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Biobanking: Methods and Protocols

William H. Yong
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Methods in
Molecular Biology 1897

William H. Yong Editor

Biobanking
Methods and Protocols
METHODS IN MOLECULAR BIOLOGY

Series Editor
John M. Walker
School of Life and Medical Sciences
University of Hertfordshire
Hatfield, Hertfordshire, AL10 9AB, UK

For further volumes:


http://www.springer.com/series/7651
Biobanking

Methods and Protocols

Edited by

William H. Yong
Division of Neuropathology, Department of Pathology and Laboratory Medicine,
Brain Tumor Translational Resource, Jonsson Comprehensive Cancer Center,
David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
Editor
William H. Yong
Division of Neuropathology
Department of Pathology and Laboratory Medicine
Brain Tumor Translational Resource
Jonsson Comprehensive Cancer Center
David Geffen School of Medicine at UCLA
Los Angeles, CA, USA

ISSN 1064-3745 ISSN 1940-6029 (electronic)


Methods in Molecular Biology
ISBN 978-1-4939-8933-1 ISBN 978-1-4939-8935-5 (eBook)
https://doi.org/10.1007/978-1-4939-8935-5
Library of Congress Control Number: 2018962741

© Springer Science+Business Media, LLC, part of Springer Nature 2019


This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is
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Dedication

In memory and honor of Dr. Henry Yong, Dr. Carl Chan, and Brigham Olson

With heartfelt thanks to Patricia, Marjorie, and Max

v
Preface

Biospecimens are the fuel that feeds the engine of modern biomedical research, and
biobanks are critical to harvesting, storing, and providing that fuel. This book covers
numerous practical topics in biomedical banking. It was crafted and written with the hope
and belief that it would be of value for novice biobankers, for practicing biobankers, and for
end-user researchers. Besides many common biobanking topics, the book spans areas not
often touched including an overview of what is needed to start a biobank, training of new
biobanking personnel, and ethnic representation in biospecimen collection. Fascinating
chapters pertaining to aspects of flora and fauna biobanking provide different insights into
our field and expand the horizons of those of us in biomedical biobanking. In particular, it is
my hope that this book is an incremental contribution toward sending cancer and other
diseases into the dusty confines of ancient history. This book would not have been possible
without the many wonderful patients, families, and colleagues who have supported our
biobanking work through the Art of the Brain Foundation at UCLA. I thank also the many
laboratory members especially Sergey Mareninov who through the years have done the hard
work at the bench. Lastly, I would like to acknowledge Dr. Afreen Jasim, Dr. Hannah Lee,
Krishil Gandhi, and Madeline Olson for their generous assistance with logistical aspects of
the book.

Los Angeles, CA, USA William H. Yong

vii
Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Contributors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
1 Sustainability in Biobanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Maram Abdaljaleel, Elyse J. Singer, and William H. Yong
2 An Introduction to Starting a Biobank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Mitra D. Harati, Ryan R. Williams, Masoud Movassaghi,
Amin Hojat, Gregory M. Lucey, and William H. Yong
3 An Introduction to Hardware, Software, and Other Information
Technology Needs of Biomedical Biobanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Kyuseok Im, Dorina Gui, and William H. Yong
4 Disaster Prevention and Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Chon Boon Eng and Wei Ling Tan
5 Minority Participation in Biobanks: An Essential Key to Progress . . . . . . . . . . . . . 43
Paula Kim and Erin L. Milliken
6 Orientation and Training of New Biobank Personnel . . . . . . . . . . . . . . . . . . . . . . . . 51
Ryan R. Williams, Diviya Gupta, and William H. Yong
7 Procurement and Storage of Surgical Biospecimens . . . . . . . . . . . . . . . . . . . . . . . . . 65
Amin Hojat, Bowen Wei, Madeline G. Olson, Qinwen Mao,
and William H. Yong
8 Autopsy Biobanking: Biospecimen Procurement, Integrity, Storage,
and Utilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Randy S. Tashjian, Ryan R. Williams, Harry V. Vinters,
and William H. Yong
9 Procurement, Storage, and Use of Blood in Biobanks . . . . . . . . . . . . . . . . . . . . . . . 89
Jaclyn N. Perry, Afreen Jasim, Amin Hojat, and William H. Yong
10 Procurement, Transportation, and Storage of Saliva, Buccal Swab,
and Oral Wash Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Jennifer S. Woo and David Y. Lu
11 Biobanking of Cerebrospinal Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Randy S. Tashjian, Harry V. Vinters, and William H. Yong
12 Biobanking of Urine Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Neda A. Moatamed
13 Procurement and Storage of Pleural and Peritoneal Fluids
for Biobanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Alberto M. Marchevsky, Shikha Bose, and Beatrice Knudsen
14 Fluid Preservation of Zoological Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Thomas P. V. Hartman
15 Photographing Fluid-Preserved Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
David Glynne Fox and Thomas P. V. Hartman

