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Draft Biobanking Standards Now Open for Comment

Tuesday, July 25, 2017   (1 Comments)
Posted by: Samantha Wale
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ISO/DIS 20387 Biotechnology – Biobanking – General requirements for biobanking 

Comments are encouraged on the draft International Standard, ISO/DIS 20387, “Biotechnology-Biobanking-General requirements for biobanking”.

Per the scope, ISO/DIS 20387 is intended to be applicable to “all organizations performing biobanking activities, including biobanking of human, animal, plant and microorganism resources for research and development.”  It achieves its objectives by providing a set of requirements to “enable biobanks to demonstrate that biobanking entities operate competently and are able to provide biological resources (biological material and associated data) of appropriate quality.” These requirements include the competence of personnel, validation of methods, and quality control. This International Standard (IS) will ultimately be accompanied by an explanatory document containing guidance on the implementation of the IS to biobanking entities of various size, application, emphases and resources.  For additional information please see the ISBER Corner Article published in the August issue of Biopreservation and Biobanking available for download here.

The scientific community is invited and urged to participate in the review of this document. 

Information on how to access ISO/DIS 20387 Biotechnology – Biobanking – General requirements for biobanking and provide comments:

ISBER Members:

ISBER members may obtain access to the document and additional instructions on how to submit comments by clicking here

Non-ISBER Members:

Non-ISBER members will need to contact their individual country mirror committees for access to the document and information on the process and timeline for submitting comments. In order to assist you, a list of contacts for some countries is provided here.

Comments...

Carol J. Weil says...
Posted Friday, September 8, 2017
Regarding: Confidentiality 4.3.1 The biobank shall ensure the protection of its biological resources’, providers’ and users’ confidential information and proprietary rights, including protecting the electronic storage and transmission of data. It is no longer impossible to ensure protection of confidential information. I suggest changing "ensure" to "make best efforts to minimize risks to privacy and confidentiality of information". Carol Weil, NCI, USA

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