Dubé Karine, Dee Lynda
Public Health Leadership Program, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
Delaney AIDS Research Enterprise Community Advisory Board (CAB), Baltimore, MD, USA.
J Virus Erad. 2020 Apr 30;6(2):81-84. doi: 10.1016/S2055-6640(20)30021-2.
This viewpoint article critiques two recent articles examining 'willingness to risk death' to advance HIV cure-related research. The 'willingness to risk death' endpoint sends the wrong signal to the HIV cure-related research community about ongoing research in otherwise healthy volunteers living with HIV. Socio-behavioural scientists have examined the acceptability of a 99% risk of death scenario, which is unrealistic and would not be acceptable by current regulatory and ethical standards. We believe that the field needs robust and relevant socio-behavioural research reflecting ongoing biomedical HIV cure-related trials. These studies will need to withstand regulatory and ethical scrutiny if cure or remission regimens are to proceed to the licensing stage. The HIV cure-related research community must continue to protect the public trust in the HIV cure-related research field and sustain societal value generated by such research. We call for the utmost prudence in designing biomedical HIV cure trials as well as in setting up socio-behavioural research experiments related to these complex trials.
这篇观点文章批评了最近两篇探讨“冒死亡风险意愿”以推进与HIV治愈相关研究的文章。“冒死亡风险意愿”这一终点向与HIV治愈相关的研究界传递了错误信号，关于在其他方面健康的HIV感染者中正在进行的研究。社会行为科学家研究了99%死亡风险情况的可接受性，这是不现实的，并且不符合当前的监管和伦理标准。我们认为该领域需要有力且相关的社会行为研究，以反映正在进行的与HIV治愈相关的生物医学试验。如果治愈或缓解方案要进入许可阶段，这些研究需要经受住监管和伦理审查。与HIV治愈相关的研究界必须继续保护公众对HIV治愈相关研究领域的信任，并维持此类研究产生的社会价值。我们呼吁在设计生物医学HIV治愈试验以及开展与这些复杂试验相关的社会行为研究实验时要极其谨慎。
