Center for Bioethics in Eastern and Southern Africa, College of Medicine, University of Malawi, Private Bag 360, Blantyre, Malawi.
Centre for Applied Bioethics, Schools of Biosciences and Veterinary Medicine and Science, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.
BMC Med Ethics. 2021 Dec 3;22(1):160. doi: 10.1186/s12910-021-00729-w.
The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants' motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi.
We conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation.
The findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role.
These findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants' concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants' needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups.
The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451).
在进行强有力的研究时，参与者招募过程是一个关键的伦理转折点。需要不断审查和改进研究试验的招募流程，并在研究人员和参与者之间建立公平有效的伙伴关系，这是确保高质量研究符合伦理要求的重要核心要素。当参与者做出公平、知情和自愿的决定参加研究时，他们同意履行自己的角色。然而，支持研究参与者履行研究要求是研究人员的一项重要道德义务，但事实证明这很难实现。本文报告了在马拉维卡松古区进行的一项饮食研究中，参与者自愿参与并继续参与的动机。
我们进行了二十次深入访谈（与酋长、宗教领袖、试验参与者和健康监测助理）、五次系统民族志观察和十四次焦点小组讨论，参与者和他们的伙伴。访谈进行了录音，并逐字记录。我们使用扎根理论方法分析数据，包括编码、详细的备忘录写作和数据解释。
研究结果表明，许多参与者在试验期间存在顾虑。从主题上看，经验包括焦虑、对研究人员的不信任、谣言、恐惧剥削和误解。从参与者那里收集到的匿名问题报告给了试验小组，这使研究人员能够适当地支持参与者。尽管最初存在担忧，但参与者表示得到了支持，并表达了继续履行职责的动机。
这些发现强调了一个多样化的概念图，其中包括什么是伦理相关的，以及什么可能会影响研究中的参与和保留。这项研究揭示了如何嵌入一种响应式方法来解决参与者的问题和伦理问题，可以支持信任关系。我们认为，需要采用嵌入式伦理策略，满足参与者的需求和积极体验，并支持研究人员履行职责。这项工作强调了研究伦理委员会需要关注不当影响的风险，防止剥削，特别是在资源和权力在研究人员和参与者群体之间高度不对称的环境中。
解决隐性饥饿与农学（马拉维）试验于 2019 年 3 月 5 日注册（ISCRTN85899451）。