ix
x Contents

16 Casts of Fluid Preserved Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155


Sarah Burhouse and Thomas P. V. Hartman
17 Collection and Preservation of Terrestrial Arthropods . . . . . . . . . . . . . . . . . . . . . . . 163
Jeffrey D. Whitman, Douglas Yanega, Cole B. G. Watson,
and Vincent W. Strode
18 Procurement and Preservation of Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Allison D. Rudalevige and Jeffrey D. Whitman
19 Biosafety and Biohazards: Understanding Biosafety Levels
and Meeting Safety Requirements of a Biobank. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Lisa Ta, Laura Gosa, and David A. Nathanson
20 Decontamination of Biobank Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Xinhai Zhang, Saied Mirshahidi, and Chien-Shing Chen
21 Laboratory Safety: Chemical and Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Saeed Asiry and Lee-Cyn Ang
22 Making Formalin-Fixed, Paraffin Embedded Blocks . . . . . . . . . . . . . . . . . . . . . . . . . 253
Alireza Sadeghipour and Pegah Babaheidarian
23 Microtomy: Cutting Formalin-Fixed, Paraffin-Embedded Sections. . . . . . . . . . . . 269
Joanne Sy and Lee-Cyn Ang
24 Performing and Cutting Frozen Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
Ramir S. Arcega, Jennifer S. Woo, and Haodong Xu
25 An Introduction to the Performance of Immunohistochemistry . . . . . . . . . . . . . . 289
Shino Magaki, Seyed A. Hojat, Bowen Wei, Alexandra So,
and William H. Yong
26 An Introduction to Performing Immunofluorescence Staining . . . . . . . . . . . . . . . 299
Kyuseok Im, Sergey Mareninov, M. Fernando Palma Diaz,
and William H. Yong
27 Making a Tissue Microarray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313
Matthew Koo, Jill M. Squires, Daphne Ying, and Jiaoti Huang
28 Nucleic Acid Isolation and Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Ling Dong, Janice Yoshizawa, and Xinmin Li
29 Fundamentals of RNA Analysis on Biobanked Specimens . . . . . . . . . . . . . . . . . . . . 345
Samuel P. Strom
30 Nucleic Acid Extraction from Human Biological Samples . . . . . . . . . . . . . . . . . . . . 359
Sureni V. Mullegama, Michael O. Alberti, Cora Au, Yan Li,
Traci Toy, Vanina Tomasian, and Rena R. Xian
31 An Overview of DNA Analytical Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385
Valerie A. Arboleda and Rena R. Xian
32 Shotgun Proteomic Profiling of Bloodborne Nanoscale
Extracellular Vesicles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403
Pete Heinzelman, David N. Powers, James A. Wohlschlegel,
and Varghese John
33 Sample Preparation for Transmission Electron Microscopy . . . . . . . . . . . . . . . . . . . 417
Parastou Tizro, Cecilia Choi, and Negar Khanlou
Contents xi

34 Processing of Primary Patient Tumors and Subsequent Generation


of Primary Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425
Laura Gosa, Lisa Ta, and David A. Nathanson
35 Domestic and International Shipping of Biospecimens . . . . . . . . . . . . . . . . . . . . . . 433
Dominique Gordy, Randy S. Tashjian, Hannah Lee,
Masoud Movassaghi, and William H. Yong

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445
Contributors

MARAM ABDALJALEEL  Division of Neuropathology, Department of Pathology and Laboratory


Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
MICHAEL O. ALBERTI  Department of Pathology and Laboratory Medicine, David Geffen
School of Medicine at UCLA, Los Angeles, CA, USA
LEE-CYN ANG  Department of Pathology (Neuropathology) and Laboratory Medicine,
University Hospital–London Health Sciences Center, London, ON, Canada; Department
of Pathology and Laboratory Medicine, Western University, London, ON, Canada
VALERIE A. ARBOLEDA  Department of Pathology and Laboratory Medicine, David Geffen
School of Medicine at UCLA, Los Angeles, CA, USA
RAMIR S. ARCEGA  Department of Pathology and Laboratory Medicine, David Geffen School
of Medicine at UCLA, Los Angeles, CA, USA
SAEED ASIRY  Department of Pathology, Lenox Hill Hospital–Northwell Health, New York,
NY, USA
CORA AU  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
PEGAH BABAHEIDARIAN  Department of Pathology, Iran University of Medical Sciences,
Tehran, Tehran Province, Iran
SHIKHA BOSE  Department of Pathology and Laboratory Medicine, Cedars Sinai Medical
Center, Los Angeles, CA, USA
SARAH BURHOUSE  Natural History Museum at Wollaton Hall, Nottingham, UK
CHIEN-SHING CHEN  Biospecimen Laboratory, Loma Linda University Cancer Center,
Loma Linda, CA, USA; Division of Hematology and Medical Oncology and Biospecimen
Laboratory, Department of Internal Medicine, Loma Linda University School of Medicine,
Loma Linda, CA, USA
CECILIA CHOI  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
M. FERNANDO PALMA DIAZ  Department of Pathology and Laboratory Medicine, David
Geffen School of Medicine at UCLA, Los Angeles, CA, USA
LING DONG  Technology Center for Genomics and Bioinformatics (TCGB), Department of
Pathology and Laboratory Medicine, University of California, Los Angeles, Los Angeles,
CA, USA
CHON BOON ENG  Tissue Repository, National University Hospital, National University
Health System, Singapore, Singapore
DAVID GLYNNE FOX  School of Life Sciences, University of Nottingham, Nottingham, UK
DOMINIQUE GORDY  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
LAURA GOSA  Department of Molecular and Medical Pharmacology, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA; Ahmanson Translational Imaging Division,
David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
DORINA GUI  Department of Pathology and Laboratory Medicine, UC Davis School of
Medicine, Sacramento, CA, USA
DIVIYA GUPTA  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

xiii
xiv Contributors

MITRA D. HARATI  Division of Neuropathology, Department of Pathology and Laboratory


Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
THOMAS P. V. HARTMAN  School of Life Sciences, University of Nottingham, Nottingham,
UK
PETE HEINZELMAN  Drug Discovery Laboratory, Department of Neurology, Mary S. Easton
Center for Alzheimer’s Disease Research, University of California, Los Angeles, Los Angeles,
CA, USA
AMIN HOJAT  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
SEYED A. HOJAT  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
JIAOTI HUANG  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA; Department of Pathology, Duke University
School of Medicine, Durham, NC, USA
KYUSEOK IM  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA; Brain Tumor Translational Resource, David
Geffen School of Medicine at UCLA, Los Angeles, CA, USA
AFREEN JASIM  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
VARGHESE JOHN  Drug Discovery Laboratory, Department of Neurology, Mary S. Easton
Center for Alzheimer’s Disease Research, University of California, Los Angeles, Los Angeles,
CA, USA
NEGAR KHANLOU  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
PAULA KIM  Center for Health and Risk Communication, George Mason University,
Fairfax, VA, USA; Translating Research Across Communities (TRAC), Green Cove
Springs, FL, USA
BEATRICE KNUDSEN  Department of Pathology and Laboratory Medicine, Cedars Sinai
Medical Center, Los Angeles, CA, USA
MATTHEW KOO  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
HANNAH LEE  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
XINMIN LI  Technology Center for Genomics and Bioinformatics (TCGB), Department of
Pathology and Laboratory Medicine, University of California, Los Angeles, Los Angeles,
CA, USA
YAN LI  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
DAVID Y. LU  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
GREGORY M. LUCEY  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
SHINO MAGAKI  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
QINWEN MAO  Department of Pathology and Laboratory Medicine, Feinberg School of
Medicine, Northwestern University, Chicago, IL, USA
ALBERTO M. MARCHEVSKY  Department of Pathology and Laboratory Medicine, Cedars
Sinai Medical Center, Los Angeles, CA, USA
Contributors xv

SERGEY MARENINOV  Department of Pathology and Laboratory Medicine, David Geffen


School of Medicine at UCLA, Los Angeles, CA, USA; Brain Tumor Translational Resource,
David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
ERIN L. MILLIKEN  Translating Research Across Communities (TRAC), Green Cove
Springs, FL, USA
SAIED MIRSHAHIDI  Biospecimen Laboratory, Loma Linda University Cancer Center, Loma
Linda, CA, USA
NEDA A. MOATAMED  Department of Pathology and Laboratory Medicine, David Geffen
School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA
MASOUD MOVASSAGHI  Division of Neuropathology, Department of Pathology and
Laboratory Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
SURENI V. MULLEGAMA  Department of Pathology and Laboratory Medicine, David Geffen
School of Medicine at UCLA, Los Angeles, CA, USA
DAVID A. NATHANSON  Department of Molecular and Medical Pharmacology, David Geffen
School of Medicine at UCLA, Los Angeles, CA, USA; Ahmanson Translational Imaging
Division, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
MADELINE G. OLSON  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
JACLYN N. PERRY  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
DAVID N. POWERS  Department of Biological Chemistry, Proteome Research Center,
University of California, Los Angeles, Los Angeles, CA, USA
ALLISON D. RUDALEVIGE  Psomas, Santa Ana, CA, USA
ALIREZA SADEGHIPOUR  Department of Pathology, Iran University of Medical Sciences,
Tehran, Tehran Province, Iran
ELYSE J. SINGER  Department of Neurology, David Geffen School of Medicine at UCLA, Los
Angeles, CA, USA
ALEXANDRA SO  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
JILL M. SQUIRES  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
VINCENT W. STRODE  Department of Entomology, University of California, Riverside,
Riverside, CA, USA
SAMUEL P. STROM  Fulgent Genetics, Temple City, CA, USA
JOANNE SY  Department of Anatomical Pathology, Concord Repatriation General Hospital,
University of Sydney, Concord, NSW, Australia
LISA TA  Department of Molecular and Medical Pharmacology, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
WEI LING TAN  Tissue Repository, National University Hospital, National University
Health System, Singapore, Singapore
RANDY S. TASHJIAN  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
PARASTOU TIZRO  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
VANINA TOMASIAN  Department of Pathology and Laboratory Medicine, David Geffen School
of Medicine at UCLA, Los Angeles, CA, USA
TRACI TOY  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
xvi Contributors

HARRY V. VINTERS  Division of Neuropathology, Department of Pathology and Laboratory


Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Brain
Tumor Translational Resource, David Geffen School of Medicine at UCLA, Los Angeles,
CA, USA; Jonsson Comprehensive Cancer Center, David Geffen School of Medicine at
UCLA, Los Angeles, CA, USA
COLE B. G. WATSON  Entomology Research Museum, University of California, Riverside,
Riverside, CA, USA
BOWEN WEI  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
JEFFREY D. WHITMAN  Departments of Pathology and Laboratory Medicine, University of
California, San Francisco, San Francisco, CA, USA
RYAN R. WILLIAMS  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
JAMES A. WOHLSCHLEGEL  Department of Biological Chemistry, Proteome Research Center,
University of California, Los Angeles, Los Angeles, CA, USA
JENNIFER S. WOO  Department of Pathology and Laboratory Medicine, David Geffen School
of Medicine at UCLA, Los Angeles, CA, USA
RENA R. XIAN  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA; Department of Pathology, Johns Hopkins
University School of Medicine, Baltimore, MD, USA
HAODONG XU  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA; Department of Pathology, University of
Washington School of Medicine, Seattle, WA, USA
DOUGLAS YANEGA  Department of Entomology, University of California, Riverside,
Riverside, CA, USA; Entomology Research Museum, University of California, Riverside,
Riverside, CA, USA
DAPHNE YING  Department of Pathology and Laboratory Medicine, David Geffen School of
Medicine at UCLA, Los Angeles, CA, USA
WILLIAM H. YONG  Division of Neuropathology, Department of Pathology and Laboratory
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Brain
Tumor Translational Resource, David Geffen School of Medicine at UCLA, Los Angeles,
CA, USA; Jonsson Comprehensive Cancer Center, David Geffen School of Medicine at
UCLA, Los Angeles, CA, USA
JANICE YOSHIZAWA  Technology Center for Genomics and Bioinformatics (TCGB),
Department of Pathology and Laboratory Medicine, University of California, Los Angeles,
Los Angeles, CA, USA
XINHAI ZHANG  Department of Pathology, Loma Linda University Health, Loma Linda,
CA, USA
Chapter 1

Sustainability in Biobanking
Maram Abdaljaleel, Elyse J. Singer, and William H. Yong

Abstract
Biobanks are storage places for biospecimens that can be used for current and future scientific research.
Biospecimens are exceptional sources of biological data that can be potentially translated from molecular
and genetic information to clinically relevant treatment modalities. Examples of such biospecimens include,
but are not limited to, blood, skin, hair, saliva, stem cells, DNA, and RNA. The volume of biospecimens
worldwide continues to grow at an extraordinary rate posing a challenge for biobanks to manage this
growth. Due to the vital role of biobanks in research, an understanding of biobanking sustainability is
important. Simply starting to collect biospecimens without strategic planning and cost analysis can lead to
failure. Components vital to sustainability include fostering public support, cost-effective banking, funding
development, standardized protocols, and interoperability.

