Thinking on ethical review during public health emergent event
10.3760/cma.j.cn113565-20230719-00015
- VernacularTitle:突发公共卫生事件下的伦理审查思考
- Author:
Yali CONG
1
Author Information
1. 北京大学医学人文学院 100191
- Keywords:
Public health emergency;
Ethical review;
Cultural dimension
- From:
Chinese Journal of Medical Science Research Management
2023;36(5):323-327
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Public health emergencies expose a significant threat to human life and health. How to efficiently conduct biomedical research while complying with ethical norms is an important way to response to public health emergent events such as pandemic outbreak. In 2023, the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine jointly issued the " Measures for Ethical Review of Life Sciences and Medical Research Involving Human Subjects", which requires the ethics committee to construct an ethical review system in advance, including, generally, the ethics committee should conduct ethical review and provide review opinions within 72 hours. Is this measure feasible and does it have any unreasonable aspects?Methods:Literature review and status quo analysis are two main methods, this article combs the international guidelines issued by World Health Organization, the Council for International Organizations of Medical Sciences and the Nuffield Council of Bioethics, selects the content related to research under the circumstances of public health emergencies, take the Hofstede′s Cultural Dimensions Theory into consideration of the complexity of quality and quantity of research during the COVID-19 pandemic in China.Results:After analyzing, this article argues preliminarily that the requirement and emphasize on ethical review system development issued by the four ministries in China is very timely and necessary. However, the requirements for review time limits is inconsistent with international consensus, and might pose substantive challenges to the independence of the ethics committee's work.Conclusions:Scientificity and ethics are the soul of biomedical research, and the basic requirements of these two aspects cannot be undermined due to the special nature of public health emergencies. However, procedures simplifiable are worth exploring.
