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GB/T 38736-2020: Ethical requirement of human biobanking
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Ethical requirement of human biobanking
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GB/T 38736-2020
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Basic data | Standard ID | GB/T 38736-2020 (GB/T38736-2020) | | Description (Translated English) | Ethical requirement of human biobanking | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 07.080 | | Word Count Estimation | 10,128 | | Date of Issue | 2020-04-28 | | Date of Implementation | 2020-11-01 | | Quoted Standard | GB/T 32089-2015; GB/T 37864-2019 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | | Summary | This standard specifies human biological samples (hereinafter referred to as "samples"), including the collection, collection, preservation, distribution, and use of human biological samples, including organs, tissues, cells, etc., containing human genome, genes and other genetic materials. Ethical requirements for relevant data. This standard applies to clinical trials, clinical drug development trials and international and domestic scientific research cooperation using human biological samples. This standard does not apply to sample-related activities for the purpose of clinical diagnosis and treatment, organ transplantation, crime investigation, forensic identification, blood collection and supply services, doping testing and funerals. | GB/T 38736-2020: Ethical requirement of human biobanking---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ethical requirment of human biobanking
ICS 07.080
C40
National Standards of People's Republic of China
Ethical requirements for the preservation of human biological samples
2020-04-28 release
2020-11-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Contents
Foreword I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Ethical principles for the preservation of human biological samples 2
5 Informed consent 3
6 Privacy and protection 4
7 Use of samples 4
8 Intellectual Property Protection 5
9 Conflict of interest 5
10 Benefit Sharing 5
11 Ethics Committee and Ethics Review 5
Reference 7
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed and managed by the National Biological Sample Standardization Technical Committee (SAC/TC559).
This standard was drafted by. Fudan University, Shanghai National Engineering Research Center for Biochips, Shanghai Xinchao Biotechnology Co., Ltd., National Health
Institute of Science and Technology of the Family Planning Commission, Shanghai Fourth People's Hospital Affiliated to Tongji University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai
Renji Hospital Affiliated to Haijiao University Medical College, Cancer Hospital Affiliated to Fudan University, Zhongshan Hospital Affiliated to Fudan University, Oriental Hepatobiliary Surgery Hospital,
Shanghai Pharmaceutical Clinical Research Center, Shenzhen Huada Life Science Research Institute, China Hematopoietic Stem Cell Donor Database Management Center, Suzhou Yikang
Medical Laboratory Co., Ltd., Institute of Medical Biology, Chinese Academy of Medical Sciences, School of Medical Humanities of Peking University, Qilu Hospital of Shandong University, Shanghai
Hai Changzheng Hospital, Hangzhou Baiban Biotechnology Co., Ltd.
The main drafters of this standard. Jin Li, Gao Hengjun, Ma Xu, Yang Yajun, Li Ka, Man Qiuhong, Zhang Xiaoyan, Gao Huafang, Wang Weiye, Hu Qingli,
Chu Jiayou, Zhu Wei, Lu Daru, Wang Guoyu, Lu Ming, Xu Jingman, Jiang Yueming, Zhang Yang, Chen Xingdong, Peng Zuoqi, Zhang Kehao, Sun Menghong, Kang Xiaonan,
Wang Xueqi, Yang Yuan, Chen Haidan, Liu Shijian, Yao Haisong, Gao Dongying.
Introduction
The activities related to the preservation of human biological samples mainly include collection, collection, preservation, distribution, transmission, use and processing, sharing, transfer,
Results release, drug development, international cooperation, etc.
The collection and use of human biological samples are based on respect for human rights.
Protect the dignity, privacy, interests, safety, health of all scientific research participants, and ensure that everyone is free from discrimination.
Human biological samples can only be collected and collected with the prior, free, clear and written consent of the relevant personnel for future
Conduct scientific research.
Ethical requirements for the preservation of human biological samples
1 Scope
This standard specifies human biological samples (hereinafter referred to as "samples"), including organs and groups containing human genome, genes and other genetic material
The ethics of collection, collection, storage, distribution, use, etc. of tissues and cells, and the ethical requirements of data related to these samples.
This standard applies to clinical trials, clinical drug development trials, and international and domestic scientific research cooperation conducted using human biological samples.
This standard does not apply to clinical diagnosis and treatment, organ transplantation, crime investigation, forensic identification, blood collection and supply services, doping testing, and funerals.
Sample related activities for the purpose.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 32089-2015 Scientific and technological research project intellectual property management
GB/T 37864-2019 General requirements for the quality and capability of biological sample banks
3 Terms and definitions
The terms and definitions defined in GB/T 37864-2019 and the following apply to this document.
3.1
Human biological material
In order to carry out scientific research, various organs, tissues, cells and other biological materials obtained from the human body, including but not limited to blood, skin, bone marrow,
Muscles, hair, secretions, internal organs, sperm and egg cells, etc.
Note. contains two parts of human biological samples and related data.
3.2
Human biological material data
Contains biological characteristics information related to the sample itself, using human biological sample materials to generate, for example, genome sequencing data, database samples
The general name of the type, quantity, storage location, classification and other information of the book.
3.3
Human biobank
An entity that manages and operates human biological samples.
Note. The main work includes collecting, collecting, using and processing human biological samples and related data.
3.4
Collection colection
The process of obtaining the required human biological samples and their associated data through legal and compliant methods and storing them temporarily.
3.5
Collect gather
The process of collecting human biological samples collected from multiple areas and storing them for future use in a variety of ways.
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