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

The American Journal of Bioethics, 14(2): 28–37, 2014 Copyright c⃝Taylor & Francis Group, LLC ISSN: 1526-5161 print / 1536-0075 online DOI: 10.1080/15265161.2013.868950 Target Article Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration Adnan A. Hyder, Johns Hopkins University Abbas Rattani, Johns Hopkins University Carleigh Krubiner, Johns Hopkins University Abdulgafoor M. Bachani, Johns Hopkins University Nhan T. Tran, World Health Organization 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. Keywords: health systems, research ethics, health systems research, implementation research, ethical review, developing world Health systems research (HSR) is a subset of public health and is defined by the World Health Organization (WHO) as “the purposeful generation of knowledge that enables soci- eties to organize themselves to improve health outcomes and health services” (World Health Organization 2009). HSR covers a wide range of subject areas that are focused on common health systems functions, such as stewardship, financing, resource inputs, and delivery of services (World Health Organization 2009). It is not usually research that fo- cuses on the discovery or development of new interventions to improve health; rather, research aims to understand how new interventions that are efficacious can be made more widely accessible to potential beneficiaries through policies, organizations and programs (Gilson et al. 2011). These stud- ies may also provide data on quality and cost-effectiveness to identify more efficient strategies for health care deliv- ery. To generate knowledge on these systems-level factors, HSR studies employ a range of experimental and quasi- experimental designs. While some adopt the traditional ran- domized controlled trial (RCT) model, many HSR studies are performed as nonrandomized, controlled or noncon- Address correspondence to Professor Adnan A. Hyder, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Suite E-8132, Baltimore, MD 21205, USA. E-mail: ahyder@jhsph.edu trolled, prospective or cross-sectional assessments of new or modified health care programs and strategies (Alliance for Health Policy and Systems Research 2012a). Given the macro focus of HSR, the participants and beneficiaries are often communities, hospitals, and health care institutions, as opposed to individuals. Since HSR has its own definitions, methods, and ana- lytic approaches, there is an increasing realization that it may raise ethical concerns that may differ from other types of research; therefore, its ethical review should arguably be tailored to address the features and unique ethical chal- lenges that are particularly salient (though not exclusive) to HSR. Unfortunately, many (if not most) institutions, in- cluding the WHO, use the same review criteria and process for HSR studies as for clinical trials, which can potentially create an imprecise application of criteria, confusion on the part of research teams, and unnecessary delays. The incon- gruity between current ethical review guidelines—which were generally developed with attention to the protection of individual subjects in clinical research—and the purpose and design of HSR raises substantive ethical concerns and ajob Downloaded by [Johns Hopkins University] at 12:08 02 May 2014 Ethical Review of Health Systems Research creates practical inefficiencies. Given the nature of HSR and the limited risk these studies typically pose to hu- man subjects, the ethical review processes of …