title: Ethical review of health systems research in low- and middle-income countries: a conceptual exploration.
abstract: Given that health systems research (HSR) involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board (IRB) and research ethics committee (REC) review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies.
authors: a Johns Hopkins University.
authors: Adnan A
authors: AA
authors: Hyder
authors: Abbas
authors: A
authors: Rattani
authors: Carleigh
authors: C
authors: Krubiner
authors: Abdulgafoor M
authors: AM
authors: Bachani
authors: Nhan T
authors: NT
authors: Tran
mesh_terms: D003906:Developing Countries; D026724:Ethical Review; D028744:Ethics Committees, Research; D006302:Health Services Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D035842:Research Subjects; D035862:Vulnerable Populations