Key words Biobank, Biospecimens, Sustainability, Interoperability, Standards, Accreditation

1 Introduction

The United Nations has estimated the world population to be 7.2


billion and projects it to reach 8.5 billion by. 2030 [1]. This growth
in the world population will be paralleled by substantial biospeci-
men volume growth, providing a powerful scientific resource for
academic, governmental, and pharmaceutical institutions world-
wide [2, 3]. Biobanks have the potential to foster technologies
and scientific discoveries that provide greater understanding of
disease processes, ultimately leading to treatments that can improve
and help achieve optimal patient health. Understanding sustain-
ability is required in order to provide a solid foundation for future
biorepositories. Some biobanks have closed or were acquired by
other entities. The Singapore Bio-Bank (SBB), which was estab-
lished in 2002, is an example of a biorepository that closed in part
due to a lack of self-sufficiency, a perceived high cost of resource
access by researchers, low utilization of biospecimens, and a loss of
public and governmental support [3]. It is a common challenge for
biobanks that the true cost of a biospecimen is prohibitive for

William H. Yong (ed.), Biobanking: Methods and Protocols, Methods in Molecular Biology, vol. 1897,
https://doi.org/10.1007/978-1-4939-8935-5_1, © Springer Science+Business Media, LLC, part of Springer Nature 2019

1
2 Maram Abdaljaleel et al.

researchers and that subsidization by the home institution, charity,


or governmental agencies is necessary. In this chapter, we discuss
issues in sustainability and some of the elements that can help a
biobank thrive and successfully support scientific research.

2 Sustainability Through Targeted and Cost-Effective Biobanking

Sustainability can be defined as “the endurance of systems and


processes.” In terms of biobanking, sustainability can be considered
within a frame of three main factors: financial, operational, and
social, as proposed by Peter Watson et al. [4]. The ability of a
biorepository to secure stable sources of funding, ability to stan-
dardize procedures and protocols that guarantee the highest quality
tissue, and compliance with legal, social, and privacy regulations,
are all important factors that will determine its endurance.
Traditionally, biospecimens have been collected and procured
with minimal thought to the goals, cost, and required infrastruc-
ture, due to which the cost of sustaining biobanks is often under-
estimated. Financial considerations are not limited to the price of a
freezer or two. There are costs of personnel needed to procure,
store, and dispense the specimens, costs related to informatics
requirements such as software and hardware, and costs related to
maintaining and monitoring freezers- electricity, carbon dioxide or
liquid nitrogen backup, remote monitoring, repairs, and freezer
replacement after 8–10 years. As banks of freezers can generate
substantial heat, there is a need of temperature-controlled rooms
as well. The running costs of biobanks are dependent on the
duration of the project, number of specimens, and the purpose of
storing them. The need to store more specimens correlates directly
with the world’s growing population, increased access to health
care, and advancements in technology that can produce increas-
ingly sophisticated characterization of biospecimens. The duration
over which specimens need to be sustained before they provide
significant value is quite variable, which requires that the cost
effectiveness of the process should be thought through carefully.
The number of specimens needed for a particular study will depend
on its statistical power requirements. Population-based epidemio-
logical cohort studies may require a large number of biospecimens
that need to be stored for long periods of time. Consideration
should be given to how biospecimens are to be stored. If such
specimens can be stored at room temperature rather than in ultra-
cold conditions, the storage costs diminish substantially. Given the
projected exponential growth of patients and potential biospeci-
mens, it is not feasible to collect everything and to store them
forever. Weighing the sustainability costs of each project in terms
of duration and project outcome is important, and costs should be
delineated prior to the start of biospecimen procurement with the
Sustainability in Biobanking 3

expected benefits and potential impact on scientific outcome or


human health clearly defined. This fiscal responsibility is necessary
to encourage public and private entities to invest in and to fund
biorepositories.

3 Sustainability Through Standardization and Accreditation

Operationally, biobanking sustainability is strengthened by the


presence of standardized protocols and procedures that assure
quality control in all aspects of the biobanking process. These
standardized protocols help to achieve high quality biospecimens
that lead to end-user research community satisfaction and mean-
ingful research that rewards the patient’s generosity and trust in
donating their biospecimens. Standard operating procedures may
encompass donor consent, tissue quality assurance, type of project,
adequate personnel and facilities, and linked deidentified clinical
data. Obstacles to sustainability also include social, legal, ethical,
and privacy-related issues. The variation in laws between countries,
along with the diverse social views of various aspects of the biobank-
ing process is a challenge in procurement itself and in facilitating
collaboration between biobanks. If appropriately designed, the
standard operating procedures can help maintain compliance with
local and international laws, rules, and regulations. Abrogation of
laws can result in the closure of a biobank or potentially suspension
of governmental funding of an entire institution. Ethical and legal
issues are present in many aspects of biobanking, with the most
prominent concerns being informed consent, privacy protection,
ownership of intellectual property, participation of minors and
incompetent individuals, and returning results to participants
[5, 6, 8]. Adherence to established consenting protocols and trans-
parency can provide reassurance to patients, their families, and the
public. Patients want to help advance research that can produce cures
for themselves and, if not for themselves, for their families and for
others. Treating them fairly and considerately is part and parcel of
repaying the patients and also earning the support of patient advo-
cacy groups that can be powerful supporters of the biobank.
Biobank accreditation consists of objective testing and obser-
vation that assures the standardization of protocols and procedures.
The biorepository accreditation program instituted by the College
of American Pathologists (CAP) assesses compliance with standards
through on-site inspections occurring every 3 years. The CAP
accreditation program is available to biobanks in America and
Canada and is not applicable for tissue stored for transplant pur-
poses. There is a moderate but not insignificant cost involved and
accreditation may not be affordable for small biobanks. Similar
inspection processes are available in other countries. It is antici-
pated that biobank accreditation will eventually be a requirement of
major national funding agencies.
4 Maram Abdaljaleel et al.

