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When a serious adverse event in research occurs, how do other volunteers react?

机译:当研究中出现严重不良事件时,其他志愿者会如何反应?

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摘要

Serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85%) had heard of the event, but few said it changed their thoughts about joining research (17%), approach to studies or questions asked (25%), or future participation (4%). Despite knowing few facts, respondents created narratives about the case that served to distance them from the event and justify their continued participation in research. Downward social comparison theory, optimistic bias, and feelings of responsibility and control may help explain these narratives. Findings underscore the importance of communication and understanding of research risks and protections.
机译:在涉及健康志愿者的研究中,严重的不良事件很少见,但对其他志愿者的影响尚不清楚。我们在一家健康研究志愿者死亡的机构中对60名健康志愿者进行了半结构化访谈。大多数志愿者(85%)听说过该活动,但很少有人说它改变了他们对加入研究的想法(17%),研究方法或提出的问题(25%)或未来的参与(4%)。尽管知之甚少,但受访者还是对该案进行了叙述,这使他们远离事件并证明了他们继续参与研究的合理性。向下的社会比较理论,乐观的偏见以及责任感和控制感可能有助于解释这些叙述。研究结果强调了交流和理解研究风险与保护的重要性。

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