免除伦理审查的操作与思考

Operation and Reflection on Exemption from Ethical Review

伦理审查是在开展涉及人的生命科学和医学研究时,对研究参与者的重要保护措施。2023年2月发布的《涉及人的生命科学和医学研究伦理审查办法》提出了“免除伦理审查”。为了在法律法规许可的范围内推行免伦理审查,在利用研究参与者的数据信息和生物样本时,保护好研究参与者的隐私和权益,需要考虑多方面的因素:谁承担免除伦理审查的职责、免除伦理审查的条件,以及免伦理审查的具体流程。与所有审查程序一样,免除审查也需要制定相应的制度,落实责任,并依赖于受试者保护体系建设,希望通过讨论能为免除伦理审查的实施开展提供思考。

Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans.Exemption from ethical review was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023.To implement the exemption from ethical review within the permitted scope of laws and regulations,and to protect the privacy and rights of research participants when utilizing their data information and biological samples,multiple factors need to be considered,including the person responsible for exemption from ethical review,the conditions for exemption from ethical review,and the specific process for exemption from ethical review.As with other review procedures,exemption from ethical review also required the development of corresponding systems,implementation of responsibilities,and reliance on the construction of subject protection systems.It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.