4 Sustainability Through Collaboration, Education, and Advocacy

Another important step to enhancing sustainability is working


closely with and educating the public, funding institutions,
researchers, and biomedical thought leaders of the importance
and value of biobanks. If a biobank is sited in a university or medical
center, close collaboration with end-users to include funding
requests for biospecimen procurement in their grant proposals is a
must. Initial low-cost or pro bono collaborations to gather prelim-
inary data can lead to successful grant funding for both the biobank
and the researcher in the long run. A biobank that successfully
yields publications and research grants provides concrete evidence
of its inherent value. Advocacy by patients, patient advocacy
groups, oncology and surgical colleagues, and the local cancer
center can drive strategic initiatives by one’s own institution to
support the biobank. Workshops and conferences aimed at discuss-
ing the positive economic and social impact of biorepositories are of
value. Advocacy by patients as well as medical or scientific associa-
tions has the potential to modify government policies in regard to
tax benefits and increased funding for biorepositories. Developing
collaborations between biorepositories and pharmaceutical compa-
nies is also a consideration. Pharmaceutical companies help to drive
the development and use of novel therapeutics: they have an impor-
tant and constructive role to play in society. Although industry
relationships can support biomedical advances, the perceived com-
mercialization of specimens is controversial from an ethical stand-
point [7–9]. Patients tend to trust academic research studies more
than industry studies. So, collaborations should be approached
with clear sightedness, and institutional safeguards, perhaps forti-
fied with patient advocate input, should be in place to protect the
public good.

5 Sustainability Through Interoperability

Interoperability means that specimens and their scientifically rele-


vant data have been collected, processed, and archived within an
ethical and legal framework, that provides those conducting the
research a way to easily combine them with related items from other
biorepositories [10]. It is an essential component of fostering
national and international multicenter research collaborations.
Interoperability provides the best usage of biospecimens and their
relevant data by potentially involving the same tissue in multiple
projects or more likely providing statistical power for a study by
leveraging many specimens from multiple biorepositories. Funding
agencies are very interested in synergistic collaborations and a clear
demonstration of interoperability can enhance a grant application.
Sustainability in Biobanking 5

Although interoperability has clear benefits, legal and ethical con-


cerns must be overcome. Ownership of specimens and data, privacy,
and utilization of specimens by more than one biorepository, are
some of the thorny issues that confront interoperability [11]. Sim-
plification and harmonization of national laws can facilitate inter-
national collaborations.
The recent absence of national and international standards and
their nascent use in different countries until now were other obsta-
cles to interoperability. Creating and using standards that are
nationally and internationally agreed upon is an important step to
overcoming these road blocks. The International Society for
Biological and Environmental Repositories (ISBER) has made
great strides in this direction and their online resources, particularly
their Recommended Best Practice for Biorepositories, are a must
read for biobankers. While one typically thinks of biobanks as
rooms with freezers or as collections of physical biospecimens, the
“virtual” biorepository wherein the metadata that represents these
biospecimens and their associated clinical and molecular data
resides is the key to identifying required biospecimens with the
desired characteristics for any given multicenter study. The ability
for each biobank’s data repository or information system to talk to
each other is critical for interoperability. The usage of Common
Data Elements (CDEs) and controlled vocabularies are recom-
mended by both the Office of Biorepositories and Biospecimen
Research (OBBR) [12] and the International Society for Biological
and Environmental Repositories (ISBER) [13]. Controlled vocab-
ulary is a restricted list of words or terms used for labeling,
indexing, or categorizing, and is used as a means to standardize
information for the purposes of capturing, storing, exchanging,
searching, and analyzing data [14]. It is controlled because only
vocabulary from the list can be used for the subject area covered by
the controlled vocabulary. Examples of such standardized vocabu-
lary created for health care are the Systematized Nomenclature of
Medicine Clinical Terms (SNOMED-CT), Logical Observation
Identifiers Names and Codes (LOINC), and the Unified Medical
Language System (UMLS) [15]. Common Data Element (CDE) is
a data element that is common to multiple data sets across different
studies, and is used to help identify, compare, and combine multiple
studies [16]. As more information systems use common vocabul-
aries and data elements, interoperability will be enhanced creating
greater value in a biobank and ultimately promoting sustainability.

6 Conclusion

Sustaining a biobank is costly, but its value is incalculable as bios-


pecimens are critical substrates for biomedical research. The bio-
banking community has made good strides forward but major
6 Maram Abdaljaleel et al.

challenges remain to be overcome in order to improve the sustain-


ability of biobanks. It is only by working with patients, researchers,
governmental entities, and other stakeholders that biobanks can
thrive and even expand the vital biospecimen pipeline.

Acknowledgments

This work was supported in part by NIH:NCI P50-CA211015,


NIH:NIMH U24 MH100929, the Art of the Brain Foundation,
and the Henry E. Singleton Brain Cancer Research Program.

