Bates Helen, Seedat Soraya, Lester Helen
1Department of Primary Care Clinical Sciences,University of Birmingham,Birmingham,England,United Kingdom.
2Professor,Department of Psychiatry,Stellenbosch University,Stellenbosch,South Africa.
Prim Health Care Res Dev. 2014 Oct;15(4):362-74. doi: 10.1017/S1463423613000443. Epub 2013 Nov 19.
To investigate the informed consent experiences of women with human immunodeficiency virus (HIV) and childhood trauma involved in a neurocognitive and neuroimaging study.
There is no previous research on the consent process for people with both HIV and childhood trauma, conditions that are syndemic in South Africa. Research on the consent process for each individual condition has shown that individuals with either of these conditions may be vulnerable research participants. This study aimed to investigate the opinions of the women involved in order to refine future consent processes and ensure that they are appropriate for this population.
A qualitative semi-structured interview was conducted with women from Khayelitsha township in South Africa involved in a cohort study on neurocognitive and neuroimaging outcomes in HIV and childhood trauma, who agreed to participate in an interview immediately following their final study appointment.
Aspects most frequently commented upon by participants during the interview were community recruitment, incentives for participation, quality of information provided, and misunderstandings and unexpected events. The overarching finding was that of therapeutic misconception; participants expected, and highlighted as incentives for participation, health benefits that were not part of the study. A minority of participants reported discomfort from questions concerning their traumatic experiences. Despite this, the consent process was well received and there was good understanding of confidentiality issues and the voluntariness of participation.
Full disclosure of true benefits from participation must be emphasised throughout the recruitment process. This is particularly important for participants with HIV who appear to participate because of perceived health incentives. Providing prior notification that questions about traumatic experiences will be asked may improve the experiences of participants. A generic but thoroughly conducted consent process is suitable in this population.
调查参与一项神经认知与神经影像学研究的感染人类免疫缺陷病毒（HIV）且有童年创伤经历的女性的知情同意体验。
此前尚无针对同时感染HIV和有童年创伤经历者（这两种情况在南非属于共病现象）的同意程序的研究。针对每种情况的同意程序研究表明，患有这两种情况之一的个体可能是易受伤害的研究参与者。本研究旨在调查相关女性的意见，以完善未来的同意程序，并确保其适用于这一人群。
对来自南非开普敦凯伊利沙镇、参与一项关于HIV和童年创伤的神经认知与神经影像学结果队列研究的女性进行了定性半结构式访谈，这些女性在最后一次研究预约后立即同意参加访谈。
参与者在访谈中最常提及的方面包括社区招募、参与激励、所提供信息的质量以及误解和意外事件。总体发现是存在治疗性误解；参与者期望并强调作为参与激励的健康益处并非研究的一部分。少数参与者表示因关于其创伤经历的问题而感到不适。尽管如此，同意程序受到了好评，并且对保密问题和参与的自愿性有很好的理解。
在整个招募过程中必须强调充分披露参与的真正益处。这对于因感知到的健康激励而参与的HIV感染者尤为重要。提前告知会询问有关创伤经历的问题可能会改善参与者的体验。一个通用但执行彻底的同意程序适用于这一人群。
