Final steps towards an ISO standard in Biobanking.

February 6th, 2018 in Committee Update
Contributed by Zisis Kozlakidis (Infection and Immunity,  University College London), Koh Furuta (Kanagawa Cancer Center, Japan), Marianna Bledsoe (Independent Consultant). Brent Schacter (University of Manitoba/CancerCare Manitoba), Clare M. Allocca (National Institute of Standards and Technology), and Nilsa Ramirez  (Nationwide Children’s Hospital, Columbus, OH)

ISBER members of the ISBER ISOTC276 Task Force have made substantial and important contributions to the process of development of the ISO20387 Biobanking Standard, now nearing completion. ISOTC276

An International Standard for Biobanking is now in sight following a recent ISO/TC276/WG2 meeting at the DIN-German Institute for Standardization in Berlin (23rd – 25th of January 2018). ISO/TC276/WG2 addressed the remaining submitted comments for the Draft International Standard (ISO/DIS 20387).  The document is poised to proceed to the next stage, Final Draft International Standard or FDIS during which only editorial comments may be submitted. In practical terms this means that the ISO standard in biobanking is now anticipated to have a publication date in late 2018 or early 2019.

ISBER had a strong presence throughout the process and the comments provided by its membership and the ISBER ISOTC276 Task Force (led initially by Fay Betsou and then by Koh Furuta) contributed greatly to the discussions. In particular, ISBER members Brent Schacter and Nilsa Ramirez led on the consistent use of language while Clare Allocca and Marianna Bledsoe contributed to various sections including Terms and Definitions, ethical issues, and applicability of the standard.

The extensive discussions held during the last two working group meetings at Rome and Berlin resolved many issues that rose during the consultation period.  Revisions of language and specific wording have resulted in a document that is easier to read and understand. The use of specific and well defined terms was of particular importance as this standard is expected to shape operations in the biobanking field in the future.

The current version of ISO/DIS 20387 was developed with a majority of experts from the human domain.  As a result, it may be perceived as less inclusive of non-human domains. These challenges will be initially addressed in the explanatory document for the ISO standard in Biobanking, ISO/AWI TR 22758, with an anticipated publication date in early 2019. Information relating to the latter document will be made available to the ISBER ISO Task Force and ISBER Standards Committee in due course.  For additional information see [BIOPRESERVATION AND BIOBANKING, Volume 16, Number 1, 2018, DOI: 10.1089/bio.2017.0117]

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