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doi.org/10.1007/s10897-010-9305-1
Chapter 2

An Introduction to Starting a Biobank


Mitra D. Harati, Ryan R. Williams, Masoud Movassaghi, Amin Hojat,
Gregory M. Lucey, and William H. Yong

Abstract
The purpose of a biobank is to process, organize, and maintain various types of biospecimens that are to be
utilized for both clinical and research-based services. There are different types of biobanks, so the goals of
the biobank should be delineated at the outset of forming a biobank. The startup of a biobank benefits from
accreditation and stringent adherence to standards of practice. Fundamental to these practices is the
protection of privacy and informed consent. A budget must be developed, and sources of funding should
be obtained to properly equip the designated space and personnel. The appropriate space for freezers and
for biospecimen processing should be identified. Information technology is also a critical part of the
biobank and effort should be expended to ensure that this aspect is effective and secure. Given the ethical
concerns surrounding biospecimens, engagement with the public is also highly valuable.

Key words Biobank, Biorepository, Biospecimen, Clinical, Research, Accreditation

1 Introduction

Biobanks or biorepositories are specialized pathology laboratories


that allow for future clinical or research studies by collecting,
processing, and storing biospecimens. Biospecimens, often
obtained from surgeries and autopsies, may be used as part of a
clinical workup or in prospective or retrospective studies [1]. In
recent years, more biobanks have been developed due to increasing
tissue requests for translational studies [2]. With this demand, there
is a need to develop standards of practice and accreditation. Stan-
dard operating procedures (SOPs) should be used in all aspects of
the biobank process, from procurement to shipment to safety
[3]. Furthermore, the development of these practices should
involve engagement with the public to resolve potential ethical,
legal, and social issues [4]. The public must also understand the
funding needs for biobanks, which are increasing together with the
growth of biotechnology. Biospecimens are no longer being simply
stored in jars of formaldehyde but may now require elaborate

William H. Yong (ed.), Biobanking: Methods and Protocols, Methods in Molecular Biology, vol. 1897,
https://doi.org/10.1007/978-1-4939-8935-5_2, © Springer Science+Business Media, LLC, part of Springer Nature 2019

7
8 Mitra D. Harati et al.

procurement processes and stringent storage requirements. As


such, there is considerable cost associated with the entire biobank-
ing process. In order to support funding, the public, clinical
research organizations, and government agencies will have to be
involved more than before [5]. Another key element of the biobank
is the creation of a protected database to track biospecimens.
Within these databases, it is crucial to provide a link to track the
specimen; including the source, collection date, clinical informa-
tion and molecular and genetic information. Furthermore, to
maintain privacy, encryption methods should be used along with a
secured server. This chapter provides considerations for the forma-
tion of a biobank including accreditation, standards of practice, and
funding issues.

2 The Purpose of Biobanks

Biobanks are established to provide a repository of biospecimens


that may be used to elucidate the pathophysiology, diagnoses, and
ultimately treatments of diseases [6]. To achieve this goal, a biobank
collects, stores, and processes human biological material in accor-
dance with current protocols supported by available scientific data.
Depending on the specimen source and study plans, biobank per-
sonnel decide how biospecimens are collected and processed. With
this in mind, the creation of multiple aliquots or samples allows for
greater leveraging of the biospecimens for both clinical and research
purposes [7]. Depending on the study goals and the kind of institu-
tion that will carry out the research, there are different types of
general biobanks, some of which are summarized below.

2.1 Disease-Oriented Perhaps the most common types of biobanks are those used to
Biobanks collect disease-specific biospecimens. The focus and breadth of
disease types and specimens in these biobanks is varied. Disease
oriented biobanks may be useful for basic research, case-control
studies and clinical trials pertinent to the disease. Some disease-
oriented biobanks may focus on a single type of tissue, such as
injured human spinal cords. Others may be much broader and
include biospecimens from throughout the body that are relevant
to a disease process such as cancer [8]. Cancer centers often have
biorepositories that store biospecimens from a broad range of can-
cers that, while sharing some similarities, are effectively different
disease entities. A cancer biobank may have lung, breast, liver, colon,
renal, prostate, and lymphoma biospecimens. Even when a cancer
branch focuses on a specific organ like the brain, a variety of very
different cancers may be collected. For example, the Brain Tumor
Translational Resource (BTTR) at the University of California, Los
Angeles stores gliomas, meningiomas, schwannomas, and other
brain tumors as well as associated blood and cerebrospinal fluids.
Starting a Biobank 9

2.2 Population- Population-based repositories that provide biospecimens, such as


Based Biobanks germ line DNA from individuals of a general population, have
broad uses. Umbilical cord blood or screening blood spots from
newborns have been used in transplantation and stem cell research
studies [9]. The need to obtain a large number of samples for the
study of rare diseases also may require this type of biobank. Screen-
ing a large population of patients may elucidate specific alleles that
may underlie a unique disease phenotype. Alternatively, studies may
attempt to distinguish environmental from genetic effects by study-
ing monozygotic and dizygotic twins. Such a prospective approach
can be used for preventive medical programs and epidemiological
studies [10].

2.3 Virtual Virtual repositories represent “clearinghouses” for stored speci-


Repositories mens located in other places. A typical model would comprise of a
searchable central database that archives the biospecimen and con-
tent at multiple existing medical center pathology departments or
research biorepositories. The virtual repository is often guided by
an oversight committee for the consortium of centers. A virtual
repository can expand efficient access to multiple distant sites with-
out the necessity, risk, and cost of moving all the samples to a
central location. This type of repository can avoid new collection
efforts, time and cost wasting and may be useful for retrospective
cohort studies [11]. Some virtual repositories will also prospec-
tively collect and index new biospecimens as well. Typically, a set
of clinical, pathology, and molecular data is linked to the virtual
biospecimens. A researcher will request a cohort of biospecimens
with specific characteristics from the virtual repository. Such poten-
tial cases will be identified and approved by an oversight committee.
The National NeuroAIDS Tissue Consortium (U.S.A) is such an
example. A central data coordinating center provides online query
tools and a centralized requesting mechanism that, after approval
from an oversight committee, can facilitate shipping of specific
biospecimens from four biobanks located in California,
New York, and Texas.

