T/XMSA 002-2023 Active Group standards

T/XMSA 002-2023 Collection Technical Specification for Healthy Human Gut Microbiota Biological Samples

Publish Date: 2023-02-20 Implement Date: 2023-02-28 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/XMSA 002-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Laboratory medicine

Publish Date: 2023-02-20

Implement Date: 2023-02-28

Scope

Scope: This document specifies the terms and definitions for the collection of biological samples of healthy human gut microbiota, the review of collection procedures, collection protocols, donor screening and management, and standardized collection of samples. This document applies to the collection of biological samples of healthy human gut microbiota. Main technical content: Terms and definitions for the collection of biological samples of healthy human gut microbiota. The review of collection procedures and collection protocols ensure the legality of the biological sample sources. In accordance with GB/T 38736 "Ethical Requirements for the Preservation of Human Biological Samples", donors should sign an informed consent form (Appendix H) and register in the biological sample bank. Before collecting biological samples, relevant ethical review approval documents should be obtained. The collection of biological samples should comply with the regulatory requirements of the "Regulations on the Management of Human Genetic Resources". After passing the screening, volunteers become qualified donors. However, they still need to undergo necessary health consultations before each donation and have an obligation to report back. That is, if the donor believes that the donated feces may pose a safety risk, they should immediately contact the biological sample bank for feedback. The biological sample bank has an obligation to protect the donor's privacy. To fully protect the donor's privacy and ensure traceability of information, the biological sample bank should establish donor coding rules, which should not include the donor's name, ID card number, or other personal information. The code should be unique and managed by dedicated personnel. For donors who are unsuitable for donation or cannot continue donating feces, appropriate explanations should be provided, and their personal information should be protected. The biological sample bank should establish procedures for ensu