Post on 11-Oct-2020
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Heidi Welberry, Usha Salagame, Peter Wejbora, Deborah Roczo,
Ruth Fernandez, Parisa Glass, Anthea Hepburn and Jim Bishop
A comprehensive review of cancer-related biobanks
in New South Wales
October 2009
Cancer Institute NSW Monograph
00
Cancer Institute NSW catalogue number: RM-2009-01
National Library of Australia Cataloguing-in-Publication data:
A comprehensive review of cancer-related biobanks in New
South Wales
State Health Publication Number: (CI) 090060
ISBN: 978-1-74187-398-6
Keywords: Biobanks, tissue banks, New South Wales, Australia.
Suggested citation:
Welberry, H., Salagame, U, Wejbora, P, Roczo, D, Fernandez, R,
Glass, P, Hepburn, A, Bishop, J. A comprehensive review of cancer-
related biobanks in New South Wales Sydney: Cancer Institute
NSW, October 2009
Cancer Institute NSW
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Eveleigh NSW 2015
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Publications www.cancerinstitute.org.au/publications
Copyright © Cancer Institute NSW October 2009.
This work is copyright. It may be reproduced in whole or
part for study or training purposes subject to the inclusion of
acknowledgement of the source. It may not be reproduced for
commercial usage or sale. Reproduction for purposes other
than those indicated above requires written permission from
the Cancer Institute NSW.
Authors
Heidi Welberry1, Usha Salagame1, Peter Wejbora1,
Deborah Roczo2, Ruth Fernandez2, Parisa Glass1,
Anthea Hepburn1, Jim Bishop1.
1Cancer Institute NSW2Healthcare Management Advisors Pty Ltd.
iii
Contents
Foreword from the Minister v
Report from the Director of Cancer Research vi
Executive summary vii
1 Introduction 1
1.1.1 What is biobanking and why is it
important for NSW? 1
1.1.2 What is involved in biobanking? 2
1.1.3 Working together to maximise
this potential 3
2 Defi nitions 4
Biobank defi nitions 4
3 Project methodology 5
3.1 Project scope 5
3.2 Review of worldwide governance
arrangements of biobanks 5
3.3 Identifi cation of biobank locations in
New South Wales 5
3.4 Survey of governance arrangements of
Australian tissue banks 6
3.4.1 Survey development and scoping study 6
3.4.2 Final survey instruments 6
3.4.3 Survey recipients 7
3.4.4 Follow up and additional information 7
3.5 Survey of researchers 7
3.6 Limitations 7
4 Worldwide governance arrangements 8
4.1 Entity status and funding sources 8
4.1.1 Non-profi t organisations 8
4.1.2 For-profi t organisations 9
4.1.3 Funding of non-profi t biobanks 10
4.2 Organisational structures 10
4.2.1 Individual biobanks: one or more
collection sites 10
4.2.2 Biobank consortia 11
4.2.3 Population-based biobanks 11
4.3 Biobank governance arrangements 13
4.3.1 Governance Boards 13
4.3.2 Other committees 14
4.4 Standard operating procedures 14
4.5 International and Australian
biobanking netoworks 16
4.5.1 Stakeholder and peak body networks 16
4.5.2 Specimen locator networks 16
5 Australian governance arrangements 18
5.1 Australian standards of governance 18
5.2 Victorian Cancer Biobank 18
5.2.1 Organisation and Governance 18
5.2.2 Benefi ts and hurdles 19
5.2.3 Standard operating procedures
and bioinformatics 21
5.2.4 Researcher access 21
5.2.5 Cost recovery 22
5.3 Biobanking in Western Australia 22
5.3.1 Biobanks within pathology departments 22
5.3.2 Data management tools and linkages 23
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
iv
6 Biobank locations in New South Wales 25
6.1 Biobank locations in New South Wales
by geographic hub 25
7 Biobank governance in New South Wales 29
7.1 Biobank general characteristics 29
7.2 Biobank design 33
7.2.1 Patient consent and types of
specimens collected 33
7.2.2 Specimen processing and storage 34
7.2.3 Single or multicentre collection and
storage sites 34
7.2.4 Specimen locator network 35
7.3 Entity status and funding sources 35
7.3.1 Entity status 35
7.3.2 Current funding 35
7.3.3 Future funding 36
7.4 Organisational structure and
governance arrangements 36
7.4.1 Biobank governance 36
7.4.2 Personnel 37
7.4.3 Biobank performance measures 37
7.5 Standard operating procedures (SOP) 39
7.5.1 Development of SOPs 39
7.5.2 Patient consent 39
7.5.3 Data collection 40
7.5.4 Data storage 40
7.5.5 Quality control measures 41
7.6 Researcher access 41
7.6.1 Key themes from biobank
governance surveys 41
7.6.2 Key themes from researcher surveys 43
8 Future options for New South Wales biobanking 44
8.1 Summary of New South Wales formalised
biobank governance 44
8.2 Future opportunities for governance
models for biobanks 44
8.2.1 Stakeholder Network 45
8.2.2 Accreditation 46
8.2.3 Specimen Locator Network 46
8.2.4 Consortia by tumour type in NSW 47
8.2.5 Consortia by tumour type Australia-wide 48
8.2.6 Consortium of all NSW Biobanks 48
8.2.7 Extension of pathology services 49
8.2.8 Data management and data linkage 49
8.2.9 Epidemiological research opportunities 49
8.2.10 Comparison of models 49
8.2.11 Infrastructure and resources required 51
8.3 Other observations to consider in the
future of biobanking 53
8.3.1 Governance committee(s) 53
8.3.2 Funding arrangements 53
8.3.3 Sample ‘ownership’ 54
8.3.4 Sharing of resources 54
8.3.5 Good will and relationships 54
8.3.6 Other types of collections 54
8.3.7 Bio-ethical Issues and considerations 55
v
8.4 Conclusion 55
9 Appendixes 57
Appendix A
Example questionnaires 57
Appendix B
Governance arrangements of
international biobanks 61
Appendix C
Comparison of international
biobank guidelines 63
Appendix D
Summary of design and governance
fi ndings for each biobanks 69
Abbreviations 79
References 81
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
vi
Acknowledgments
We would like to thank all NSW and other biobank staff
and researchers who made the time to contribute their
information and insights to this review. We would also like to
thank Peter Geary from the Canadian Tumour Repository
Network and members of the Cancer Research Advisory
Committee for reviewing this report.
vii
Foreword from the Minister
Providing access to key enabling infrastructure is one of
the NSW State Government’s strategies for ensuring
that we can attract and retain the best cancer researchers
in our State. Such research infrastructure will allow research
discoveries of international signifi cance to be made.
To make the most effi cient use of current infrastructure
resources, the NSW State Government is working to fi nd
new ways that cancer research and associated research
platforms can be shared by a wide range of researchers.
One such research platform that has gained signifi cant
prominence over recent years is tumour and tissue banking.
The systematic collections of biospecimens have become an
indispensable and invaluable resource for cancer researchers
in both basic and clinical research settings.
As it is such a recent phenomenon, much work still needs
to be undertaken to capture fully the opportunities that
are opened up by this resource. Consequently, we now see
a world wide emphasis on identifying the best practices
for tissue banking in respect to the methods of storing,
cataloguing and distributing samples, as well as to the most
effective fi nancial and governance structures.
This report is a timely review that contributes to these
efforts by examining the scope, nature and future potential
of cancer tissue banking in NSW. This document will help
inform further development of these resources in our State,
enabling researchers, clinicians and ultimately patients to
benefi t from the exciting new technological and scientifi c
advances in the fi ght against cancer.
I commend this report to you.
The Hon. Barbara Perry MP
Minister for Local Government
Minister Assisting the Minister for Health
(Mental Health and Cancer)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
viii
Report from the Director of Cancer Research
A ‘Biospecimen bank’ or ‘biobank’ refers to a standardised
collection of human biological materials, including tissue
and tumour samples, blood and blood products, DNA and
relevant donor medical and demographic data collected and
stored with appropriate ethical consent.
Biobanking is now internationally recognised as a basic
enabling tool for cancer research, with the future of
molecular and translational research relying heavily on the
availability of high quality biospecimens linked to data on
actual clinical outcomes.
This publication, A comprehensive review of cancer-related
biobanks in NSW, provides a snapshot of tumour tissue
banking activity across the State, identifying and mapping the
‘biobanks’ used for cancer research across the 12 geographic
research hubs in NSW.
Furthermore, this review examines the governance
structures of national and international tumour and tissue
banks. It explores a number of cost-effective administrative
options, such as the possible networking of NSW tissue
banks, which could assist in creating internationally
competitive and sustainable biobanking facilities in NSW.
There are still many challenges ahead of us before we enable
researchers to fully utilise the potential of biobanking for the
benefi t of future cancer patients. However, it is clear that,
in addressing these challenges, a key challenge is to improve
access to high-quality tissue samples for researchers.
It is hoped that the information contained in this review will
provide a further step towards this goal by enhancing our
understanding of the current state of biobanking. Such data
should provide a solid basis to develop a better, fi nancially
more viable future network of biobanks. This essential
infrastructure will assist cancer researchers to answer
research questions in the area of cancer prevention and early
detection and develop new cancer therapies.
Dr Peter Wejbora Grad Dip (Arts Mgt) MA PhD
Director of Cancer Research, Cancer Institute NSW
ix
Executive summary
Within NSW, 23 tumour collections were identifi ed, 17 of which were confi rmed as formalised tissue banks.
This report presents an overview of the scope and nature
of tissue banking in NSW by mapping their geographic
location across the 12 cancer research hubs in NSW, as
well as examining their governance arrangements. Through
increasing knowledge and awareness of NSW cancer bio-
banking activities, the ultimate goals of this review are to
assist in:
assessing the current level of investment in tissue banking ▪and identify future resource requirements
improving researcher access to tissues collected in a ▪range of cancers
improving effi ciency and reducing duplication of ▪administrative processes
building capacity that is cost-effective and sustainable. ▪
The project included a review of international and national
biobanks, with a focus on organisational structures and
governance models. It also included a two-phase survey
within NSW to fi rstly identify active biobanks and then
to understand in more detail the current operational and
governance structures of these banks.
International models for biobanking
The majority of international biobanks reviewed were
operating as part of a consortium or network where
individual banks work together to develop consistent
approaches to biobanking and, in some instances, the
pooling of resources. Less frequently, the international
banks reviewed fell within the categories of either
individual biobanks (with one or multiple collection sites) or
population-based epidemiological biobanks.
The use of standard operating procedures was common
among all biobanks and there are many international
guidelines on procedure development for consideration, such
as the National Cancer Institute Guidelines in the US, the
Confederation of Cancer Biobanks Guidelines in the UK and
the International Society for Biological and Environmental
Repositories Guidelines in Europe.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
x
Australian biobanking
Australian biobanks are constituted in a similar manner and
their operations also require ethics and scientifi c advisory
committees’ approval.
The Victorian Cancer Biobank provides an example of a
consortium model for clinical biobanking where four separate
clinical biobanks are linked through one over-arching
management committee. A slightly different approach has
been taken in Western Australia, where tissue banking is
embedded within certain pathology services and core data
management and linkage platforms are being developed
to ensure consistent and effi cient management of research
studies involving biospecimens. The Western Australian
approach is wider than just cancer and aims to maximise
linked datasets to answer epidemiological as well as clinical
research questions.
The Australasian Biospecimen Network (ABN) is an example
of a network approach that aims to assist researchers locate
biospecimens through an online facility that allows searching
of multiple biobanks at one time. It also provides a forum to
address technical, legal/ethical, and managerial issues relevant
to human biospecimen repositories within Australia and
New Zealand.
Cancer biobank locations in New South Wales
Within NSW, 23 tumour collections were identifi ed, 17 of
which were confi rmed as formalised tissue banks.
Biobank activities in New South Wales: key themes from surveys
Design
Each of the formal biobanks in NSW gains patient ▪consent for broad, as yet unspecifi ed future research
with specimens at most tissue banks also being collected
for specifi c research projects on request.
Specimens routinely collected and stored generally ▪include fresh frozen tumour tissue and, at most banks,
matched normal tissue, blood and blood products.
Several banks also store paraffi n embedded specimens.
DNA and RNA are not routinely extracted at most
banks but can be extracted on request.
The design of the biobanks in terms of single or multiple ▪collection and/or storage sites is in large part dictated by
the original intent of the bank and by tumour incidence,
patient type, specifi c collection and storage requirements
for the tumour or institution, availability and funding
for dedicated tumour bank staff and storage facilities,
and how to best develop expertise in tissue and data
collection, storage and distribution.
Two of the biobanks have specimen locators for ▪researchers to search for specimen availability within a
specifi c tumour bank and three others are members of
the Australasian Biospecimen Network (ABN).
Entity status and funding sources
All exist as non-profi t organisations or as departments ▪(or units within departments) within hospitals or
research institutions.
All but four banks rely to some extent on grant funding ▪for their operation, with 85–90 per cent of funds
generally spent on staffi ng.
Organisational structure and governance arrangements
All biobanks collecting from multiple non-local ▪geographical sites are governed in some capacity by
executive or management committees or independent
arm’s length advisory groups. In addition, these large
biobanks have other committees under this governing
committee, responsible for the development of policies,
procedures and operations and either have already got,
or are in the process of establishing, scientifi c advisory
groups.
Biobanks with either single or local-only collection ▪and storage sites are generally governed by a Biobank
Committee constituted from within the hosting
institution. Expert advice is sought by these committees
as required.
Where more than one biobank exists at an institution, ▪storage facilities are often shared, yet with individual
biobank committees responsible for operational
issues and, in most cases, researcher requests and
specimen distribution.
xi
Standard operating procedures and data management
Although there are some variances across the NSW ▪biobanks, standard operating procedures are similar and/
or are based on the same source (with the exception
of procedures specifi c to a certain type of tumour or
specimen not routinely collected).
All banks had established their own databases to register ▪basic client information and link this information to the
physical sample through a coded system (generally in
Microsoft Excel or Access). Clinical information and
follow up data were often kept separately from the
biobank database with manual searches often required
to include this information with samples for researchers.
Banks varied widely in the extent of clinical information ▪collected and recorded and the extent to which the data
was governed by data dictionaries.
Researcher access and performance measures
Almost all biobanks interviewed have a formal ▪researcher access policy, with most stipulating priority
access for participating institutions or their affi liates
and collaborators.
Most tumour banks charge researchers either nothing or ▪freight costs only.
Almost all biobanks require researchers to acknowledge ▪the biobank in any publications arising and to send copies
of publications to the bank.
Biobanks generally measure their performance by: the ▪number of donors and specimens collected; the number
of specimens accessed by researchers; and the numbers
of publications arising.
Future options for New South Wales biobanking
From the review of current NSW biobanking activities,
several opportunities exist for maximising the potential
of biobanking in NSW. First, alternative organisational or
networking models of existing biobanks could be considered.
These range in complexity from minimal changes to the
current arrangements and infrastructure to substantial
change and re-structure. Second, core infrastructure
requirements could be examined including the current role
of pathology providers in tissue banking, data management
and linkage platforms.
Alternative models for biobanking
Minimal change approach
Stakeholder network with or without biospecimen locator
Related individual biobanks could form (or join existing)
stakeholder networks while retaining their current
organisational arrangements (e.g. samples are still ‘owned’
by the individual banks and the researcher must still apply
individually to each bank when samples are located). This
networked structure provides a forum for working with
other banks to improve consistency of approach and
standardised procedures. In addition, a biospecimen locator
could further benefi t researchers by increasing their ability
to quickly and easily search multiple banks and/or multiple
storage/collection nodes at one time for samples.
However, there are limitations to this approach, particularly
in respect to the quality and consistency of tissue samples
across the network, which, in the absence of an over-arching
monitoring body or mandating process, may be diffi cult
to achieve.
Accreditation
Accreditation procedures across multiple banks could be
implemented to increase consistency and coordination.
There are signifi cant benefi ts to researchers if the quality
and consistency of stored tissue are increased. However, this
approach would not assist in location of specimens across
banks, so a biospecimen locator approach may also need to
be considered.
No changes would be required to the organisation or entity
status of the individual biobanks, although there may be
procedural changes required within individual banks in order
to meet accreditation standards and would require fi nancial
investment from banks.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
xii
Consortia approach
Biobanks could also look at the option of forming a
consortium, which would override their entity as individual
biobanks. This would have implications on governance
arrangements of individual banks and would require
the formation of an over-arching body, such as a central
management committee to lead the consortium. Issues,
including sample storage and ownership, SOPs, funding
and cost recovery, may all have to be dealt with through
consensus among the members.
This approach has the greatest potential to increase the
consistency and quality of biospecimens and associated
clinical and outcome data. It may require considerable
investment to provide enough resources and incentive
to ensure compatibility of processes and systems among
individual banks.
A consortium could be set up within NSW or could be
Australia-wide. It could also be tumour-specifi c, restricted to
certain cancers or could be general for all cancer types.
Enhancing biobanking infrastructure
Pathology-based biobanking
Pathology departments play an integral role in all
biospecimen banks. There are currently few well-established
data linkage networks between pathology and clinical
databases in NSW biobanks. Most biobanks interviewed
are aiming to establish more sophisticated networks but are
constrained by fi nancial and human resources including lack
of technical expertise.
Data management and tracking systems
As biobanking activities expand and more collaborations
are established, sophisticated data management and tissue
sample tracking will become essential. Software applications
such as the Laboratory Information Management System
(LIMS) of WAGER and the VCBs custom designed database
are two examples of systems specifi cally developed for the
Australian market. There are also international initiatives,
such as the National Cancer Institute’s caBIG and the
Canadian CTRNet project which seek to establish common
data-sharing platforms for biobanks. While it is outside the
scope of this study to make any detailed assessment of the
various tools currently available, it is clear that any further
developments of biobanking collaborations in NSW should
build on and learn from the experiences of the established
systems, rather than duplicating these efforts.
Data linkage and epidemiological biobanks
The WAGER initiative also provides the basis by which
Western Australia is increasing the depth of their
epidemiological datasets, in addition to managing clinical
samples. Most biobanks identifi ed within NSW have been
set up for clinical research purposes rather than focussing on
epidemiological research questions. The Centre for Health
Record Linkage (CHeReL) currently provides excellent
capacity within NSW for linking existing statewide datasets
and, other than Western Australia, is the only such facility in
Australia. There may be an opportunity to leverage off this
existing data linkage capacity.
1
1 Introduction
Biospecimen banks have rapidly become key pieces of research infrastructure, particularly in fi elds such as cancer research.
1.1.1 What is biobanking and why is it important for NSW?
A ‘biospecimen bank’ or ‘biobank’ refers to a standardised
collection of human biological materials, including tissue
and tumour samples, blood and blood products, DNA and
relevant donor medical and demographic data collected and
stored with appropriate ethical consent.
Biobanks generally fall into three categories: population-
based biobanks; disease-oriented epidemiological biobanks;
and disease-oriented clinical biobank.1 The fi rst two are
within the domain of epidemiology that seeks to understand
factors affecting the health and disease of a population.
The latter type of biobank falls more within the realms
of clinical and translational research which focus more on
patients following diagnosis of a disease. All three have the
ultimate aim of improving health by increasing the quality of
preventative or clinical healthcare.
Population-based biobanks seek to collect samples of
biospecimens (generally DNA) that are representative of
the whole population (both healthy and diseased) and may
be used to address questions of genetic susceptibility to
disease. While research questions may be disease-specifi c, for
example identifying genes that place an individual at higher
risk of melanoma and understanding how these interact with
environmental factor,2 the collection of biospecimens tends
to be large scale and represent the whole population. The
research arising from such collections could help to develop
more targeted and more effective prevention strategies.
Disease-oriented epidemiological biobanks generally focus on
individuals with particular risk factors or particular diseases.
An aim of such collections may be to understand in which
circumstances risk factors lead to disease. The Kathleen
Cuningham Foundation Consortium for research into
Familial Breast cancer (kConFab) is one such example of an
Australian-based disease-oriented biospecimen resource.
The primary aim of kConFab is to facilitate research into
familial cancers by amassing a large and comprehensive
resource of epidemiological and clinical data with
biospecimens from individuals at high risk of breast and/or
ovarian cancer, and from their close relatives.3
Disease-oriented clinical biobanks again tend to focus on
a particular disease, but generally after a diagnosis of the
disease and may include collection of diseased and healthy
tissue as well as blood products and DNA. Rather than
address questions related to exposure and risk factors, these
collections provide opportunities to focus on understanding
disease progression and may be used to try to identify
determinants of good and poor prognosis and response to
particular treatments. Rapid advances in the understanding of
biological pathways of disease and the increase in therapies
that target particular pathways have opened the door to a
new ‘personalised’ approach to treatment. For example, it is
now apparent that a complex array of molecular pathways
may be implicated in understanding how a healthy cell makes
the transition to a cancerous cell. Knowing which pathways
have been disrupted at a molecular level in a tumour will
allow treatments to be chosen based on their ability to
combat the particular molecular defects. Clinical biobanks
which link biospecimens to rich clinical and patient outcome
datasets have been, and will continue to be, essential in
building knowledge of such pathways and mechanisms of
disease and testing the effectiveness of treatments.
Biospecimen banks have rapidly become key pieces of
research infrastructure particularly in fi elds such as cancer
research. There are many compelling reasons for developing
and expanding this important infrastructure and some
urgency is required if the benefi ts of such information-rich
resources are to be fully maximised.
Since the completion of the human genome project in
2003,4 there have been rapid technological advances in the
study of genetic components of disease. This has resulted in
accelerated research interest and, as a result, rapidly reduced
cost and timelines to generate research data. However,
while the ability to rapidly analyse biospecimens is ever
increasing, the timelines required to collect a large sample
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
2
of biospecimens and outcome data is generally quite long
- typically ranging from two to 15 years depending on the
disease site and study design.1 This suggests that the future
benefi ts of such genomic advances will only be fully realised
if appropriate high quality data sources (such as biobanks)
are developed now. An additional concern for the future of
clinical biobanks is the ever decreasing size of biospecimen
samples due to increasing success of early detection and
screening programs. There is already a perception that some
collections, such as breast cancer, are being biased towards
later stage disease.
NSW already has a very substantial medical and health
research capacity, including strengths in many areas of
biomedical, clinical, public health and health services
research.5 The identifi cation of biobanks in NSW and
identifi cation and implementation of best practices in
biobanking should continue to build on this NSW research
capacity by further facilitating cancer research and assisting in
the utilisation and collection of biospecimens. This will allow
NSW researchers to assist in the ‘global research effort to
control cancer but will also place NSW in a better position for
tackling local health problems and encourages research oriented
health system that is able to rapidly incorporate the most recent
evidence based medicine into practice’.5
1.1.2 What is involved in biobanking?
Successful biobanking is dependant on the coordinated
activity of a number of personnel with different areas of
expertise. While the size of the biobank may determine
the number of dedicated staff involved in the activities, it is
important to consider all the possible key players involved to
explore the optimal models for biobanking.
Biospecimen Collection
The process of procuring samples requires informed consent
from the patient, which is usually dependant on the treating
clinician or nurse. The surgeon and his staff in the operation
theatre then have to be informed of this consent so that
the tissue may be collected and snap frozen if necessary.
The biobank offi cer has to be informed so that the sample
may be immediately transported to the storage centre,
either within the same institution or at a central storage
facility, where it is processed, coded, catalogued and stored.
For epidemiological banks the process would be similar,
substituting study participants for patients noting that the
collection would generally include only a blood sample.
Storage and cataloguing
Laboratory technicians may be involved in processing of
the tissue and blood products, which may include DNA
extraction and making of paraffi n blocks. Additionally,
pathologists and pathology technicians will likely be involved
in histological analysis and microscopic analysis, grading etc.
Usually the tumour bank offi cer is responsible for monitoring
the freezers and cryostats where the samples are stored
and a database manager develops and manages the database
for an inventory of the stored samples. The database
manager also: develops and maintains the system for linkage
of the samples to unique identifi ers as well as to associated
information about the sample; tracks the addition of new as
well as any returned and unused tissue samples; and manages
the removal and despatch of samples for researchers.
Management of the bank
Generally a biobank will have an appointed manager who
is responsible for the overall day-to-day running of the
biobank. The manager is the link between the personnel
employed within the bank and any governing biobank
committee. This body, or the biobank committee, usually
consists of representations from the stakeholders, scientifi c
advisory committee, the ethics committee, as well as the
host institution. Additionally, a host institution may have
a management committee, which could be involved in
decisions regarding facilities and equipment related to
the biobank.
The successful running of a biobank is a complex operation
and this highlights the necessity of good governance
principles, as well as the implementation of best practice
guidelines.
The more complex organisational structures of biobanks,
such as those with multiple collection sites or a consortium
of biobanks, involve more personnel. This could include more
staff for collection and transport of samples, overarching
3
governing bodies with members from all collecting nodes, IT
personnel who design and maintain integrated information
systems and specimen locators.
1.1.3 Working together to maximise this potential
The concept of collecting and storing human tissues and
other biological samples for research purposes is not a new
one. However, many small clinical biobanks have arisen from
individual laboratories or projects and they are often reliant
on the passion of one researcher to champion it. It has not
been until recently that the need for more structured and
extensive biobanks has been realised due to the advances in
scientifi c technologies, especially genomics and proteomics,
driving the demand for high-quality tissue samples and large
scale collections. The scale of population-based biobanks by
defi nition is very large and these types of epidemiological
banks have emerged more recently, due again to advances in
genomics and proteomics. It is not possible to contemplate
the development of population-based biobanks without a
high level of cooperation and signifi cant funding.
There are several benefi ts to having a consolidated approach
to biobanking, including: increased researcher awareness of
specimen availability; increased access for researchers from
larger pools of samples; increased quality and consistency
of samples from standardised collection procedures; and
increased effi ciencies and economies of scale.6
To be able to answer new research questions, biobanks are
evolving to cover more geographical sites for collections,
increasing types and quality of samples stored and improving
the clinical data associated with samples. Consequently, the
IT infrastructure of biobanks is also evolving to track and
monitor increased sample numbers, track clinical data and
follow-up data and provide biospecimen search functions
for researchers. As such, the governance, structure and
regulation of biobanks are also evolving to encompass the
new directions taken.
Governance of biobanks has to now consider at least:
type of entity (e.g. not for profi t, for profi t, charity) ▪
separate entity (with a separate board of directors) or ▪included as a part of a hospital/health service and as such
reporting to the hospital/health service board
of directors
single or multiple collection sites ▪
a part of a consortium of biobanks or single entity ▪
research approval board (in addition to ethical approval ▪for research)
standard operating procedures ▪
reporting commitments and transparency ▪
stakeholders ▪
funding arrangements ▪
pricing of samples and priority of sample provision (e.g. ▪to academia or commercial companies)
quality assurance measures and review processes ▪
risk assessment and mitigation. ▪
‘Tissue banking, or the standardised collection of tissues and
associated clinical and demographic data with appropriate
ethics consent, is now internationally recognised as a basic
tool for cancer research. Whilst the value of biorepositories
to the research community is not in question, the collection
of samples and data from an adequately large number of cases
is typically beyond the scope of any single institution. It is also
clear that duplication is uneconomical, and an active network
of like-minded “bankers” should facilitate information sharing
as well as resource sharing whilst increasing the overall value
and quantity of tissue resources available.’7
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
4
This report has used the terminology biobank to include banks collecting any biospecimens that have a focus on cancer research.
2 Defi nitions
In addition to the distinction between epidemiological and
clinical biobanks, there are also many different types of
clinical biobanks and several different naming conventions.
Historically, tissue banks would refer to all collections of
human tissue, including tissue collected for transplantation
purposes. Tissue banks could also refer to collections of
blood and blood products. Tumour banks, as the name
suggests, refer to collections of tumour tissue, but also often
contain ‘matched-normal’ tissue from the same donor, as well
as blood and blood products. Tumour banks can be general
across many cancer types, or specialised with a focus on one
or two specifi c cancers.
A new terminology emerging is ‘biospecimen bank’ or
‘biobank’. These refer to collections of human biological
samples including tissue samples (and can include tumour
samples), blood and blood products, DNA and associated
relevant donor medical information.
This report has used the terminology biobank to include
banks collecting any biospecimen, including tissue and
blood products that have a focus on cancer research. Banks
collecting samples specifi cally for other disease research (eg
neurological diseases) or for transplantation purposes have
not been considered.
Biobank defi nitions
The structure and organisation of biobanks and tissue
collections can vary depending on the nature and purpose of
collections. Therefore, for the purposes of this project, the
following defi nitions have been applied:
Formalised biobank
Tissue repository established to bank biospecimens for future
unspecifi ed research, with the intent to distribute samples
to requesting researchers (subject to approval). May or may
not also collect for specifi ed research project(s). These may
have single collection and storage site, multiple collection
but single storage sites, or multiple collection and multiple
storage sites.
Specifi ed specimen collection
Tissue repository established to collect and store
biospecimens for specifi ed research project(s), generally for
use within the host laboratory/institution.
Note that this defi nition of a specifi c specimen collection
does not include tissue repositories at anatomical pathology
or other laboratories if they are collected and stored
solely as part of routine diagnostic procedures and storage
requirements. These collections can include large repositories
of often paraffi n-embedded tissue but, as reported by one
head of pathology, may have been collected or stored in an
‘ad hoc manner’.
Biobank consortium
Consortium refers to the collaboration of two or more
biobanks under an overarching governance arrangement,
so that individual banks continue to manage their own
collection and storage site(s), but the consortium has overall
responsibility and manages requests for samples centrally.
Stakeholder network
Stakeholder/peak body networks refer to collaborations
between biobank managers and other stakeholders to
discuss universal topics in the fi eld such as standard operating
procedures for collection, storage, treatment and shipping of
biospecimens, ethics and informed consent for donors and
data/information storage and retrieval.
Specimen locator networks
Specimen locator networks provide the ability for
researchers to search multiple biobanks or consortia via a
website to identify availability of specimens.
5
3 Project methodology
This project aimed to identify the location of biobanks used for cancer research across 12 geographic cancer research hubs in NSW.
3.1 Project scope
This project aimed to identify the location of biobanks used
for cancer research across 12 geographic cancer research
hubs in NSW, and understand the governance arrangements
of cancer biobanks and networks in a subset of six
geographical research hubs. The ultimate aims of this project
are to:
improve researcher access to tissues collected in a range ▪of cancers
improve effi ciency and reduce duplication of ▪administrative processes
build capacity that is cost-effective and sustainable ▪
identify the current investment in tissue banking and ▪strategies to optimise value for money.
The project comprised the following stages: a literature
review of international biobank governance arrangements
focussing on the US, UK and Canada; a literature review
and web search on biobank governance arrangements
within Australia with telephone or face-to-face interviews
with three biobanks in non-NSW states (with the aim of
informing survey design); identifi cation of biobank locations
in NSW and collection of high-level information, including
cancer type and purpose of tissue collection; telephone or
email survey of biobank governance arrangements in the six
major geographical hubs that were identifi ed as comprising a
high proportion of cancer research in NSW5 (Central Sydney,
Darlinghurst, Northern Sydney, Newcastle/Hunter, Western
Sydney and Randwick); identifi cation and contact with
researchers to gather information on barriers or facilitators
to access of biospecimens; and development of future
options for biobanking in NSW.
