Medical Ethics

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Overview of Establishment of Medical Ethics Committee of Tongji Hospital, Tongji Medical College of HUST

In order to strengthen and regulate the management of ethical review of biomedical researches involving human subjects, Tongji Hospital, reorganized its Medical Ethics Committee and improved the relevant systems and standard operating procedures (SOPs) in accordance with ethical principles accepted both in China and the rest of the world as well as relevant regulatory and statutory requirements in January 2016. In December 2017, the Medical Ethics Committee was registered in the National Medical Research Registration Information System in accordance with the requirements of the Health and Family Planning Commission of Hubei Province.


Following the principle of independence, diversity and transparency, the Medical Ethics Committee of Tongji Hospital carries out ethical reviews of drug clinical trials, medical device and reagent clinical trials, and other biomedical researches involving human subjects conducted in the Hospital in accordance with the Declaration of Helsinki (2013), the Measures for the Ethical Review of Biomedical Research Involving Human Subjects (2016), the Good Clinical Practice (2020), the Good Clinical Practice for Medical Devices (2016), and other laws and regulations. The Medical Ethics Office is located in the Department of Scientific Research, with one director and one secretary (part-time) who are responsible for the routine management of the Medical Ethics Committee. The Medical Ethics Committee reviews biomedical researches involving human subjects to be conducted in the Hospital primarily through conference review and expedited review.


Any biomedical researches involving human subjects to be conducted in the Hospital must be reviewed by the Medical Ethics Committee before its implementation and can be implemented only after it is approved by the Medical Ethics Committee. During the implementation of biomedical researches involving human subjects, the Medical Ethics Committee will implement further follow-up and review as necessary to strengthen process supervision and management, to ensure the safety and health of subjects and protect the rights and interests of subjects.

 


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