Abstract
BackgroundThere 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.ResultsThe 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.ConclusionsThe 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.
Highlights
There have been notable investments in large multi-partner research programmes across the agricul‐ ture-nutrition-health (ANH) nexus
Study design An action research project was undertaken from May to October 2019 to document and critically examine the implementation of the real-time research ethics approach’ (RTREA) and map how the bioethics team (BT) engaged with the Trial Implementation Team and Trial participant (TP)
A principle-based approach was used within this work as the most applicable ethical framework for informing the analysis of the ethical issues raised and it was deemed to be in line with the approach used within Research Ethics Committee (REC) evaluations that inform the ethical standards set for this type of trial
Summary
There have been notable investments in large multi-partner research programmes across the agricul‐ ture-nutrition-health (ANH) nexus These studies often involve human participants and commonly require research ethics review. 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 establishment of formalised ethical principles and general standards provides a structure for research practice [4], these guidelines are often unable to fully consider new ethical terrains that emerge during research practice In these instances, researchers face challenges and questions that are unaddressed by existing standards [4]. Research dialogue and active participant engagement have been reported to promote discussions on values, norms, and virtues [5], creating a deliberative model for researcher and participant partnerships to resolve ethical challenges as they emerge [6], referred to as ‘embedded empirical ethics’
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