3.2 Review of worldwide governance arrangements of biobanks
Peer-reviewed literature was sought from internet searches
using GoogleTM and Entrez-PubMed database searches using
key words (and key word combinations) including:
Tissue/tumour/biobank. ▪
Networks. ▪
Governance. ▪
Ethics. ▪
Regulations. ▪
Standard operating procedures. ▪
Information on international biobanks was obtained from
web searches and publically available information on the
biobanks’ websites. Further clarifi cation was sought via email
in some instances.
3.3 Identifi cation of biobank locations in New South Wales
To identify the locations of cancer-related biobanks in NSW,
a contact list was created for the initial identifi cation phase of
the project via a number of mechanisms:
A list of research organisations, institutes, university 1.
departments and hospital departments was created
based on a recent survey of cancer researchers in
NSW.5 This provided a list of possible locations for
biobanks or specimen collections. Prior to contacting
these organisations, a further web search was conducted
where possible for each site to obtain additional
information on the research group and the most
appropriate contact person (i.e. research group head).
Research governance offi cers, cancer regulatory affairs 2.
offi cers and cancer services development managers in
NSW were also identifi ed as personnel who may be able
to provide additional information. Contact was made
with these people via email.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
6
In addition, executive offi cers for all NSW Health 3.
Human Research Ethics Committees were contacted via
email and asked to provide any additional information
regarding biobank locations, collection sites and details of
contact personnel if known.
Additionally, any information discovered through website 4.
searches, or given from the contacts/researchers listed
above was used in order to compile an exhaustive list of
biobanks in NSW.
In total, more than 150 individual contacts were made via
email or telephone across 69 organisations. Contact was
made via telephone where possible, or via email if telephone
details were unavailable or if no response was obtained via
telephone. Where contact details were only available for an
institution switchboard or where research group details were
found to be incorrect, a telephone call was made to the
institution requesting to be transferred to the Anatomical
Pathology Department and/or Cancer Research Group/Unit
to identify the appropriate person to speak with.
Information regarding biobank status was gained on the
majority of contact institutions or organisations. Only six
of the 69 organisations contacted were unable to provide
comment in any capacity regarding biobank status (note:
this does not include the many individual researchers or
contacts within these organisations who did not respond).
It was not possible to obtain responses from some research
organisations / institutes / university departments / hospital
departments within the timeframe of the study.
3.4 Survey of governance arrangements of Australian tissue banks
3.4.1 Survey development and scoping study
A questionnaire on governance arrangements for biobanks
in Australia was developed based on suggested best practice
recommendations from the international literature. The
questionnaire addressed fi ve major areas:
general information including specimen type and ▪collection/storage facilities
entity status and funding sources ▪
organisational structure and governance arrangements ▪
standard operating procedures ▪
researcher access. ▪
Before rolling out this survey to NSW biobanks in the six
major geographical hubs, three banks were selected to pilot
the questionnaire and scope for further detail that may
need to be incorporated or modifi ed in the document. This
scoping survey was used in face-to-face interviews with two
large non-NSW-based bio banks (Victorian Cancer Biobank
and Australian Prostate Cancer Collaboration BioResource)
and in a telephone interview with a large NSW-based
biobank (Breast Cancer Tissue Bank). Non-NSW biobanks
were included in the scoping study to ensure the Australian
as well as the NSW perspective was obtained.
The three scoping interviews highlighted the diversity of
arrangements in biobanks. In addition, interim results of
telephone/email contact with potential biobank locations
indicated that biobank numbers were unlikely to exceed
20–30 banks. Therefore, the governance surveys were
conducted via teleconference rather than as an emailed
questionnaire (as originally planned), as this method was
likely to generate a higher response rate and also allow more
exploratory discussions regarding organisational structure
and governance arrangements. Contacts were emailed the
survey questions prior to the teleconference to allow time to
consider or prepare responses. Where telephone interviews
were not possible, biobank representatives were emailed a
written version of the questionnaire to complete.
3.4.2 Final survey instruments
Following the testing of the governance questionnaire in the
scoping survey, the survey instrument was modifi ed slightly
and used as a telephone questionnaire to enable biobank
heads or managers to describe the following characteristics
of their biobank(s): general information regarding specimen
type and collection/storage; entity status and funding sources;
organisational structure and governance arrangements;
standard operating procedures; and researcher access.
A copy of this survey instrument appears in Appendix A, Section 9.1.1. Where the biobank was identifi ed as a
specimen collection based on initial contact – and therefore
7
only collecting and banking specimens for a specifi c research
project(s) – the contact person was asked to respond
to a short list of emailed questions relating to collection,
cancer type, specimens collected, and whether specifi c or
unspecifi ed consent had been obtained. A copy of these
survey questions appears in Appendix A, Section 9.1.2.
3.4.3 Survey recipients
In the initial identifi cation phase of the project, 23 biobanks
or collections were identifi ed. Of these, six were classifi ed
as specifi ed collections or banks in planning rather than
existing folmalised biobanks. Each of the specifi ed collections
completed a short emailed questionnaire covering basic
information on the types of patient consent, types of tissues
and type of cancer.
The remaining 17 biospecimen resources were identifi ed
as formalised biobanks and 13 of these responded within
the specifi ed timeframe and completed the fi rst telephone
survey on governance arrangements.
The data was collected via either telephone or email.
Where telephone contact was unavailable or diffi cult for the
recipient, an offer was made to send the survey via email for
completion and return.
3.4.4 Follow up and additional information
Additional information was sought from the biobanks
to capture further details of the number of donors and
tissue samples held by the banks, the number of samples
distributed, funding arrangements and measures of success
for the bank. This information was captured using a second
survey tool distributed to managers of formalised biobanks
identifi ed during the initial surveying. A copy of this tool
appears in Appendix A section 9.1.3.
The four biobank managers who were unable to be
interviewed initially were included in this follow-up survey
and they were recontacted to complete both the original
and second surveys regarding their biobank. Surveys were
distributed to biobank managers electronically via email.
Biobank managers were given the option to either return
the survey electronically, via fax, or request a telephone
interview for the survey. Responses were received from 13
biobanks (all electronically), including two of the four biobank
managers that did not respond to the initial survey.
3.5 Survey of researchers
As part of the survey of governance arrangements, biobanks
were asked to provide name(s) of researchers who had
used their biobank and could be contacted to discuss
access arrangements. Four researchers were contacted to
participate in the telephone survey, with two researcher
telephone interviews subsequently conducted using a
questionnaire designed to allow researchers to report on
access arrangements to biospecimens and the barriers/
facilitators to this access. A copy of these survey questions is
at Appendix A, Section 9.1.4.
3.6 Limitations
The ability to accurately locate all biobanks in NSW,
both formalised banks and specimen collections, is largely
dependent on the following: a comprehensive contact list of
those with an interest in this fi eld; the availability of contacts
to confi rm biobank status during the period of the project;
and the willingness of contacts to share information regarding
their biobanks.
While it is believed that most of the more formalised
biobanks have been identifi ed during this project via the
contact lists, it is possible that there are many more small
banks or specimen collections housed by researchers for
current or historical specifi c research project purposes.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
8
Non-profi t companies are by far the most common entity status for biobanks and networks worldwide.
4 Worldwide governance arrangements
This chapter discusses the evidence in the literature and
from examples of biobanks on governance arrangements for
biobanks worldwide. It includes examples of good practices
as well as highlights issues that banks have encountered. Key
themes of discussion include:
entity status and funding sources ▪
organisational structure and governance arrangements ▪
standard operating procedures ▪
international biobanking networks. ▪
4.1 Entity status and funding sources
There are several different types of entity that a biobank
could be established as, such as:
A non-profi t company (or charity) funded by public, ▪private (e.g. philanthropic) and government funding.
A non-profi t company (or charity) funded by public and ▪private (e.g. philanthropic) funding (but not funded by
government).
A company privately owned or publicly listed by shares. ▪
4.1.1 Non-profi t organisations
Non-profi t companies are by far the most common entity
status for biobanks and networks worldwide (Europe, UK,
US and Canada). Some of the advantages of a non-profi t
company are:
fl exibility in funding arrangements and funders ▪
positive public perceptions regarding use and intent of ▪bio-samples, i.e. the samples will be used in a way which
will best benefi t science and medical discoveries and not
purely to profi t stockholders
avoids, to some extent, legal issues regarding the ‘sale’ ▪of human bio-samples for profi t (distinct from cost
recovery fees for collection, storage, modifi cations
and shipping of samples) and enables more fl exible fee
setting in line with what researchers can and will pay
for samples.8
It is for these reasons that the research into establishing
a National Biospecimen Network (NBN) in the US
recommended that the network be established as a non-
profi t company with a mix of public and private funding (e.g.
charitable and philanthropic donations, industry funding,
government funding and fees for service).8 Similarly, in the
UK, onCore UK (the national biosample and information
resource for cancer research) was established as a non-profi t
and charitable organisation, which is funded by government
and non-government agencies (the Department of Health
in England and the Medical Research Council and Cancer
Research UK). The collaboration operates under the
umbrella of the National Cancer Research Institute (NCRI),
which is a partnership of all the major funders of cancer
research from the public, charity and private sectors.9
Other international biobanks that are non-profi t with
government or mixed funding include:
The Cooperative Human Tissue Network ▪ (CHTN),
supported by the National Cancer Institute (NCI),
provides investigator-defi ned, prospective procurement
of malignant, benign, diseased and ‘normal’ adjacent
tissues, as well as tissue microarrays for researchers
across the US.10
The Early Detection Research Network ▪ (EDRN),
supported by the NCI, which collects samples to
develop diagnostic biomarker tests for cancer.11
Cooperative Breast Cancer Tissue Resource ▪ (CBCTR)
funded by the NCI, supplies researchers with primary
breast cancer tissues and associated clinical data.12
The Canadian Tumour Repository Network ▪ (CTRN),
funded by the Canadian Institute of Health Research
(CIHR) under direction of the Canadian Association of
Provincial Cancer Agencies (CAPCA), is a consortium of
9
leading biobanks and programs and provides researchers
with a streamlined process of obtaining biosamples.13
Generation Scotland ▪ broad health study of the Scottish
population:
Generation Scotland: Donor DNA Databank – ,
funded by the Chief Scientist Offi ce (CSO)
Biomedical and Therapeutic Research Committee,
aiming to provide well characterised control DNA
samples for the Scottish population for future
research projects.14
Generation Scotland: Genetic Health in the 21st –
Century (GS:21CGH) funded by the Scottish
Higher Education Funding Council (now the
Scottish Funding Council) through their Strategic
Research Development Grant Initiative. The aim
of GS:21CGH is to build control cohorts that
are representative of Scotland’s sub-populations
by recruiting 2,500 individuals (500 each from
fi ve different regions of Scotland) to supply basic
physical measurements, a blood sample, and
lifestyle information.15
Generation Scotland: Scottish Family Health –
Study (GS:SFHS) project funded by the Scottish
Executive’s Genetics and Healthcare Initiative,
which aims to build up a large, intensively
phenotyped, family-based cohort with which
to study the genetic basis of common complex
diseases and response to treatments.16
The Spanish National Cancer Research Centre ▪ (CNIO)
Tumour Bank Network (TBN) is coordinated by the
Molecular Pathology Programme (MMP) and aims to
promote biobanks in Spanish hospitals through the
application of standardised operating procedures for the
collection, processing and storage of tumour and normal
tissue samples.17 CNIO was founded by the Carlos III
Institute of Health, dependent upon the Ministry of
Health, in 1998.18
The Genome Austria Tissue Banks ▪ (GATiB) (part
of the BioResource-Med at the Medical University of
Graz, Austria) is an internationally focused collection of
diseased human tissues designed to support the needs
of research into human diseases, drug discovery and
public health. The bank is currently funded through
research grants primarily from the Genome Research in
Austria Fund (supported by the Ministry for Science and
Research).19,20
Examples of the governance arrangements for some of the
biobanks researched for this document are presented at
Appendix B.
4.1.2 For-profi t organisations
In the US, there are also private companies that provide
biobank services, such as:
Bioserve is a for-profi t company, which provides, among ▪other services and manipulation techniques, a global
repository (in partnership with Genomics Collaborative)
containing human DNA, RNA, tissue samples and serum
samples collected from four continents.21
Asterand is a publicly listed for-profi t company, which ▪supplies human tissue and human tissue-based research
services to drug discovery scientists. The company was
formed in 2006 from a merger of Asterand, a human
tissue biorepository, and Pharmagene, a human tissue-
based drug discovery company and has offi ces in the UK
(Royston) and US (Detroit, Michigan).22
Other private companies in the US provide bioinformatic
support for companies and researchers, such as HealthCare
IT, which provides web-based software solutions for
biomedical research and drug development.23
In Australia, however, there is no precedence for ‘for-
profi t’ biobanks or networks to date. Establishing a for-
profi t company for the distribution of human bio-samples
would also necessitate discussion regarding the legality of
selling human tissues or bio-samples (versus cost-recovery
pricing) as well as the need to distinguish between when the
sample has been modifi ed suffi ciently (e.g. DNA and RNA
extractions, micro array tiles) to no longer be regulated by
human-tissue regulations.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
10
4.1.3 Funding of non-profi t biobanks
The amount of funding the non-profi t biobanks receive
worldwide varies enormously. Some examples are
provided below:
onCore UK1. : In the fi nancial year ending 31 March 2007,
the principle grant funding for onCore UK was just over
£2m. Funds used during the fi nal year totalled £864,000
(with £865,000 on operating costs and £19,000 on
governance related costs.9
Generation Scotland: Donor DNA Databank2. (GS:3D)
is a £170,209 project funded by the Chief Scientist
Offi ce (CSO) Biomedical and Therapeutic Research
Committee.14
Generation Scotland: Genetic Health in the 21st 3. Century (GS:21CGH), funded by a £1.79m grant from
the Scottish Higher Education Funding Council (now
the Scottish Funding Council) through their Strategic
Research Development Grant Initiative.15
Generation Scotland: Scottish Family Health Study 4. (GS:SFHS) is a £4.4 million project funded by the Scottish
Executive’s Genetics and Healthcare Initiative.16
4.2 Organisational structures
The organisational structure of a biobanks will infl uence the
types of governance arrangements established for the bank.
Internationally, disease-specifi c or clinical biobanks either
operate as individual banks with one or more collection
sites or as part of a biobank consortium. Population-based
biobanks differ again on structure.
4.2.1 Individual biobanks: one or more collection sites
Historically, many biobanks originated from individual
research laboratories collecting for specifi c research purposes
(specimen collections). As technology improved and
demand subsequently increased, some of these collections
have become more formalised biobanks with established
governance arrangements. Many of these biobanks remain
departments within hospital or institutions and as such are
governed by the hospital boards and committees. Some,
however, have been established as independent entities and
therefore have their own governing bodies and committees,
although may still be subject to regulations of the hospital/
institution in which they are housed.
An example of a non-profi t biobank is provided in Case Study 1.
Case Study 1: Genome Austria Tissue Bank (GATiB)
The Genome Austria Tissue Banks (GATiB) is a part of the
BioResource-Med (a research core facility) at the Medical
University of Graz, Austria. The biobank previously established
at the at the Medical University of Graz has been developed
into an internationally focused collection of diseased human
tissues designed to support the needs of research into human
diseases, drug discovery and public health. In order to minimise
international distribution of the limited human samples, GATiB
places an emphasis on sample analysis, allowing the distribution
of high quality tissue-derived data, rather than the original tissue
samples themselves.19
Key components of GATiB are a) archival tissue samples
associated with long-term follow up and medical data, b)
prospectively collected tissue and blood samples associated
with standardised information on disease and environmental
exposure, c) animal models molecularly validated for their human
disease relevance and d) IT-tools supporting sample tracking, data
storage, data mining and protecting sample donor privacy.19
The resource currently contains biological samples from 888,000
patients representing a non-selected patient group characteristic
for central Europe. These are samples from all human diseases
treated by surgery or diagnosed by biopsy, thus representing
cancers and non-cancerous diseases from all organs.19
In 2006, GATiB had paraffi n embedded samples from 888,000
patients and a further 8,090 fresh frozen samples. Medical
information routinely associated with samples includes disease
diagnosis, histopathological report (classifi cation, grading and
staging of tumours), immunohistochemical characterisation
and molecular genetic characterisation. Follow-up survival data
is available for 63,000 samples (24,000 patients). In addition,
medical records are available for 470,000 patients and this is in
the process of being uploaded into a searchable database for
electronic accessibility.19
A secure data management systems support collection,
administration and retrieval of data. In addition, a data mart was
designed to enable complex queries combining genetic data with
detailed medical information, while protecting sample donor
privacy by preventing re-identifi cation of individual patients.19
11
4.2.2 Biobank consortia
More recently the idea of biobank networks or consortia
are emerging both overseas and within Australia. A biobank
consortium typically includes several biobanks under
one overarching governance arrangement. Most of the
international biobanks researched in section 4.1.1 have been
established as a consortium, providing an umbrella under
which multiple biobanks can network.
For example:
onCore UK1. was established as a non-profi t and
charitable organisation, funded by both government
and non-government agencies. onCore UK works
with selected public hospitals across the UK to collect
biosamples (primarily blood and paraffi n embedded
tissue) donated by cancer patients. Training and standard
operating procedures (e.g. for collection and sample
preparation) are provided to the hospital and samples
are transported from the participating hospital to a
central storage repository and data entered onto a
central database.9
The US National Biospecimen Network2. (NBN) trialled
a biobank consortium for prostate cancer in 2004 and
2005, the Prostate SPORE (Specialised Program of
Research Excellence) National Biospecimen Network
Pilot.24 This project was discontinued in 2005 as it was
considered to be not technically optimal and therefore
not cost effective. However, the NCI continue to work
on the NBN concept and have learned much from the
Prostate SPORE trial including the need for bioinformatic
tools and the development of the Cancer Biomedical
Informatics Grid (caBIG).25
The Spanish National Cancer Research Centre (CNIO) 3.
Tumour Bank Network (TBN) is a biobank consortium
which provides standardised operating procedures and
training for the collection, processing and storage of
tumour and normal tissue samples in Spanish hospitals.
The participating banks are a part of hospital pathology
departments and routinely collected paraffi n embedded
and fresh frozen biospecimen samples. The success
of the TBN has prompted use of this model in other
biobank consortium development including the Biobank
Ireland Trust.26 For further details, see Case Study 2.
The Canadian Tumour Repository Network4. (CTRN)
is a non-profi t consortium of leading biobanks to aid
Canadian health research. CTRN provides researchers
with a streamlined process to obtain quality human
tissue and human tissue products from member
biobanks.13 For further details, see Case Study 3 below.
More detailed examples of biobank consortia are provided in
Case Study 2 and 3.
4.2.3 Population-based biobanks
Population-based biobanks are designed to collect genetic
information representative of population cohorts. Examples
of this are the Generation Scotland projects (DNA
Databank, Genetic Health Study and Family Health Study)
and UK biobank.
UK Biobank (a registered charity funded by the Wellcome
Trust, the Medical Research Council, the Department of
Health, the Scottish Executive and the Northwest Regional
Development Agency) aims to improve the prevention,
diagnosis and treatment of a wide range of serious and life-
threatening illnesses (e.g. cancer, heart diseases, diabetes,
arthritis and forms of dementia) through the collection of
blood and urine from 500,000 people aged 40–69 across
England. As well as the samples, UK biobank collects basic
health information and health checks (e.g. blood pressure and
weight). UK biobank is designed as a long-term project and
does not expect to provide results from the epidemiological
studies that will be performed for at least 10 years. To date
the project has collected samples and information from more
than 200,000 people.
As opposed to collecting tissue samples for future research
projects on specifi c disease, these population-based
banks are collecting information on which large scale
epidemiological studies can be performed to examine trends
and linkages between genetic information and disease/
population health. These studies generally collect blood and
DNA products, as well as clinical information, but do not
typically collect tissue samples.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
12
Case Study 2: The Spanish National Cancer Research Centre (CNIO) Tumour Bank Network (TBN)
The Spanish National Cancer Research Centre (CNIO) Tumour Bank Network (TBN) is a biobank consortium coordinated by the
Molecular Pathology Programme (MMP) and aims to promote biobanks in Spanish hospitals through the application of standardised
operating procedures for the collection, processing and storage of tumour and normal tissue samples. The purpose of the consortium is
to facilitate molecular studies by avoiding the bias of multi-centre studies possible. This model does not have a centralised bank, rather a
cooperative and coordinated consortium of banks based in the pathology department of participating hospitals. The banks are connected
through a computer data system which enables biospecimens to remain at the hospital of collection whilst encouraging multi-hospital
cancer research and of cooperation between basic and clinical researchers. The TBN is promoted by CNIO which undertake the role of
coordinating, database maintenance and adherence to quality control.17
There are currently 16 participating hospitals across Spain and each are required to sign a memorandum of understanding (MOU) in order
to participate. The MOU states that for a hospital biobank to collaborate with the TBN the following criteria need to be met:
acceptance of the collaboration by the entire hospital, with the collaboration of the hospital management and (at least) the oncology ▪and pathology departments
guarantee that the procedural manual of the TBN ▪is respected
provision of adequate material resources for the correct handling and preservation of the tissue, including -80ºC freezers with the ▪appropriate security measures
a technician working for the biobank ▪
a part-time medical specialist in pathology ▪
provision of appropriate infrastructure and physical space for the banks and IT requirements ▪
the existence of protocols from the surgical area that facilitate the rapid mobilisation of surgical specimens from the surgeons to ▪pathology.17
The TBN has standard operating procedures (SOPs) for:
transfer of tissue from surgeons to the pathologist ▪
fi rst examination of the biopsy or surgical specimen ▪
non-neoplastic tissue ▪
fi xation and processing ▪
freezing ▪
identifi cation of samples ▪
conservation of fi xed tissue ▪
conservation of frozen tissue ▪
security measures for frozen tissue. ▪ 17
Data routinely collected by the TBN consortium banks are: Identifi cation data (hospital of collection, local case code, date of birth and
sex); and Pathology Data (date of pathological study, time of sample deposit in the pathology department, anatomical location of neoplastic
process, complete pathological diagnosis, histological grade, stage of tumour, primary or relapse tumour, material available and sample type
(eg biopsy, autopsy material)).17
Researchers accessing samples from the TBN are required to acknowledge the TBN (including the hospitals from which samples were
provided) in any publications resulting from work undertaken using the samples. In addition researcher must provide two copies of the
publications to CNIO. Depending on how much contribution the hospital providing samples has given to the project, researcher may be
asked to include the hospital bank as a collaborator in publications.17
13
Case Study 3: The Canadian Tumour Repository Network (CTRN)
The Canadian Tumour Repository Network (CTRN) was formed in 2004 and operates as a non-profi t consortium of leading biobanks
to aid Canadian health research. CTRN provides researchers with a streamlined process to obtain quality human tissue and human
tissue products from member biobanks. CTRN is governed by a board of representative member bank, responsible for the day to day
management of the consortium.13
The consortium provides standard operating procedures for all aspects of banking for participating banks including:
general institutional requirements ▪
administrative processes ▪
patient recruitment management ▪
recoding and documentation management ▪
facility management and operations ▪
quality assurance procedures ▪
safety and training ▪
material handling; and material release. ▪ 13
In order to access samples from the CTRN, researchers must fi rst register for free membership. The membership provides: ability to
search and apply for tissue samples from Canada’s leading tumour banks in one central location; learning opportunities using online tools;
online collaboration with researchers, epidemiologists, pathologists and other experts across Canada; and invitation to CTRN workshops
and conferences.13
Despite coordinated searching functions and applications, the CTRN still respects individual biobanks status on the supply of samples to
commercial entities and the shipment of samples outside of Canada (i.e. whether or not samples can be provided to commercial entities or
shipped outside of Canada is up to the individual biobanks discretion).13
Tissue samples available include fresh frozen, paraffi n embedded, blood products and saliva. Routinely collected information includes:
clinical information (composition of the tissue, the size and type of tumour, results of clinical tests, treatment type, follow-up and outcome
information); and de-identifi ed personal information relevant to the disease in question.13
4.3 Biobank governance arrangements
Focusing on the non-profi t biobanks, the governance
arrangements of individual biobanks will depend on a variety
of factors, including whether the bank is a stand-alone entity,
a part of a research institute/hospital and/or a part of a larger
network or consortia of biobanks.
Biobanks established under the control of a research
institute or hospital are generally governed by the hospital/
institute board and scientifi c advisory council/committee. If
these banks are also a part of a consortium, then they will
be (partially or fully) governed by the Board of Directors
or Governors of the consortium (which may include
representatives from the hospital/institute). Although the
bank may not be governed by the institute in which it is
housed, it will mostly likely be required to provide regular
reports to the institute as well as the governing board.
Consortia or individual banks that are not associated with
a hospital or institute (aside from sample collection) will be
independently governed.
4.3.1 Governance Boards
The US NBN Blueprint that examined arrangements for
an independent (i.e. non-associated) consortia of biobanks
proposed a three tier governance arrangement. The
organisational structure of the proposed NBN (depicted
Figure 1) focused on day-to-day operations (operations
centre) controlling six business units, and in turn being
governed by a board of governors.8
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
14
Figure 1 Proposed operating structure for the National Biospecimen Network (NBN)
Likewise, onCore UK is managed by a board of trustees. The
Board is accountable to the members of the company (the
Medical Research Council and Cancer Research UK), and
act as company directors and as charity trustees. The Board
consists of representatives from each of the three funding
bodies (the Department of Health, Cancer Research UK
and the Medical Research Council), a lay-representative and
an independent Chair. Day-to-day running of onCore UK is
conducted by the CEO and a management team (depicted in
Figure 2).9
Similarly, other independent biobank consortia have
established boards of directors or governors to control the
network and their strategic directions, including: UK Biobank,
CHTN (US)10 and the Ontario Tumour Bank.28
4.3.2 Other committees
In addition to the general governing boards and
arrangements, all biobanks require a scientifi c advisory
committee to which all applications for samples will be
submitted. The purpose of the advisory committee is to
approve the research for which the samples are requested
as benefi cial for sample use. This is over and above ethical
approval for research which researchers need to obtain from
their housing institution’s ethical board (or a similar ethical
body e.g. National Health and Medical Research Council in
Australia) prior to biobank application.
4.4 Standard operating procedures
The development of biobank consortia across countries or
regions has led to a global push to develop standardised
operating procedures for biospecimen collection,
preservation, treatment, storage and distribution. The aim of
this is to provide researchers assurance that samples across
multiple banks will have the same integrity and quality. This
would allow researchers to use multiple banks to collect
the number of required specimens, without jeopardising the
quality of the research project.
National Biospecimen Network guidelines, US
In 2002 in the US, the National Cancer Dialogue (now
C-Change) identifi ed an issue in researcher access to
biospecimen samples and established the Tissue Access
Working Group to explore the requirements for a National
Biospecimen Network (NBN). Extensive research was
conducted in 20038 on arrangements for the NBN, including
type of entity, funding arrangements, ethical considerations
and informed consent and best practice guidelines for:
biospecimen collection ▪
biospecimen processing, annotation, storage and ▪distribution
15
Figure 2 Operating structure for onCore UK
Board of Trustees / Directors:funding body representatives, lay-person representative,
independent chair person
CEO
Management Team
day-to-day operations
bioinformatics ▪
consumer/user needs ▪
business plan and operations ▪
privacy, ethical concerns and consent issues ▪
intellectual property and legal issues ▪
public relations, marketing and education. ▪
A summary of the NBN Guidelines is presented at
Appendix C.
National Cancer Institute guidelines, US
Subsequent to this research, in 2007 the National Cancer
Institute, in collaboration with the National Institutes
of Health and the US Department of Health and
Human Services, released best practices guidelines for
biorepositories, summarised in comparison to the NBN
guidelines at Appendix C.
Confederation of Cancer Biobanks guidelines, UK
In the UK, the Confederation of Cancer Biobanks developed
guiding principles for human research tissue banks/resources/
biobanks. The guidelines are summarised comparatively in
Appendix C.
The comparison of the guidelines from these three sources
alone highlights many similar themes for biobanking, especially
regarding informed consent, bioinformatics and appropriate
linkage of samples to clinical information.
Consensus points within these international guidelines
indicate that:
Samples (at least invasive samples) should be collected •
during the process of diagnostic or therapeutic
interventions and the sample assessed by a pathologist
to determine the amount required by diagnostic
pathology prior to the sample being stored in a bank for
research purposes.
Informed consent from donors is mandatory before •
samples can be included in the bank.
SOPs should be developed and staffed trained •
appropriately to promote consistency and quality of
samples. SOPs should be for all aspects of biospecimen
banking and specifi c to each sample type (eg blood,
tissue, DNA) and preservation method.
Samples need to be stored appropriately and with •
suitable back-ups in place should they be required.
Suitable tracking and retrieval methods of samples are •
required, including ‘shipping logs’ for distributed samples.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
16
Banks need to be responsive to the needs of researchers •
and develop/implement new technologies as required.
Suitable bioinformatic systems need to be developed/•
implemented to allow privacy of samples to be
maintained, i.e. samples to be de-identifi ed at the
end-user.
4.5 International and Australian biobanking networks
4.5.1 Stakeholder and peak body networks
Stakeholder and peak body networks are formed when
multiple biobanks and/or biobank consortia collaborate to
discuss universal topics in the fi eld such as standard operating
procedures (SOP) for collection, storage, treatment and
shipping of bio-samples, ethics and informed consent
for donors and data/information storage and retrieval.
Although the stakeholder collaborations represent biobanks
and consortia, as an entity they are not biobanks and are
often unincorporated. Examples of stakeholder networks
internationally and within Australia include:
Confederation of Cancer Biobanks (CCB) in the UK. ▪
NCI Offi ce of Biorepositories and Biospecimen Research ▪(OBBR) in the US.
Australasian Biospecimens Network (ABN) in Australia. ▪
The generalised objectives of these collaborations are to:
provide a forum to share information and develop ▪educational materials on technical issues, regulatory
issues, and human subject and confi dentiality issues
develop and review consensus standards and best ▪practice guidelines for biobanks
promote transfer of knowledge and experiences ▪between banks
assist in developing regulations for biorepository ▪activities
develop new technologies/products to meet changing ▪user needs
provide information to users about existing repositories ▪and their collections through searchable databases.31–33
In addition, both the CCB and ABN have also developed
searchable specimen locators which researchers can use to
look for relevant biosamples from member organisations as
discussed below. Technically, the OBBR does not have this
function, however another NCI program, the NCI Specimen
Resource Locator (discussed below) does.
