Understanding the update of application materials for initial ethics review of human life sciences and medical research / 中华医学科研管理杂志

ABSTRACT

Objective:To sort out the new requirements for the initial ethical review application materials put forward by the Measures for the Ethical Review of Life Science and Medical Research Involving Humans that issued in 2023, to explore the ethical considerations behind these new requirements, and to put forward feasible suggestions on the key details and practical operations that should be paid attention to in the preparation of various initial ethical review application materials, so as to provide a certain reference for researchers, ethical review committees and institutions to standardize and promote ethical review.Methods:Compared with the relevant provisions of the 2016 Measures for the Ethical Review of Biomedical Research Involving Humans, this paper discusses the frontier hotspots of ethical theory and the practice of ethical review.Results:The preparation of application materials for initial ethical review should be based on an accurate understanding of the Measures, emphasize compliance, and avoid formally implementing regulatory requirements and increasing unnecessary burdens.Conclusions:It is the responsibility of researchers to prepare high-quality ethical review application materials, but institutions and ethical review committees must provide corresponding support, including clarifying the latest requirements of policies and regulations, updating the standard operating procedures of ethical review of their institutions, and ensuring timely and continuous ethical training and ethics consultation for researchers. The standardization and improvement of ethical review work requires a more comprehensive perspective and systematic planning to strengthen the responsibility of all parties.