Assistant Professor, Department of Community Medicine, ESIC Medical College and PGIMSR, KK Nagar, Chennai 600 078 INDIA.
Indian J Med Ethics. 2020 Oct-Dec;V(4):1-6. doi: 10.20529/IJME.2020.77.
Health policy and systems research refers to the research conducted on the formulation, impact, organisation and functioning of health policies, and how to optimise the functioning of health systems and policies towards achieving health for all. There is emerging scholarship on the ethics of conducting such health policy and systems research. Ethics of health policy and systems research, though similar to the ethics of traditional clinical research in many ways, has several important distinctions. In traditional clinical research on human participants, where two treatments or interventions are compared, clinical equipoise is an important ethical consideration. This refers to the genuine uncertainty among professional peers on whether one of the interventions is better than the other. This uncertainty is in the biomedical efficacy of the intervention. Unless such equipoise exists, clinical research is said to be unethical from the benefit-risk balance and justice perspectives. In health policy and systems research, the question of clinical equipoise is often not relevant. This article will describe the condition of clinical equipoise in health policy and systems research, its applications and challenges.
卫生政策和体系研究是指针对卫生政策的制定、影响、组织和运作,以及如何优化卫生系统和政策的运作以实现全民健康而开展的研究。目前,关于进行此类卫生政策和体系研究的伦理问题已经有了一些新兴的学术研究。卫生政策和体系研究伦理与传统临床研究伦理在许多方面相似,但也有一些重要的区别。在针对人类参与者的传统临床研究中,如果比较两种治疗方法或干预措施,临床均衡就是一个重要的伦理考虑因素。这是指专业同行之间对于哪种干预措施比另一种更好存在真正的不确定性。这种不确定性存在于干预措施的生物医学疗效中。除非存在这种均衡,否则从利益风险平衡和公正的角度来看,临床研究是不道德的。在卫生政策和体系研究中,临床均衡的问题通常并不相关。本文将描述卫生政策和体系研究中临床均衡的状况、应用和挑战。