4.5.2 Specimen locator networks
Specimen locator networks enable researchers to search
multiple banks at one time (via a website) to identify if the
samples they require are currently available anywhere. An
example of this is the NCI specimen resource locator, which
enables researchers to search all the NCI affi liated biobanks
for samples by type of tumour, type of sample (eg blood,
DNA, normal matched) by preservation technique (eg fresh-
frozen, formalin fi xed, OCTi fi xed) and by data required
(e.g. demographic data, exposure history, family history and
laboratory data).32
Similar in concept to this is the Confederation of Cancer
Biobanks (CCB) Biosample Search Portal (UK) which enables
researchers to search for samples from the CCB member
banks by tumour type, sample type and diagnosis/broad
morphology. CCB members include:
CamUro-Onc Biorepository. ▪
Candis Cancer Tissue Bank Research Centre. ▪
Glasgow Biobank. ▪
Human Biomaterials Resource Centre. ▪
Northern Ireland Tumour Bank. ▪
onCore UK. ▪
Tayside Tissue Bank. ▪
UK DNA Banking Network. ▪
Wales Cancers Bank. ▪ 33
In Australia the Australasian Biospecimens Network (ABN)
provides a similar function to CCB by allowing researchers
to search ABN member banks for samples using the Tissue
Specimen Locator webpage. The samples can be searched
by primary cancer site, broad morphology and sample type.
ABN member banks include:
OCT fi xation is a type of preservation method used for tissue samples.i.
17
Peter MacCallum Cancer Centre Tissue Bank (Vic). ▪
Kathleen Cuningham Foundation Consortium for ▪research into Familial Breast cancer (kConFab)
(Australasian).
Children’s Hospital at Westmead (NSW). ▪
Westmead Gynaecological Oncology Tissue ▪Bank (NSW).
Queensland Institute of Medical Research (QIMR) Cell ▪Line Bank.
Western Australia Research Tissue Network. ▪ 34
Request for samples from all ABN members (except
kConFab) can now be completed through a standardised
application form (downloadable from the ABN website) and
submitted to the ABN hub for approval.34
The ABN is the main biospecimen locator network in
Australia and is currently funded by an NHMRC Enabling
Grant of $1.75 million over fi ve years (2004 to 2009). The
funding was shared between the seven founding member
banks and is approximately distributed as follows: 80 per cent
personnel, 10 per cent IT infrastructure/maintenance and 10
per cent other running costs. At this stage new members are
not asked to contribute fi nancially.35
This style of networking provides an easy and consistent
entry point for researchers and enables multiple banks to
be searched in one step. In addition, the ABN functions
as a forum to discuss common issues in biobanking, new
technologies, best practices and standard operating
procedures. This type of forum is likely to be invaluable in
the future of biobanking. Other stakeholder networks have
also been established, such as the Australian Prostate Cancer
Collaboration (APCC) which aims to promote collaboration
between all organisations researching prostate cancer. The
APCC has also established its own biobank with collection
nodes across Australia and is in the process of developing a
specimen locator for prostate cancer samples.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
18
One of the main hurdles that had to be overcome to establish the consortium was a willingness of all banks to participate.
5 Australian governance arrangements
This chapter describes the Australian standards of
governance which businesses, including biobanks, should
adhere to. It also gives two examples of governance
structures established for biobanks in Victoria and Western
Australia and a data management and linkage system being
used for biobanking in Western Australia. Other types of
governance arrangements established by biobanks with
storage or collection sites in NSW are discussed in Chapter 6, which summarises the fi ndings from the telephone
interviews or email surveys of NSW biobanks.
5.1 Australian standards of governance
Information regarding best practice governance
arrangements can be obtained from the Standards Australia
Good Principles of Governance.36 Governance for biobanks
by a board of directors is in keeping with the Standards
Australia Good Principles of Governance, which state that
organisations (both for-profi t and non-profi t) should include:
defi ned roles, powers and responsibilities for the board
and board members; and defi ned and transparent codes
of conduct and reporting responsibilities. According to
Standards Australia, responsibilities of the board include:
strategic direction of the entity, with clearly documented ▪objectives
approve all major decisions ▪
approval of budgets and other performance indicators ▪
compliance with applicable laws and regulations ▪
appropriate risk identifi cation and mitigation strategies ▪
ensuing appropriate policies are in place and adhered to ▪
appointment and evaluation of performance of a chief ▪executive offi cer (CEO).36
In general, the board should ensure that collectively it has
the appropriate level of skills and experience (operational
and technical) required to fulfi l its responsibilities and board
members should be independent of management to avoid
(where possible) confl icts of interest.36
Standards Australia also comments on non-profi t
organisations, which are generally incorporated associates
or companies limited by guarantee. An important distinction
in this sector is between member-serving and community-
serving organisations. The distinction between the two can
be diffi cult, but generally member-serving organisations
designate the rights of members, e.g. voting rights or rights
to services. However, for community-servicing organisations,
defi ning the groups and/or types of membership can be
more diffi cult and may cover, for example, donors, other
supports, members by application, members by invitation,
governments and service recipients. In this case, each
membership type may enjoy different entitlements.36
5.2 Victorian Cancer Biobank
The Victorian Cancer Biobank (VCB) is a Victorian
State Government (Department of Innovation, Industry
and Regional Development) funded project to improve
coordination between biobanks in Victoria and to improve
researcher access. The VCB has been established as a not for
profi t organisation, hosted by the Cancer Council Victoria.
Table 1 shows the fi nancial status of the VCB for 2006 and
2007, which shows that the majority of the $4m funding over
two years has gone to research grants and associated costs
(over $2.5m). It should also be noted that the VCB spent
$38,000 in 2007 (approximately two per cent of the years
funding) on advertising, printing and promotional activities
to promote the use of the biobank and raise awareness with
researchers.
5.2.1 Organisation and Governance
The VCB is a consortium of the four major biobanks in
Victoria (Peter McCallum Cancer Centre, Melbourne Health,
Austin Health and Southern Health). These four biobanks
had been independently established as formalised biobanks,
each with multiple collection sites but one major storage site
(depicted in Figure 3).
19
Table 1 Financial status of the VCB 2006 and 2007
2007 (Jan to Dec) $’000 2006 (Jan to Dec) $’000
Income
DIIRD Grant 1,800 2,200
Other 1 -
Total 1,801 2,200
Expenditure
Grants and other research costs 1,084 1,583
Payroll and staff expenditure 178 13
Advertising 38 -
Other 83 27
Total 1,383 1,623
Surplus
Net surplus for the year 418 577
Balance of surplus to carry forward 995 577
As a consortium the four individual banks are governed as a
single entity, hosted by the Cancer Council Victoria
(Figure 4).
Each biobank in the consortium has a tissue bank steering
committee and/or management committee responsible for
the day to day operations of the banks, including hiring of
staff, fi nancial management, equipment and infrastructure
management and management of the relationships with
collection sites. Ethics approval for tissue collection and the
consent process has been established by the Hospital Ethics
Committee of the main sites of the four biobanks.
Overall, the consortium is governed by the Consortium
Committee which set the strategic directions for the
consortium. Underneath this is central operations
responsible for oversight of the four biobanks including input
in to strategic directions, setting SOPs, development of a
business plan, budgeting and expenditure and overall fi nances
of the consortium. Alongside is the Tissue Bank Managers
Advisory Group, which is responsible for implementing the
business plan.
Other sub-committees include the Access Committee
responsible for approving tissue sample requests and the
Informatics Committee responsible for data collection/
linkage operations and software development.
5.2.2 Benefi ts and hurdles
There were several hurdles to overcome in order to
establish such a consortium, but the benefi ts are perceived
to outweigh the negatives. By operating as a consortium the
benefi ts to researchers include:
Improved access to tissue samples for researchers ▪because researchers can now apply through one central
application to access the four main biobanks (and the
sub-collection centres) in a standardised process.
Removal of potential bias for biobanks to prioritise ▪internal researchers over external researchers, and
ensuring specimens are available to all researchers in
Victoria, Australia and internationally without bias.
Increase in availability of rare or hard to get samples ▪because researchers now have access to the whole of
the Victorian specimen collection in one application.
An example of this is the collection of fresh tissue
samples which can be diffi cult to obtain and to deliver to
researchers as a fresh sample.
The VCB has been able to give funding to the biobanks ▪for a pathology registrar (one at each bank) through
the grant funding of the consortium to recognise the
demand on pathology services.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
20
Figure 3 VCB Biobanks and Collection Sites
21
Figure 4 VCB governance arrangements
‘Previously, access to biospecimens was only from one or two
hospitals involved in the research project. Now, through the
Biobank Consortium, collection is from multiple sites and I
have access to a wider network.’
Cancer Researcher, Peter MacCallum Cancer Centre, from
VCB Newsletter, BioBank Brief, April 2008
One of the main hurdles that had to be overcome to
establish the consortium was establishing a willingness of all
banks to participate based on the benefi ts to the researcher.
Reluctance to participate often stemmed from the
perception of having to ‘give up’ their samples and a loss
of control over their bank. This was overcome by
maintaining the existing management of day-to-day practices
and the inclusion of biobank representatives in higher
management committees.
5.2.3 Standard operating procedures and bioinformatics
In order to establish consistency across the four biobanks,
the VCB has developed standard operating procedures
(SOPs) covering all four banks. The SOPs were based on
ISBER standards. Despite having the SOPs, there is still a
need to monitor the procedures of individual banks from
time to time as there can be drift (eg for minimum
data collection).
Each of the biobanks has their own individual identifying
number system to identify samples and to link to data.
Currently each site has data systems for this purpose, with
a shared minimum data set. However, the VCB are planning
to move to a centralised database system. The system will
collect basic information (minimum data set) on the sample
and patient, and will use the BioGrid Australia Cancer Data
Linkage system43 to link to follow up data and outcomes data.
5.2.4 Researcher access
Currently the VCB advertise the biobank consortium
through: their website, which includes a page for prospective
donors as well as researchers; directed marketing campaigns,
e.g. media reports (television, radio, newspaper); and
quarterly newsletters circulated to all cancer researchers in
Victoria. The VCB also produce an annual report detailing
highlights and future direction, governance arrangements,
milestone progress and funding arrangements.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
22
In addition, at least one of the four biobanks (Peter
MacCallum Cancer Centre) is a member of the Australasian
Biospecimen Network (ABN), enabling researchers to search
for specimens on line through the biospecimen locator. VCB
is also in the process of creating their own biospecimen
locator program to enable researchers to search across all
collection sites for all samples housed in one shot. Marketing
appears to be an important component of the consortium
business plan to let researchers know about the banks and
the samples collected to ensure maximum usage of
the system.
5.2.5 Cost recovery
VCB charge a cost recovery fee for samples. This is based
on a three tiered set up. There are two tiers for academic
research, with those organisations providing ‘in kind support’
receiving a bit of a discount and the highest cost being
charged to commercial research.
The service areas of the tissue collection, processing and
storage process have been broken down into modules for
costing units. This enables researchers to purchase different
sections of service and be charged accordingly, for example in
clinical trials where the company may only want/need certain
aspects of service such as collection and processing because
they have obtained their own consent for the study.
Cost recovery only equates to approximately 20 per cent of
the actual cost of the biobanking process.
5.3 Biobanking in Western Australia
5.3.1 Biobanks within pathology departments
A new model of biobanking that has emerged in Western
Australia (WA) is to extend the capacity of pathology
department services. This model has been established by Dr
Nikolajs Zeps at St John of God Pathology, associated with
St John of God Health Care in Western Australia. St John of
God Health Care is a Catholic, non-profi t organisation and is
one of the largest health care and pathology providers
in WA.37,38
Originally, Dr Zeps and his team established the Western
Australian Research Tissue Network (WARTN). WARTN
was established as a biobank consortium for WA through
a translational research collaboration between the School
of Surgery, University WA and Radiation Oncology
Department, Sir Charles Gairdner Hospital, and was the
fi rst statewide biobank consortium established. WARTN
experienced some diffi culties however, including lack of
interest by surgeons in biobanking and lack of pathology
resources to aid in occasional banking activities as required.
The perception of the biobanking activities as an add-on
to traditional pathology services also resulting in large and
unsustainable fi nancial costs.37 Therefore the Zeps team
considered a different approach. Moving away from housing
the biobanking under the research arm, the team established
the biobank within the Pathology Department of St John
of God Pathology (which has 43 collection centres across
Perth and regional WA). This new project is a collaboration
between St John of God Pathology and the St John of God
Colorectal Service.37
This model required a shift in the routine preparation of
samples by pathology to include fresh frozen samples and
some molecular testing, as well routine paraffi n embedding.
There were many benefi ts noted from this model of
biobanking, such as:
(1) Staff attitude:
The perception of pathologists that they were being ▪asked to undertake additional ad hoc procedures was
removed by installing a set of new routine procedures
in pathology.
Increased pathology staff attention and interest through ▪increased role variety and responsibility.
(2) Reduced costs: Costs associated with processing
and storing the samples were reduced as it was no longer an
additional service provided by pathology (and hence charged
at the full rate), but a routine procedure factored into
pathology costs (hence costs were only staff time
and consumables).
(3) Increased sample collection: As all tissue samples
are processed through pathology for diagnostic processes,
housing the biobank within pathology results in all possible
samples being identifi ed by the biobank.ii With this, good
Samples are often missed when the biobank is separate from pathology as the biobank staff are reliant on information from, and hence ii.
good relationships with, the surgeons and pathology staff.
23
relationships with surgeons collecting samples are maintained.
(4) Improved diagnostic results: Improved molecular
test results for diagnostic purposes as fresh frozen samples
rather than paraffi n embedded samples could be used.37
One potential issue arising with this model of biobanking
is that in Australia it has only been tested to date with
high volume tumours (e.g. colorectal, breast and prostate).
Inclusions of other more rare tumours may increase costs.
In addition, the SOP for the freezing of fresh tissue does
not currently require immediate freezing after surgery. If
immediate freezing was required for other tumour types
this would also increase costs of staff time, as someone
would need to collect the sample from the surgery room
immediately after it was removed during the surgery.37
(Note that an alternative approach may be to position liquid
nitrogen canisters in the surgical theatres to ensure that the
specimens are snap frozen without delay. This procedure
is used for specimen collection from private hospitals
associated with the Kolling NeuroEndocrine Tumour Bank
(see Section 7.5.5), where biobank staff are not available
onsite for immediate specimen collection).
Consent processes
Consent for biobanking of tissues removed during surgery for
future research has been included on the standard surgery
form at the St John of God hospitals participating to prevent
duplication of this process (traditionally, biobank personnel
would collect consent from patients post surgery if there was
enough sample remaining post diagnostic testing).37
Standard Operating Procedures and Quality Assurance
Being a part of the pathology department, the SOPs are
a part of a NATA accredited facility and are based on
international quality assurance protocols.39
Cost recovery and measures of success
As a part of the pathology department with only incremental
increases to pathology costs, the biobank has been funded
as a standard protocol within the pathology department.
As such, there is no need for the biobank to request fees
for samples from researchers. Instead, the biobank requires
from researchers, the following as a measure of ‘success’ and
methods of sustainability:
Researchers must include the biobank as an 1.
acknowledgement (at least) or collaborator on any
publication resulting from research with the samples
(there have been three collaborative publications
this year).
The biobank may request that, once published, the 2.
data from the research is to be made available to other
researchers through inclusion in the biobank database.37
Other examples of pathology based biobanking
This model of biobanking through pathology departments
has been used successfully internationally, for example the
Spanish National Cancer Research Centre (CNIO) Tumour
Bank Network (TBN).18
There are also examples of the use of pathology
departments in biobanking within NSW. For example,
the tumour bank at Children’s Hospital in Westmead,
although established through and funded under the research
department, has close collaborations with the pathology
department. In this example, the pathology department
process and store all samples for the biobank. Biobank staff
are then able to collect consent for use of the samples from
the patients/parents and store those consented to in the
biobank for future use. The close relationship with pathology
ensures that all possible samples are examined for use in
biobanking and that good relationships are maintained with
the surgeons who collect the samples.
‘It cannot be more strongly emphasised that tumour banking is
a team effort which is heavily reliant on the surgeons and their
persistence in training their staff (e.g. interns and registrars) to
help the laboratory staff.’
Comment made by biobank head in NSW.
5.3.2 Data management tools and linkages
An important aspect of biobanking is the clinical data that
accompanies samples and the management of the data and
tracking of samples. This becomes particularly important as
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
24
the biobank grows in size and sample numbers; and merges
or collaborates with other banks.
Traditionally, biobanks have developed internal databases
for the collection of related data and tracking of sample
locations, which are often outgrown by the expansion of the
biobank. In WA however, a new service has been developed
by the Western Australian Genetic Epidemiology Resource
(WAGER) to provide laboratories (including biobanks) with
Laboratory Information Management Systems (LIMS).40,41
The LIMS allow researchers to store and manage clinical
and other information collected for research or biobanking
purposes. If the information is associated with tissue samples,
the location of the samples can also be tracked (to specifi c
freezer boxes within freezers) and monitored for volume
and use. Data can be uploaded into the LIMS via a secure
and encrypted webpage only accessible to members of the
WAGER LIMS once their account is activated (researchers
are sent a program to load onto their computers to allow
access to the webpage). Data is then stored in a highly secure
and reliable, purpose built data bank located at the University
of Western Australia. Data stored through WAGER is still
‘owned’ by the individual researcher and access to the data is
at the discretion of the researchers.41
Other functions of WAGER are data extraction and
analysis tools and study support. WAGER does not charge
researchers to become members for use of LIMS or these
tools, nor to access data through WAGER. Other services
that WAGER are developing, such as statistical help for
research studies, are charged a nominal amount for WAGER
staff time.40,41
WAGER does ask however, that researchers using their
service acknowledge WAGER in any publications resulting
from access to the WAGER informatics resource. To date
there have been more than 230 publications acknowledging
WAGER.40,41
Data linkage
Another benefi t to researchers using WAGER for data
management is the agreement between WAGER and the
Western Australian Data Linkage System (WADLS) of the
WA Health Department.42 WADLS enables linkage of WA
population health data collections and other external data
sets by assigning a unique identifi er to each subject based
on demographic information (e.g. name, sex, date of birth,
address) in each data set to be linked. Information and data
are not stored in WADLS; it is just a mechanism to link
various data sets.
Linkages to other data sets can be facilitated through
WAGER based on the agreement between WAGER and
WADLS. WAGER itself however cannot link data sets,
therefore two studies both using WAGER to manage data
will still need to be linked through WADLS as required. In
relation to biobanking however, biobanks using WAGER to
manage their data could use the subject linkages generated
through WADLS to obtain follow-up and other clinically
relevant data based on WA population health data sets.41
There are many research projects that use WAGER to track
and manage tissue samples and information, but not many
of these are actual biobanks, rather specimen collections.
There is a DNA Biobank that uses WAGER and the St John
of God Pathology biobank (and before that the WARTN)
use WAGER to manage data and also submits information
to WADLS via the Cancer Registry of WA. This process is
facilitated through WAGER.37,41
Other data linkage systems that have been developed
in Australia are BioGrid Australia,43 which is currently
developing the Australia-wide Cancer Grid (funded by
the Department of Innovation, Industry and Regional
Development, Victoria) to allow tracking of patient
information across many tumour types and hospitals across
Australia; and the Centre for Health Records Linkage
(CheReL),44 a NSW initiative that creates links between
health databases based on subjects demographic details
(e.g. name, date of birth and address). Similar to WADLS,
CHeReL does not provide access to the data sources, only
a link between data sources which researchers/clinicians can
then use to match data.
Although no large scale population-based epidemiological
biobanks are established in Australia to date, the use of data
linkage systems, such as those described above, can add
greatly to the depth of epidemiological research that can
be undertaken.
25
6 Biobank locations in New South Wales
Most biobanks relating to cancer research were for specifi c cancer types rather than a generalist approach.
6.1 Biobank locations in New South Wales by geographic hub
The results of identifying biobanks in NSW (Table 2)
showed that:
The existing banks or collection nodes cover a range of ▪cancer/tumour types, such as: breast (x4); lymphoma and
leukaemia (x3); colorectal (x3); skin cancer (x2); neuro-
endocrine and brain (x3); gynaecological (x2); myeloma
(x1); prostate (x1); pancreas (x1); gastro-intestinal (x1);
paediatric (x2); sarcoma (x1).
The majority of banks/collections collected samples from ▪one (30 per cent) or two (30 per cent) geographical
sites. The most collection sites currently for any one
bank was eight (Children’s Cancer Institute Australia
Tissue Bank) and six (Australian Breast Cancer Tissue
Bank). Four banks collected from three sites (17 per
cent) and four were unconfi rmed (17 per cent). Several
commented that they are in the process of seeking ethics
approval from other sites with the aim of expanding the
number of collection centres for the bank.
One bank collected samples from Australian states ▪outside NSW (Australasian Brain Tumour Bank
collects from NSW and Western Australia) and one
bank collected samples from Australia and overseas
(Children’s Cancer Institute Australia Tissue Bank collects
from NSW, Queensland, Victoria, South Australia,
Tasmania and New Zealand).
The majority of the individual banks/collections were ▪identifi ed in the Northern Sydney hub (33 per cent).
Most biobanks relating to cancer research were for specifi c
cancer types rather than a generalist approach (the notable
exceptions to this were banks related to childhood cancers).
Despite several of the banks having multiple collection sites,
there were still some instances of multiple individual banks
covering the same tumour types.
A summary of the biobanks and specimen collections
identifi ed in NSW by geographic hub are presented in
Table 2 and Table 3.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
26
Table 2 Biobanks in NSW by geographic hub
# Name of Tissue Repository Tumour type(s) Central Location
Tissue Storage Nodes
Collection Sites
Central Sydney
1 Sydney Melanoma Unit Bio-
Specimen Bank
Any skin cancer, with
majority melanomas
RPAH RPAH
(Anatomical
Pathology)
RPAH; Mater Hospital; Ethics
approval being sought at other
sites
Darlinghurst
2 Australian Prostate Cancer
BioResource, NSW Node
Prostate Garvan Institute
of Medical
Research
Garvan Institute
of Medical
Research
St Vincent’s Hospital
3 South Western Sydney
Colorectal Tissue Bank
Colorectal Garvan Institute
of Medical
Research
Garvan Institute
of Medical
Research
Liverpool and Bankstown
Hospitals 2000 – 2003
4 NSW Pancreatic Cancer
Network Tissue Bank
Pancreas Garvan Institute
of Medical
Research
Garvan Institute
of Medical
Research
Kolling Institute
of Medical
Research
Bankstown Hospital; RNSH
5 Colorectal Cancer Tissue Bank Colorectal Integrated
Cancer
Research,
UNSW
Garvan Institute
of Medical
Research
St. Vincent’s Hospital
Northern Sydney
6 Breast Cancer Tissue Bank,
Kolling Institute(distinct from
storage node for WMI Breast
Cancer Tissue Bank, also at
Kolling Institute)
Breast Kolling Institute
of Medical
Research
Kolling Institute RNSH; RNS Private; Mater
7 Gynaecological Tissue Bank,
Kolling Institute
Gynaecological Kolling Institute
of Medical
Research
Kolling Institute RNSH; RNS Private; Mater
8 Upper GI Tissue Bank (including
pancreatic tissue bank), Kolling
Institute
Upper GI including
pancreas
Kolling Institute
of Medical
Research
Kolling Institute RNSH; RNS Private
9 NeuroEndocrine Tumour Bank,
Kolling Institute
Neuroendocrine including
low grade brain tumours,
pituitary tumours, CNS
tumours, brain metastases
Kolling Institute
of Medical
Research
Kolling Institute RNSH; RNS Private
10 Australasian Brain Tumour Bank High grade brain tumours Kolling Institute Kolling Institute RNSH; RNS Private; WA
collection partner in 2008 with
planned roll-out to other sites
27
Table 2 Biobanks in NSW by geographic hub (cont’d)
# Name of Tissue Repository Tumour type(s) Central Location
Tissue Storage Nodes
Collection Sites
Western Sydney
11 Breast Cancer Tissue Bank Breast Westmead
Millennium
Institute
(management
hub)
Westmead
Millennium
Institute
RPAH
(Anatomical
Pathology)
St Vincent’s
RNSH (Kolling
Institute)
John Hunter
Port Macquarie
(Symbion
Pathology)
Listed Storage nodes; NSW
Breast Cancer Institute
12 Westmead Gynaecological
Tissue Bank
Gynaecological tissue
including ovarian, uterian,
perinatal, cervix, fallopian
tube, appendix (when
thought to be ovarian).
Some colorectal samples
from St Vincent’s Hospital.
Westmead
Millennium
Institute
Westmead
Millennium
Institute
Westmead Hospital; (some
colorectal samples from St
Vincent’s Hospital)
13 Children’s Hospital Westmead
Tumour Bank
57 types of paediatric
tumour specimens.
Children’s
Hospital
Westmead
Children’s
Hospital
Westmead
Children’s Hospital Westmead
Randwick
14 Children’s Cancer Institute
Australia Tissue Bank
Acute leukaemia (for
specifi c trials); other
childhood cancers including
neuroblastoma, solid
tumour of varying types,
NHL and acute myeloid
leukaemia.
Children’s
Cancer Institute
Australia
Children’s
Cancer Institute
Australia
Westmead; Sydney Children’s
Hospital; Royal Children’s,
Melbourne; Royal Children’s,
Brisbane; Women and
Children’s, Adelaide; John
Hunter Hospital; Royal
Hospital, Hobart; Starship,
Auckland; Wellington Hospital;
Christchurch Hospital
15 Brain Tumour Bank Brain tumours Prince of Wales
Private Hospital
Prince of Wales
Private Hospital
Prince of Wales Private
Hospital
16 Surgical Oncology Group
Sarcoma Tumour Bank
Sarcoma Prince of Wales
Hospital
Prince of Wales
Hospital
Prince of Wales Hospital;
Canberra Hospital
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
28
Table 3 Specimen Collections in NSW by geographic hub
# Formal Bank or Specifi c Collection(s)
Tumour type(s) Central Location Tissue Storage Nodes Collection Sites
Central Sydney
18 In planning Lymphoma and
leukaemia
RPAH - planned Planned storage site
at Centenary Institute
adjacent to RPAH
RPAH - planned
19 Specimen collection(s) Mostly multiple myeloma RPAH RPAH Haematology
Laboratory
RPAH
20 In planning Bladder Concord Hospital Concord Hospital
(Anatomical Pathology)
Unconfi rmed
Darlinghurst
21 Specimen collection(s) Breast Garvan Institute of
Medical Research
Garvan Institute of
Medical Research
St Vincent’s Hospital
RPAH
Northern Sydney
22 Specimen collection(s) Breast Mater Hospital Mater Hospital Mater Hospital
Western Sydney
23 Specimen collection Mostly acute leukaemias Westmead Millennium
Institute
Westmead Millennium
Institute
Westmead Hospital
Children’s Hospital
Westmead
Concord Colorectal Tumour Bank and the John Hunter and Calvary Mater hospitals in Newcastle were not able to be surveyed to know if there is a
formal biobank or specimen collection.
# Name of Tissue Repository Tumour type(s) Central Location
Tissue Storage Nodes
Collection Sites
Other NSW
17 The Cancer Council NSW Blood specimens from
individuals with any non-
melanoma skin cancer
(specifi c studies).
Blood specimens related to
other specifi c studies.
The Cancer
Council NSW
The Cancer
Council NSW
Several
Table 2 Biobanks in NSW by geographic hub (cont’d)
29
7 Biobank governance in New South Wales
The biobanks investigated in NSW presented a mix of single and multicentre collection and/or storage sites.
This chapter discusses the fi ndings of the governance survey
of formal biobanks. Table 9.3 at Appendix D presents a
summary of the fi ndings for each of the formal
biobanks interviewed.
7.1 Biobank general characteristics
Table 4 outlines general characteristics of biobanks surveyed
in Phase 1 and/or Phase 2 of the study, including their year
of establishment, specimen source site(s) and total numbers,
donor numbers and researcher access. The table highlights
the following characteristics of existing tumour banks
in NSW:
Almost all biobanks surveyed in NSW were established 1.
in the last decade, with the majority of these started in
the past two–fi ve years.
Funding for the biobanks is generally from grants, and 2.
ranges from less than $100,000 to over $2,000,000.
Further details regarding tissue bank funding sources and
entity status are discussed in Section 7.3.
Sites from which tumours are collected are dependent 3.
on the nature of the tumour collection or the source
population. For example, biobanks may collect site
specifi c tumours such as breast or prostate, may collect
tissue from various tumour sites due to the nature of
the cancer such as sarcoma, or collect from multiple
tumour sites due to the nature of the population such as
paediatric biobanks.
Numbers of specimens and contributing donors to date 4.
and by month varies greatly and is dependent on tumour
type and incidence, as well as whether the bank collects
from single or multiple sites. Donors per month ranges
from 1.5 in the Surgical Oncology Group Sarcoma
Tumour Bank at Prince of Wales (POW) Private
Hospital to 65 in the Breast Cancer Tissue Bank based
at Westmead Millennium Institute, which has several
collection and storage nodes.
The APCC BioResource, Breast Cancer Tissue Bank 5.
(Westmead), Westmead Gynaecological Tissue Bank
and the CHW Tumour Bank are all formalised banks
with specimens available to all Australian researchers
based on appropriate approvals and some priority
access policies (see Section 7.6.1). Other banks have
historically only provided specimens to local researchers
or their collaborators, and do not have formalised
researcher access policies. Other banks, such as the
NSW Pancreatic Cancer Network Tumour Bank, have
restricted access to members of the NSW Pancreatic
Cancer Network, as there are insuffi cient specimens and
staff to allow requests beyond this.
Several banks indicated that they have rare specimens in
limited supply. These are listed in Table 5.
Some biobanks have developed collaborations to facilitate
the collection of rare specimens. For example, the Kolling
Institute NeuroEndocrine Tumour Bank has developed
collaborations both with internal professorial medical/
surgical staff and staff at other institutions in Australia and
New Zealand to collect and store rare specimens within the
Kolling biobank.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
30
Tab
le 4
Curr
ent
Stat
us
of N
SW
Bio
ban
ks (
Oct
ober
2008)
Bio
bank
Nam
eYe
ar
esta
b.Fu
ndin
g si
nce
ince
ptio
nFu
ndin
g so
urce
s (p
revi
ous
and
curr
ent)
Spec
imen
sou
rce
site
(s)
Tota
l no.
sp
ecim
ens
Tota
l co
ntri
butin
g do
nors
App
rox.
no.
of
don
ors
/ m
onth
Gen
eral
a or
rest
rict
ed
rese
arch
er a
cces
s
Sydney
Mela
no
ma
Unit B
io-S
peci
men
Ban
k
2007
Par
t of gr
ant
fundin
g fo
r
multip
le p
roje
cts
CI N
SW
Tra
nsl
atio
nal
Pro
gram
Gra
nt;
NH
MR
C P
rogr
am
Gra
nt
Pri
mar
y m
ela
no
ma;
meta
stat
ic
mela
nom
a; n
on-m
ela
nom
a sk
in
lesi
ons
213
b658 (
those
donat
ing
blo
od
sam
ple
)
60-8
0 b
lood
20-3
0 t
issu
e
Pri
ori
ty a
ccess
to
those
ass
oci
ated
with S
MU
or
colla
bora
tors
Aust
ralia
n
Pro
stat
e C
ance
r
Bio
Reso
urc
e (4
Aust
nodes
incl
Gar
van)
2005
Ove
r $2.5
MPro
stat
e C
ance
r
Foundat
ion
Aust
ralia
;
Cm
mo
nw
eal
th
Ban
k; A
ndro
logy
Aust
ralia
;
NH
MR
C E
nab
ling
Gra
nt
Pro
stat
e4,2
72
c1,
487
45-5
0G
enera
l
South
West
ern
Sydney
Colo
rect
al
Tum
our
Ban
k
2000
Unkn
ow
n
(his
tori
cal
speci
mens
only
)
CI N
SW
Car
eer
Deve
lopm
ent
Fello
wsh
ip
Colo
rect
al~
1,200
d403
n/a
Rest
rict
ed
NSW
Pan
creat
ic
Can
cer
Netw
ork
Tum
our
Ban
k
2002
Ove
r $500K
Var
ious
(not
liste
d)
Pan
creas
2,3
00
e 300
(pro
spect
ive,
non-a
rchiv
al
speci
mens)
40-4
5R
est
rict
ed t
o
mem
bers
of
NSW
Pan
creat
ic
Can
cer
Netw
ork
Inte
grat
ed
Can
cer
Rese
arch
Colo
rect
al C
ance
r
Tis
sue
Ban
kf
1993
Genera
l
labora
tory
fundin
g
Genera
l
labora
tory
fundin
g
Colo
rect
alR
est
rict
ed
Genera
l acc
ess
refe
rs t
o s
peci
mens
bein
g av
aila
ble
to a
ll A
ust
ralia
n r
ese
arch
ers
, with s
om
e ban
ks t
hen h
avin
g pri
ori
ty a
ccess
sch
em
es
(i.e
. pri
ori
ty a
ccess
for
those
invo
lved
a.
in s
peci
men c
olle
ctio
n o
r th
eir c
olla
bora
tors
).
