Reflection and Practice on Exemption from Ethical Review / 中国医学伦理学

According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.

Practice and cogitation of ethical review of medical research involving human subjects / 中华医学科研管理杂志

Objective To enhance the recognition of the ethical principles and provide reference for the ethical review in medical research involving human subjects.Methods By summarizing the ethical review of the projects involving human subjects in past three years,analyzing common issues identified,and proposing the corresponding solutions.Results Conducting ethical review for research involving human subject according to ethical principles,is helpful for the protection of human subject,and also for the internationalization of medical research in China.Conclusions For the development of medical research in long term,the ethical review is necessary.All investigators need to improve their understandings and execute the ethical principles well in their research practice.

The Common Issues During the Meeting of Ethic Review(II)-Comparison of the ethic committee meeting between China and U.S.A / 中国医学伦理学

This paper specifically elaborated the ethics committee of China and the United States review meet-ing in the project report , project FAQ, ethical discussion , voting and so on each link , analyzes the ethical review mode difference between the two countries , and according to the mode of ethical review meeting in China and the United States are compared , and the model helps to find their own ethical review meeting , improve their efficiency of ethical review committee meeting .

Practice and experience of ethic review of clinical researches / 中华医学科研管理杂志

With the development of techniques and methods of medical researches, the ethic review of clinical research has become essential for healthy development of medical research. This article analyseds the practice of ethic reviews of research projects involving human subjects in our hospital and the difficulties in the process are discussed.

Using Medical Staff' Understanding of Medical Ethics to Guide the Medical EthicsEducation / 中国医学伦理学

Objective: To understand the medical staff' cognition of medicalethics.Method: Descriptive study and various analysis were performed. Results: Four aspects including the understanding of hospital Ethic Review Committee, the status of medical ethics education, the understanding of medical ethics in clinic and research, the requirement of medical ethics training were surveyed among the medical staff in five hospitals. Conclusion: The influence of medical ethics in clinical practice and medical research were greatly improved. The hospital Ethic Review Committee should be strengthened and a lot of works was needed for medical ethics education.