Ethical Review of Health Systems Research in Low-and Middle-Income Countries: A Conceptual Exploration by Adnan A. Hyder, Johns Hopkins University - Abbas Rattani, Johns Hopkins University - Carleigh Krubiner, Johns Hopkins University _unza

Description

This academic article explores the distinct ethical considerations for reviewing health systems research (HSR) in low- and middle-income countries (LMICs), arguing that traditional ethical review frameworks designed for clinical trials are often misaligned with the aims and methodologies of HSR. It outlines eight key ethical domains particularly salient in HSR: the nature of system-based interventions, types of research subjects (often groups or communities), units of intervention and observation, informed consent processes, appropriate controls and comparisons, risk assessment (emphasizing social and communal risks), inclusion of vulnerable groups, and the definition of benefits (including health systems strengthening and capacity building). The authors contend that research ethics committees (RECs) and institutional review boards (IRBs) need tailored review processes to address these nuanced features, ensure efficient oversight, and provide adequate human protections, especially in LMIC contexts where HSR is critical for strengthening health