Exc
ludin
g blo
od a
nd b
lood p
roduct
s. T
ota
l speci
mens
incl
udin
g blo
od a
nd b
lood p
roduct
s is 8
71.
b.
Exc
ludin
g blo
od a
nd b
lood p
roduct
s. T
ota
l speci
mens
incl
udin
g blo
od a
nd b
lood p
roduct
s is 4
8,6
91.
c.
H
isto
rica
l speci
mens
only
, curr
ently
no p
rosp
ect
ive
colle
ctio
n.
d.
In
cludin
g 2000 a
rchiv
al s
peci
mens.
e.
C
onduct
ed P
has
e 1 s
urv
ey o
nly
so d
ata
rega
rdin
g sp
eci
men a
nd d
onor
num
bers
not
avai
lable
.f.
Tota
l for
3 K
olli
ng
Inst
itute
Tum
our
Ban
ks in
cludin
g B
reas
t C
ance
r, U
pper
GI an
d G
ynae
colo
gica
l.g.
D
eta
ils for
this b
ank
refe
r to
the
Neuro
co
mponent
of th
e Kolli
ng
Neuro
Endocr
ine
Tum
our
Ban
k w
hic
h in
corp
ora
tes
the
Aust
rala
sian
Bra
in T
um
our
Ban
k.h.
31
Bio
bank
Nam
eYe
ar
esta
b.Fu
ndin
g si
nce
ince
ptio
nFu
ndin
g so
urce
s (p
revi
ous
and
curr
ent)
Spec
imen
sou
rce
site
(s)
Tota
l no.
sp
ecim
ens
Tota
l co
ntri
butin
g do
nors
App
rox.
no.
of
don
ors
/ m
onth
Gen
eral
a or
rest
rict
ed
rese
arch
er a
cces
s
Kolli
ng
Bre
ast
Can
cer
Tum
our
Ban
k
2003
~$700K
g
CI N
SW
; Can
cer
Counci
l (ST
REP);
NBC
F; N
HM
RC
;
RN
SH
Key
Can
cer
Are
ac
Bre
ast
Not
pro
vided
162
40-5
0
Has
only
been
loca
l rese
arch
ers
and c
olla
bora
tors
to d
ate
Kolli
ng
Upper
GI
Tum
our
Ban
k
Mid
1990s
Pan
creas
; liv
er;
bile
duct
/
chola
ngi
o; g
astr
ic; o
eso
phag
us
Not
pro
vided
297
Kolli
ng
Gyn
aeco
logi
cal
Tum
our
Ban
k
2003
Ova
ries; e
ndo
metr
ium
; cerv
ix;
vulv
a
Not
pro
vided
153
Kolli
ng
Neuro
Endocr
ine
Tum
our
Ban
k
1992
$30K+
Andre
w O
lle
Mem
ori
al T
rust
;
Sydney
Neuro
-
Onco
logy
Gro
up; C
INSW
est
ablis
hm
ent
gran
t
Adre
nal
; par
athyr
oid
; thyr
oid
;
mis
cella
neo
us
endo
crin
e
2,3
07
1,990
13-2
2
Aust
rala
sian
Bra
in
Tum
our
Ban
kk
2004
Bra
in a
nd C
NS: g
liom
as;
menin
gio
mas
; meta
stas
es;
pituitar
y ad
eno
mas
; oth
er
tum
ours
of C
NS
885
841
20-2
5
Bre
ast
Can
cer
Tis
sue
Ban
k
2006
Ove
r $2.5
MN
HM
RC
; NBC
F;
CI N
SW
Bre
ast
20,5
00
1,270
65
Genera
l
West
mead
Gyn
aeco
logi
cal
Tis
sue
Ban
k
1992/3
$100-5
00K
NH
MR
CO
vari
es; p
eri
toneum
; fal
lopia
n
tube; u
teru
s; c
erv
ix; c
olo
rect
al;
unkn
ow
n
518
507
8-1
0G
enera
l
Tab
le 4
Curr
ent
Stat
us
of N
SW
Bio
ban
ks (
Oct
ober
2008)
(cont’d)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
32
Bio
bank
Nam
eYe
ar
esta
b.Fu
ndin
g si
nce
ince
ptio
nFu
ndin
g so
urce
s (p
revi
ous
and
curr
ent)
Spec
imen
sou
rce
site
(s)
Tota
l no.
sp
ecim
ens
Tota
l co
ntri
butin
g do
nors
App
rox.
no.
of
don
ors
/ m
onth
Gen
eral
a or
rest
rict
ed
rese
arch
er a
cces
s
Child
ren’s H
osp
ital
West
mead
Pae
dia
tric
Tum
our
Ban
k
1998
Ove
r $500K
Benevo
lent
benefa
cto
rs;
Dept
of H
eal
th;
NH
MR
C E
nab
ling
Gra
nt; C
I
NSW
Rese
arch
Infr
astr
uct
ure
Gra
nt; O
nco
logy
Child
ren’s
Foundat
ion
ALL; A
ML; C
ML; a
cute
leuka
em
ia o
ther;
car
cino
ma
vari
ous; a
dre
nal
tum
our
(oth
er)
;
bra
in t
um
our;
rar
e benig
n
tum
our;
Ew
ing’
s sa
rco
ma;
sarc
om
a oth
er;
neuro
bla
sto
ma
and v
aria
nts
; germ
cell
tum
our;
hae
mat
olo
gica
l oth
er;
hepat
obla
sto
ma;
lym
pho
ma;
his
tiocy
tosi
s; r
enal
; sch
wan
nom
a;
ost
eosa
rco
ma;
peri
phera
l
neuro
ect
oderm
al t
um
our;
retino
bla
sto
ma;
rhab
dom
yosa
rcom
a
Not
pro
vided
2,4
70
10G
enera
l
Child
ren’s C
ance
r
Inst
itute
Aust
ralia
Tum
our
Ban
k
2000
2 x
$10
0-5
00K
Inte
rnal
Bone
mar
row
; peri
phera
l blo
od
~77,
000
~5,0
00
50
So
me
rest
rict
ed
to c
linic
al t
rial
s
Bra
in T
um
our
Ban
k
Pri
nce
of W
ales
Pri
vate
2002
Unkn
ow
n
Char
itab
le fundin
gB
rain
tum
ours
100
100
Not
report
ed
Unkn
ow
n
Surg
ical
Onco
logy
Gro
up S
arco
ma
Tum
our
Ban
k,
Pri
nce
of W
ales
Pri
vate
2000
n/a
(in
tern
al
fundin
g)
Inte
rnal
fundin
gSar
com
a80
80
1.5
Unkn
ow
n
Can
cer
Counci
l
NSW
2006
n/a
(in
tern
al
fundin
g)
Inte
rnal
fundin
gB
lood fro
m p
atie
nts
with a
ll
cance
r ty
pes
plu
s co
ntr
ols
~900
~900
50
Rest
rict
ed
Tab
le 4
Curr
ent
Stat
us
of N
SW
Bio
ban
ks (
Oct
ober
2008)
(cont’d)
33
Table 5 Specimens in rare supply
Biobank Name Rare specimens in limited supply
Sydney Melanoma Unit Bio-Specimen Bank Primary melanomas.
NSW Pancreatic Cancer Network Tumour Bank All; plus some rare non-ductal neoplasms.
South Western Sydney Colorectal Tumour Bank All rare.
Kolling Endocrine Tumour Bank Medullary thyroid carcinomas; phaeochromocytomas;
adrenocortical carcinomas.
Kolling Neuro Tumour Bank (incl ABTB) Low grade gliomas (grade II astrocytomas, grade II
oligodendrogliomas); anaplastic astrocytomas; pituitary adenomas and
carcinomas.
Breast Cancer Tissue Bank Some specifi c subtypes of breast cancer in proportion to their
incidence in the patient population.
Westmead Gynaecological Tissue Bank Primary fallopian tube serous adenocarcinoma; primary ovarian
mucinous adenocarcinoma, granulose cell tumour, malignant mixed
mullerian tumour, immature teratoma; primary uterus placental site
trophoblastic tumour; primary cervical melanoma.
Children’s Hospital Westmead Paediatric Tumour Bank All rare.
Children’s Cancer Institute Australia Tumour Bank Stage 4 neuroblastoma.
Surgical Oncology Group Sarcoma Tumour Bank,
Prince of Wales Private
All rare.
7.2 Biobank design
7.2.1 Patient consent and types of specimens collected
Each of the formal biobanks reported that they gain patient
consent for broad, as yet unspecifi ed future research.
Specimens at most biobanks can also be collected for specifi c
research projects on request, given appropriate approvals.
This means that as long as collection/processing/storage
procedures are comparable between institutions and over
time, researchers should be able to utilise tissue from several
repositories in research projects without having to seek
additional patient consent for each project.
Some banks consist partly or solely of historical specimens
(e.g. South Western Sydney Colorectal Tumour Bank
contains historical samples only, and Sydney Melanoma Unit
(SMU) contains archival samples from the previously named
MASCRI bank). These specimens may or may not have been
originally collected with broad consent, so require additional
ethics approval to access.
At almost all biobanks, specimens collected include tumour
tissue, matched normal tissue, blood and blood products,
with some variation particularly on blood products. There
are some tumour-specifi c exceptions to this, for example
matched normal tissue is not collected for brain tumours. At
some biobanks including the SMU Bio-Specimen Bank, many
more patients consent and donate blood than those who
eventually donate cancer tissue. This is due to the nature
of the tumour and process of removal. Melanomas are
routinely removed by general practitioners, skin clinics and a
dermatologist prior to the patient attending SMU, and tissue
is either not retained for banking or there is insuffi cient tissue
for banking following diagnostic procedures.
The Cancer Council NSW biobank currently comprises
blood derivatives rather than tumour tissue from patients
with all cancer types except non-melanoma skin cancer. This
bank was established as a result of specimen collection for
specifi c studies (one with broad patient consent) although a
decision regarding future use of these specimens has not yet
been made.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
34
7.2.2 Specimen processing and storage
Almost all biobanks routinely store fresh frozen tissue and
the majority of banks also routinely store blood and blood
products, which variously include whole blood, plasma,
serum, buffy coat, clotted blood and EDTA blood. Fresh
frozen matched normal tissue is collected and stored where
possible (i.e. not for brain tumours or melanomas). Several
banks also routinely store paraffi n embedded specimens
(APCC BioResource, NSW Pancreatic Network Tissue Bank,
Breast Cancer Tissue Bank, CHW Tumour Bank, Westmead
Gynaecological Tissue Bank, and glioma samples at the Kolling
NeuroEndocrine Bank).
DNA and RNA are not routinely extracted at most banks,
although most are able to undertake this on request from
researchers. Routine H&E staining is only undertaken at
the Breast Cancer Tissue Bank, with three additional banks
indicating that they are able to undertake this on request.
Other processes undertaken at one or more banks on
request from researchers include tissue microarrays, cutting
and mounting of paraffi n specimens, and
tumour cryosections.
Specimens are routinely stored in -80C freezers, which are
often shared with other biobanks existing at the same site.
Several banks also own or have access to liquid nitrogen
tanks or dewars for tissue storage, and centrifuges
for processing.
7.2.3 Single or multicentre collection and storage sites
The biobanks investigated in NSW presented a mix of
single and multicentre collection and/or storage sites. Four
biobanks have single or local-only (including onsite Public and
Private Hospitals) collection and storage sites. These are the
Children’s Hospital Westmead Paediatric Tumour Bank, the
Gynaecological Oncology Tumour Bank at the Westmead
Millennium Institute, the Brain Tumour Bank at Prince of
Wales Private Hospital and the Neuroendocrine Tumour
Bank (excluding the Australasian Brain Tumour Bank) at the
Kolling Institute for Medical Research.
Eight of the banks interviewed have multiple collection sites
with a single storage site. These include the Australasian
Brain Tumour Bank (although blood will be stored at the
WA DNA Bank as part of a collaboration in the future),
Breast Cancer Tissue Bank, Upper GI Tissue Bank and
Gynaecological Tissue Bank all located at the Kolling Institute,
the Sydney Melanoma Unit Biospecimen Bank, the Children’s
Cancer Institute Australia Tumour Bank and the Surgical
Oncology Group Sarcoma Tumour Bank. Collection sites
range from local geographical area to nationwide. Some
banks rely on biobank staff to physically collect specimens
and transport to the central location for storage, while
others rely on external transport arrangements.
Four of the banks have multiple collection sites and storage
nodes and two of these banks link sites via a specimen
locator network. These include the Australian Breast Cancer
Tissue Bank managed from the Westmead Millennium
Institute, which currently has six storage nodes located in
NSW, and the Australian Prostate Cancer BioResource
managed from the Royal Adelaide Hospital which has four
storage nodes in four Australian states including NSW. The
NSW Pancreatic Research Network collects and stores
data at two sites and the Australasian Brain Tumour Bank
has recently established a collaboration with the WA DNA
Bank to store blood associated with high-grade brain tumour
specimens stored at the Kolling Institute.
In addition, several of the collection and storage sites not
only collect specimens for affi liated NSW biobanks, but
are also collection points for other large national trials
such as the Australian Ovarian Cancer Study, which has 20
collection sites around Australia, or the Kathleen Cuningham
Foundation Consortium for research into Familial Breast
cancer (kConFab) which collects samples from all over
Australia and New Zealand. In both of these examples, the
samples are not banked locally but are sent to a central
storage site, both located at the Peter MacCallum Cancer
Centre in Melbourne.
The design of the biobank in terms of single or multiple
collection and/or storage sites is in large part dictated by
the tumour or patient type and the cancer incidence. For
example, for more commonly occurring cancers such as
breast cancer, several institutions house biobanks with
dedicated full or part-time staff. These may or may not be
linked to multiple collection sites or larger consortia. Similarly,
all paediatric tumours can be collected and housed in one
facility such as the Children’s Hospital Westmead Paediatric
35
Tumour Bank. In contrast, for less common cancers such
as melanomas or gliomas, full or even part-time staff at
institutions may not be viable, so consolidation occurs by
having multiple collection sites but a single storage facility.
In large institutions, this may also be overcome by housing
several biobanks in the one facility.
The design of current biobanks is also dependent on
the original intent of the bank. Some facilities have been
established with the intent of developing a bank of
biospecimens for future research (e.g. Breast Cancer Tissue
Bank at Westmead). Others such as the CCIA Tumour Bank
have collected the majority of samples as part of a clinical
trial involving a range of hospitals, but are now collecting
other non-trial samples on a more ad-hoc basis.
‘Tumour banks need to rationalise what they collect in order
balance possible future research needs with storage space and
staffi ng requirements’.
Comment made by a biobank head.
One advantage of specimen storage at the site of collection
may be that it helps to establish local expertise in collection
and preservation of specimens and data, and minimise
additional handling and data entry required with movement
of biospecimens.
Additionally, an issue arising from multiple collection sites
with a central storage facility is the question of who ‘owns’
the biospecimens and associated data. Several comments
were made suggesting a reluctance to send specimens to a
common storage facility separate to the collecting institution,
if the specimen and associated data is perceived to be ‘lost’
to that institution and its associated researchers.
7.2.4 Specimen locator network
Several of the NSW biobanks have specimen locators
designed for researchers to search for specimen availability
within a specifi c biobank, regardless of whether the samples
are all housed at one site or not. These include the Breast
Cancer Tissue Bank based at the Westmead Millennium
Institute and the APCC BioResource.
In addition, three biobanks are members of the ABN
(Breast Cancer Tissue Bank, WMI; Gynaecological Oncology
Tissue Bank, WMI; CHW Paediatric Tumour Bank) where
researchers are able to search for specimen availability
across all member biobanks via a biospecimen locator
network. This enables researchers to gain basic information
about sample availability from multiple banks at one time.
It should be noted though that currently not all available
specimens at these member banks are necessarily listed on
the ABN biospecimen locator. For example, the Westmead
Gynaecological Oncology Tissue Bank has listed specimens
collected subsequent to NHMRC grant funding from ABN
on the ABN tissue specimen locator, but is still in the process
of expanding this to cover specimens collected prior to
this time.
‘It is very time consuming being part of a physical network
where you collect from others or send to other sites. Putting
funding into the establishment of virtual networks though
would improve things enormously, where specimens are
collected and stored locally, with information stored on a
network for researcher access.’
Comment made by a biobank head.
7.3 Entity status and funding sources
7.3.1 Entity status
All the biobanks consulted exist as not for profi t
organisations or as departments (or units within
departments) within hospitals or research institutions.
7.3.2 Current funding
Funding sources
While some biobanks are supported by NSW Department
of Health or institutional funding, all but fi ve rely to some
extent on grant funding for their operation. The CCIA
Tumour Bank, the Surgical Oncology Group Sarcoma
Tumour Bank, the Integrated Cancer Research Colorectal
Tumour Bank and the Cancer Council NSW biobank are
entirely internally funded. The Brain Tumour Bank at Prince
of Wales Private is funded by charitable donations. Grant
funding for other banks includes, but is not restricted to,
NHMRC enabling grants, Cancer Council NSW strategic
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
36
partnership grants and Cancer Institute NSW infrastructure
grants. For biobanks relying on grant funding, governance
arrangements and focus of the biobank are determined to
some extent by the terms of the grant. Several comments
were made regarding the diffi culty in establishing or
implementing long-term plans for biobanks when funding
arrangements are fi nite. Rather than decisions being made
based on long-term strategic plans, some major decisions
regarding bank expansion were reported as being more
opportunistic based on grant funding received.
‘It is very diffi cult to set up tissue banks in real time when you
don’t know your future funding arrangements.’
Comment made by a biobank head.
Funding allocation
For most banks, 85–90 per cent of grant funding is allocated
to staff, including some allocation to staff involved in clinical
data collection. For larger banks such as the Breast Cancer
Tissue Bank, staff at collection sites are employed by the local
institution, so a greater proportion of funds for this bank
(20 per cent) can be allocated to equipment. Most banks
allocate a small percentage of funds to equipment, IT, general
maintenance and/or other items such as consumables if not
available internally.
7.3.3 Future funding
Current grant funding for all biobanks expires variously
between 2008 and 2012.
Most biobanks relying on grant funding have applied or plan
to apply for ongoing funding from bodies such as the Cancer
Institute NSW and National Health and Medical Research
Council, including collaborative grants for multicentre banking
initiatives. In addition to this, some banks are also planning
to seek funds from fundraising agencies or via involvement in
clinical trials.
Comments regarding formalised long-term strategic funding
plans were not provided or not available for most banks.
An exception to this was the Breast Cancer Tissue Bank
(BCTB), which developed a long-term funding plan after
consideration of biobank funding models, both in Australia
and internationally. The BCTB is aiming for grant funding for
its fi rst two fi ve-year terms, then aiming for long-term stable
funding through a combination of not-for-profi t sources,
including Federal and State Government health funding,
granting agencies and breast cancer foundations. It may
also explore private sponsorship and partial cost recovery.
Funding models considered by the BCTB included those
for broad tissue inventories, which are generally funded by
granting agencies, specialised mechanisms, multi-institution
funding (e.g. from NCI) or by government (e.g. onCore
UK, Victorian Cancer Biobank), and disease-specifi c tissue
inventories which can also receive funding from disease-
focussed foundations.
Regardless of whether long-term plans are in place for
sustenance of the biobank, many banks made comments
regarding the diffi culties around fi nite funding arrangements
when relying on grant funding.
‘Securing future funding is an ongoing major diffi culty.’
‘Funding for tissue bank personnel is very limited and unless
funding comes from other sources, the future is very bleak.’
Comments made by biobank heads.
7.4 Organisational structure and governance arrangements
7.4.1 Biobank governance
All biobanks collecting from multiple non-local geographical
sites are governed in some capacity by executive or
management committees or ‘arms-length’ advisory groups,
independent of the housing institution. These committees are
responsible for the strategic direction and major decisions
of the bank, and generally comprise chief investigators or
professorial heads from various participating institutions
and/or research groups. The large biobanks with multiple
storage nodes (APCC BioResource and the Breast Cancer
Tissue Bank, WMI) also have other committees under this
governing committee who are variously responsible for
policies and procedures and operational issues. In addition,
these large networked biobanks either have or are in the
process of establishing Scientifi c Advisory Groups as part of
a formal review process for assessment of scientifi c merit and
feasibility of research applications.
37
Local-only: for example, tissue banks at the Kolling Institute for Medical Research collecting from on-site or local public and iii.
private hospitals only.
Biobanks with either single or local-onlyiii collection and
storage sites are generally governed by a biobank committee,
which is not independent of the housing institution, although
may have outside representation to provide expertise in
clinical or non-clinical areas. These biobank committees are
generally responsible for all aspects of biobank governance
including strategic direction (within the confi nes of the
grant(s)), policies and procedures, operational issues, review
of scientifi c merit and feasibility of researcher applications,
and decisions regarding specimen distribution. Expert advice
is sought by these committees as required.
Where more than one biobank exists at an institution,
storage facilities are often shared, but each has its own
biobank committee responsible for operational issues and in
most cases, researcher requests and specimen distribution.
Only the Kolling Institute for Medical Research has dedicated
staff to manage the operations of all four biobanks housed at
the institution (rather than separate staff for each biobank),
and a separate biobank committee, in addition to individual
biobank committees, which oversees and sets the strategic
directions of all biobanks at the institution.
Some institutions house biobanks not only for their own
tissue collections but also act as storage nodes for other
biobanks. For example, the Kolling Institute of Medical
Research has its own breast cancer biobank containing
specimens collected from three sites, but is also a storage
node for the Australian Breast Cancer Tissue Bank managed
from the Westmead Millennium Institute. Specimens for
the latter biobank are also collected from other institutions
such as the Sydney Adventist Hospital. These biospecimen
collections, whilst managed by local staff, fall under the
governance of the biobank for which specimens are collected.
Ethics approval for all biobanks is provided by human
research ethics committees at each of the collecting and
housing institutions.
7.4.2 Personnel
The number of FTE staff employed by the biobanks varies
from zero to 10. For example, the Surgical Oncology
Sarcoma Tumour Bank is essentially managed by two
professorial staff employed by Prince of Wales Private
Hospital and therefore does not have any additional
dedicated biobank staff. The Breast Cancer Tissue Bank
employs 9.6 FTE staff in positions including a project manager,
tumour bank offi cers and assistants, database manager and
administrative/data entry position.
Staff are most commonly employed in positions including
biobank or project managers or coordinators, tissue bank
offi cers, technical assistants or clinical data managers.
7.4.3 Biobank performance measures
For most biobanks where the primary focus is banking for
future research purposes, the performance of the bank is
measured by the number of donors and specimens collected;
the number of specimens accessed by researchers; and the
number of publications arising. For some of the newer banks
that are still being established, researchers may not yet
have accessed specimens or published papers, but these are
planned future measures of success. Some banks also include
the number of PhD student project completions arising from
access to the biobank as a measure of performance. One
bank, the CHW Tumour Bank, stipulates that publications
arising must be in internationally peer review journals to be
considered a measure of successful performance.
Whilst most banks reported using similar general measures
of success, information was not gathered on actual indicators
of the successful number of donors, specimens collected,
specimens accessed or publications arising, or the time
frame for each of these measures. Thus, although biobanks
may have their own target performance indicators in these
areas, bank performance against these indicators was not
conducted in this report. It is likely that performance targets
may vary considerably by biobank size and rarity of tumours.
Also, fundamental differences between the banks and
variability in defi nitions relating to specimens collected
and stored means that at this stage comparative analysis
of biobank performance cannot be conducted. Several
options for future internal or comparative analysis of biobank
performance were considered in the preparation of this
report and are presented below. Issues relating to these
options are also discussed.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
38
Indicators using specimen or donor numbers
As specimen numbers and donor numbers are dependent on
tumour type (i.e. rare versus common tumours) and biobank
size (i.e. multiple collection sites versus single site), an analysis
of total specimens accessed as a proportion of total specimens
collected, or total publications arising as a proportion of total
specimens collected, were considered to be more useful
performance measures than specimen or donor numbers
themselves. These could then indicate for example, the
number of specimens accessed per 1000 specimens collected or
the number of publications arising per 1000 specimens collected
for each biobank. These were not presented in the current
project as the number of specimens was variously defi ned by
different biobanks to include: total fresh frozen tumour tissue
only; total fresh frozen tumour and matched normal tissue;
total tissue including fresh frozen and paraffi n embedded;
both tissue and blood products and/or other specimens;
the number of donors contributing one or more specimens,
which may or may not equate to the number of specimens
per se; historical or archival specimens as well as prospective
collections; or specimens collected for clinical trials but
also stored by the biobank. Similarly, the number of donors
was variously defi ned to include or exclude those donating
blood samples only, so these fi gures could also not be used
in a comparative analysis. In addition, comparisons between
biobanks using measures such as these must be used carefully
as newly operating banks may still be in their establishment
phase where specimens are being collected but are either
not yet available to researchers or have not yet resulted in
publications. Also, common defi nitions of ‘publications’ must
be used in any comparative analysis (i.e. the CHW Biobank
stipulates that publications must be in international peer
review journals).
Average number of publications per year
The number of publications per year will depend on various
factors including size of bank, how long established, tumour
incidence and specimens available. Number of specimens
available cannot currently be used in comparative analyses
for the reasons described above. An analysis of number of
publications per year per 1000 donors was considered as a
more informative measure of success once banks are well
established. At this stage however, comparative analysis
using this measure may be misleading due to the following
differences in defi nitions of terms between banks:
Total donor numbers ▪ . Defi nitions of donor may vary
across biobanks to variously include those donating only
tumour tissue, tissue and blood, or only blood.
Total number of publications arising ▪ . Publications arising are
variously defi ned as a measure of success by biobanks.
For example, the Kolling Institute biobanks not only
measure publications arising, but also number of PhD
project completions as a measure of success. The CHW
defi nes successful publications as those occurring only in
international peer review journals, so fi gures for CHW
may underestimate the comparative publication rate per
1000 donors.
Average publications per year per 1000 donors ▪ .
Comparison of these fi gures must be done with caution.
Newer banks may show low publication rates per donor
for several years until established. Banks collecting
multiple tumour types may also take several years
to build up suffi cient specimens relating to particular
tumour types for research purposes, so while donor
numbers may be high, numbers relating to specifi c
tumour types may be low.
Donor numbers and collection site numbers
Number of donors per year per collection site was
also considered as a possible internal or comparative
performance measure. Again though, use of donor numbers
per year will be infl uenced by defi nition of donor, rarity of
cancer or tumour type, the purpose for which the bank
was established and presence of other biobanks at one or
more collection sites. In addition, referral patterns for each
collection site may vary and infl uence donor numbers (i.e.
the catchment area for referrals to a particular hospital may
be statewide for a particular cancer type or restricted to a
regional or local area).
39
7.5 Standard operating procedures (SOP)
7.5.1 Development of SOPs
All biobanks surveyed indicated they had standard operating
procedures for the main aspects of the banking procedure
including patient consent, specimen collection and storage,
and bio-informatics.
Operating procedures for specimen collection and storage
tend to have been developed internally at each bank,
although some banks have based their procedures on
external sources such as international standards (e.g. the
International Society for Biological and Environmental
Repositories (ISBER) Best Practices for Repositories,45 the
National Cancer Institute Best Practices for Biospecimen
Resources46), other Australian biobanks (including the
Breast Cancer Tissue Bank at WMI, Peter MacCallum
Cancer Centre Tissue Bank (now a part of the Victorian
Cancer Biobank which has standardised procedures across
Victoria, based on ISBER procedures)) or the Australasian
Biospecimen Network Biorepository Protocols.47 Many banks
also review their procedures routinely to keep them up-to-
date with the latest techniques.
‘Collection of standardised data is really important for any
network of tissue banks – minimum data sets provided by
Cancer Institute NSW and Cancer Council NSW have been
very helpful.’
Comment from a tissue bank head.
Whether standard operating procedures were guided by
external sources or developed internally only, they have been
adapted at each institution to suit tumour specifi c, institution
specifi c and/or researcher group specifi c requirements. In
some instances this is based primarily on historical practices
of particular pathology laboratories and staff.
Although there are some variances across the NSW
biobanks, standard operating procedures are similar and/or
based on the same source (with the exception of procedures
specifi c to a certain type of tumour or specimen not
routinely collected).
7.5.2 Patient consent
Patient information and consent forms were kept broad by
all banks surveyed to ensure that the samples collected have
the potential to be used for any scientifi cally valid research
request. The consent forms and patient information provided
varies across banks, depending on size, number of collection
sites, type of biospecimens to be collected and intended use.
In general however, all forms/information included:
that the research undertaken on the samples provided ▪could be in one of a variety of areas and may not yet be
defi ned but will be subject to approval of scientifi c merit
that research may take many years and any information ▪gained will not benefi t the patient or their family
personally or fi nancially
a list of the biospecimen samples to be included in the ▪bank and the option to select which ones to be included
options to withdraw samples from the bank at any time. ▪
Broad consent enables increased fl exibility of research with
the sample collected, but it must be obtained in a way
that the patient has fully understood the implications of
‘donating’ their samples, and the patient should have the
option to agree to elected parts of the consent as they
feel appropriate. Patients must also be given the option to
withdraw their samples at any time. For further discussion on
the ethical issues regarding consent see Chapter 7.
The process for obtaining patient consent at each of the
biobanks surveyed is included under Standard operating
procedures in Table 9.3 in Appendix D. Patients are generally
consented using a Biobank Patient Consent Form by biobank
staff, surgeon or nurse pre-operatively, or if this does not
occur, post-operatively. Most banks report a success rate
of more than 90 per cent using this procedure, with several
reporting 99–100 per cent for recruitment of donors. The
Surgical Oncology Group Sarcoma Tumour Bank at POW
Private, rather than having a separate patient consent form
and process for tumour banking, includes this in the hospital
admission form. Success rates for this procedure were not
provided.
