GB/T 47332-2026Biobanks - Sharing specification for human biological materials and related data (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed and is under the jurisdiction of the National Technical Committee on Standardization of Biosamples (SAC/TC559). This document was drafted by: Shanghai ChipSuper Biotechnology Co., Ltd., China Biotechnology Development Center, and Guangdong Provincial Hospital of Traditional Chinese Medicine (Guangzhou University of Traditional Chinese Medicine). The Second Affiliated Hospital of Fudan University, Beijing Friendship Hospital affiliated to Capital Medical University, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Fudan University Chinese Center for Disease Control and Prevention, National Health Commission Institute of Science and Technology, Shanghai First People's Hospital, Taizhou Enze Medical Center (Group), Zhejiang Cancer Hospital, Fudan University Cancer Hospital, Sun Yat-sen University Cancer Center, Tianjin Cancer Hospital (Tianjin Medical University) University Cancer Hospital), Tianjin First Central Hospital, Peking Union Medical College Hospital, Institute of Zoology, Chinese Academy of Sciences, Fudan University Affiliated Zhongshan Hospital of Xi'an Medical University, Xijing Digestive Diseases Hospital of Air Force Medical University, West China Hospital of Sichuan University, Shanghai Institute of Biomedical Technology, China Institute of Hematology, Chinese Academy of Medical Sciences; Shanghai Branch of Beijing Han Kun Law Offices; Shenzhen Medical University College, Guangzhou National Laboratory, Shenzhen Center for Disease Control and Prevention, First Affiliated Hospital of Xi'an Jiaotong University, Shantou Central Hospital, Chongqing Municipal Public Health Medical Treatment Center, Hangzhou Seventh People's Hospital (Hangzhou Psychological Crisis Research and Intervention Center), Beijing Municipal Laboratory Animal Management Center Beijing Municipal Human Genetic Resources Management Office, Shanghai Biochip Co., Ltd., Shanghai East Hospital (affiliated with Tongji University) Oriental Hospital), Qingdao Dashu Huachuang Technology Co., Ltd., Shanghai Yikang Medical Laboratory Co., Ltd., Jiangsu Shenlv Life Science Technology Co., Ltd. Company. Qingdao Haier Biomedical Co., Ltd. The main drafters of this document are. Gao Hengjun, Zhang Xiaoyan, Du Lili, Zhu Min, Chen Qubo, Zhang Yun, Kang Xiaonan, Yang Yajun, Wei Qiang, and Gao Huafang. Chen Huan, Lin Aifen, Zheng Zhiguo, Sun Menghong, Zheng Xiaohui, Li Haixin, Wang Zhenglu, Guo Dan, Hao Jie, Li Ka, Nie Yongzhan, Huang Wei, Li Jizong, Ma Shihui Gu Yang, Zhang Yuzhen, Li Qiyuan, Zhong Wen, Lü Ziquan, Wang Weiye, Wang Yawen, Wang Shaohong, Wang Yuanyuan, Chen Yemiao, Xu Yan, Wang Xi, Zhao Qinghui, Lang Xumei, Lu Sijia, Zhang Tieqiang, Liu Zhanjie. Biobank of human biological samples and related data Shared Specifications

1 Scope

GB/T 47332-2026 is the Chinese national standard covering sharing human samples and the data attached to them - the consent that has to cover the sharing, the de-identification, the access review, the material transfer terms and the record of where a sample has gone. First edition, in force since 1 July 2026. It was issued on 31 March 2026 and has been in force since 1 July 2026, as a first edition. The document is under the responsibility of the Standardization Administration of China. This page is published from the official record of the 2026 edition; the clause text of a standard this recent is not yet in circulation, and the figures, limits and tables it contains are those of the document itself, delivered in full with the English translation.

This document specifies the principles, sharing assurance requirements, sharing process, and sharing procedures for sharing human biological samples and related data in biobanks. Management requirements. This document applies to the sharing of human biological samples and related data in biobanks.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

GB/T 35273 Information Security Technology - Personal Information Security Specification

GB/T 37864-2019 General requirements for the quality and competence of biobanks

GB/T 38736 Ethical Requirements for the Preservation of Human Biological Samples

GB/T 39766-2021 Management Standards for Human Biobanks

GB/T 39767-2021 Standard for the Management of Human Biosamples

3 Terms and Definitions

The terms and definitions defined in GB/T 37864-2019, GB/T 39766-2021, and GB/T 39767-2021, as well as the following terms and definitions, apply. This document.

3.1 compliance Fulfill all legal and contractual responsibilities and obligations of the organization. [Source: GB/T 35770-2022, 3.26, with modifications]

3.2 Sharing Biobanks provide human biological samples and related data to requesters in accordance with relevant agreements to complete scientific research or legal procedures. Other purposes permitted by law.

3.3 Individuals or organizations that request the sharing of biological samples and/or related data with a biobank.

Note. Hereinafter referred to as the sample demand side.