Centre for Medical Ethics and Law, Department of Medicine, Faculty of Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
Institute for Cellular and Molecular Medicine, Department of Immunology, University of Pretoria, Pretoria, South Africa.
BMC Med Ethics. 2019 Jan 24;20(1):9. doi: 10.1186/s12910-019-0348-z.
Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research.
In total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals - audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted.
The majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants.
Unique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.
在过去的三十年中，涉及 HIV 预防研究的临床试验的同意过程在全球范围内引发了相当大的争议。HIV 治愈/清除研究在科学上更为复杂，因此，该领域临床试验的同意过程可能会带来重大挑战。鉴于研究工作现在正在朝着 HIV 清除的方向发展，及时让利益相关者参与，为这类研究提供适当的伦理监督是适时的。本研究旨在了解广泛的 HIV 治疗和研究利益相关者的观点，为治愈研究的同意过程提供信息。
共有 68 名南非利益相关者参与了两种定性研究方式。对 42 名有目的的个人进行了深入访谈（IDIs）-征得同意后进行录音。26 名利益相关者参加了三次焦点小组讨论（FGD）。对转录的 IDI 和 FGD 进行了主题分析。
大多数受访者表示，HIV 治愈研究可能存在独特的挑战，需要特别关注。特别是，鉴于治愈科学的复杂性，将概念转化为白话对于潜在参与者来说至关重要，以便他们能够充分了解早期研究中与实验干预相关的风险和收益。此外，为了在治愈的绝望背景下帮助理解风险和收益，需要专门培训的协调员在同意治愈之前协助进行心理评估，以避免治愈误解。为了评估治愈的持久性，长期的参与者参与将意味着同意过程会延长，需要每年重新同意。建立信任以维持这种长期关系对于留住研究参与者至关重要。
南非治愈研究的独特同意要求将包括最大限度地提高对试验程序、风险和长期随访的理解的重大努力。然而，治愈的心理层面不容忽视。除了对治愈科学的理解之外，HIV 治愈的进展对治愈的影响将治愈从治愈的话语推进到治疗的话语。因此，治愈研究的同意过程需要得到加强，包括心理支持和咨询。这对 HIV 治愈研究同意的研究伦理审查要求有几个重要的影响。
