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Common Minimum Technical Standards and Protocols for Biological WORLD HEALTH ORGANIZATION INTERNATIONAL AGENCY FOR RESEARCH ON CANCER IARC Working Group Reports Volume 2 COMMON MINIMUM TECHNICAL STANDARDS AND PROTOCOLS FOR BIOLOGICAL RESOURCE CENTRES DEDICATED TO CANCER RESEARCH Published by the International Agency for Research on Cancer, 150 cours Albert Thomas, 69372 Lyon Cedex 08, France © International Agency for Research on Cancer, 2007 Distributed by WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 3264; fax: +41 22 791 4857; email: [email protected]). Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city, or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The authors alone are responsible for the views expressed in this publication. The International Agency for Research on Cancer welcomes requests for permission to reproduce or translate its publications, in part or in full. Requests for permission to reproduce or translate IARC publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). IARC Library Cataloguing in Publication Data Common Minimum Technical Standards and Protocols for Biological Resource Centres dedicated to Cancer Research / editors, E. Caboux, A. Plymoth, P. Hainaut (IARC Working Group Reports ; 2) 1. Biomedical Research – Standards 2. Biological Specimen Banks – Organization & Administration 3. Biological Specimen Banks – Standards 4. Neoplasms. IV. Title V. Series ISBN 9789283224426 (NLM Classification: W1) This report was prepared at the initiative of the IARC World Cancer Forum, a network of Directors of National Cancer Centres coordinated by IARC. Its development has involved several steps. After the initial meeting of the workgroup in Singapore on April 19-21, 2006, a draft report was issued in November 2006 and widely circulated through the IARC website for a 6-month consultation period. Comments, remarks, criticisms and recommendations on additional information that were received during the consulation period were taken into account to prepare the final report. The report was compiled and edited by an IARC secretariat composed of Elodie Caboux, Amelie Plymoth and Pierre Hainaut. In publications, it should be referred to as: COMMON MINIMUM TECHNICAL STANDARDS AND PROTOCOLS FOR BIOLOGICAL RESOURCE CENTRES DEDICATED TO CANCER RESEARCH, WorkGroup Report 2, Caboux E, Plymoth A and Hainaut P, Editors, IARC, 2007. i ii TABLE OF CONTENTS Working group participants vii Preamble ix Definitions xi Roles of biological resource centres in cancer research 1 Importance of BRCs 1 BRCs are critical for cancer research 1 BRCs are important for developing personalised medicine 1 BRCs have an impact on biotechnological and medical innovation 2 Importance of networking and exchanges between BRCs 2 Issues in developing BRCs and using banked specimens 2 Principles for sustainable BRCs 3 Recommendations for BRCs 5 Protection of persons 5 Biological hazards 5 General laboratory safety 5 Data management and informatics security 6 Biosecurity 6 General considerations for establishing a BRC 6 Institutional commitment 6 BRC management and staff 7 Infrastructure and facilities 7 Storage conditions 8 Cryopreservation 8 Other fixation and preservation methods 9 Liquid nitrogen (LN2) tanks 10 Mechanical freezers 10 Dry ice 10 Standard operating procedures 11 Records management 11 Specimen labelling 11 Specimen collection, processing and storage 12 Collection of blood or blood-derived products 12 Blood 12 Buffy coat 13 Collection of solid tissues 14 Collection of other specimens 14 Urine 14 Buccal cells 14 Cytobrush 14 Mouthwash 15 Treated cards 15 Saliva 15 iii Bronchoalveolar lavage (BAL) 15 Bone Marrow Aspirate (BMA) and Fine Needle Aspirate (FNA) 16 Cerebrospinal fluid (CSF) 16 Semen 16 Cervical and urethral swabs 17 Hair 17 Nail 17 Specimen annotations, data collection 17 Annotations on patients/individuals 17 Annotations on stored specimens 18 Quality control 18 Specimen shipping 18 Regulations 19 Packaging 19 Labelling 20 Access to stored materials and data for research purposes 20 Principles for international specimens exchanges 21 BRC work flow pattern 22 Selected protocols 23 Processing of blood specimens 23 Filter papers 23 Blood pellets (white cells) 23 Plasma 24 Platelet-poor plasma 24 Serum 24 White blood cells 24 Buffy coat cells 25 Whole blood 25 Processing of