a Johns Hopkins University.
Am J Bioeth. 2014;14(2):28-37. doi: 10.1080/15265161.2013.868950.
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.
鉴于卫生系统研究（HSR）与更传统的临床试验相比，涉及不同的目标、方法和方法，HSR 中存在的伦理问题可能是独特的或特别微妙的。本文概述了 HSR 中特别突出的八项相关伦理问题，并认为伦理审查过程应更好地适应，以确保对 HSR 进行更有效和适当的监督，同时对人类进行充分保护，特别是在中低收入国家。我们讨论的八个伦理领域包括干预的性质、研究对象的类型、干预和观察的单位、知情同意、对照和比较、风险评估、弱势群体的纳入以及研究的益处。涉及人类参与者的 HSR 对于确保加强卫生系统和提高医疗质量以及明智地指导公共政策是必要的。卫生系统研究人员必须仔细定义他们的意图和目标，并公开阐明可能影响研究方案前提和设计的价值观。随着新型人群水平研究活动变得越来越普遍，机构审查委员会（IRB）和研究伦理委员会（REC）审查过程必须发展，以评估这些研究方案，以解决这些研究的细微特征。
