对于改善帕金森病研究中的患者招募至关重要.

关键词:

福利福利福利福利福利这是一个沉重的负担.临床试验是指临床试验中的临床试验.可评价性假设评价性假设开放科学是一个开放的科学.研究伦理研究伦理学

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