Center for Bioethics in Eastern and Southern Africa, University of Malawi, College of Medicine, 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. 2022 Jan 11;23(1):3. doi: 10.1186/s12910-021-00740-1.
There have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of 'ethics in practice' by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel 'real-time research ethics approach' (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the 'Addressing Hidden Hunger with Agronomy'. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation.
The RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants' 'lived research experience'. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants' (TPs) perspectives and experiences.
The use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers 'ethical mindfulness' which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels.
在农业-营养-健康（ANH）领域，已经有大量多伙伴合作的研究计划进行了投资。这些研究通常涉及人类参与者，通常需要进行研究伦理审查。这些 ANH 研究非常复杂，可能会引发需要前期工作、伦理监督的伦理问题，并且需要一个嵌入式流程来识别、描述和管理研究工作开展过程中的伦理问题，因此需要更具嵌入性和动态性的伦理流程。这项工作通过开发一种方法来促进大型研究计划中的伦理反思，建立在“实践中的伦理学”的概念之上。本研究探讨了一种新颖的“实时研究伦理方法”（RTREA）的应用以及如何支持伦理意识。这涉及在研究实施过程中嵌入伦理分析和决策，并在参与者和研究人员之间进行持续对话。目的是提高伦理响应能力和参与者体验，从而在道德上支持遵守和保留。在这个案例研究中，一个生物伦理学团队（BT）被嵌入到在马拉维农村地区进行的一项基于社区的随机对照试验中，该试验名为“通过农艺学解决隐性饥饿”。为了识别伦理问题，研究人员进行了十次焦点小组讨论，十四次对关键知情人的深入访谈，两次研讨会，观察了试验团队进行的两次宣传和三次活动会议，并分析了从试验前到实施期间的十五份报告。
RTREA 有助于识别社会和伦理问题，并使研究人员意识到参与者的“研究体验”。为了解决问题和顾虑，BT 与研究人员合作，为讨论社会和伦理问题创造对话空间。对话空间旨在建立合作伙伴关系，并促进参与性方法，以捕捉试验参与者（TPs）的观点和体验。
使用 RTREA 显示了 TP 和研究人员之间实时和持续互动的价值。这些实时流程可以嵌入到传统的伦理指导和专家意见中。更深入的参与似乎支持了更全面地实施包容、赋权和参与者自主权原则，并支持研究人员的“伦理意识”，这反过来又可能支持高招募、保留和遵守水平的工具性结果。
