Moorhouse Rika, Slack Catherine, Quayle Michael, Essack Zaynab, Lindegger Graham
Faculty of Health Sciences, Simon Fraser University, 8888 University Drive, Burnaby, British Columbia, Canada.
BMC Med Ethics. 2014 Jun 30;15:51. doi: 10.1186/1472-6939-15-51.
South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders' perspectives on ethical guidance related to prevention and care in HIV vaccine trials.
Site staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: "Familiarity with", "Ease of Understanding", "Ease of Implementing", "Perceived Protection", and "Agreement with" each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups.
Both care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was "Ease of Implementing," and the least problematic was "Agreement with," suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations.
We propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for "Ease of Implementing", and/ or "Ease of Understanding" in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.
南非是艾滋病预防试验的主要中心,计划于2015年启动一项许可试验。艾滋病疫苗试验中适当的护理和预防标准是复杂且存在争议的问题,伦理准则提供了一些指导。然而,对于南非利益相关者对艾滋病疫苗试验中与预防和护理相关的伦理指导的看法,实证探索有限。
邀请参与南非当前艾滋病疫苗试验的现场工作人员、社区咨询委员会成员和研究伦理委员会成员参与对他们观点的探索。一份问卷列出了从两套广泛使用的生物医学艾滋病预防试验伦理准则中得出的10条护理建议和10条预防建议。受访者(n = 98)在五个维度上对每条建议进行评分:“熟悉程度”、“易于理解程度”、“易于实施程度”、“感知保护程度”以及“对每条伦理建议的认同程度”。这些评分用于描述利益相关者对每条建议各维度的看法。各维度评分在五个维度上进行平均,并用作每条建议总体价值的指标。在各维度之间、以护理为导向和以预防为导向的建议之间以及利益相关者群体之间探索差异。
护理和预防建议总体评分都很高,中位数评分远高于量表中点。一般来说,知情同意建议的评分最为积极。与护理相关的建议评分明显比与预防相关的建议更积极,评分最低的五条建议与预防相关。所有建议中最成问题的维度是“易于实施程度”,最不成问题的是“认同程度”,这表明利益相关者最紧迫的担忧是实际问题而非理论问题;也就是说,受访者认同这些建议,但认为在实现这些建议方面存在障碍。
我们建议优先完善预防建议,特别是那些在“易于实施程度”和/或“易于理解程度”方面得分较低的建议,以帮助疫苗利益相关者更好地理解和实施这些建议。进一步的定性研究也有助于更好地理解利益相关者在实施此类建议时的保留意见中的细微差别。