GB/T 38736-2020Ethical requirement of human biobanking (English PDF)
人类生物样本保藏伦理要求
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for GB/T 38736-2020 in 30 minutes.
Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
April 28, 2020
Implementation date
November 1, 2020
Scope
GB/T 38736-2020 is the English-translated version of 人类生物样本保藏伦理要求.
GB/T 38736-2020 sets the ethical requirements that govern human biological samples - organs, tissues and cells containing the human genome, genes and other genetic material - and the data related to those samples, across their collection, storage, distribution and use.
Clause 1 says the standard applies to clinical trials, clinical drug development trials and international and domestic scientific research cooperation carried out using human biological samples, and that it does not apply to sample-related activities whose purpose is clinical diagnosis and treatment, organ transplantation, crime investigation, forensic identification, blood collection and supply services, doping testing or funerals.
After the scope, the normative references and the terms, the body runs through Ethical principles for the preservation of human biological samples, Informed consent, Privacy and protection, Use of samples, Intellectual Property Protection, Conflict of interest, Benefit Sharing and Ethics Committee and Ethics Review, and closes with a reference list.
Clause 2 cites GB/T 32089-2015 and GB/T 37864-2019. Clause 3 adopts the terms defined in GB/T 37864-2019 and adds its own, among them human biological material, human biological material data, human biobank, collection and collect.
The introduction states that the activities concerned include collection, preservation, distribution, transmission, use and processing, sharing, transfer, release of results, drug development and international cooperation, and that human biological samples may only be collected with the prior, free, clear and written consent of the people concerned, for scientific research to be conducted later.
The standard was proposed and is managed by the National Biological Sample Standardization Technical Committee (SAC/TC559), and the page records it under ICS 07.080 and the Chinese classification C40. It was issued on 2020-04-28 and has applied since 2020-11-01.
Found what you need?
Document preview — GB/T 38736-2020
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- C 40
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Ethical principles for the preservation of human biological samples
- 5 Informed consent
- 6 Privacy and protection
- 7 Use of samples
- 8 Intellectual Property Protection
- 9 Conflict of interest
- 10 Benefit Sharing
- 11 Ethics Committee and Ethics Review
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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.
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 document. 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
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
The process of collecting human biological samples collected from multiple areas and storing them for future use in a variety of ways.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
Cited by
- GB/T 47332-2026Biobanks - Sharing specification for human biological materials and related data
- GB/T 45633-2025Collection and processing of human saliva biomaterial
- GB/T 43776-2024Technical specification of sample collection and processing for single cell sequencing
- GB/T 39766-2021Management specification for human biobank
Similar standards
How to Download GB/T 38736-2020
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 32089-2015 — Intellectual property rights management in science and technology research projects
GB/T 37864-2019 — General requirements of quality and competence for biobank
GB/T 7251.4-2026 — Low-voltage switchgear and controlgear assemblies - Part 4: Particular requirements for assemblies for construction sites (ACS)
Secure payment via Stripe
Payments accepted
GB/T 38736-2020
$150.00