China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines

Abstract

China's newly revised and released Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings has established more detailed and comprehensive ethical review rules. The revised rules incorporate the Ancient Chinese Medical Ethics (ACME) and fully reflect concern for the respect and protection of human beings. However, the rules still have problems, such as poor interface with the 2016 rules, or that corporate entities are not included in the regulatory scope. Moreover, the actual effect is still to be tested in practice. Entities conducting life science and medical research activities involving human beings in China need to pay attention to the compliance requirements on research ethics review implied by the new rules, such as research qualification, research value, confidentiality obligations, etc., as well as the ethics review requirements for specific populations, in order to reduce the corresponding risk of research ethics review.