Kennedy Caitlin E, Kass Nancy, Myers Rachel K, Fuchs Edward J, Flexner Charles
Johns Hopkins University, Bloomberg School of Public Health, Department of International Health, Baltimore, MD 21205, USA.
J Empir Res Hum Res Ethics. 2011 Jun;6(2):47-56. doi: 10.1525/jer.2011.6.2.47.
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.
涉及健康志愿者的研究中严重不良事件很少见,但它们对其他志愿者的影响尚不清楚。我们在一名健康研究志愿者死亡的机构对60名健康志愿者进行了半结构化访谈。大多数志愿者(85%)听说过该事件,但很少有人表示这改变了他们参与研究的想法(17%)、对研究的态度或所提问题(25%),或未来参与的意愿(4%)。尽管了解的事实很少,但受访者编造了关于该事件的叙述,以使他们与该事件保持距离,并为自己继续参与研究找理由。社会比较向下理论、乐观偏差以及责任感和控制感可能有助于解释这些叙述。研究结果强调了沟通以及对研究风险和保护措施的理解的重要性。