A framework and practical approach to identify and address ethical issues arising in interventional health systems research.

BACKGROUND: Embedded, interventional health systems research is increasingly promoted to better understand and strengthen the performance of health systems. However, for these forms of research, boundaries between clinical care, quality improvement, and public health can be blurred, and ethical implications and frameworks to draw upon are unclear. While there is evolving ethical guidance, few health systems studies have documented ethical dilemmas experienced post ethics approval, and the value of support processes introduced to manage arising dilemmas. In this discussion paper, we share our approach to handling the ethical dilemmas that arose while conducting embedded interventional health systems research in public-sector newborn units in Kenya. METHODS: Building on our past research, and literature on debriefs, reflective learning, ethics reflection groups and moral case deliberations, we evolved an approach to holding regular structured ethics debriefs to discuss and agree upon how to handle ethical issues experienced during 'fieldwork'. The research team maintained a 'living log' of all discussions, detailing all emerging ethical issues and any agreed actions. To prepare this paper, we conducted a thematic analysis of the living log and associated meeting minutes/recordings, and held a series of wider team meetings to reflect upon our learning. FINDINGS AND DISCUSSION: Numerous dilemmas were shared by research staff in our debrief fora. We grouped ethical issues encountered into 1) 'bystander' issues (defined here as background issues impacting health system functioning, facility staff, patients or families that were not caused or exacerbated by our research activities), 2) issues for those groups that were 'research imposed' and 3) issues related to the 'comfort and well-being of research team members'. Most dilemmas raised related to feeling like bystanders in highly constrained health systems, complicated by our positionalities as 'outsiders-within', whereby as health researchers spending time in facilities we were neither fully 'outsiders' nor 'insiders' to the health system. There was constant moral labour involved in considering our responsibilities for action, which ranged from immediate action from a safety perspective, through rethinking how the research was conducted, to various forms of engagement and feedback across a web of stakeholders. CONCLUSION: The approach we developed offers a framework to assist research team members with the significant ethical dilemmas and challenges that arise over the course of conducting studies. We suggest activities to support working prospectively through emerging ethical dilemmas in future studies.