CESP-Center for Research in Epidemiology and Population Health, INSERM U 1018, Université Paris-Saclay, Villejuif Cedex, France.
MIT-Maladies Infectieuses et Transmissibles, Hôpital Tenon, AP-HP, Paris, France.
J Acquir Immune Defic Syndr. 2018 Oct 1;79 Suppl 1:S51-S58. doi: 10.1097/QAI.0000000000001808.
The authors, who took part in designing and conducting the first phase-1 clinical trials of the HIV vaccine between 1991 and 1996, discuss the history of this innovative program, in particular, the conditions under which volunteers were recruited. They recall its multidisciplinary aspects; the team included, along with clinicians who were used to performing such trials, epidemiologists, psychiatrists, psychoanalysts, social psychologists, and a philosopher specialized in ethics. When forming this team, officials at France's National Research Agency on AIDS (ANRS) were careful to identify the volunteers social characteristics and pay heed to their subjective motivations for participating, given the context, namely a rising incidence of HIV infection and the challenges that were undermining confidence in medicine. Important in this context was the application of the Huriet-Sérusclat Act (1988) with its provisions for protecting participants. These clinical trials led to reformulating several ethical questions, for instance, the tension between the need of such trials and the necessity to not expose volunteers to poorly known risks; the importance of precise scientific information for delivering free, informed consent; and the possibility for volunteers to take part on the basis of their autonomy and "risk choice." The network of volunteers, which operated on this basis for nearly 25 years, is a rare example of collaboration between basic research in biomedicine, medical doctors, psychologists, psychoanalysts, and ethicists.
作者曾参与 1991 年至 1996 年间进行的 HIV 疫苗首次 I 期临床试验的设计和实施，他们讨论了该创新项目的历史，特别是志愿者招募的条件。他们回顾了该项目的多学科特点；该团队包括临床医生（他们习惯于进行此类试验）、流行病学家、精神科医生、精神分析师、社会心理学家和一位专门研究伦理学的哲学家。在组建该团队时，法国国家艾滋病研究署（ANRS）的官员非常谨慎地确定志愿者的社会特征，并注意到他们在这种背景下（HIV 感染发病率上升，以及削弱人们对医学信心的挑战）参与的主观动机。在这种情况下，Huriet-Sérusclat 法案（1988 年）的适用及其对保护参与者的规定非常重要。这些临床试验导致重新制定了几个伦理问题，例如，此类试验的必要性与不使志愿者面临未知风险之间的紧张关系；为知情同意提供准确科学信息的重要性；以及志愿者基于自主和“风险选择”参与的可能性。该志愿者网络在近 25 年的时间里以此为基础运作，是基础生物医学研究、医生、心理学家、精神分析师和伦理学家之间合作的罕见例子。
