Technical specifications for ethics review of human stem cell research

Author:

Peng Yaojin12345ORCID,Ma Aijin56,Xiao Zhenyu57,Hao Jie12358ORCID,Feng Ruohan12,Wang Changlin59,Hu Baoyang12345ORCID,Zhai Peijun510,Li Ka511,Wang Lei12358,Cao Jiani12345,Xiang Peng512,Zhang Yu513ORCID,Wei Jun513,Wang Xiaolong514,Fu Boqiang515,Chen Qubo516,Wei Qiang517,Gao Hengjun1819,Lv Jianwei20,Liu Xing21,Ma Yonghui20,Cheng Tao22,Huang Xiaoru3,Su Yeyang23,Zhang Haihong24,Zhou Qi1235ORCID,Zhao Tongbiao12345ORCID

Affiliation:

1. State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences Beijing China

2. Beijing Institute for Stem Cell and Regenerative Medicine Beijing China

3. University of Chinese Academy of Sciences Beijing China

4. Institute for Stem Cell and Regeneration, Chinese Academy of Sciences Beijing China

5. Chinese Society for Stem Cell Research Shanghai China

6. Beijing Technology and Business University Beijing China

7. School of Life Science, Beijing Institute of Technology Beijing China

8. National Stem Cell Resource Bank, Institute of Zoology, Chinese Academy of Sciences Beijing China

9. China National Institute of Standardization Beijing China

10. China National Accreditation Service for Conformity Assessment Beijing China

11. Institute of Clinical Science, Zhongshan Hospital Fudan University Shanghai China

12. Center for Stem Cell Biology and Tissue Engineering, Key Laboratory for Stem Cells and Tissue Engineering, Ministry of Education Sun Yat‐Sen University Guangzhou China

13. Zephyrm Biotechnologies Co., Ltd Beijing China

14. China National Research Institute of Food and Fermentation Industries Beijing China

15. National Institute of Metrology Beijing China

16. State Key Laboratory of Dampness Syndrome of Chinese Medicine The Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China

17. National Pathogen Resource Center, Chinese Center for Disease Control and Prevention Beijing China

18. Tongji Hospital, School of Medicine Tongji University Shanghai China

19. Institute of Digestive Disease, School of Medicine Tongji University Shanghai China

20. Xiamen University Xiamen China

21. Xiangya Hospital Central South University Changsha China

22. State Key Laboratory of Experimental Hematology and National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin China

23. Institute of Basic Medicine and Cancer, Chinese Academy of Sciences Hangzhou China

24. Peking University Health Science Center Beijing China

Abstract

AbstractThe rapid advancement of human stem cell research and its expansion into emerging areas has resulted in an escalation of ethical challenges associated with these studies. As a result, there has been a corresponding increase in both the volume and complexity of institutional ethics reviews, coupled with higher expectations for the quality of the review process. In response to these challenges, this standard provides a comprehensive outline of the fundamental principles, content, types, and procedures of ethics review, specifically focusing on non‐clinical human stem cell research. Its purpose is to provide clear operational and procedural guidelines, as well as recommendations, for the ethics review of such studies. The document was originally published by the Chinese Society for Cell Biology on August 30, 2022. It is our hope that the publication of these guidelines will facilitate the integration of ethical considerations and evaluations in a structured manner throughout the entire process of stem cell research, ultimately fostering a healthy and orderly development of the field.

Funder

National Key Research and Development Program of China

Youth Innovation Promotion Association of the Chinese Academy of Sciences

Publisher

Wiley

Subject

Cell Biology,General Medicine

Reference9 articles.

1. T11/CSSCR 001 General Requirements for Stem Cells.

2. Translation 2021 International Society for Stem Cell Research. Guidelines for stem cell research and clinical

3. T/CSCB 0002‐2020 Human Embryonic Stem Cell.

4. Ministry of Science and Technology. Ethical guidelines for human embryonic;Ministry of Health;Stem Cell Res,2003

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