The Breast Cancer Tissue Bank is currently conducting a
small pilot study at one of the collection sites on donor
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
40
attitudes to tissue banking and patients’ preferred method
of recruitment.
7.5.3 Data collection
Biobanks showed considerable variation in the types and
extent of data collected for each patient. These data may
be considered in the following categories: identifi cation
data; pathology data; clinical data including demographic
information; and clinical follow-up data.
Identifi cation data. Patient identifi cation information,
including name, DOB, and/or medical record number, is
generally recorded with specimen storage numbers or
identifi ers in a secure database. Information may also include
such things as name of surgeon and date of surgery. This
information can then be de-identifi ed for researchers.
Pathology data. This is generally stored with identifi cation
data in the biobank database (see below). Respondents
in this project were not asked to report on the types of
pathology data collected.
Clinical data. Biobanks vary widely in the extent of clinical
information collected and recorded. Some collect no clinical
data and go through a time-consuming manual process of
linking pathology and clinical data if required for subsequent
research. For those banks collecting clinical data, this may
include one or more of the following: past medical history;
family history; diagnosis; diagnosis date; hospital; referring
doctor; surgeon; type of surgery (biopsy or resection);
treatment (radiotherapy, chemotherapy); outcomes;
subsequent surgeries and treatment; survival outcomes.
‘Clinical information collection is a very frustrating exercise and
to date, there is no Clinical Data Collection Form. In addition,
according to our tumour bank ethics approval, the clinical
database must be kept separate from the tumour
bank database.’
Comment from a biobank head
Clinical follow-up data. Again, biobanks vary widely in
the extent to which clinical follow-up data are collected.
Two banks reported data linkage with Clinical Cancer
Registries (CCR) for notifi cation of date and cause of
death. The Breast Cancer Tissue Bank reported collecting
treatment information (radiotherapy and chemotherapy)
from the Cancer Institute NSW minimum dataset, however,
commented that this information is only available for patients
treated in public facilities and is not a straightforward
exercise. The Cancer Council NSW reports that clinical
follow-up data will be done via linkage through the Centre
for Health Record Linkage (CHeReL).
7.5.4 Data storage
All tissue banks had established a database to register basic
client information and link this to the physical sample through
a coded system. Each bank had developed a database, often
in Microsoft Excel or Microsoft Access. All tissue banks
(except one), restricted researcher access to de-identifi ed
data. Only tissue bank staff are able to re-identify patient
information as required.
‘If clinical information linked to specimen information is
required for research, it is a “scratching and scrounging”
exercise to retrieve, although not impossible.’
Comment from a biobank head.
Clinical information and follow-up data were often kept
separately from the tissue bank database, with manual
searches required to include this information with samples
for researchers. Some tissue bank managers had heard
of or considered using specifi c data linkage platforms to
facilitate this process (e.g. the Centre for Health Record
Linkage (CHeReL) in NSW or BioGrid Australiaiv), but were
concerned about the quality of data collected and the use (or
lack) of standardised data sets.
‘Collecting follow up data for samples that are accessed for
projects is time consuming – there are always differences
across hospitals and tumour bank databases in the way data is
collected and stored. Data linkage platforms like CheReL and
BioGrid could be useful in theory but there would probably
need to be more standardised data collection methods for
them to be useful.’
Comment from a biobank head.
There are currently few well-established data linkage
networks between pathology and clinical databases in NSW
biobanks. Most biobanks surveyed are aiming to establish
more sophisticated networks, but are constrained by fi nancial
and human resources including lack of technical expertise.
CHeReL and BioGrid are data linkage platforms able to link de-identifi ed data from multiple data sets. For more information see their iv.
respective websites: http://www.cherel.org.au/; http://www.biogrid.org.au/pages/index.php.
41
7.5.5 Quality control measures
All but one of the biobanks reported that they had
mechanisms in place to ensure specimen integrity. In all these
banks freezers are locked, alarmed and/or electronically
monitored with 24 hour temperature monitoring and
recording. The CHW Tumour Bank also commented that
they have a liquid CO2 injection system for back-up and
freezer failure. Three banks (APCC BioResource, SMU Bio-
Specimen Bank and Breast Cancer Tissue Bank) reported
that specimens are divided and housed separately in case
of freezer failure. The Breast Cancer Tissue Bank reported
SOPs to ensure that samples shipped between collection
centres are temperature monitored during shipment.
The Kolling NeuroEndocrine Bank made the following
comments in relation to quality control measures for
ensuring specimen integrity:
‘It essentially comes down to routine. A liquid nitrogen canister
is positioned on the wall of the surgical theatre in the private
hospital which ensures that the specimen is snap frozen with
minimal delay. All surgical staff are trained by the researchers
to correctly label and freeze the specimen. In the case of the
public hospital, the tumour bank offi cer is called prior to the
removal of the tumour and is present in the theatre at the
time of tumour removal. The tumours are brought back to
the laboratory and logged in to the data book and stored at
–80°C. The tumour Bank freezer is monitored daily.
‘When the tumour is used for scientifi c purposes, a technique
has been developed to maintain tumour integrity during
processing. The tumour sections are cut on a plastic petri dish
which is pre-frozen at –80°C and then laid out on a bed of dry
ice. The tumour is never exposed to ambient temperature. All
dissection tools are autoclaved prior to use and treated with
a solution called RNAse Zap to ensure inhibition of RNAses
which can cause specimen deterioration.’
While most biobanks require researchers to return unused
specimens to the bank, the Kolling NeuroEndocrine Bank
and the Breast Cancer Tissue Bank made specifi c comment
that this was not a requirement, as the biobank could not
guarantee specimen integrity once it had been removed from
the bank.
7.6 Researcher access
7.6.1 Key themes from biobank governance surveys
Researcher access policies
Almost all biobanks interviewed have a formal researcher
access policy. These are available from biobank websites
(where they exist) or can be sent to researchers on request.
The tissue access policy for the APCC BioResource was
developed using the guidelines provided by the NHMRC
for biobanks funded via the Enabling Grant initiative. Most
biobanks have an associated standard Researcher Access
Form which they send to researchers via email on request.
Researchers are able to access some biobanks (e.g. CHW
Paediatric Tumour Bank) via the website.
Researcher access to biospecimens generally involves:
Initial researcher contact with biobank to determine ▪availability of specimens. This may be done via a web-
based search (i.e. ABN Tissue Specimen Locator) or via
telephone or email contact.
Mandatory Human Research Ethics Committee ▪(HREC) approval for the research, usually from
researcher institution.
Submission of Researcher Access Form to Biobank with ▪appropriate HREC approval documented as required.
Review of submission by a Scientifi c Advisory Group ▪or Biobank Management Committee to determine
the scientifi c merit of the application and whether it is
practical, feasible and a high priority use of the specimens
requested. If applications have been peer reviewed by
major scientifi c bodies (i.e. NHMRC, CI NSW) there
may be no additional requirement for scientifi c review by
the Biobank.
Provision of requested material to researcher upon ▪receipt of signed agreements.
All biobanks with multiple collection/storage sites stipulate
priority access for participating institutions or their affi liates
or collaborators. Similarly, the NSW Pancreatic Research
Network Tissue Bank restricts access to members of the
NSW Pancreatic Research Network, as it currently has
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
42
insuffi cient tissue and staff resources to allow access beyond
this. Several biobanks stipulate that access will not be
provided to commercial organisations, although the Breast
Cancer Tissue Bank WMI for example states that ‘meritorious
cases may be referred to the BCTB Advisory Panel for
further consideration’.
BREAST CANCER TISSUE BANK ACCESS POLICY
The following factors will be taken into consideration:
Review of the scientifi c merit of the project by the BCTB ▪Scientifi c Review Panel/BCTB Management Group. This
will be based on scientifi c validity; study design; technical
parameters (e.g. reproducibility, sensitivity, specifi city);
clinical or scientifi c impact; project balance within the
BCTB; practicality and feasibility (e.g. amount of tissue,
number and type of samples required).
First priority will be given to peer-reviewed, funded ▪research projects.
Second priority will be given to developmental projects ▪and new researchers developing projects in academic
centres.
Investigators directly involved in the operation of ▪collection centres will be given an agreed priority access
in proportion to the number of specimens collected.
Researchers making large requests or requests for very ▪rare tissue may have their applications further reviewed
by the BCTB Advisory Panel who will consider the
application in light of the interests of the bank.
Applications made by commercial organisations will not ▪in general be supported; however meritorious case may
be referred to the BCTB Advisory Panel for further
consideration.
Excerpt from BCTB Access Policy (Version 2.4).
Almost all biobanks require researchers to acknowledge the
biobank in any publications arising from use of specimens,
and most require researchers to send copies of publications
to the bank. Most banks also require researchers to report
back to the bank regarding integrity and quality of
samples supplied.
It would be ideal to allow access to biospecimens for all
Australian academic researchers (or possibly international
researchers in the case of rare tumours) following mandatory
Human Research Ethics Committee approval and review
of scientifi c merit and feasibility of project (including sample
availability). However, most biobanks have a priority access
system to ensure priority is given to collecting institutions,
or their collaborators or affi liated research groups, and
to ensure that suffi cient tissue and human resources are
available to meet requests. This type of priority system
would need to be reviewed if banks were to become a part
of a consortium as there will be many collections sites across
the state.
Researcher awareness of biobanks
In all cases, the primary method of making researchers
aware of the biobank was via word of mouth. For biobanks
primarily used by local or affi liated researchers, this was
sometimes also done via presentations given to interested
parties. For biobanks with broader researcher access,
word of mouth recommendations included those from
other researchers or via direct contact with biobank staff,
particularly at conferences. One biobank head routinely
initiates contact with researchers to inform them of the
biobank, based on knowledge obtained from conference
presentations about the researcher’s interests. Other
methods by which researchers become aware of biobanks
are via biobank publications or, less commonly, via the ABN
or the specifi c biobank website.
Two well-established biobanks heads (from the APCC
BioResource and the CHW Paediatric Tumour Bank)
commented that one of the most important future needs
of established banks was to maintain or increase researcher
utilisation of biospecimens.
‘The defi nition of a tissue or tumour bank should be where
specimens go in as well as get withdrawn. One of the issues for
large banks is getting withdrawals.’
Comment from a biobank head.
Costs to Researchers
Most biobanks charge researchers either nothing or freight
costs only. The APCC BioResource previously had a partial
cost recovery system in place, but found that this limited
researcher requests so this requirement was lifted in 2007.
Since removing this system the APCC BioResource has had
fourteen requests for specimens, all approved. The Breast
Cancer Tissue Bank, WMI, charges an additional cost for
43
DNA and is planning to introduce a partial cost recovery
scheme in the future. The Gynaecological Oncology Tissue
Bank, WMI, generally charges only for freight costs, but also
has some project dependent cost recovery charges (i.e. if
the research project has grant funding for biobanking). The
CHW Paediatric Tumour Bank charges freight costs only as
its ‘current philosophy is that the bank has been established to
facilitate genuine research resulting in published papers rather
than as a business where full cost recovery may be important.
The more genuine research papers that are published, the more
likely that these can be used to leverage ongoing funding’.
‘If provisions of the funding grant for the tumour bank include
the provision of samples to researchers, then cost recovery
would appear to be double-dipping. If, however, the tumour
bank has not been set up with grant or other funding to cover
the costs of collecting, processing, storing, shipping etc, then
cost recovery would seem appropriate.’
Comment from a researcher.
Researcher requests, access and publications arising
Requests from researchers to established biobanks for
biospecimen access over the past 12 months ranges from
four to 20. All but one of these were approved. Numbers
of specimens accessed in the last year in relation to these
researcher requests ranges from fi ve to more than 200 and
is dependent on the nature of the research, the size of the
bank and the rarity of the specimens requested. Some banks
do not record numbers of publications arising. Where this
information is known, it ranges from nil for newly established
banks to 39 since 1995 for the Kolling Institute Banks.
Number of requests, specimens accessed and publications
arising for each of the biobanks surveyed can be seen at
Appendix D.
7.6.2 Key themes from researcher surveys
Barriers to access for researchers
These can be summarised as:
The dispersed nature of the biobanks and ▪specimen locations.
No central register of biobanks allowing researchers to ▪locate specimens.
No single scientifi c advisory committee for submission of ▪applications if needing samples from multiple sites.
Application to researcher institutional HREC requires ▪details of ethics approvals of biobanks to which the
researcher is applying. If this includes multiple banks, this
is extremely time consuming.
Generally there is insuffi cient research funding to cover ▪any costs associated with biospecimen access other than
freight.
Facilitators of access for researchers
These can be summarised as:
A central register of specimen locations, ideally grouped ▪by cancer type.
More streamlined approval process for ethics approval ▪at researcher institution and for scientifi c advisory
committee approval and access to specimens at housing
institutions.
Minimal costs associated with access to biospecimens, ▪unless these are covered by the research grant.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
44
The opportunities presented are not mutually exclusive and many can be built upon over time to incrementally work towards system change.
8 Future options for New South Wales biobanking
As previously stated, the ultimate purpose of this
comprehensive review was to assist in the facilitation of
the following:
improve researcher access to tissues collected in a range ▪of cancers
improve effi ciency and reduce duplication of ▪administrative processes
build capacity that is cost-effective and sustainable ▪
identify the current investment in biobanking and ▪strategies to optimise value for money.
This Chapter draws together fi ndings from the interviews
with biobanks in NSW and international arrangements, to
present several governance arrangement models observed
and the benefi ts and issues associated with each governance
model. In addition, other aspects of opportunity for
biobanking in NSW will be discussed.
8.1 Summary of New South Wales formalised biobank governance
The majority of biobanks in NSW identifi ed in the project
have been established as formalised biobanks with single
or multiple collection sites and centralised storage of
biospecimens at the main site. The majority of banks were
clinical biobanks rather than epidemiological biobanks. Some
of the biobanks identifi ed were also a part of specimen
locator networks such as the ABN (e.g. Children’s Hospital at
Westmead Tumour Bank), but many were not. The majority
of banks provide access to all academic researchers subject
to approval based on scientifi c merit (and assuming ethics
approval for the research is granted). However, depending on
the size of the biobank and the availability of samples, many
banks prioritise research conducted by staff in the institution
the bank is located over external researchers, and prioritise
academic research over commercial research. Some banks
do not provide samples outside of their own institution and
others do not provide samples to commercial research. Most
banks do not charge researchers for the samples provided
(other than the cost of freight to deliver the sample), but
a few of the larger banks have established cost recovery
procedures. The nature of the cost recovery varies
between banks.
In addition to formalised biobanks, there are a number of
specimen collections throughout NSW (only a few were
identifi ed in this project, most likely due to the limitations
of the methodology in contacting appropriate staff/
researchers). The intent of these collections is generally for
use solely within the host laboratory and as such do not
have formalised or structured governance arrangements in
place. Therefore, this type of tissue collection has not been
considered in the discussion below.
8.2 Future opportunities for governance models for biobanks
As a result of this review, several options and opportunities
were identifi ed for Biobanking in NSW.
Level A – Minimal Change: no changes to local governance
of banks or physical structures required:
stakeholder network ▪
specimen locator network ▪
accreditation. ▪
Level B - Consortia Approach: changes to local governance
arrangements required, possible changes to physical set up
required depending on type of existing setup:
consortia by tumour type in NSW ▪
consortia by tumour type Australia-wide ▪
consortium of all biobanks in NSW. ▪
45
Other opportunities for consideration:
extension of pathology services ▪
data management and tracking infrastructure ▪
data linkage and extending epidemiological ▪research capacity.
The opportunities presented are not mutually exclusive and
many can be built upon over time to incrementally work
towards system change. Figure 5 diagrammatically represents
future opportunities for biobanking in NSW and how they
relate to each other.
8.2.1 Stakeholder Network
A stakeholder network would comprise biobank managers
and other stakeholders meeting on a regular basis to enable
formal discussions on topics common to all biobanking such
as standard operating procedures, ethical issues, consent
and application processes and committee member make up,
with the intent of developing consensus views and guidelines
to promote consistency across biobanking practices. Such
Figure 5 Opportunities for biobanking in NSW
S takeholder Network
AccreditationS pecimen
Locator Network
Level A:No governance or physical changes
NS W consortia by
Tumour
Consortia all NS W
Australian consortia by
Tumour
Level B:Governance changes, possible physical changes,
•
Extension of Pathology services
•
Population Studiesa network would enable biobanks to remain up-to-date on
various aspects of banking and to discuss banking issues in a
structured and meaningful environment.
Stakeholder networks are unlikely to attract funding or
sponsorship themselves and would rely highly on the good
will and donations of time of interested members. The
further development of accreditation processes and/or
specimen locator networks in association with a stakeholder
network would probably require some additional funding
for resources.
These types of stakeholder networks are common
internationally (e.g. the Confederation of Cancer Biobanks in
the UK and the Offi ce of Biorepositories and Biospecimen
Research in the US). In Australia, the formation of the
Australasian Biospecimen Network (ABN) included
development of a stakeholder network comprising biobank
managers and stakeholders from the founding member
biobanks. To date the ABN has developed recommended
SOPs for biobanking, guideline consent forms and
standardised application forms for members.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
46
8.2.2 Accreditation
Extending on the development of the SOPs for biobanking in
NSW (and/or Australia), the stakeholder networks could be
charged with the development of an accreditation process
for biobanks. This could include the mandatory use of
agreed SOPs for tissue collection, preparation/manipulation
and storage, as well as standards for businesses such as the
International Organization for Standards quality management
standards (e.g. ISO 9000) or National Association of Testing
Authorities (NATA) accreditation.
NATA assess technical competence through standard
testing and accreditation of businesses in terms of: people
excellence; technical excellence; innovative and fl exible
service delivery; superior value and service; networking and
organisation; organisational growth; and public interest. In
Australia, St John of God Pathology and hence the biobank
are NATA accredited.
The ISO 9000 standards cover aspects such as procedures
regarding all key processes in the business; monitoring
processes to ensure they are effective; keeping adequate
records; checking output for defects, with appropriate and
corrective action where necessary; regularly reviewing
individual processes and the quality system itself for
effectiveness; and facilitating continual improvement.
Internationally banks such as UK Biobank and the CNIO TBN
have or are planning to obtain ISO 9000 certifi cation.
Accreditation would enable a consistency in procedures and
policies across multiple biobanks without the need to change
governance or funding arrangements. Conforming to the
agreed accreditation process may require some additional
resources for biobanks (namely in staffi ng) and there may be
costs associated with accreditation, e.g. for administration
and review processes and costs associated with recognised
bodies such as NATA and ISO.
8.2.3 Specimen Locator Network
Further extension of SOPs and/or accreditations processes,
would be the development of a specimen locator network(s).
Specimen locator networks, made available to researchers
through a centralised website, would enable researchers
to search many biobanks for required samples at once,
although application for specimens may still require individual
application procedures for each bank.
In this model, each member biobank would maintain their
existing governance arrangements, including committees
and committee members, SOPs, and sample ‘ownership’.
The biobanks would then be able to choose whether or not
to use the advice and guidelines developed by the virtual
network of stakeholders to modify/improve their practices
(to which they would have contributed to the development).
This type of model would work as a general resource for
all tumour types (e.g. ABN) or a tumour-specifi c resource
(e.g. the APCC). The benefi ts of a general (all tumour types)
network are that all biobanks (including those of rare tumour
types) could benefi t and that researchers would only have
one network to consider in looking for samples. Conversely
however, there may be issues specifi c to particular tumour
types where a tumour-specifi c network may be more
appropriate. As clinical researchers typically have a narrow
research focus, it is likely their bio-specimen needs would still
fall under one tumour type.
The specimen locator network could be limited to banks in
NSW only or it could be expanded to cover all of Australia
and even Australasia (both APCC and ABN are Australia
wide). The model has been established in small scale already
and has proven to work well both for general cancer (ABN)
and tumour specifi c (APCC). Funding arrangements for such
a network could be established in one of three ways:
In the two examples of a specimen locator network, ▪to date, both have received funding to establish the
network, which has been distributed amongst the
member biobanks. This model of funding could be
pursued in establishing other networks. The issue with
this is that as the membership increases the required
funding may also increase and may
become unsustainable.
Biobanks could maintain their current funding ▪arrangements and the specimen locator network could
apply for small funding grants for maintenance and
ongoing costs (e.g. website, specimen locator, organised
meetings, development of guidelines).
47
Biobanks could maintain their current funding ▪arrangements and apply for individual grants. Each
member may then be asked to contribute a small
amount to the running costs of the network.
This model presents a fl exible and relatively low cost
option to improve coordination, consistency, marketing
and awareness across biobanks in NSW. Options such
as specimen locators and standardised application forms/
processes would increase the ease of application
by researchers.
8.2.4 Consortia by tumour type in NSW
A tumour-specifi c consortium of biobanks across NSW
could encompass all existing biobanks collecting samples of
a particular tumour group, similar in nature to the Australian
Breast Cancer Tissue Bank. In this model, all biobanks
and collection sites would be rolled into a single entity
representing a tumour-specifi c biobank consortium with
multiple collection and multiple storage sites across NSW.
The establishment of such a consortium would require
new governance arrangements for the banks under a
central governance committee. This committee should
include representatives from all collection/storage sites,
which contribute to the setting of strategic directions for
the consortium. Similarly, other sub-committees, such as
scientifi c advisory committees, would need to be centralised,
but still maintain appropriate representation from experts
in the fi eld and representation from all collection/storage
sites. It will also be necessary to nominate the lead agency
for the consortium (or establish a new lead entity), which
would be responsible for ethical approval for tissue collection
through the Human Research Ethics Committee (note,
other participating institutions may still require internal ethics
approval for collection and storage).
Importantly, this model would enable one application process
for all tumours of the same type in NSW, regardless of the
institution the samples were coming from. The consortia
model would bring consistent operating procedures for
consent, tissue collection, processing and storage across
tissue collection by cancer type in NSW. This would enable
researchers to be confi dent of the same quality of sample,
regardless of which institution the sample was collected at,
and allow a single application process to cover the whole
of NSW for a specifi c tumour type. In addition, marketing
and promotion of the biobanks could be centralised and
coordinated, and specimen locator software on a centralised
website would facilitate researcher awareness of
available samples.
Another benefi t of the consortia model is increased
economies of scale based on shared resources and
centralised administration processes, which would enable
greater resource to be used for centralised applications
processes, advertising and marketing of the biobanks and
quality assurance measures across banks.
One potential issue with this model, however, is that as a
single entity ‘ownership’ of tissue samples may no longer
belong to the individual banks, but to the new biobank
consortium. Subsequently, individual banks would not be able
to prioritise internal researchers (from their institution) over
external researchers. This in itself would benefi t researchers,
especially those at organisations that do not have biobanks,
but may cause anxiety among biobank managers and result in
an unwillingness to participate. In addition, some banks have
strong policies on whether to allow commercial research to
access samples, while others do not. Merging of the biobanks
into a single consortium would require a consensus stand on
issues such as this, hence the importance to have adequate
representation from individual biobanks on the governance
committee. Such representation may also help ease the
anxiety of biobanks regarding sample ‘ownership’.
A compromise to complete consensus of governance
arrangements (as described above) would be to have
consensus for the essential issues, but allow fl exibility on
issues such as whether samples can be sent to commercial
agencies or not. Internationally, the Canadian Tumour
Repository Network (CTRN) has such fl exibility within the
governance arrangements of their consortium. The CTRN
has SOPs for all biobanking aspects, a centralised website and
specimen locator network, but allows individual banks to be
fl exible regarding supply of samples to commercial entities or
not and shipment of samples outside of Canada or not.13
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
48
The funding arrangements for a NSW tumour specifi c
biobank consortium are likely to depend on the existing
arrangements of each individual bank and may be a
combination of:
External grant funding, with single/joint funding ▪applications submitted (rather than individual banks each
submitting an application).
Contributions from host institutions, especially in relation ▪to space, equipment (which may be shared), and
other infrastructure.
Cost recovery models, as a larger network there are ▪likely to be the resources to develop and maintain cost
recovery models for samples.
Other issues to be considered include database management
and data linkage systems. Most biobank databases have
been developed internally and vary across all banks. As
a consortium, it may be possible to streamline these
processes and develop standardised databases with standard
procedures to link samples to follow up data. Past experience
of other biobank consortia, such as the Victorian Cancer
Biobank and other linkage systems (the WAGER / WADLS
arrangements) should be considered to avoid unnecessary
re-invention/duplication of processes and software.
A consortium of NSW tumour-specifi c biobanks could also
be a part of a stakeholder network to discuss and share
new information and issues and a specimen locator network
(possibly external to their own), providing researchers with
another point of access to samples.
8.2.5 Consortia by tumour type Australia-wide
An extension of the consortia of biobanks across NSW
model is to include biobanks from other Australian states/
territories and/or other Australasian countries as well, based
on tumour type. Some biobanks in NSW already do have
collection sites outside NSW, such as the Australian Brain
Tumour Bank being established at the Kolling Institute which
will have collection sites in NSW and WA, and kConFab and
the Children’s Cancer Institute Australia biobanks which both
have collection sites across Australian and New Zealand.
As banks will be merged into a single entity, this model will
present similar issues around governance (centralised) and
appropriate committee membership, ‘ownership’ of samples,
storage and collection sites, prioritisation of researcher
access and funding arrangements. Similar researcher benefi ts
will be generated through increased awareness, centralised
application processes, specimen locator functions and
increased access from de-prioritisation based on
research institute.
This model of governance may also be benefi cial for biobanks
of rare tumour types which may have diffi culty forming a
biobank network in NSW alone due to lack of samples
available. By extending to all of Australia/Australasia, rare
tumour bank networks will be able to increase the sample
range and provide coordinated access to researchers
across Australia/Australasia. It is for these reasons that the
Australian Sarcomav Study Group is being developed and the
sarcoma specimen collection at Prince of Wales Hospital is
becoming a member of this consortium.
8.2.6 Consortium of all NSW Biobanks
In order to establish ultimate consistency and coordination
across biobanks in NSW, a consortium of all NSW biobanks
could be established, similar in principle to the Victorian
Cancer Biobank (VCB). This model represents a single
biobank entity for all of NSW and as such would also present
the same issues to be considered regarding governance,
funding, ‘ownership’, collection and storage and prioritisation
as the cancer-specifi c network models (NSW or Australia/
Australasia wide). Similarly, the researcher benefi ts would
be increased awareness; coordination and consistency of
applications and other processes; and specimen
locator capability.
Additional benefi ts of a consortium model would be
increased marketing potential at the statewide level through
pooled resources, roll out of best-practice procedures/policy
to the whole state and ability to establish consistent database
technology for all biobanks in NSW, with the potential to
develop data linkage procedures with WADLS, CHeReL or
BioGrid Australia (similar to the VCB model).
An additional hurdle to the consortium model in NSW is the
tumour-specifi c nature of existing biobanks. In NSW, many
biobanks focus on a specifi c type or group of tumours. While
Sarcomas are rare tumours and it is diffi cult to obtain suffi cient numbers of samples from one hospital and indeed one state/territory alone.v.
49
there are general biobanking issues/policies that hold true
for any bank, there are also tumour-specifi c concerns, which
may hinder processes such as setting strategic directions,
if all biobanks are to be under a single entity. It would be
necessary to examine these issues in more detail if this model
was to be considered.
8.2.7 Extension of pathology services
In addition to the type of entity status biobanks are
established with in the future, consideration should be given
to the location of the biobank within the health system.
There are examples of successful biobanks which have been
established within the pathology departments of hospitals
(e.g. Spanish National Cancer Research Centre Tissue Bank
Network and the St John of God Pathology Biobank in WA).
As described in Section 5.3.1 there are several benefi ts
to establishing biobanks within pathology departments,
namely reduced costs, established infrastructure including
accreditation and SOPs, and good relationships with
surgeons to ensure appropriate sample collection.
One of the concerns raised by a biobank head was that the
introduction of large biobank consortia may negatively impact
on the relationships with surgeons as the personal aspects
of smaller or institutional only biobanks are lost. Introducing
biobank consortia through the pathology departments may
be a way to counter this based on the need for all samples
to go to pathology fi rst for diagnostic purposes and hence
reinforce the strong relationship between pathology staff
and surgeons.
Issues relating to the use of pathology departments to house
biobanks include:
The issue of sample ‘ownership’: moving from the ▪existing set up on separate biobanks to inclusion in
pathology departments may present problems with
ownership and perceptions of ‘giving up’ samples.
Possible lack of pathology resources: although the staff ▪time required for many of the biobanking processes
is minimal on top of existing pathology duties, some
pathology departments are already under resourced.
In addition, the expansion of samples storage may
require additional storage facilities and increase IT/data
management capacity.
8.2.8 Data management and data linkage
The growth of biobanks over the past fi ve to 10 years has
already yielded a need for more sophisticated bioinformatic
processes and systems to be used. If future growth through
development of biobank consortia is to be realised, then
the need for improved data management and data linkage
systems will increase. In redeveloping databases and data
management, biobanks and biobank consortia could, for
example, through the use of tools such as the LIMS at
WAGER and data linkage systems (such as WADLS, CHeReL
or BioGrid Australia), systematically track follow-up and
outcomes data for donors and enable new uses for biobank
specimen data in terms of population studies.
It is also worth noting that a variety of free software tools
are available to biobanks (such as CaBig, Caisis, CTRNet’s
ATiM) to facilitate operations. There are also important data
standardisation initiatives in the United States, Canada and
Europe as well as Australia. Biobanks in NSW could benefi t
tremendously from leveraging off existing resources in
these areas.
8.2.9 Epidemiological research opportunities
Internationally, there are studies being established to collect
biological samples (e.g. blood and urine) along with clinical
information on subjects for future epidemiological studies
of defi ned cohorts. This will provide powerful new tools for
the research into familial diseases, including cancers. There
is some participation in these collections within NSW (such
as with kConFab researching familial breast cancer), although
most biobanking activity in NSW is more clinically focussed.