solid tissue specimens 25 Snap-freezing 25 Formalin fixation 28 RNAlater 28 Processing of urine and buccal cells 28 Urine 28 Buccal cells 29 Saliva 29 Processing of cervical cells 30 Processing of hair and nails 31 Hair 31 Nails 31 Annexes Abbreviations 32 Glossary 33 Bibliography 35 iv WORKING GROUP PARTICIPANTS Drs Peter Boyle, Paolo Boffetta, Dr Petcharin Srivatanakul Pierre Hainaut, Melissa Southey Chief, Cancer Control Unit and Bakary Sylla National Cancer Institute International Agency for Research on Cancer 268/1 Rama VI Rd. 150 cours Albert Thomas Bangkok 10400, Thailand 69008 Lyon, France Professor Khee Chee Soo Professor Ketayun Dinshaw Director Director National Cancer Centre Tata Memorial Centre 11 Hospital Drive E. Borges Marg., Parel Singapore 169610, Singapore Mumbai 400 012, India Professor Yun-tian Sun Dr Balman Singh Karki Director, Pathology Department Executive Director Cancer Institute, CAMS B.P. Koirala Memorial Cancer Hospital Peking Union Medical College Bharatpur, Chitwan, Nepal Panjiayuan, Chaoyang District Beijing 100021, China Professor David Kerr Department of Clinical Pharmacology Professor Robert Thomas University of Oxford Director, Division of Surgical Oncology Radcliffe Infirmary Peter MacCallum Cancer Institute Woodstock Road St Andrew’s Place Oxford OX2 6HE, United Kingdom Melbourne 3002, Victoria, Australia Dr Thiravud Khuhaprema IARC Secretariat Director Ms Caroline Granger National Cancer Institute International Agency for Research on Cancer Rama VI Road, Rajthevi 150 cours Albert Thomas Bangkok 10400, Thailand 69008 Lyon, France Dr In-Hoo Kim NCCS Secretariat Director, Research Institute Ms Lee Shok Chuin National Cancer Center Post Graduate Cancer Education 809 Madu 1-dong, Ilsan-gu National Cancer Centre Goyang-si Gyeonggi-do 11 Hospital Drive 411769 Seoul, Korea Singapore 169610, Singapore Dr Gilbert Lenoir Directeur de la Recherche Institut Gustave Roussy 39 rue Camille Desmoulins 94805 Villejuif cedex, France v Acknowledgements: The Workgroup and editors are grateful to the many expert colleagues that contributed comments, advice, corrections and protocols and among them: Chris Bajdik Nicole Lockhart Cancer Control Research Program - BC Cancer National Institutes of Health - National Cancer Agency Institute - Office of Biorepositories and Biospecimen 3.114 - 675 West 10th Avenue Research Vancouver BC V5Z 1L3 Building 31, Room 10A49 Canada 31 Center Drive, MSC 2580 Bethesda, MD 20892-2580 Fay Betsou Unites States of America Biobanque de Picardie BP 7 Peter Riegman 80480 Saleux Head, Erasmus MC Tissue Bank France Coordinator of the European Human Frozen Tissue Bank (TUBAFROST) Jane Cope Department of Pathology National Cancer Research Institute Josephine Nefkens Institute Be 235b PO Box 123 PO box 2040 61 Lincoln’s Inn Fields 3000CA Rotterdam London The Netherlands WC2A 3PX United Kingdom Kurt Zatloukal Medical University of Graz - Institute of Pathology Lisa Devereux Auenbruggerplatz 25 Peter Mac Callum Cancer Centre Tissue Bank A-8036 Graz Manager Austria Australasian Biospecimen Network (ABN) Locked Bag 1, A’Beckett St, East Melbourne VIC 8006 Australia Alexandre Passioukov EORTC Avenue Mounierlaan, 83/11 Brussels, 1200 Belgium Beate Pesch BGFA - Institut der Ruhr-Universität Bürkle-de-la-Camp-Platz 1 D-44789 Bochum Germany vi PREAMBLE Biological Resource Centres (BRCs), as defined by the Organisation for Economic Co-operation and Development (OECD), are service providers and repositories of living cells, as well as genomes of organisms, of archived cells and tissues, and of information relating to these materials (Organisation for Economic Co- operation and Development and Directorate for Science, 2001). Collection, annotation and use of human biospecimens are essential activities of cancer research. These processes are becoming critical in allowing patient access to molecular-based diagnosis and prognosis. BRCs need to comply with strict ethical and technical requirements and may be subject to regulation and/or legislation at various levels (institutional, local or national governmental, international). The aim of this document is not to replace such regulations. It is limited to tissue collections not needed for diagnosis or transplantation. The present document focusses on developing recommendations towards common minimum technical standards
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