Department of Sociology, University of Amsterdam, Amsterdam, Netherlands.
Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
J Acquir Immune Defic Syndr. 2018 Oct 1;79 Suppl 1(Suppl 1):S30-S36. doi: 10.1097/QAI.0000000000001818.
As with all early-stage testing of investigational drugs, clinical trials targeting HIV/AIDS can pose unknown risks to research subjects. Unlike sick participants seeking a therapeutic benefit, the motivations and barriers for healthy volunteers are more complex and understudied. Drawing on interviews and clinical trial data from 178 healthy volunteers, we examine how they perceive HIV/AIDS studies in the early stages of testing. A subset of healthy volunteers see phase I HIV/AIDS studies as particularly risky for reasons ranging from fear of catching the disease or having long-lasting and uncomfortable side effects to inexplicable fears that they cannot even articulate. Some participants have had past negative experiences in such trials that inform these views, but others cite information from staff and other participants as influential. Healthy volunteers' general fears concerning AIDS also shape their views of participating in phase I HIV/AIDS clinical trials.
与所有处于早期阶段的试验性药物一样,针对艾滋病病毒/艾滋病的临床试验可能会给研究对象带来未知的风险。与寻求治疗益处的患病参与者不同,健康志愿者的动机和障碍更加复杂,研究也较少。本研究通过对 178 名健康志愿者的访谈和临床试验数据,考察了他们如何看待处于早期试验阶段的艾滋病病毒/艾滋病研究。有一部分健康志愿者认为,第一阶段的艾滋病病毒/艾滋病研究特别危险,原因包括担心感染疾病、出现长期且不适的副作用,以及他们甚至无法解释的莫名恐惧。一些参与者过去在这类试验中有过负面经历,从而形成了这些看法,但也有一些参与者提到工作人员和其他参与者的信息对他们有影响。健康志愿者对艾滋病的普遍担忧也影响了他们对参加第一阶段艾滋病病毒/艾滋病临床试验的看法。