3 Requirements for Biospecimen Collection

3.1 Accreditation Pathology laboratories in most countries must have the appropriate
accreditations as determined by law. Accreditation of a biobank
ensures that the laboratory controls and optimizes the use of bios-
pecimens in good professional practice, as defined by internation-
ally established standards. Necessary requirements for accreditation
include an operational quality management system and a continu-
ous control of the methods used for diagnostic purposes [12]. In
this way, the biobank is recognized for maintaining high quality
processes and these are ultimately reflected in patient care and
10 Mitra D. Harati et al.

research. The process of accreditation gives the biobank recogni-


tion by ensuring consistency and standardization of practice. For
some countries, the accreditations standards may be found in ISO
15189 and ISO 17025. In the USA, biorepository accreditation
standards are promulgated by the College of American Pathologists
(CAP). These standards are similar in that they require pathology
laboratories to implement a system of quality management and to
continuously monitor protocols. Accreditation of a laboratory is
therefore intended as a strong indicator of quality for the biobank,
which should thereby produce reliable results.

3.2 Informed As biotechnology continues to grow, biobanks are faced with many
Consent, Ethical, new ethical and legal concerns which must be addressed with the
and Legal public. Therefore, all clinical and research protocols that involve the
Considerations biobank must be approved by a relevant Institutional Review Board
(IRB) and/or Medical Ethics Committee (MEC) [13]. The bed-
rock of human bioethics is informed consent, which requires the
patient and/or subject to be given an overview of the study, discus-
sion of protocol specifics, and a disclosure of potential benefits and
risks. General information of participants should also be maintained
to contact them for future studies. However, since a re-consent
approach of large-scale studies has some practical difficulties and
adds labor and costs, many biobanks obtain a broad informed
consent that participants can accept for current and future studies.
In other words, participants may fill out consent forms without any
information of future studies, but these consents may not encom-
pass all potential ethical issues [14]. Beyond informed consent,
additional unresolved ethical issues for biobanks include participant
withdrawal and the potential of some protocols to interfere with
patient diagnosis or treatment. Furthermore, as there are different
kinds of health issues between different population groups, bio-
banks must also often consider gender and ethnicity. Thus, orga-
nizing biobanks while recognizing different racial populations may
be useful to progress treatments and disease prevention [15]. Given
the potential for new and/or unresolved ethical issues, biobanks
must maintain transparency and have open engagement with the
public.

3.3 Standard There are a variety of standard operating procedures (SOPs) or best
Operating Procedures practice protocols for biobanks and determining which to use is
often dependent on the particular needs of the clinical or study
being performed. The International Society for Biological and
Environmental Repositories (ISBER) and the National Cancer
Institute Biorepositories and Biospecimen Research Branch (NCI
BBRB) have published best practices that are available online
[16]. ISBER published a biobank handbook called Best Practices
for Repositories that includes topics such as specimen collection,
processing, and retrieval, training, ethical issues, and many more
Starting a Biobank 11

[17]. IBSER website should be checked periodically to stay up to


date with the latest revisions biobanking protocols. The NCI BBRB
similarly provides guidelines to promote biospecimen and data
quality, and to address ethical and legal issues. The SOPs used by
these organizations assist practitioners and help them provide good
clinical decision making when developing a biobank [18]. Patient
privacy and safety of biobank personnel are recurrent themes
throughout all SOPs and as such will be discussed in greater detail
below.

3.4 Personnel Depending on the size, multiple types of personnel may be required
Considerations to properly staff a biobank [19]. There are major considerations
when hiring personnel. The first is the quality of the person and the
second is their knowledge and prior training or certification
(if available). With respect to hiring high quality personnel, criteria
that should be considered include work ethics, timeliness, intellec-
tual capacity, teamwork, and communication skills. With respect to
knowledge and prior training, histopathology, molecular, or other
relevant laboratory or management experience are advantageous.
Education materials and programs should be provided to give
personnel the necessary certifications [20]. Furthermore, to ensure
consistency of processes across time, certifications should be
renewed on a regular basis. Biobank personnel may have a range
of responsibilities such as procurement, processing, storage, and
disbursement of specimens along with database maintenance. In
order to meet all these needs, core personnel may also include a
director, a pathology supervisor, laboratory manager, quality con-
trol manager, and full-time laboratory technicians. Such positions
may be covered by one or more people, depending on the size and
needs of the biobank.

3.5 Biosafety There are numerous potential biosafety hazards that may be
Requirements encountered when working with biospecimens. Therefore, it is
imperative that all personnel take the appropriate safety precau-
tions. To achieve this, the National Institutes of Health (NIH)
provides the required biosafety guidelines. These guidelines pro-
vide safety information related to work in laboratory research and
should be a part of established good practice SOPs. At a local level,
an Institutional Biosafety Committee (IBC) will help establish
further guidelines and oversee the biosafety requirements, and all
protocols used by a biobank should be submitted to the IBC for
approval. In addition, biosafety information documents for all
materials used in the biobank should be reviewed by relevant per-
sonnel and be made readily available. These include the Material
Safety Data Sheets (MSDS), which contain health hazard informa-
tion for chemicals and infectious agents, and requirements for
when to use chemical fume hoods and biosafety cabinets
[21]. Occupational Safety & Health Administration (OSHA) also
12 Mitra D. Harati et al.

publishes information about blood-borne pathogens and needle


stick prevention and offers some required training courses to
improve knowledge about safety issues. Basic training should
include the use of appropriate protective gear, such as hand/arm
protection, lab coats, and closed-toe shoes, as well as knowledge
about decontamination procedures to remove and minimize the
effect of biohazardous materials. However, it is ultimately the
responsibility of all personnel to be properly trained and adhere to
safety requirements.