8.2.10 Comparison of models
A brief comparison of the governance and other
arrangements for the potential biobanking models is provided
in Table 6.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
50
Table 6 Comparison of biobanking models – indication of the changes from current practice
Category Level A: Minimal Change Level B: Consortia Approach
Stakeholder Network
Accreditation Specimen Locator Network
NSW Consortia – Tumour Specifi c
Australia Consortia – Tumour Specifi c
NSW Consortia General
Entity status for current biobanks
No change No change No change Single entity Single entity Single entity
Governance No change No change No change Central
committees
– appropriate
representation
Central
committees
– appropriate
representation
Central
committees
– appropriate
representation
Sample storage No change Possible changes
depending on
accreditation
recommendations
No change No change –
possibility of
central storage as
appropriate
No change –
possibility of
central storage as
appropriate
No change
Samples ‘ownership’
No change No change No change Centrally ‘owned’ Centrally ‘owned’ Centrally ‘owned’
SOPs Development of
consensus SOPs–
non-compulsory
Modifi ed to
consensus –
compulsory
Promotion of
consensus SOPs–
non-compulsory
Modifi ed to
consensus –
compulsory
Modifi ed to
consensus –
compulsory
Modifi ed to
consensus –
compulsory
Consent Development of
consensus – non-
compulsory
Modifi ed to
consensus –
compulsory
Promotion of
consensus SOPs–
non-compulsory
Modifi ed to
consensus –
compulsory
Modifi ed to
consensus –
compulsory
Modifi ed to
consensus –
compulsory
Researcher awareness
No direct change No direct change Increased through
communal
website
Increased through
central website
Increased through
central website
Increased through
central website,
other marketing
campaigns
Researcher access
Apply to individual
banks
Apply to individual
banks
Apply to individual
banks
Single application,
centralised per
consortia
Single application,
centralised per
consortia
Single application,
centralised for all
NSW
Application processes
Development of
consensus – non-
compulsory
Modifi ed to
consensus –
compulsory
Promotion of
consensus SOPs–
non-compulsory
Modifi ed to
consensus –
compulsory
Modifi ed to
consensus –
compulsory
Modifi ed to
consensus –
compulsory
Funding No additional
funding – reliant
on good will of
members
Individual bank
funds required
for accreditation
processes
Joint or
institutional
funding to set up
/ maintain website
and specimen
locator software
Joint funding
plus institutional
funding and
possible cost
recovery
Joint funding
plus institutional
funding and
possible cost
recovery
Joint funding
plus institutional
funding and
possible cost
recovery
Marketing No direct change Increased through
implementation of
SOPs
In creased
opportunity
through
communal
website
Increased through
central website,
other marketing
campaigns
Increased through
central website,
other marketing
campaigns
Increased through
central website,
other marketing
campaigns
Region NSW or Australia
/ Australasia
NSW or Australia
/ Australasia
NSW or Australia
/ Australasia
NSW Australia /
Australasia
NSW
51
8.2.11 Infrastructure and resources required
Level A
Minimal change approach: infrastructure and resources required
Level A options would require little governance or physical
changes to existing biobanking arrangements. As such,
there would be a lower level of infrastructure or resourcing
requirements and costs associated with these options.
It is expected that the stakeholder networks would develop
from good will of existing managers/staff and other interested
parties and as such would not require any additional staffi ng
to be formed. Resources that may be required would include
staffi ng for coordination activities, conference facilities such
as teleconferencing, web-conferencing and face to face as
required. It may also be necessary to produce reports of the
developments and promote this through a website.
Additional resources required for the accreditation
opportunity would depend largely on the type of
accreditation and the existing structure of the biobank. All
biobanks would need to fund the accreditation process,
which could range from several $100 to $3,000–$4,000.
Depending on the biobank, it may also be necessary to
employ extra staff (e.g. 0.5 FTE) to manage the accreditation
processes and some investment in upgrading or changing
processes may be required to adhere to requirements.
Development of a specimen locator network would require
IT infrastructure to establish and maintain a website and
specimen locator software. It may also be necessary to
employ staff (e.g. 0.5–1.0 FTE) to manage the processes and
ensure the network is up-to-date with all member biobank
information. Expansion of existing specimen locator networks
where possible could reduce costs and resources required.
Therefore, Level A opportunities provide relatively low
cost strategies that are implementable in the short term to
improve biobanking arrangements and improve research
access in NSW.
Level B
Consortia approach: infrastructure and resources required
In pursuing the opportunities represented in Level B, as well
as the changes to governance arrangements described above,
more signifi cant infrastructure and other resources would
be required.
All biobank consortia would require the following
infrastructure and resources. However, much of this will
already be established or available at the existing biobanks:
Staff1. : all biobank consortia should have at least 0.5 – 1.0
FTE to manage the bank, process samples, data entry
and follow up data collection, coordinate consent and
application processes and shipment of samples. The
number of staff FTE required would depend largely
on the number of donors/samples and the number of
collection/storage sites. Banks collecting samples for
common cancers are likely to have large volumes and
multiple collection sites, hence the need for additional
staff. It may be diffi cult for banks for rarer tumours to
be able to afford staffi ng alone based on the volume of
work required. In these cases, sharing of infrastructure
and staff can be benefi cial to increase the economies
of scale. This is the case at the Kolling Institute where
at least three tumour-specifi c banks share staffi ng
and infrastructure. It is not possible to specify a
benchmarked number of staffed based on sample or
donor number, but the types of staffi ng roles typically
employed (especially in larger biobanks) include: manager,
coordinator, offi cer, technical assistant, data manager
and administration assistance. Staffi ng and staff time
contribute to approximately 70 per cent to 90 per cent
of biobank running costs (based on survey responses).
Freezers and liquid nitrogen2. : all biobanks will require
at least access to a –80˚C freezer and possibly liquid
nitrogen tanks, as well depending on the types and
numbers of samples being stored. Responses to the
survey suggest that most biobanks share freezer space
and liquid nitrogen tanks with other laboratories.
Average freezer usage by biobanks was between 80 and
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
52
2,500 donors per freezer. Considering freezers can hold
between 14,000 and 50,000 plus samples (depending
on sample size and freezer size), even if banks were to
store multiple samples per donor, they are unlikely to
require individual freezers at this stage. In addition, banks
with multiple storage sites will have samples spread
across all sites (e.g. the Australian Breast Cancer Tissue
Bank has samples across fi ve freezers at fi ve storage
sites and four liquid nitrogen tanks at four of the fi ve
collection sites). Products requiring storage at –80˚C
or in liquid nitrogen: 93 per cent of biobanks surveyed
routinely stored fresh frozen samples (for tumour tissue
and approximately 47 per cent stored fresh frozen
matched normal tissue as well) and approximately 67
per cent routinely stored blood and blood products.
Approximately 20 per cent and 13 per cent of biobanks
routinely stored DNA and RNA, respectively and a
further 47 per cent would prepare DNA and RNA
upon request. Of the biobanks surveyed, most indicated
that an average of fi ve per cent to 10 per cent of funds
was spent on equipment and a further 10 to15 per
cent on maintenance. Twenty-seven per cent of banks
did not attribute a cost to equipment and 40 per cent
of banks did not attribute a cost to maintenance. Two
banks (13 per cent) indicated higher equipment costs of
approximately 20 per cent of funds, with an additional 5
per cent on maintenance for one of these banks). Both
of these banks had large number of donors (1,000 plus
and 2,000 plus). One of the banks had fi ve collection/
storage sites, likely to increase the equipment costs for
this bank, the other had additional equipment not listed
by other biobanks including a virtual microscope slide
scanner, a manual tissue arrayer and a high-throughput
immunohistochemistry staining station.
Room temperature storage3. : in addition to access
to storage at –80˚C or in liquid nitrogen, biobanks
will require room temperature storage space if they
routinely store paraffi n embedded tissue samples and/
or H&E stained samples. Of the biobanks surveyed,
approximately 40 per cent routinely stored paraffi n
embedded samples and only one biobank (seven per
cent) routinely stored H&E stained tissue. A further 27
per cent of banks would process H&E staining
upon request.
Other equipment and consumables4. : in addition to
storage facilities, other large equipment that biobanks
may require (or require access to) are a centrifuge (for
processing of blood) and a microtome for sectioning
of paraffi n embedded tissues for staining. Biobanks
will also require consumables (e.g. chemicals, cryo-
tubes, stationary) for the processing and storage of
samples. Other miscellaneous costs for biobank included
conferences and travel. Biobanks indicated an average
of four per cent–10 per cent of funds are contributed
towards consumables and miscellaneous items.
Computing and databases5. : biobanks require IT
infrastructure to: track and monitor sample locations;
manage clinical information about donors including
de- and re-identifi cation of samples as required; and
monitor follow-up and outcomes data of donors. Of
the banks surveyed, 60 per cent did attribute costs to
IT infrastructure, 27 per cent attributed one per cent
of funding to IT and another 13 per cent attributed
5–8 per cent of funds to IT. Considering the essential
role of IT in data management, the survey suggested
relatively little to no money was actively invested in
this area of biobanking. Twenty per cent of biobanks
surveyed did not yet have any computing hardware
attributable to the biobank, and the remaining banks had
internally developed databases located on institutional
servers. The number of computers per biobank ranged
from zero to fi ve (one at each of the storage sites). As
biobanks grow, it will be important that they invest
into their IT and data management systems. Tools such
as the laboratory information management system
from WAGER could be used to help biobanks with
data management issues and lessons from other well
established biobanks (e.g. Victorian Cancer Biobank)
could be taken in regards to appropriate software and
database systems for biobanking needs. Eighty per cent
of biobanks surveyed collected follow-up information
on donors (either systematically every six to 12 months
or in an ad hoc as required fashion). Ninety-two per
cent of these banks collected the information manually.
Increased usage of data linkage systems (as discussed in
Section 8.2.8) could greatly facilitate these processes and
reduce the staff time required for this important task.
53
8.3 Other observations to consider in the future of biobanking
8.3.1 Governance committee(s)
Regardless of the model of governance established, all
biobanks will need to have a governance committee and
several sub-committees with appropriate representation.
In line with the Australian Standards of Governance,36 the
overarching governance committee should be responsible
for: setting the strategic directions of the bank with clearly
documented objectives; approval of major decisions; budgets
and performance indicators; risk management; policy/
procedure development and adherence; and adherence to
appropriate laws and regulations.
As such, the committee should consist of appropriate
representatives from participating institutions (both
collection and storage sites), clinicians, researchers, pathology
and ethical committees. Governance committees could also
consider patient/donor and/or general public representation
to ensure strategic directions are in line with views of the
public. Other committees essential for a biobank include a
Human Research Ethics Committee (HREC) and a Scientifi c Advisory Committee.
Most host institutions/hospitals have an established HREC,
which biobanks are required to seek approval for specimen
collection and consent procedures. When multiple
institutions are involved, ethical approval for collection and
consent may be required from all HRECs of participating
institutions. Models such as the statewide consortium model
of biobanking, could present an opportunity to develop
statewide policies around biobanking ethics so that in
future approval from one HREC will carry over all HRECs
in the state, to avoid administrative duplication. HRECs
are required by law to have representation of the general
public (lay representation), thus providing one avenue for
the general public and donors/patients to have input into
the collection procedures and consent process. Currently
all research for which specimen samples are requested
must have ethical approval for the research. This is generally
provided by the institution or affi liated university at which
the research is being conducted. These ethical approval
processes for research should remain in line with NHMRC
ethics polices and guidelines.
In addition to HREC approval for consent and collection
processes (responsibility of the bank) and for research
(responsibility of the researchers), biobanks should establish
or have access to a Scientifi c Advisory Committee,
responsible for assessing the scientifi c merit of a research
request. Scientifi c committees should have representation
from clinical and academic experts in the fi eld of interest.
In models such as the consortium, where there are many
tumour types, it may be necessary to have different scientifi c
advisory committees for each tumour group to maintain a
suffi cient level of knowledge in the committee.
8.3.2 Funding arrangements
At present, the funding arrangements for biobanks varies
across NSW, but the majority of banks rely on government
funding grants, such as the NHMRC enabling grant,
institute/department funding and good will (e.g. space, staff,
equipment sharing, infrastructure), and other philanthropic
donations. The issue for many banks is that fi nite funding
grants limit the strategic directions that can be set, and the
ability to gain additional investment, as there is no certainty
of ongoing funding for the future. Similarly, institutional/
departmental funding relies on the good will and wealth of
the host institute and cannot be guaranteed indefi nitely.
Clearly then, it is important for biobanks to be able to
measure their ‘success’ in order to apply for ongoing funding.
Currently this appears only to be based on publications
generated from research that used specimens, highlighting
the importance for biobanks to follow up the research to
which they have supplied samples. Some banks are able to
overcome this by collaborating with researchers in projects
they supply samples to, thus guaranteeing acknowledgement
on publications.
Other performance indicators and measures of ‘success’
could include the number of samples deposited compared
to the number of samples withdrawn from the bank in a
specifi ed time period. To maximise this type of performance
indicator however, marketing plans would need to be
incorporated to the business plan of all banks to ensure
researchers are aware of the bank and the samples provided.
Aside from websites (which themselves appeared to be ad
hoc for biobanks in NSW), the VCB was the only biobank
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
54
surveyed that actively marketed themselves to researchers
through various media campaigns and provision of
newsletters/updates circulated to all research institutions in
Victoria. This style of marketing, which is more cost-effective
for large networks or consortia, may be useful for biobanks in
NSW as well.
Another method of ‘funding’ is that of cost recovery for
samples. Many banks currently do not charge researchers
for samples, or only charge for freight costs to deliver the
samples. Some larger banks have established cost recovery
procedures to, in part; recover the costs associated with
collecting, processing and storing the samples. There are two
main concerns with cost recovery:
One is the resources required to follow up payments, ▪especially if there are tiers to cost recovery (e.g. based
on type of researcher – academic or commercial – and/
or types of samples and level of processing required) or
if requests are sent in batches based on tissue availability.
Another concern is that researchers will not be able ▪to afford to pay for tissue samples as these costs are
generally not budgeted for in the research grants. For
cost recovery processes to work optimally in future
it may require a shift in the way researchers apply for
funding (i.e. to allow for costs of tissue sample) when
proposing future research projects.
One advantage of adopting the consortium of biobanks
governance model is that funding applications would be
for one unifi ed group, therefore eliminating competition
between individual banks. The combined infrastructure is
also likely to make following up of publications easier to
manage. Another advantage is that innovative cost recovery
models can be generated (e.g. the modular cost recovery
model of VCB) to enable partial cost recovery of samples.
8.3.3 Sample ‘ownership’
The idea of sample or specimen ‘ownership’ is important
for biobanks. Some researchers are reluctant to the idea of
consortiums for fear of losing control of ‘their’ samples and
having less say in which research the samples will go to. This
also impacts on collection versus storage sites, with many
banks reluctant to send their samples to centralised site for
storage for similar reasons.
8.3.4 Sharing of resources
There are currently small biobanks for rare cancers, which by
themselves could not afford the infrastructure of a biobank.
These banks therefore tend to share facilities and even
staff with larger banks at the institution in which they are
housed. This is an economical solution for these small banks.
This type of infrastructure sharing however, could present
complication regarding funding arrangements in a cancer
specifi c network model.
8.3.5 Good will and relationships
Biobanks rely on good relationships and communication
between surgeons, pathology, biobanks and researchers.
One of the concerns regarding a large biobank network
or consortium raised was that a lack of human interaction
(especially important to maintain the good will of surgeon
and pathology laboratories), could dissolve the relationships
established resulting in a breakdown of communication.
Therefore, if a network or consortium were to be
considered, specifi c provisions regarding the maintenance of
relationships at each participating hospital would be essential.
8.3.6 Other types of collections
Other types of tissue collections not discussed in this chapter
which could be explored in future include:
Collections located in anatomical pathology laboratories ▪in hospitals, which store unused specimens for up to 20
years. Consent, collection and storage protocols may
vary from formalised biobanks, but introduction of SOPs
could increase the ‘usability’ of these specimens in future.
Specifi c collections in individual laboratories collected ▪specifi cally for one research study. Unused samples
could potentially be used for other research if consent
for tissue use was broad or re-collected. In this case,
it would probably be necessary for a researcher to
donate their unused samples to formalised biobanks,
which would require the good will of the researcher and
assume there was no reluctance to share samples.
55
8.3.7 Bio-ethical Issues and considerations
When discussing biobanks, there are certain bio-ethical issues
that need to be considered, such as ‘ownership’ of donated
samples and the ethics of making a profi t from human tissue
(e.g. what are the consequence of supplying samples for
commercial research?); the inclusion of lay persons (patient/
donor) as representatives on biobank committees such
as HREC (mandatory) or scientifi c advisory committees;
issues around consent, what is broad consent, what are the
limitations of this consent, can there be staged choice for
consent (i.e. a donor consents to certain aspects, but not all)
and can the donor withdraw consent at any time?vi While
several of these issues have been considered by biobanks
(for example, broad consent for all banks includes the ability
to withdraw samples at any time, many banks have staged
consent were donors select the level(s) of research they will
consent to and the Australian Breast Cancer Tissue Bank
has a lay representative in their governance committee), the
issues will need further exploration as different models of
biobank governance arise.
At a minimum, biobanks (including consortia if established)
should adhere to the NHMRC guidelines regarding consent
for tissue collection and data linkage/re-identifi cation.
NHMRC states that in relation to collection of tissue in
research consent may be:
specifi c ▪ : limited to the specifi c project tin consideration
extended ▪ : for the use of data or tissue in future research
projects (that are an extension of the original or closely
related to the original project)
unspecifi ed ▪ : for the use in future research.48
The limited information on the type of research to be
conducted for extended or unspecifi ed consent must still
give suffi cient and adequate information for the donor to
make an informed decision, and may also include permission
to enter data or tissue into a bank. Patients do not need to
give a reason if they choose not to consent or to withdraw
consent and should not be disadvantage because of their
decision. Participants are able to withdraw consent at
any time.50
The NHMRC Guidelines also state that data collected for the
purposes of biobanking must be re-identifi able (i.e. identifi ers
removed and replaced by code, but retain the ability to be
re-identifi ed as required). While most data are collected,
aggregated and stored for a single purpose or activity,
permission can be sought from participants to ‘bank’ their
data for possible use in future research projects.49
8.4 Conclusion
There are currently various models of governance
arrangements for biobanks located in NSW, ranging from
small biobanks with one collection site, to larger banks
with several collection sites and storage sites across NSW
and in some cases Australia. The complexities of biobank
governance arise when considering ‘ownership’ of samples,
SOPs, cost recovery and prioritisation.
In future there is much to be gained by increasing
coordination and consistency across biobanks and increasing
access by researchers. One relatively simple method to do
this is to develop stakeholder networks, which allow formal
discussion among stakeholders regarding these issues and
can allow for development of specimen locators to facilitate
searches for specifi c samples across multiple banks at one
time. Building on this, banks could become accredited
to ensure adherence to agreed SOPs and consistency of
samples across biobanks. The simplicity of these models is
that they do not require any changes to existing governance
arrangements.
In addition to this, formalised biobanks could develop
consortia across NSW or Australia based on tumour groups.
The increased resources from this model would enhance
consistency across biobanks, but the required governance
changes to a single entity could generate anxiety amongst
existing biobanks.
A fi nal model for consideration is to develop a statewide
consortium of biobanks across NSW, which will allow
enhanced resource sharing and generate consistency
statewide. This model may have advantages relating to
funding options and generation of cost recovery models.
The bioethical issues and considerations for future research on tissue banks were raised from discussions with the Centre for Values, Ethics vi.
& the Law in Medicine (VELiM) (Associate Professor Ian Kerridge, Emeritus Professor Miles Little, Dr Wendy Lipworth and Bronwen
Morrell) University of Sydney, 17 July 2008.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
56
However, it would still require governance under a single
entity which may not be welcome by existing biobanks.
Other important issues to be considered in any model
for biobanks include: the role of pathology departments
and providers; supporting key infrastructure such as data
management and data linkage; the distinction between clinical
and epidemiological biobanks; recommended committee
memberships; consistency of SOPs; funding model options;
maintaining relationships between biobanks, surgeons and
pathology; and bio-ethical considerations, especially relating
to consent from donors.
In order to assess the best approach to maximise the
future of biobanking in NSW, it will be important for all
stakeholders to actively contribute to the discussion of
options and arising issues. This may include biobank heads,
researchers, specimen donors, bio-ethicists, clinicians
and pathologists.
57
9 Appendixes
9.1.1 Formalised Biobank Governance Arrangements: telephone questionnaire
Background Information
Date of survey. ▪
Name of biobank. ▪
Name of person interviewed. ▪
Position of person interviewed. ▪
Contact email/telephone/address. ▪
Website, if available. ▪
General Information
Purpose of tissue/tumour collection: Does the bank 1.
collect general samples for future (as yet unspecifi ed)
research and/or samples for specifi c research proposals
for researchers?
Broad types of tumour samples collected (e.g. Breast, 2.
Prostate, Melanoma, Multiple, etc)?
Broad types of specimens collected (e.g. blood and blood 3.
products, tissue (normal and/or tumour, DNA/RNA)?
Single or multiple collection sites: does the bank collect 4.
only from the one site, or multiple sites? If multiple
collection sites – are samples stored at the other
collection sites, or are all samples transported to the
main site? At each collection site, are samples collected
from the site itself and/or transported to the site from
other hospitals/institutions? If other hospitals/institutions,
what are their names?
Are there other biobanks located at the institution? Do 5.
you share facilities/staff with other biobanks?
How the samples and data are linked (e.g. barcode 6.
system, identifying number/code)?
How is the data for the samples de-identifi ed and re-7.
identifi ed as required?
Entity status and funding sources
What is the entity status of your biobank (e.g. 8.
department within a hospital/institution, not for profi t
organisation with government funding, not for profi t
organisation without government funding, for profi t
organisation)?
What was the funding source for the establishment 9.
of the biobank (hospital/institutional, government e.g.
NHMRC grant, philanthropic, etc)?
What is the current funding source for the biobank?10.
Does the biobank charge researchers (e.g. cost recovery 11.
or administration fees) for access to samples? What are
the fee arrangements (eg is there a different fee for
internal researchers compared to external researchers
or pharmaceutical companies? Is there a different fee
depending on the amount of processing/manipulation
required for the sample type?).
Organisational Structure and Governance Arrangements
What are the internal management arrangements of the 12.
biobanks, i.e. to whom does the bank report (eg biobank
board or management committee, hospital board)?
If there are multiple collection/storage sites, to whom 13.
do the individual sites report (eg biobank board
or management committee, hospital board)? If the
collection is for banking for future research, who
provides ethics approval for this collection?
Who/what body is responsible for setting the strategic 14.
directions of the biobank?
What other committees/groups are involved with the 15.
biobank (e.g. scientifi c advisory group)?
Is the biobank a part of or affi liated with broader 16.
network/consortium of biobanks? In what capacity?
APPENDIX A EXAMPLE QUESTIONNAIRES
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
58
Standard Operating Procedures (SOP)
Does the biobanks have SOPs for:17.
Consent. ▪
Specimen collection. ▪
Preservation. ▪
Manipulation (i.e. making tissue arrays). ▪
Storage. ▪
Distribution (i.e. to researchers). ▪
De-identifi cation and re-identifi cation of data. ▪
Bioinformatics (i.e. data storage). ▪
Data collection (demographic, clinical, outcomes). ▪
Researcher access. ▪
Were these internally developed or based on external 18.
sources (e.g. other biobanks procedures)?
Can you provide HMA with a copy of the SOPs?19.
Researcher access
How would researchers fi nd out about your biobank and 20.
the types of samples you have (eg webpage and sample
search facilities, telephone, other researchers)?
How many requests have you had for tissue samples 21.
(either normal or tumour) in the last 12 months?
How many of these were approved by the banks?22.
9.1.2 Specifi c Tissue Collections: email questionnaire
What is the broad cancer category of the tissue ▪collected (i.e. breast, colorectal etc)?
What type of specimens were collected (ie tissue – ▪normal/tumour, blood and blood products, DNA,
other etc)?
Was the study for which the specimens were collected ▪part of a specifi c research project or clinical trial? If yes,
which one(s)?
Was consent for the collection and use of samples ▪restricted to the study(s) in question, or was broad
consent given by the donor so that the samples can also
be used in future research projects?
9.1.3 Follow-up survey for Formalised Biobanks
General Information
Name of Tissue Bank:
Central Location of Tissue Bank:
Could you please provide us the information on the 1.
current size of your collection and categorise by tumour
site if possible.
Tumour Site No. of specimens
Total number of specimens:
To date, how many donors have contributed to your 2.
tumour bank?
What is the average (approximate) number of donors 3.
per week/month (as appropriate)?
From each donor, what are the types of samples 4.
routinely stored? (i.e. paraffi n embedded samples, fresh
frozen samples, fresh samples, blood, DNA, RNA etc.)?
What additional processes can be undertaken by your 5.
tissue bank on request from a researcher (i.e. DNA or
RNA extraction, H&E staining etc.)?
Does your tissue bank have any rare samples in limited 6.
supply? If yes, what is/are the tumour type(s), tumour
location(s) and number of specimens?
What infrastructure currently exists at your tissue bank 7.
in terms of IT (i.e. computers, databases etc.) or other
(i.e. large equipment such as freezers etc.)?
59
Entity Status and Funding Sources
How much funding has the tissue bank received since 8.
its inception, and from which funding agency/agencies?
Please complete whatever information you are able
to provide on the table below, plus the total funding
received by the tissue banks and the year the bank
began operation.
Year(s) of funding(i.e. 2004–2009)
Funding agency Amount funded by category:
<$1,000$1,000 - $50,000
$50,001 - $100,000$100,001 - $500,000
>$500,000
Total funding since inception (by funding category above):
Year tissue bank began operation:
In broad terms, what percentage of funds has been 9.
allocated to each of the following categories:
Personnel ▪
IT resources ▪
Equipment ▪
General maintenance ▪
Other (please list if possible) ▪
When does your current funding expire?10.
What plans or strategies are in place for securing future 11.
funding and for the long term sustenance of the bank?
Organisational Structure and Governance Arrangements
How many personnel are employed by the tissue bank 12.
(full time equivalents), and what are their positions?
Do you measure the performance of your tissue bank? 13.
If yes, how? (i.e. number of specimens stored, number of
specimens accessed by researchers, number of research
publications resulting from specimen use etc)?
Standard Operating Procedures (SOP)
What is the routine procedure for obtaining patient 14.
consent, and the approximate success rate for obtaining
patient consent? If possible, please provide HMA a copy
of your standard Patient Consent Form if you have not
already done so?
What clinical information is routinely collected from each 15.
donor? If possible, please provide HMA a copy of your
standard Clinical Data Collection Form(s) if you have not
already done so?
Do you collect any additional clinical follow-up data from 16.
donors? If so, how is this done (i.e. via a data linkage
system such as CHeReL or manually)?
What quality control measures are in place for ensuring 17.
specimen integrity (i.e. systems for storage, monitoring,
security etc)?
Researcher Access
Would the researchers accessing specimens from the 18.
tumour bank be expected to :
Acknowledge the tumour bank in their publication? ▪
Provide the tumour bank with copies of the ▪accepted publication?
Return unused specimens to tumour bank? ▪
Provide additional information on the specimens they ▪have studied?
Other? ▪
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
60
Could you please provide us information on the number 19.
of specimens accessed by researchers over the following
time periods:
Over the past 12 months. ▪
Since tissue bank inception. ▪
Could you please provide us information on the number 20.
of publications arising from researcher access to your
tissue bank since its inception if known and if not
already provided?
9.1.4 Researchers: telephone questionnaire
Date:
Name of Person Interviewed:
Institute:
Contact email:
Contact phone:
Which tumour/biobank have you accessed?1.
How did you fi nd out about the biobank?2.
How did you access the biobank? For example, was it 3.
online via the web, did you download a form and post/
email back, etc.
If you obtained specimens from multiple banks, how 4.
were the different banks accessed? Were there any
diffi culties with this process?
Were you able to easily fi nd out if the bank had the 5.
specimens you required?
How long did it take to acquire specimens? Was this 6.
within your expected time frame?
What are the reporting requirements to the biobank 7.
for using their samples? Do these requirements create a
burden to the research?
Were there any costs associated with obtaining the 8.
samples? If so, were the costs acceptable or a deterrent
to obtaining samples?
What do you see as the barriers to access for 9.
researchers in retrieving specimens from biobanks?
What do you see as the facilitators to access for 10.
researchers in retrieving specimens from biobanks?
61
APPENDIX B GOVERNANCE ARRANGEMENTS OF INTERNATIONAL BIOBANKS
Country Bank Name Entity Status Governed by Funders Sample Collection
UK onCore UK Non-profi t and charity Board of trustees Department of Health
England;
Medical Research
Council; and
Cancer Research UK
Scotland Generation Scotland Non-profi t Scientifi c committee;
Advisory board
Scottish University
Medical Schools,
Biomedical Research
Institutes,
NHS in Scotland
UK UK Biobank* Registered charity Wellcome Trust
Medical Research
Council
Dept of Health
Scottish Executive
Northwest Regional
Development Agency
EU Tubafrost (The
European Human
Tumor Frozen Tissue
Bank)
Group of pathology and
research depts across
Europe all involved
in cancer care and/or
research
Cordis: Community
Research and Dev
Information Service
Organisation of
European Cancer
Institutes
Tissues collected
internationally but
stored at local sites
EU Genome Austria Tissue
Bank
Non-profi t Medical University of
Graz
Primarily the Genome
Research in Austria
project
Tissues and blood
collected internationally
but stored on site
Spain Spanish National
Cancer Research
Centre Tumour Bank
Network
Non-profi t Spanish National Cancer
Research Centre,
Molecular Pathology
Programme
Ministry of Health Tumour and matched
normal tissue collected
and stored at
participating hospitals
in Spain.
Sweden Swedish National
Biobank Program
Wallenberg Consortium
North (joint funder)
governed by Advisory
Group consisting of
Vice Chancellors of
participating universities,
then a Coordinating
Group as Executive
Mgt.
Swegene Consortium
Wallenberg Consortium
North
10 participating
biobanks
Table 9.1 Governance arrangements of international biobanks
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
62
Country Bank Name Entity Status Governed by Funders Sample Collection
Canada Ontario Tumour Bank Non-profi t Board of directors;
Scientifi c Advisory
Board
Government of Ontario More than 5 hospital
sites in Ontario
Canada Alberta Research
Tumor Bank
Provincial Executive
Committee;
Academic partners
(university); and
Health authority
partners
Canadian Breast Cancer
Foundation – Prairies/
NWT Chapter
Alberta Cancer Board
Canadian Tumour
Repository Network
3 treatment facilities
Canada Canadian Tumour
Repository Network
Non-profi t Institutes of Health
Research under
direction of the
Canadian Association
of Provincial Cancer
Agencies
6 charter members
(bio-banks) across
Canada
US Cooperative Human
Tissue Network
Non-profi t Coordinating
Committee including
Principal Investigator
and audit member from
each division
National Cancer
Institute
6 Divisions
US Mayo Clinic Scottsdale Multiple Myeloma
Research Consortium
14 contributing sites in
US and Canada
US Early Detection
Research Network
Non-profi t National Cancer
Institute
US Cooperative Breast
Cancer Tissue Resource
Non-profi t National Cancer
Institute
More than 4
participating hospitals /
organisations
US National Biospecimen
Network: Prostate
SPORE Pilot
Non-profi t Board of Governors;
Operations Centre;
Business Units
National Cancer
Institute
US Bioserve For-profi t Samples from four
continents
US/UK Asterand For-profi t Board of Directors Investors/stockholders 36 donor institutions
world-wide
*UK Biobank currently stores baseline information from blood and urine, not tissue, samples and is not solely focussed on cancer research
(from www.ukbiobank.ac.uk).
Table 9.1 Governance arrangements of international biobanks (cont’d)
63
APPENDIX C COMPARISON OF INTERNATIONAL BIOBANK GUIDELINES
Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB
NBN52 NCI53 CCB54
Best Practices for Biospecimen Collection
Collection priority based on defi ned purpose
of each biospecimen resource
Collect from ethnically and geographically
diverse populations of all ages.
Biospecimens collected from populations with
demographic characteristics and diversity
appropriate to the research
Draw from large network of academic and
community medical centres.
Collection can be from a variety of context
including surgical procedures, organ donation,
transplantation...
Relevant data including collection and
processing protocols and time elapsed
during collection and processing recorded by
biospecimen resource.
