Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, P.R. China.
J Evid Based Med. 2020 May;13(2):173-177. doi: 10.1111/jebm.12388. Epub 2020 May 22.
The number of research involving human subjects on coronavirus disease 2019 (COVID-19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review-related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity-improving and efficiency-improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.
关于 2019 年冠状病毒病(COVID-19)的研究涉及人体受试者的数量正在迅速增加,这给伦理审查委员会(ERC)在大流行期间的审查速度和特殊伦理考虑方面带来了挑战。然而,现有的伦理审查制度和规定存在局限性,无法满足快速有效的疫情控制的需求。由于公共卫生紧急情况下的研究与在熟悉的情况下进行设计和实施的研究不同,因此令人满意的 ERC 应对策略应平衡保护个体参与者的责任以及从疾病控制中衍生出的特殊公共需求。建议更新与伦理审查相关的法规,并建立一个统一的监管体系来监督整个 ERC。需要采取 ERC 合作、提高能力和提高效率的措施。关于审查指南,建议在解释国际规范时,应更多地考虑当地情况和这种公共卫生紧急情况下的特殊情况。需要共同努力,以更好地开展研究。