3.6 Equipment The type and quantity of materials that will be collected and pro-
and Space cessed, will determine the different equipment and space require-
Considerations ments [22]. Therefore, the necessary equipment and facilities
should be established according to the overall mission of the bio-
bank as well as specific SOPs. The biobank room must meet
requirements to provide a safe place for the staff and material
stored. In order to design a workflow, Lean Laboratory Design
may be used as a reference [23]. The room should have enough
space for equipment, specimens, biohazard hood, chemical hood
for tissue fixation, handling biohazardous materials, workstation,
computers, specimen receiving area, chemical storage cabinet, an
emergency eyewash and shower station, water bath and utility sink.
Storage in freezers or at room temperature may necessitate addi-
tional space [24]. Furthermore, space may be needed for tissue
processing, tissue embedding, molecular workstations, automated
slide staining and labeling. When possible, each lab space should
have up to two exits [25]. The laboratory also should be built close
to operating rooms and autopsy rooms in order to reduce the time
of specimen collection, and it should be in close association to office
personnel.

3.7 Information Equally important to a biobank’s role in the procurement and


Technology processing of biospecimens is the management of relevant clinical
and research data for each of those biospecimens. Hence, it is
3.7.1 Software
crucial to maintain a software system which supports data collec-
tion, analysis and management while providing strong security and
protection of privacy. There are many different types of software on
the market, but in general the software should have some important
abilities that are recommended in the aforementioned practice
guidelines. These include allowing authorized users to operate at
various locations and computers, and to have easy access to docu-
ments and records. In addition, the software should provide a
secure environment that protects data, includes an exclusive and
unchangeable ID for all of the biological samples, and an ability to
continuously track the sample’s location. Encryption, which is the
process of encoding data in a software system, is another important
way of protecting data from being recovered by nonauthorized
users. A well-designed software system should have infrastructure
Starting a Biobank 13

that supports the operation 24 hours a day/7 days a week and also
has the ability to cope with disasters and downtimes and to recover
stored data.

3.7.2 Hardware Access to information in today’s changing world is getting easier by


using Information Technology (IT). It is important to access data
through suitable computers that can handle the infrastructure
required by software systems. Media storage, network share drives,
printers, scanners, fax machines and cameras are other examples of
hardware, which will be part of the network. Although hardware
provides a huge benefit to its users, there are some disadvantages in
regard to lifetime, battery life, and possible breaches that may affect
the storage of data. Therefore, it is critical to store the hardware in
locked rooms, back up all the data, and try to replace them when
they are getting close to the end of their life expectancy [26]. Com-
puter hard drives, external hard drives, USB sticks, and other
portable memory should be appropriately encrypted to the latest
standards.

4 Funding

Biobanks need funding for both their development and long-term


maintenance. Furthermore, as the size and scale of biobanks
increases together with biotechnology, so will the demand for
funding. Thus, obtaining funding for a biobank is a perpetual
task. Various startup costs are associated with the formation of a
biobank, including the purchase of equipment and preparation of
the space. To maintain the biobank, budgets will include salary for
personnel, facilities and material costs. Additionally, consideration
must be taken as to what biospecimens are necessary to collect, in
order to prevent duplication of efforts and unnecessary costs
[27]. To meet these costs, there are various funding sources includ-
ing federal, state, university, and hospital, pharmaceutical, and
foundation/private donors. Examples of different types of funding
models and steps to obtain funding are listed below:

4.1 Public Biobank Public biobanks are supported through governmental funding
Model organizations. In the USA, the National Institutes of Health
(NIH), part of the US Department of Health and Human Services,
acts to support biomedical researches financially [28]. Whereas in
the UK, biobanks are funded publicly by the National Health
System and by a charity service, the Wellcome Trust. State and
county governments may see fit to support biobanks as well.

4.2 Biosocial Model Within biosocial models of funding, patient activity groups, grass-
roots, and private organizations are more intimately involved in the
development and maintenance of biobanks [29]. For example, the
14 Mitra D. Harati et al.

Genetic Alliance biobank in Washington, D.C. was created by


patient’s grassroots activities, and the UCLA AIDS Institute is
supported in part by individual donors and charity events.

4.3 Applying The application process varies slightly between different organiza-
for Funding tions and institutions. In the USA, the best place to start is
through Grants.gov. In doing this, it is critical to understand the
legal aspects for the different types of funding, and carefully read
the application instructions that are described by each awarding
institute. As a next step, current application forms and documents
should be completed and thoroughly reviewed, as these may
change from one funding cycle to the next. With these docu-
ments, specific budget data should be carefully documented,
including room for additional unexpected costs. Some granting
agencies may choose to only fund a portion of the budget. Most
applications may simply be downloaded from the Internet and
submitted electronically. Formal evaluation of the grants is typi-
cally performed by a committee or study section, which provides
scores based on ethical standards and scientific merit. After the
application is reviewed, scored, and determined to be eligible for
funding, the awards will be issued. Progress reports are then
submitted to the granting agency at regular intervals to ensure
proper use of the funding and the potential for receiving future
awards [30–32].

5 Conclusion

The development of a biobank has similar requirements to other


pathology and research laboratories, with perhaps an emphasis on
ethical considerations. However, by obtaining the necessary accred-
itations, and following stringent SOPs, biobanks have the potential
to offer the public unique clinical and research-based services.
Biospecimens are the critical fuel needed for human disease-
oriented research. It is vital that governmental and private funding
agencies continue to recognize the importance of biobanks in
advancing our understanding of health and disease.

Acknowledgments

This work was supported in part by NIH:NCI P50-CA211015,


NIH:NIMH U24 MH100929, the Art of the Brain Foundation,
and the Henry E. Singleton Brain Cancer Research Program.
Starting a Biobank 15

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