Pathologist determines proportion of
specimen needed for diagnosis.
Pathologist to determine specimen portions
necessary for pathologic diagnosis, to ensure
patient care is not compromised.
Samples collected during the course of
diagnostic or therapeutic interventions.
Standardized, monitored shipping procedures
with a tracking system.
Specimen quality assurance through ‘H and
E’ analysis, pathologist review, and integrity
check.
Scannable bar codes to track specimens. Each storage vessel to have a unique identifi er
or combination of identifi ers fi rmly affi xed to
the container.
Standard operating procedures for specimen
collection.
Train collection personnel using standard
protocols. and
Ensure personnel are trained and qualifi ed to
ensure high quality samples. Use of SOP for
consistency.
Close contact with collection site personnel
to ensure standards.
Best Practices for Biospecimen Processing and Annotation
Procure and process specimens for storage
within one hour post-excision using detailed,
standardised protocols.
Minimise time for collection for solid tumours
and reduce temperature ASAP. Rapid
processing may not be as critical for other
specimen types e.g. blood
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
64
NBN52 NCI53 CCB54
Best Practices for Biospecimen Processing and Annotation (cont’d)
Processing should use the method that
preserves the most analytes unless the aim
of a particular study specifi cally required an
alternative.
Use pathologists to verify and evaluate
biospecimens.
Link all assay/test results and relevant
annotation to specimens and provide
information to researchers.
All relevant information should be tied to the
unique identifi er.
Provide information/annotation obtained
during quality control of specimen in a
database for researchers to access.
Uniform non-redundant vocabulary for data
collection e.g. caBIGTM).
Use common data elements for standardised
data collection.
Collect complete data on all elements of a
minimal data set to meet user needs.
Track researcher request for data to review
and modify minimal data set as required.
Collect and store longitudinal data. Collect longitudinal data as required for study
purposes which may include demographic
data, lifestyle factors, environmental and
occupational exposures, cancer history,
diagnostic studies, treatment data and
outcomes data. Data to be stored and
collected according to SOP and privacy
regulations.
Ensure the accuracy of data entry through
the use of standardised terminology and
computer data-entry forms. and
Implement independent checks of data. Employ techniques to validate data accuracy.
Best Practices for Biospecimen Storage and Distribution:
Samples to be stored in specifi cally designed
facilities to maintain quality and security.
Collect non-diseased matching adjacent tissue
(normal tissue) and blood/serum specimens.
Develop standards for storage depending on
tissue type and storage condition.
Individual specimen types (e.g. frozen tissue,
paraffi n embedded tissue, glass slides, blood,
serum, urine, RNA and DNA) should have
individual SOP for preservation and storage
developed.
Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB (cont’d)
65
NBN52 NCI53 CCB54
Best Practices for Biospecimen Storage and Distribution (cont’d):
SOPs to include storage temperatures
such as: paraffi n blocks stored below 27˚C;
liquids (blood, urine) specimen components
separated before storage; tissues stored in
the vapour phase of liquid nitrogen freezers
kept below -140˚C.
Storage personnel to record storage
information especially deviations from SOP
and freeze/thaw episodes.
Specimens should be stored in a stabilised
state with minimal unnecessary freeze/
thawing.
Storage vessels to be appropriate for
conditions of storage and volumes of samples.
Monitor specimens around the clock,
perform, weekly maintenance and annual
quality checks of freezers, and use freezer
backup procedures.
Automated security systems to continuously
monitor the function of storage equipment,
with automatically activated back up
equipment (e.g. power supply).
Retrieve samples according to SOP to
safeguard specimen quality.
Use multiple storage sites (on or off site).
And periodically audit, inventory, and certify
location, identity, and quality of specimens.
Ship samples at as constant a temperature
as possible with appropriate temperature
control packs for the distance of travel e.g.
freezer packs cooled to -20˚C for frozen
samples, dry ice for samples stored at -70˚C
and freezer packs cooled to -15˚C to maintain
fridge temperatures.
Recipients to be notifi ed when samples are
shipped and repository notifi ed when samples
received. Tracking method/shipping log to
be implemented (either computerised or
written).
Best Practices for Bioinformatics:
Maintain close relationship with system
developers, researchers, data managers, and
repository managers.
Systems should be able to link with local
systems.
Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB (cont’d)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
66
NBN52 NCI53 CCB54
Best Practices for Bioinformatics (cont’d):
Use automated data extraction or
multiple checks/standardised language in
bioinformatics system.
Bioinformatics system to track all aspects
of biospecimen collection, processing and
distribution to support annotation. Must
comply with privacy regulations.
Feed research results back into system for
access by researchers.
Employ a searchable and minable Web-based
system. and
Provide extensive network security and
access control.
System to be secure and to be able to
provide audit logs of all access to protected
health information
Include tools to extract free text from e.g.
pathology reports.
Best Practices for Consumer/User Needs
End-users should only request samples that
are going to be used.
Transparent and open communication
between research and community (donors or
potential donors)
Give priority to researchers at collecting
institutions.
Samples given on basis of best use.
Base prioritisation on merit review using
tissue utilisation committee and standardised
criteria.
Have policies to prevent last sample
distribution and researcher monopolisation of
samples.
Separate provision polices may be required
for samples which are close to depletion.
Directly solicit researcher feedback on
particular samples/shipment.
Feedback questionnaire on the quality of
samples received should be standard practice.
Evaluate repository performance through
committees/review groups.
Regularly assess and change in response to
researcher needs.
Develop policies around data sharing
of results keeping in mind the need for
researcher to protect publication rights of
research.
Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB (cont’d)
67
Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB (cont’d)
NBN52 NCI53 CCB54
Best Practices for Business Plan and Operations
Establish a written quality management
system or adheres to a published system.
Quality management should be integral to the
management of any biosample resource.
Develop a SOP manual for all aspects from
collection to distribution.
Establish and maintain close relationships with
all relevant staff at collection sites.
Current SOPs available for all staff at all times
Ensure standard biohazard regulations and
general laboratory safety is in place.
Combine banking and prospective tissue
collection.
Accurately determine costs of all stages of
repository operation to fi nancially sustain
repository.
Samples should be assigned a monetary value;
rather fees should be levied to recover costs
towards collection and storage of samples
and/or in exchange for services that add utility
to the samples.
Continually assess and incorporate new
technologies. and
Review all SOPs every 2 years and whenever
signifi cant changes in practices, procedures,
technologies or law/regulation are made.
Require acknowledgment of repository in
publications and provide specifi c language
with which to do so.
Best Practices for Privacy, Ethical Concerns, and Consent Issues
Comply with applicable privacy statutes and
regulations.
Limit access of medical information to only
those required.
Responsible custodianship of samples. Repositories are only custodians of samples.
Limit access to codes that link patient
identifying information to their tissue
specimens through physical and/or cyber
procedures.
Privacy protection according to federal
regulations of privacy.
Use institutional review board oversight of
repository practices.
Require institutional review board review of
research for researchers requesting samples.
Use bioethics advisory board or other
governance and oversight board/committee
to oversee privacy/confi dentiality procedures.
Access decision guided by set of general
principles.
Samples used (where possible) on the basis
of the likelihood of being put to a good
and benefi cial use in a timely fashion after
donation
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
68
NBN52 NCI53 CCB54
Best Practices for Privacy, Ethical Concerns, and Consent Issues (cont’d)
Obtain specimens obtained from fully
consented tissue sources.
Informed consent according to NCI
regulations.
Informed consent for use of samples, including
reciprocal policies internationally and across
cultural differences where necessary.
Use tiered consent process.
Best Practices for Intellectual Property and
Legal Issues
Develop and adhere to specifi c IP policy. Develop IP and resource sharing policy.
Allow tissue sources to withdraw samples if
they are not de-identifi ed.
Use a formal agreement with researchers that
specifi es appropriate sample use.
Specify responsibility for assuming risks for
use of biospecimens in tissue use agreements.
and
Carefully review researcher submissions and
credentials.
Best Practices for Public Relations, Marketing,
and Education
Market the tissue resource, using word of
mouth, journal advertisements, and exhibits
at scientifi c meetings.
Provide information about generalised
research fi ndings to tissue sources, physicians,
and researchers.
Categories are based on those from NBN. NCI and CCB themes were organised to align with these themes for comparison purposes.
Table 9.2 Comparison of biobank guidelines from NBN, NCI and CCB (cont’d)
69
AP
PE
ND
IX D
S
UM
MA
RY
OF
DE
SIG
N A
ND
GO
VE
RN
AN
CE
FIN
DIN
GS
FO
R E
AC
H B
IOB
AN
K
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Sydney
Mela
no
ma
Unit
Bio
-Speci
men B
ank
(succ
ess
or
to M
ela
no
ma
and S
kin C
ance
r R
ese
arch
Inst
itute
Tum
our
Ban
k
whic
h n
o lo
nge
r exis
ts –
MA
SCR
I sp
eci
mens
now
under
SM
U c
ura
tion)
Est
ablis
hed in
2007.
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
and
speci
fi c
pro
ject
s.C
urr
ently
multip
le c
olle
ctio
n s
ites
and o
ne
stora
ge s
ite.
Shar
ed s
tora
ge fac
ilities
with B
reas
t C
ance
r T
issu
e
Ban
k (R
PAH
node)
.
Routinely
sto
re fre
sh
froze
n t
issu
e, w
hole
blo
od,
pla
sma,
seru
m, b
uff
y co
at.
Additio
nal
pro
cess
es
on
request
incl
ude D
NA
or
RN
A e
xtr
action, H
&E
stai
nin
g. 2
x -
80C
fre
eze
rs.
1x c
entr
ifuge
.
Depar
tment
within
inst
itution (
Univ
ers
ity
of Sy
dney
Facu
lty
of
Medic
ine)
.
Funded b
y pro
gram
gra
nts
(CI N
SW
and N
HM
RC
).
Curr
ent
fundin
g expir
atio
n
201
0.
Bio
speci
men B
ank
Co
mm
itte
e se
par
ate
fro
m h
ousi
ng
inst
itution
resp
onsi
ble
for
polic
y,
pro
gress
, rese
arch
feedbac
k an
d r
evi
ew
of
applic
atio
ns
for
use
of
speci
mens.
3.5
FT
E s
taff.
Ban
k perf
orm
ance
meas
ure
d b
y num
ber
of
speci
mens
store
d.
SOPs
for
pat
ient
conse
nt
and s
peci
men
colle
ctio
n, p
roce
ssin
g an
d
stora
ge. T
he
SM
U t
eam
endeav
ours
to c
onse
nt
all n
ew
SM
U p
atie
nts
with ~
90%
succ
ess
. Most
then p
rovi
de
a blo
od
sam
ple
and s
om
e ar
e
subse
quently
suitab
le for
tiss
ue
colle
ctio
n. B
ioban
k
dat
a st
ore
d o
n E
XC
EL
spre
adsh
eet
usi
ng
dat
a
entr
y gu
idelin
es,
with
pap
er
note
of sp
eci
men
loca
tion. T
reat
ment,
follo
w-u
p a
nd p
atholo
gy
deta
ils a
re e
nte
red in
to
a re
sear
ch d
atab
ase.
Deve
lopin
g lin
k to
SM
U
clin
ical
dat
abas
e. S
OPs
deve
loped u
sing
guid
ance
fro
m: B
CT
B; d
ocu
ments
sourc
ed fro
m A
BN
incl
udin
g IS
BER
Best
Pra
ctic
e G
uid
elin
es,
WA
Rese
arch
Lab
ora
tori
es,
Pete
r M
cCal
lum
tis
sue
and
blo
od b
anki
ng
pro
cess
es.
Freeze
rs a
larm
ed a
nd
reco
rd t
em
pera
ture
devi
atio
ns.
Speci
mens
div
ided a
nd s
tore
d in
separ
ate
freeze
rs.
Open t
o a
ll re
sear
chers
with p
riori
ty a
ccess
giv
en
to r
ese
arch
ers
ass
oci
ated
with o
r co
llabora
ting
with
SM
U. R
ese
arch
ers
will
be
char
ged fre
ight
cost
s only
.
Hav
e h
ad n
o r
ese
arch
er
request
s to
dat
e fo
r SM
U
speci
mens
(ban
k only
initia
ted in
Oct
ober
2007),
but
120 h
isto
rica
l MA
SCR
I
speci
mens
acce
ssed
by
rese
arch
ers
in p
ast
year
. Unkn
ow
n n
um
ber
public
atio
ns
aris
ing
fro
m
speci
men a
ccess
.
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
70
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Aust
ralia
n P
rost
ate
Can
cer
Colla
bora
tion (
APC
C)
Bio
Reso
urc
e
Est
ablis
hed in
2005.
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
pro
ject
s.
Multip
le c
olle
ctio
n s
ites
and four
stora
ge n
odes
in four
Aust
ralia
n s
tate
s,
linke
d v
ia a
web-b
ased
dat
abas
e. A
t G
arva
n
node, f
acili
ties
shar
ed w
ith
bre
ast
and p
ancr
eat
ic
cance
r re
sear
ch g
roups.
Affi li
ated w
ith A
BN
but
not
a m
em
ber.
Routinely
store
fre
sh fro
zen n
orm
al
and c
ance
r tiss
ue, p
araf
fi n
em
bedded t
issu
e, f
roze
n
pla
sma,
seru
m, b
uff
y co
at,
ambie
nt
tem
pera
ture
whole
blo
od G
uth
rie
blo
ts. A
dditio
nal
pro
cess
es
on r
equest
incl
ude D
NA
and R
NA
extr
action. 1
x
-80C
fre
eze
r per
node.
So
me
acce
ss t
o li
quid
nitro
gen s
tora
ge.
Not
for
pro
fi t
org
anis
atio
n
curr
ently
funded b
y
NH
MR
C e
nab
ling
gran
t.
Fundin
g so
urc
es
hav
e
incl
uded P
rost
ate
Can
cer
Foundat
ion A
ust
ralia
,
Co
mm
onw
eal
th B
ank,
Andro
logy
Aust
ralia
,
NH
MR
C. 8
5%
funds
allo
cate
d t
o p
ers
onnel,
with r
em
ainder
to
equip
ment, m
ainte
nan
ce,
IT. C
urr
ent
fundin
g
expir
atio
n 2
009.
Gove
rned n
atio
nal
ly b
y
Exe
cutive
Co
mm
itte
e
consi
stin
g of Pro
fess
ori
al
Head
s of Pro
stat
e
Can
cer
Rese
arch
Gro
ups
at e
ach n
ode, w
ith
resp
onsi
bili
ty for
stra
tegi
c
dir
ect
ion. M
anag
ed b
y
nat
ional
Bio
Reso
urc
e
Man
agem
ent
Co
mm
itte
e
resp
onsi
ble
for
polic
ies
and p
roce
dure
s. A
nat
ional
Tis
sue
Ban
k C
oord
inat
ors
Co
mm
itte
e an
d lo
cal
tiss
ue
ban
k co
mm
itte
es
are
resp
onsi
ble
for
opera
tional
issu
es.
A
nat
ional
Bio
Reso
urc
e
Tis
sue
Acc
ess
Co
mm
itte
e
dete
rmin
es
scie
ntifi c
meri
t
and feas
ibili
ty o
f re
sear
ch
applic
atio
ns.
5 F
TE s
taff
(one
Stat
e C
oord
inat
or
at G
arva
n n
ode)
. Ban
k
perf
orm
ance
meas
ure
d
by
num
ber
of par
tici
pan
ts,
pro
port
ion d
onat
ing,
speci
mens
rele
ased t
o
rese
arch
ers
.
SOPs
for
pat
ient
conse
nt,
speci
men/d
ata
colle
ctio
n,
pro
cess
ing
and s
tora
ge.
Uro
logi
st a
ppro
aches
pat
ient
re t
issu
e
donat
ion. I
f ag
reed, S
tate
Coord
inat
or
pro
vides
info
rmat
ion a
nd c
onse
nts
pat
ient. 9
9%
succ
ess
rat
e.
Min
imum
pat
holo
gy a
nd
clin
ical
dat
a se
ts r
outinely
colle
cted a
nd s
tore
d
on w
eb-b
ased c
entr
al
dat
abas
e. A
dditio
nal
clin
ical
dat
a co
llect
ed
man
ual
ly. S
OPs
bas
ed
on e
xte
rnal
sourc
es
incl
udin
g IS
BER
, NC
I 2nd
genera
tion, O
EC
D T
issu
e
Ban
king
Best
Pra
ctic
e
Guid
elin
es.
Fre
eze
r units
alar
med a
nd m
onitore
d.
Speci
mens
div
ided a
nd
house
d s
epar
ately
. Tis
sues
his
tolo
gica
lly r
evi
ew
ed
pri
or
to r
ele
ase.
Rese
arch
er
Acc
ess
Polic
y
deve
loped u
sing
NH
MR
C
guid
elin
es
for
Tis
sue
Ban
ks
under
enab
ling
gran
ts.
Pri
ori
ty o
f ac
cess
to lo
cal
site
rese
arch
ers
, and n
o
acce
ss t
o c
om
merc
ial
org
anis
atio
ns.
Rese
arch
ers
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
ns,
pro
vide
ban
k w
ith c
opie
s
of public
atio
ns,
pro
vide
dat
a on s
peci
men
inte
grity,
retu
rn u
nuse
d
speci
mens
to b
ank.
The
need t
o “
mar
ket”
the
bio
reso
urc
e to
pote
ntial
rese
arch
ers
has
been
reco
gnis
ed t
o e
nsu
re u
se
of bio
speci
mens.
Only
50%
of st
ore
d m
ateri
al
fro
m a
ny
pat
ient
rele
ased
ove
r fi rs
t 5 y
ear
s. H
ad
a par
tial
cost
reco
very
syst
em
in p
lace
but
this
limited r
ese
arch
er
use
so
ceas
ed t
his in
2007.
Hav
e
since
had
14 r
equest
s,
all a
ppro
ved. S
peci
mens
acce
ssed: 1
2 m
icro
arra
ys
and 8
5 fro
zen t
issu
es.
No
public
atio
ns
aris
ing
fro
m
speci
men a
ccess
to d
ate.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
71
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
NSW
Pan
creat
ic C
ance
r
Netw
ork
Tis
sue
Ban
k
Est
ablis
hed in
2002.
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
and
speci
fi c
pro
ject
s. T
wo
colle
ctio
n a
nd s
tora
ge
site
s. S
om
e st
ora
ge
faci
litie
s sh
ared w
ith
oth
er
bio
ban
ks a
t G
arva
n.
Routinely
sto
re fre
sh
tiss
ue, p
araf
fi n b
lock
s,
extr
acte
d D
NA
and R
NA
.
Additio
nal
pro
cess
es
on r
equest
incl
ude d
ata
QA
, tis
sue
mic
roar
ray,
H&
E s
tain
s, IH
C. S
eve
ral
freeze
rs.
Not
for
pro
fi t
org
anis
atio
n.
Curr
ently
funded v
ia
Stra
tegi
c R
ese
arch
Par
tners
hip
Gra
nt
fro
m
Can
cer
Counci
l NSW
.
Inte
rnal
support
als
o.
Curr
ent
fundin
g expir
atio
n
201
0.
Gove
rned b
y Exe
cutive
Co
mm
itte
e of th
e
NSW
Pan
creat
ic
Can
cer
Netw
ork
whic
h
is in
dependent
of th
e
housi
ng
inst
itution. T
his
Co
mm
itte
e co
mpri
ses
Chie
f In
vest
igat
ors
fro
m
fi ve
Netw
ork
sites
plu
s
two o
ther
Netw
ork
staf
f, an
d is
resp
onsi
ble
for
stra
tegi
c dir
ect
ions
and s
cientifi c
revi
ew
of
rese
arch
er
applic
atio
ns.
10 F
TE s
taff (
inte
rnal
and e
xte
rnal
). B
ank
perf
orm
ance
meas
ure
d
by
speci
men n
um
bers
,
public
atio
ns
and
pre
senta
tions
aris
ing,
regu
lar
audits
of tiss
ue
request
s an
d a
ccess
.
SOPs
for
pat
ient
conse
nt,
speci
men a
nd d
ata
colle
ctio
n, p
roce
ssin
g
and s
tora
ge. P
atie
nts
conse
nte
d b
y N
SW
Pan
creat
ic C
ance
r
Netw
ork
sta
ff o
n s
ite.
Genera
l clin
ic-p
atholo
gica
l
info
rmat
ion c
olle
cted
incl
udin
g m
anag
em
ent,
medic
al h
isto
ry, o
utc
om
es.
Dat
abas
e lin
king
pat
holo
gy
and c
linic
al d
ata
desi
gned
in-h
ouse
. Dat
a lin
kage
with C
CR
for
notifi ca
tion
and c
ause
of deat
h. S
OPs
deve
loped in
tern
ally
to
meet
with in
stitution
and r
ese
arch
gro
up
speci
fi c
requir
em
ents
,
with s
om
e re
view
of N
CI
best
pra
ctic
e gu
idelin
es.
Freeze
rs a
larm
ed a
nd
monitore
d.
Form
al R
ese
arch
er
Acc
ess
Polic
y, w
ith a
ccess
rest
rict
ed t
o r
ese
arch
ers
who a
re p
art
of th
e N
SW
Pan
creat
ic R
ese
arch
Netw
ork
as
there
are
insu
ffi c
ient
tiss
ue
and s
taff
reso
urc
es
to a
llow
acc
ess
beyo
nd t
his
. Rese
arch
ers
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
ns,
pro
vided c
opie
s of
public
atio
ns
to b
ank,
retu
rn u
nuse
d s
peci
mens
to b
ank.
No c
har
ge t
o
rese
arch
ers
. Aro
und 6
request
s fo
r fr
esh
tis
sue
and 2
0 for
arch
ival
tis
sue
in la
st y
ear
, all
appro
ved. 6
public
atio
ns
aris
ing
in la
st
2 y
ear
s.
South
West
ern
Syd
ney
Colo
rect
al T
um
our
Ban
k,
Gar
van
Bega
n o
pera
tion in
2000.
Curr
ently
his
tori
cal
speci
mens
only
with n
o
furt
her
colle
ctio
n. E
thic
s
appro
val o
bta
ined for
speci
fi c
rese
arch
pro
ject
s
usi
ng
these
his
tori
cal
speci
mens.
All
speci
mens
were
fre
sh fro
zen a
nd
incl
ude n
orm
al a
nd c
ance
r
tiss
ue, b
lood. A
dditio
nal
pro
cess
es
on r
equest
incl
ude
RN
A. -
70C
fre
eze
r.
Curr
ently
funded
by
CI N
SW
Car
eer
Deve
lopm
ent
Fello
wsh
ip.
85%
funds
allo
cate
d t
o
pers
onnel a
nd 1
5%
to
genera
l mai
nte
nan
ce.
Curr
ent
fundin
g expir
atio
n
201
1.
No s
taff e
mplo
yed
by
the
ban
k. N
o b
ank
perf
orm
ance
meas
ure
s
(his
tori
cal s
peci
mens
only
).
Pat
ient
clin
ical
deta
ils
store
d in
Exc
el d
atab
ase
in p
assw
ord
pro
tect
ed
serv
er.
Stan
dar
d p
atholo
gy
dat
a is c
olle
cted, a
nd
surv
ival
dat
a co
llect
ed b
y
CC
R. E
thic
s ap
pro
val t
o
acce
ss t
his in
form
atio
n for
this c
ohort
of pat
ients
. No
additio
nal
follo
wup d
ata
colle
cted. F
reeze
r lo
cked
and a
larm
ed.
Rest
rict
ed r
ese
arch
er
acce
ss t
o c
olla
bora
tors
,
with jo
int
auth
ors
hip
in p
apers
. Rese
arch
ers
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
ns,
pro
vide
ban
k co
pie
s of
public
atio
ns,
retu
rn u
nuse
d
speci
mens
to b
ank.
No
speci
mens
acce
ssed in
last
12 m
onth
s w
ith u
nkn
ow
n
num
ber
pri
or
to t
his
. 2
public
atio
ns
aris
ing.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
72
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Kolli
ng
Inst
itute
Tis
sue
Ban
ks:
Bre
ast
Can
cer
Tis
sue
Ban
k
Neuro
-endocr
ine
Tis
sue
Ban
k
Upper
GI T
issu
e B
ank
Gyn
aeco
logy
Tis
sue
Ban
k
Bre
ast
and G
ynae
colo
gica
l
ban
ks e
stab
lished 2
003,
Endocr
ine
ban
k 19
92 a
nd
Upper
GI ban
k m
id 1
990s.
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
and
speci
fi c
pro
ject
s. M
ultip
le
colle
ctio
n (
mai
nly
loca
l
public
and p
riva
te
hosp
ital
s) a
nd s
ingl
e
stora
ge s
ite. F
our
bio
ban
ks
shar
e s
tora
ge fac
ilities
and
3 b
ioban
k st
aff.
Bre
ast,
Gyn
aec
and U
pper
GI
ban
ks r
outinely
sto
re
tum
our
and n
orm
al t
issu
e,
clott
ed b
lood, E
DTA
blo
od (
Bre
ast
& G
yn
only
). N
euro
-endocr
ine
routinely
sto
res
froze
n
tiss
ue
with m
atch
ed
blo
od s
ample
. Par
affi n
em
bedded g
liom
a sa
mple
s
also
sto
red. N
euro
ban
k
will
extr
act
DN
A a
nd
RN
A, a
nd c
ut
and m
ount
par
affi n s
peci
mens
on
request
. 2 -
80C
fre
eze
rs.
3 c
om
pute
rs.
Depar
tment
within
an in
stitution w
ith n
o
gove
rnm
ent
fundin
g. G
rant
fundin
g fo
r 3 b
ioban
k
staf
f fr
om
CI N
SW
(infr
astr
uct
ure
gra
nt)
,
Can
cer
Counci
l NSW
(Str
ategi
c par
tners
hip
gran
t) a
nd S
tate
Bre
ast
Can
cer
money.
90%
funds
allo
cate
d t
o p
ers
onnel,w
ith
rem
ainder
to e
quip
ment,
consu
mab
les
and IT.
Curr
ent
fundin
g expir
atio
n
201
1/12
.
Ban
ks a
re g
ove
rned b
y a
Tis
sue
Ban
k C
om
mit
tee
consi
stin
g of Pro
fess
ori
al
Head
or
repre
senta
tive
of eac
h T
issu
e B
ank.
Resp
onsi
ble
for
stra
tegi
c
deci
sio
ns.
Indiv
idual
Tis
sue
Ban
k co
mm
itte
es
are
resp
onsi
ble
for
scie
ntifi c
meri
t an
d for
deci
sions
rega
rdin
g sp
eci
mens,
with
expert
advi
ce s
ough
t as
requir
ed. 3
FT
E s
taff. B
ank
perf
orm
ance
meas
ure
d
by
num
ber
speci
mens
store
d, n
um
ber
speci
mens
acce
ssed, n
um
ber
of
public
atio
ns
and P
hD
student
com
ple
tions.
SOPs
for
pat
ient
conse
nt
slig
htly
diffe
rent
acro
ss
the
four
ban
ks. S
OPs
exis
t
for
speci
men c
olle
ctio
n,
pro
cess
ing
and s
tora
ge.
Pat
ients
conse
nte
d p
rior
to s
urg
ery
by
ban
k st
aff
or
surg
eon. P
atholo
gy
dat
a st
ore
d in
AC
CESS
dat
abas
e. N
o form
al li
nks
to c
linic
al d
atab
ase
yet
est
ablis
hed. S
OPs
for
eac
h b
ioban
k hav
e b
een
adva
nce
d s
epar
ately
but
movi
ng
tow
ards
an
ove
rall
stan
dar
d. I
nte
rnal
ly
deve
loped b
ut
usi
ng
exte
rnal
sourc
es
as a
guid
e
(i.e
. fro
m P
ete
r M
cCal
lum
).
Freeze
rs a
larm
ed a
nd
monitore
d.
Var
iations
in R
ese
arch
er
Acc
ess
Polic
y ac
ross
bio
ban
ks. S
om
e hav
e
form
al A
ccess
Form
s,
oth
ers
still
bas
ed o
n v
erb
al
request
(w
ith a
ppro
pri
ate
HR
EC
and s
cientifi c
appro
val). P
rio
rity
of
acce
ss t
o lo
cal r
ese
arch
ers
or
affi lia
tes
– n
o e
xte
rnal
no
n-a
ffi li
ated r
ese
arch
ers
hav
e re
quest
ed a
ccess
to
dat
e. R
ese
arch
ers
requir
ed
to a
cknow
ledge
ban
k
in p
ublic
atio
ns,
retu
rn
unuse
d s
peci
mens
to b
ank,
pro
vide
info
rmat
ion o
n
sam
ple
qual
ity.
No c
har
ge
to r
ese
arch
ers
. A c
opy
of an
y re
sultin
g ab
stra
cts
or
public
atio
ns
must
be
forw
arded t
o T
issu
e B
ank.
5-1
0 r
equest
s in
the
last
year
, all
appro
ved. O
ver
200 s
peci
mens
acce
ssed
ove
r la
st y
ear
, plu
s 10
7
Endocr
ine
speci
mens.
39 p
ublic
atio
ns
aris
ing
since
1995 (
excl
udin
g
Neuro
Endocr
ine)
, plu
s
appro
x 40 fro
m E
ndocr
ine
ban
k plu
s 15
PhD
com
ple
tions.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
73
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Aust
rala
sian
Bra
in T
um
our
Ban
k (K
olli
ng
Inst
itute
)
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
and
speci
fi c
pro
ject
s.
Expan
din
g to
multip
le
Aust
ralia
n c
olle
ctio
n s
ites
with s
ingl
e tiss
ue
stora
ge
site
(Kolli
ng
Inst
itute
) an
d
singl
e blo
od s
tora
ge s
ite
(WA
DN
A B
ank)
. Bio
ban
k
staf
f an
d fac
ilities
shar
ed
with four
bio
ban
ks a
t th
e
Kolli
ng
Inst
itute
. Affi li
atio
n
with A
GO
G a
nd W
AIM
R
to e
stab
lish n
atio
nal
bra
in
tum
our
bio
reso
urc
e.
Pla
nnin
g to
routinely
sto
re
fresh
fro
zen o
r par
affi n
blo
ck t
um
our
tiss
ue
and
whole
blo
od. A
dditio
nal
pro
cess
es
incl
ude
DN
A
and R
NA
extr
action,
par
affi n s
peci
men c
utt
ing
and m
ounting.
-80C
freeze
r. Liq
uid
nitro
gen
dew
ars.
Unit w
ithin
Neuro
-
endocr
ine
Tis
sue
Ban
k
at t
he
Kolli
ng
Inst
itute
.
Gra
nt
fundin
g fo
r bio
ban
k
staf
f (s
ee
oth
er
Kolli
ng
Tis
sue
Ban
ks a
bove
). P
lus
a co
llabora
tive
gra
nt
fro
m
Can
cer
Counci
l NSW
to
est
ablis
h n
atio
nal
bra
in
tum
our
bio
reso
urc
e
with W
AIM
R. 9
0%
funds
allo
cate
d t
o p
ers
onnel
and 1
0%
to m
ainte
nan
ce.
Curr
ent
fundin
g expir
atio
n
201
2.
No in
dependent
man
agem
ent
com
mit
tee
– fal
ls u
nder
the
Neuro
-
endocr
ine
Tis
sue
Ban
k
Co
mm
itte
e at
the
Kolli
ng
Inst
itute
. 0.2
FT
E p
lus
acce
ss t
o 0
.1 F
TE. B
ank
perf
orm
ance
meas
ure
d
by
num
bers
of sp
eci
mens,
public
atio
ns
aris
ing,
and
PhD
pro
ject
co
mple
tion.
SOPs
exis
t fo
r pat
ient
conse
nt
and s
peci
men
colle
ctio
n, p
roce
ssin
g
and s
tora
ge. P
atie
nts
are
conse
nte
d w
ith a
75%
succ
ess
rat
e by
neuro
surg
ical
nurs
e pri
or
to s
urg
ery
. Rem
ainin
g
25%
conse
nte
d p
ost
opera
tion p
rior
to
dis
char
ge. P
atholo
gy
dat
a st
ore
d in
AC
CESS
dat
abas
e on K
olli
ng
serv
er.
Tum
our
ban
k eth
ics
appro
val r
equir
es
that
clin
ical
dat
abas
e be
kept
separ
ate
fro
m p
atholo
gy
dat
abas
e. C
linic
al d
atab
ase
in d
eve
lopm
ent. T
he n
eed
for
a m
ore
sophis
tica
ted
syst
em
linki
ng
pat
holo
gy
and c
linic
al d
ata
has
been
reco
gnis
ed (
i.e. W
AIM
R
syst
em
). F
reeze
r al
arm
ed
and m
onitore
d. S
OPs
to m
ainta
in s
peci
men
inte
grity
duri
ng
pro
cess
ing
(ie s
o n
eve
r expose
d t
o
ambie
nt
tem
pera
ture
).
Hav
e e
ndeav
oure
d t
o u
se
NA
EF
fro
m N
SW
Heal
th
to fac
ilita
te r
ese
arch
er
acce
ss b
ut
hav
e had
diffi cu
lty
usi
ng
in W
A a
nd
hav
e had
co
mpla
ints
fro
m
rese
arch
ers
rega
rdin
g its
use
. Rese
arch
ers
requir
ed
to a
cknow
ledge
ban
k
in p
ublic
atio
n, p
rovi
de
public
atio
n c
opie
s to
ban
k, a
dvi
se o
n a
ny
sam
ple
unsu
itab
ility
. Only
requir
ed a
mount
give
n
to r
ese
arch
ers
as
unuse
d
speci
mens
may
bre
ach
SOPs
(ie
re s
peci
men
inte
grity
and s
tora
ge). N
o
char
ge t
o r
ese
arch
ers
.
Pla
nnin
g to
run lo
cal
info
rmat
ion s
ess
ions
to
rais
e b
ank
awar
eness
. 7
request
s fo
r sp
eci
mens
in la
st y
ear
, all
appro
ved.
Appro
x. 1
500 N
euro
speci
mens
acce
ssed fro
m
Neuro
Endocr
ine
Ban
k
(incl
udin
g A
BT
B)
in la
st
year
. 8 p
ublic
atio
ns
aris
ing
since
ince
ption.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
74
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Bre
ast
Can
cer
Tis
sue
Ban
k
(BC
TB), b
ased a
t W
MI
Est
ablis
hed 2
006.
Mem
ber
of A
BN
. Ban
king
for
unsp
eci
fi ed futu
re
rese
arch
pro
ject
s. M
ultip
le
colle
ctio
n a
nd s
tora
ge
site
s. A
t eac
h s
tora
ge
node, f
acili
ties
are s
har
ed
with o
ther
bio
ban
ks a
s
requir
ed (
i.e. s
har
ed
liquid
nitro
gen t
anks
).
Routine
stora
ge o
f FF
PE
with m
atch
ing
H&
E s
lide,
fresh
fro
zen c
ance
r an
d
adja
cent
no
rmal
tis
sue,
whole
blo
od, p
lasm
a,
seru
m, b
uff
y co
at, D
NA
,
dig
ital
imag
e of H
&E
tum
our
sect
ion. O
n
request
can
pro
vide
DN
A a
nd R
NA
isola
tion,
par
affi n e
mbedded
tum
our
sect
ions,
tum
our
cryo
sect
ions,
tis
sue
mic
roar
rays
. 5x
-80C
freeze
rs (
5 s
ites)
, 4x
vapour
phas
e nitro
gen
tanks
plu
s tr
ansp
ort
ship
pers
, refr
igera
ted
centr
ifuge
s, r
obotic
DN
A
extr
actio
n in
stru
ment.
Not
for
pro
fi t
org
anis
atio
n
with n
o g
ove
rnm
ent
fundin
g. F
unded v
ia
gran
ts c
urr
ently
fro
m
NH
MR
C, C
I N
SW
(fo
r
dat
a m
anag
em
ent
and
colle
ctio
n) a
nd N
BC
F.
Staf
f at
colle
ctio
n s
ites
em
plo
yed b
y lo
cal
inst
itution. 6
5%
funds
allo
cate
d t
o p
ers
onnel,
20%
equip
ment,
rem
ainder
to c
onsu
mab
les,
IT, o
ther.
Curr
ent
fundin
g
expir
atio
n 2
008/0
9.
Gove
rned b
y M
anag
em
ent
Gro
up c
onsi
stin
g of C
hie
f
Inve
stig
ators
of eac
h
pro
ject
. Under
this g
roup
is E
xecu
tive
Co
mm
itte
e
resp
onsi
ble
for
day
-
to-d
ay o
pera
tions
and
feas
ibili
ty o
f re
sear
cher
request
s. “
Arm
s-le
ngth
”
Advi
sory
Gro
up c
onsi
stin
g
of A
ust
ralia
n e
xpert
s in
fi eld
of bio
ban
king
and
rese
arch
pro
vides
advi
ce
on s
trat
egi
c dir
ect
ion
(within
conte
xt
of fu
ndin
g
agre
em
ents
), d
ispute
reso
lution, b
ioeth
ics
and
com
pla
ints
. Est
ablis
hin
g
a fo
rmal
sci
entifi c
revi
ew
pro
cess
for
rese
arch
ers
– c
urr
ently
seek
expert
advi
ce a
s re
quir
ed t
o
revi
ew
sci
entifi c
meri
t
of ap
plic
atio
ns.
9.6
FT
E
staf
f. B
ank
perf
orm
ance
meas
ure
d b
y sp
eci
mens
colle
cted a
nd a
ccess
ed,
speci
men q
ual
ity,
rese
arch
er
applic
atio
ns.
SOPs
for
pat
ient
conse
nt
bas
ed o
n in
div
idual
HR
EC
requir
em
ents
at
eac
h
hosp
ital
. Oth
er
SOPs
are
stan
dar
d a
cross
the
six
site
s an
d a
re a
dap
table
for
use
by
oth
er
Bio
ban
ks.
Pat
ients
are
usu
ally
conse
nte
d b
y nurs
e or
phys
icia
n e
ither
pre
or
post
opera
tive
ly, w
ith 9
9%
succ
ess
. SO
Ps
exis
t fo
r
speci
men a
nd c
linic
al d
ata
colle
ctio
n, p
roce
ssin
g an
d
stora
ge. C
linic
al h
isto
ry,
pat
holo
gy a
nd t
reat
ment
info
rmat
ion is
colle
cted
and e
nte
red in
to B
CT
B
dat
abas
e (s
ituat
ed o
n
serv
er
at m
anag
em
ent
hub, w
ith s
ite-s
peci
fi c
acce
ss). P
C a
nd d
ocu
ment
scan
ners
at
eac
h c
olle
ctio
n
site
. SO
Ps
were
deve
loped
bas
ed o
n N
CI,
OB
BR
Best
Pra
ctic
e G
uid
elin
es,
and ISB
ER
Best
Pra
ctic
e
Guid
elin
es.
Qual
ity
guid
elin
es
follo
win
g IS
BER
Best
Pra
ctic
es
adhere
d
to. A
ll st
ora
ge e
quip
ment
lock
ed, t
em
pera
ture
monitore
d a
nd a
larm
ed.
Tem
pera
ture
monitori
ng
of sh
ipped s
ample
s.
Speci
mens
div
ided a
nd
store
d s
epar
ately
. Uniq
ue
labelli
ng.
RN
A s
ample
s
qual
ity
test
ed p
rior
to
rele
ase.
Rese
arch
er
Acc
ess
Polic
y
avai
lable
fro
m w
ebsi
te.
Applic
atio
ns
acce
pte
d
fro
m a
ll A
ust
ralia
n
rese
arch
ers
with p
riori
ty
give
n t
o p
eer
revi
ew
ed
pro
ject
s an
d in
vest
igat
ors
asso
ciat
ed w
ith c
olle
ctio
n
centr
es
in p
roport
ion
to t
he
num
ber
of
speci
mens
colle
cted.
Co
mm
erc
ial a
pplic
ants
will
be
consi
dere
d o
nly
if
meri
tori
ous.
Rese
arch
ers
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
ns,
pro
vide
public
atio
ns
or
deta
ils t
o b
ank,
pro
vide
qual
ity
report
on s
ample
s.
Unuse
d s
peci
mens
not
retu
rned a
s sp
eci
men
inte
grity
cannot
be
guar
ante
ed. S
peci
men
avai
labili
ty c
an b
e se
arch
ed
via
web. R
ese
arch
ers
are
char
ged fre
ight
cost
s an
d
som
e ad
ditio
nal
char
ge
for
DN
A. P
lannin
g to
intr
oduce
additio
nal
cost
reco
very
fee
stru
cture
late
r th
is y
ear
. 5 s
peci
mens
supplie
d t
o r
ese
arch
ers
in p
ast
year
, with 6
5 in
pro
gress
. No p
ublic
atio
ns
aris
ing
to d
ate, a
s ban
k is
rela
tive
ly n
ew
.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
75
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
West
mead
Gyn
ae-
colo
gica
l Tis
sue
Ban
k
Est
ablis
hed 1
992/9
3.
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
pro
ject
s.
Sin
gle
colle
ctio
n a
nd
stora
ge s
ite. S
har
e
som
e st
ora
ge fac
ilities
with B
CT
B. N
o form
al
arra
nge
ment
to d
ate
to
shar
e s
taff d
ue
to d
iffe
rent
fundin
g so
urc
es.
Affi li
ated
with A
BN
. Routine
stora
ge o
f fr
esh
fro
zen
and p
araf
fi n e
mbedded
sam
ple
s. A
dditio
nal
pro
cess
es
on r
equest
incl
ude D
NA
and R
NA
extr
action, H
&E s
tain
ing.
Shar
ed -
80C
fre
eze
r.
2x
liquid
nitro
gen t
anks
,
shar
ed v
apour
phas
e
isoth
erm
al s
tora
ge.
Depar
tment
within
West
mead
Hosp
ital
,
Gyn
aeco
logi
c O
nco
logy
Gro
up. C
urr
ently
funded
by
NH
MR
C e
nab
ling
gran
t as
par
t of A
BN
, and
by
West
mead
Hosp
ital
Gyn
aeco
logi
c O
nco
logy
Dept. 9
0%
funds
allo
cate
d
to p
ers
onnel,
10%
to
equip
ment. C
urr
ent
fundin
g expir
atio
n 2
009.
Gove
rned b
y T
issu
e
Ban
k C
om
mit
tee
whic
h
com
pri
ses
clin
icia
ns,
surg
eons,
sci
entist
s an
d
consu
mer
repre
senta
tive
s.
This c
om
mit
tee
is
resp
onsi
ble
for
the
stra
tegi
c dir
ect
ion o
f
the
ban
k an
d p
rovi
des
scie
ntifi c
advi
ce o
n p
roje
ct
applic
atio
ns,
with o
ther
expert
advi
ce s
ough
t
as r
equir
ed. 1
x 0.6
FT
E
staf
f. B
ank
perf
orm
ance
meas
ure
d b
y num
ber
speci
mens
store
d,
speci
mens
acce
ssed b
y
rese
arch
ers
, clin
ical
follo
w-
ups
and p
aths
revi
ew
ed,
tiss
ues
pro
cess
ed,
public
atio
ns
resu
ltin
g,
clin
ical
tri
als
support
ed
and s
ample
s co
llect
ed for
clin
ical
tri
als.
SOPs
for
pat
ient
conse
nt,
speci
men a
nd d
ata
colle
ctio
n, p
roce
ssin
g an
d
stora
ge a
nd r
ese
arch
er
acce
ss. P
atie
nt
conse
nte
d
pri
or
to s
urg
ery
then p
ost
surg
ery
for
“Mole
cula
r
Bio
logy
of G
ynae
colo
gic
Dis
eas
e”, w
ith 1
00%
succ
ess
. Speci
mens
colle
cted p
ost
NH
MR
C
gran
t fu
ndin
g fr
om
AB
N
are
store
d o
nsi
te in
AB
N s
peci
men lo
cato
r
dat
abas
e. A
imin
g to
hav
e
all s
peci
mens
put
on A
BN
speci
men lo
cato
r dat
abas
e
in futu
re (
incl
udin
g th
ose
colle
cted p
rior
to g
rant)
. A
more
sophis
tica
ted s
yste
m
for
linki
ng
pat
holo
gy a
nd
clin
ical
follo
w-u
p d
atab
ases
would
be
welc
om
ed.
Curr
ently
clin
ical
follo
w-u
p
dat
a co
llect
ed m
anual
ly
fro
m D
epar
tmenta
l
and H
osp
ital
Medic
al
Reco
rds.
SO
Ps
were
inte
rnal
ly d
eve
loped a
nd
are
regu
larl
y as
sess
ed a
nd
updat
ed. L
oca
l SO
Ps
were
use
d t
o d
eve
lop S
OPs
for
AB
N. F
reeze
r an
d
isoth
erm
al lo
cked, a
larm
ed
and m
onitore
d. L
iquid
nitro
gen d
ew
ars
in lo
cked,
alar
med la
bora
tory
and
leve
ls c
heck
ed.
Acc
ess
ava
ilable
to A
ust
ralia
n a
nd
inte
rnat
ional
rese
arch
ers
,
who o
ften c
olla
bora
te
loca
lly. R
ese
arch
ers
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
ns,
and p
rovi
de
copie
s or
refe
rence
deta
ils t
o
ban
k. U
nuse
d s
peci
mens
are
not
retu
rned t
o
ban
k. R
ese
arch
ers
genera
lly fi n
d o
ut
about
ban
k th
rough
word
of
mouth
, confe
rence
s an
d
public
atio
ns.
Rese
arch
ers
are
char
ged fre
ight
cost
s,
with o
ther
cost
reco
very
char
ges
bein
g pro
ject
dependent. F
or
exam
ple
,
if th
e pro
ject
has
gra
nt
fundin
g fo
r bio
ban
king,
will
char
ge r
ese
arch
er
acco
rdin
gly.
2 n
ew
and
2 o
ngo
ing
request
s th
is
year
, all
appro
ved. O
ver
the
pas
t 12
month
s, 5
04
sam
ple
s ac
cess
ed b
y
rese
arch
ers
(in
cludin
g
sect
ions
froze
n, fi
xed,
RN
A, D
NA
). 1
,094
sam
ple
s ac
cess
ed s
ince
tiss
ue
ban
k in
ception.
Appro
xim
ately
23
public
atio
ns
aris
ing.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
76
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Child
ren’s H
osp
ital
West
mead
Pae
dia
tric
Tum
our
Ban
k
Est
ablis
hed 1
998. F
oundin
g
and c
urr
ent
mem
ber
of A
BN
. Ban
king
for
unsp
eci
fi ed futu
re r
ese
arch
and s
peci
fi c
pro
ject
s.
Has
als
o e
stab
lished
a Pat
holo
gy S
upport
Lab
ora
tory
pro
vidin
g
rese
arch
ori
ente
d t
issu
e
han
dlin
g expert
ise
to
scie
ntist
s as
soci
ated w
ith
the
bio
ban
k. Info
rmal
rese
arch
netw
ork
s w
ith
nat
ional
and in
tern
atio
nal
rese
arch
gro
ups.
Sin
gle
colle
ctio
n a
nd s
tora
ge
site
. Routine
stora
ge o
f
peri
phera
l blo
od (
froze
n
whole
), b
one
mar
row
aspir
ates
(fro
zen)
and
slid
es,
solid
tum
our
bio
psi
es
fresh
fro
zen a
nd
FFPE. A
dditio
nal
pro
cess
es
on r
equest
incl
ude D
NA
and R
NA
extr
action,
tiss
ue
em
beddin
g an
d
mounting,
mic
roar
rays
.
-80C
fre
eze
r, m
anual
tiss
ue
arra
yer,
stai
nin
g
stat
ion.
Par
t of th
e O
nco
logy
Depar
tment
within
hosp
ital
. Curr
ently
funded
by
Depar
tment
of H
eal
th,
benefa
cto
r fu
ndin
g, a
nd
gran
t fu
ndin
g (C
I N
SW
infr
astr
uct
ure
gra
nt
and
NH
MR
C e
nab
ling
gran
t
via
AB
N). 7
0%
fundin
g
allo
cate
d t
o p
ers
onnel,
20%
equip
ment
and r
est
to IT
and m
ainte
nan
ce.
Curr
ent
fundin
g expir
atio
n
2009.
Man
aged b
y B
ioban
k
Co
mm
itte
e w
hic
h is
under
the
gove
rnan
ce o
f th
e
Onco
logy
Rese
arch
Unit,
Onco
logy
Depar
tment
and R
ese
arch
Div
isio
n o
f
the
hosp
ital
. The
Bio
ban
k
Co
mm
itte
e co
mpri
ses
clin
ical
and r
ese
arch
expert
s an
d a
long
with
the
Onco
logy
Rese
arch
Unit a
nd O
nco
logy
Depar
tment, is
resp
onsi
ble
for
the
stra
tegi
c dir
ect
ion
of th
e ban
k. 4
.5 F
TE
staf
f. B
ank
perf
orm
ance
meas
ure
d b
y publis
hed
pap
ers
in in
tern
atio
nal
ly
peer
revi
ew
journ
als.
Deve
loped in
stitute
speci
fi c
SOPs
in li
ne
with t
hose
for
AB
N
(ava
ilable
to d
ow
nlo
ad
fro
m A
BN
websi
te).
These
hav
e d
eve
loped
ove
r tim
e an
d a
re
curr
ently
bein
g updat
ed.
Pat
ients
conse
nte
d v
ia
dir
ect
consu
ltat
ion w
ith
par
ents
/guar
dia
n follo
win
g
colle
ctio
n o
f bio
psy
, blo
od
or
bone
mar
row
asp
irat
e
for
dia
gnost
ic p
urp
ose
s.
Clin
ical
, pat
holo
gy a
nd
long
term
follo
w-u
p d
ata
colle
cted b
y O
nco
logy
Dept, a
nd a
vaila
ble
to
tum
our
ban
k on r
equest
.
Bio
ban
k dat
abas
e co
nta
ins
bas
ic d
em
ogr
aphic
info
rmat
ion b
ut
is n
ot
linke
d t
o c
linic
al d
atab
ase
store
d in
Onco
logy
Depar
tment. A
more
sophis
tica
ted s
yste
m t
o
link
dat
abas
es
would
be
welc
om
ed for
rese
arch
,
alth
ough
may
need t
o b
e
tailo
red t
o p
aedia
tric
s /
multip
le t
um
our
types.
One
com
pute
r house
s th
e
tum
our
ban
k dat
abas
e.
Freeze
r m
onitore
d a
nd
alar
med, w
ith p
ager
carr
ied a
t al
l tim
es.
Liq
uid
CO
2 in
ject
ion s
yste
m for
bac
k up a
nd fre
eze
r fa
ilure
.
Rese
arch
er
Acc
ess
Applic
atio
n v
ia t
he
CH
W
Tum
our
Ban
k w
ebsi
te.
Open t
o a
ll nat
ional
and
inte
rnat
ional
rese
arch
ers
with a
ppro
pri
ate
eth
ics
appro
val a
nd
dem
onst
rate
d s
cientifi c
valid
ity.
Rese
arch
ers
requir
ed t
o a
cknow
ledge
tum
our
ban
k an
d
auth
ors
hip
in p
ublic
atio
n,
pro
vide
ban
k co
pie
s of
public
atio
n, r
etu
rn u
nuse
d
speci
mens
to b
ank.
Bio
ban
k ac
tive
ly p
rom
ote
s
itse
lf to
rese
arch
ers
by
conta
ctin
g dir
ect
ly.
Occ
asio
nal
ly r
ese
arch
ers
fi nd s
peci
mens
via
AB
N
or
CH
W T
um
our
Ban
k
websi
te. C
urr
ently
only
char
ges
rese
arch
ers
fre
ight
cost
s. A
round 1
0 r
equest
s
in la
st y
ear
, all
but
one
appro
ved. 7
15 s
peci
mens
acce
ssed in
pas
t ye
ar,
and 1
,500 s
ince
tis
sue
ban
k in
ception. O
ver
24
public
atio
ns
aris
ing
in
inte
rnat
ional
ly p
eer
revi
ew
journ
als.
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
77
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Child
ren’s C
ance
r In
stitute
Aust
ralia
(C
CIA
) Tum
our
Ban
k
Est
ablis
hed 2
000.
Ban
king
for
unsp
eci
fi ed
rese
arch
and fro
m
seve
ral h
osp
ital
s as
par
t
of a
clin
ical
tri
al (
sam
ple
s
kept
afte
r pro
cess
ing
and a
nal
ysin
g fo
r m
inim
al
resi
dual
dis
eas
e). M
ultip
le
colle
ctio
n a
nd s
ingl
e
stora
ge s
ite. R
outinely
sto
re fi c
olle
d b
one
mar
row
or
whole
blo
od.
On r
equest
can
undert
ake
DN
A e
xtr
action. 2
x -8
0C
freeze
rs, 2
x cr
yoplu
s 3,
besp
oke
dat
abas
e an
d 3
com
pute
rs.
Unit w
ithin
a n
ot
for
pro
fi t
org
anis
atio
n
without
gove
rnm
ent
fundin
g. F
unded b
y C
CIA
.
90%
fundin
g al
loca
ted
to p
ers
onnel,
10%
consu
mab
les.
Bio
ban
k M
anag
em
ent
Co
mm
itte
e co
mpri
sed
of se
nio
r C
CIA
sci
entist
s
(clin
icia
ns
and n
on-
clin
icia
ns)
resp
onsi
ble
for
ban
k go
vern
ance
incl
udin
g
sett
ing
stra
tegi
c dir
ect
ion.
2.6
FT
E s
taff. B
ank
perf
orm
ance
is m
eas
ure
d
by
staf
f ap
pra
isal
aga
inst
posi
tions
desc
riptions
and
goal
s fo
r ye
ar.
SOPs
for
pat
ient
conse
nt
and s
peci
men c
olle
ctio
n,
pro
cess
ing
and s
tora
ge.
Most
pat
ients
conse
nte
d
as p
art
of cl
inic
al t
rial
s.
Non-t
rial
pat
ients
conse
nte
d b
y doct
or
with
~70%
succ
ess
. Routine
clin
ical
info
rmat
ion s
tore
d
incl
udes
fi rs
t an
d s
urn
ame,
sex, D
OB
, dia
gnosi
s dat
e,
hosp
ital
, refe
rrin
g doct
or,
dia
gnosi
s an
d p
rim
ary
site
.
Lim
ited c
linic
al follo
w-u
p
dat
a co
llect
ed a
nd e
nte
red
man
ual
ly (
ie d
ate
and s
ite
of re
lapse
, dat
e of deat
h).
SOPs
inte
rnal
ly d
eve
loped.
Freeze
r lo
cked w
ith
secu
rity
acc
ess
. Dat
abas
e
secu
re a
nd r
egu
larl
y
check
ed v
s sa
mple
s in
freeze
r.
Rese
arch
er
Acc
ess
Polic
y,
with a
ccess
rest
rict
ed
acco
rdin
g to
pat
ient
conse
nt
(i.e
. rest
rict
ed t
o
use
in c
hild
ren’s c
ance
r
rese
arch
). R
ese
arch
ers
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
ns,
pro
vide
copie
s to
ban
k,
retu
rn u
nuse
d s
peci
mens
to b
ank.
Rese
arch
ers
lear
n o
f bio
ban
k by
word
of m
outh
or
experi
ence
with C
CIA
. No c
har
ge t
o
rese
arch
ers
. 5 r
equest
s
in la
st y
ear
outs
ide
clin
ical
tri
als,
all
appro
ved.
Public
atio
ns
aris
ing
not
reco
rded, b
ut
star
ting
to
captu
re t
his in
form
atio
n.
Surg
ical
Onco
logy
Gro
up
Sar
com
a Tum
our
Ban
k,
Pri
nce
of W
ales
Hosp
ital
Est
ablis
hed 2
000.
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
and
speci
fi c
pro
ject
s. M
ultip
le
colle
ctio
n a
nd s
ingl
e
stora
ge s
ite. R
outine
stora
ge o
f fr
esh
tum
our
tiss
ue. L
arge
fre
eze
r
in O
nco
logy
Rese
arch
Centr
e.
Depar
tment
within
a
hosp
ital
, with n
o e
xte
rnal
fundin
g.
Man
aged b
y tw
o
pro
fess
ori
al s
taff
resp
onsi
ble
for
the
Onco
logy
Depar
tment
fro
m w
hic
h a
lmost
all
sam
ple
s ar
e co
llect
ed.
Eth
ics
appro
val f
or
ban
k
pro
vided b
y SESIH
S Eth
ics
Co
mm
itte
e.
Deve
lopin
g
a nat
ional
netw
ork
via
the
Aust
ralia
n S
arco
ma
Study
Gro
up. N
o s
taff e
mplo
yed
by
the
ban
k.
SOPs
for
pat
ient
conse
nt
and s
peci
men c
olle
ctio
n,
pro
cess
ing
and s
tora
ge.
Pat
ient
conse
nt
form
s
incl
uded in
Adm
issi
on
Form
. Routine c
linic
al
info
rmat
ion in
cludes
dem
ogr
aphic
, tum
our
and
treat
ment
char
acte
rist
ics,
outc
om
es.
Sam
ple
s an
d
dat
a lin
ked v
ia M
RN
and s
urn
ame. D
atab
ase
updat
ed a
fter
pat
ient
visi
ts w
ith a
nnual
revi
ew
of outc
om
es.
SO
Ps
deve
loped in
tern
ally
usi
ng
som
e exte
rnal
sta
ndar
ds.
No q
ual
ity
contr
ol
meas
ure
s cu
rrently
in
pla
ce t
o e
nsu
re s
peci
men
inte
grity.
Sar
com
a re
sear
chers
know
n w
ithin
Aust
ralia
.
Rese
arch
ers
are
not
requir
ed t
o a
cknow
ledge
ban
k in
public
atio
n b
ut
are
requir
ed t
o p
rovi
de
copie
s
to b
ank.
One
request
for
sam
ple
s in
last
12 m
onth
s,
appro
ved. 8
speci
mens
acce
ssed in
pas
t ye
ar, a
nd
15 s
ince
ban
k in
ception. 3
public
atio
ns
aris
ing
(ow
n
work
).
Tab
le 9
.3
Design
and G
ove
rnan
ce F
indin
gs for
Eac
h B
ioban
k In
terv
iew
ed a
nd/o
r Surv
eyed (
cont’d)
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
78
Bio
bank
Nam
eB
ioba
nk D
esig
nEn
tity
Sta
tus
and
Fund
ing
Sour
ces
Org
anis
atio
nal S
truc
ture
Stan
dard
Ope
ratin
g Pr
oced
ures
Res
earc
her
Acc
ess
Colo
rect
al C
ance
r T
issu
e
Ban
k, Inte
grat
ed C
ance
r
Rese
arch
UN
SW
Est
ablis
hed 1
993.
Est
ablis
hed for
labora
tory
rese
arch
purp
ose
s, w
ith
bro
ad c
onse
nt
obta
ined
for
futu
re u
nsp
eci
fi ed
rese
arch
pro
ject
s. S
ingl
e
colle
ctio
n a
nd s
tora
ge s
ite.
Routine
stora
ge o
f ca
nce
r
and n
orm
al t
issu
e an
d
blo
od p
roduct
s. A
dditio
nal
pro
cess
es
incl
ude
DN
A
and R
NA
extr
action.
Genera
l lab
ora
tory
fundin
g, n
o e
xte
rnal
fundin
g.
Eth
ics
appro
val f
or
ban
king
and s
tudie
s vi
a St
Vin
cent’s
Hosp
ital
Eth
ics
Co
mm
itte
e (c
olle
ctio
n
site
). L
abora
tory
Head
resp
onsi
ble
for
stra
tegi
c
dir
ect
ion o
f ban
k. F
orm
al
agre
em
ent
with A
BN
to
send e
xcess
sam
ple
s to
West
mead
Gyn
aeco
logi
cal
Tis
sue
Ban
k.
SOPs
for
pat
ient
conse
nt
and s
peci
men c
olle
ctio
n,
pro
cess
ing
and s
tora
ge.
Pat
ients
conse
nte
d b
y
clin
ical
nurs
e w
ho a
lso
colle
cts
speci
mens
and
ente
rs d
atab
ase
deta
ils.
SOPs
inte
rnal
ly d
eve
loped
ove
r la
st 1
5 y
ear
s of ban
k
opera
tio
n. I
nte
rnal
ly
deve
loped d
atab
ase
to
link
speci
mens
to d
ata.
In t
he
pro
cess
of lin
king
with B
ioG
rid d
ata
linka
ge
syst
em
.
Rest
rict
ed a
ccess
to
loca
l rese
arch
ers
or
colla
bora
tors
.
Bra
in T
um
our
Ban
k, P
rince
of W
ales
Pri
vate
Hosp
ital
Ban
king
for
unsp
eci
fi ed
futu
re r
ese
arch
. Sin
gle
colle
ctio
n a
nd s
tora
ge
site
. Routinely
sto
re fre
sh
froze
n t
issu
e. A
dditio
nal
speci
mens
can in
clude
peri
phera
l blo
od. -
80C
freeze
r.
Depar
tment
within
hosp
ital
. So
me
char
itab
le
funds
(for
purc
has
e of
freeze
r).
Eth
ics
appro
val f
or
ban
k
via
Pri
nce
of W
ales
Pri
vate
Eth
ics
Co
mm
itte
e. N
o
FT
E s
taff e
mplo
yed b
y th
e
ban
k.
Pat
ients
conse
nte
d u
sing
stan
dar
d h
osp
ital
conse
nt
form
. Clin
ical
dem
ogr
aphic
dat
a o
nly
obta
ined.
Freeze
rs a
larm
ed a
nd
monitore
d.
No m
arke
ting
of ban
k or
rese
arch
er
request
s to
dat
e, a
lthough
acc
ess
is
not
rest
rict
ed.
The C
ance
r C
ounci
l NSW
Tis
sue
Ban
k*
Ban
king
for
speci
fi ed
rese
arch
pro
ject
s, b
ut
with c
onse
nt
to c
onduct
unsp
eci
fi ed futu
re
rese
arch
fro
m p
artici
pan
ts
in o
ne
study.
Routinely
store
blo
od d
eri
vative
s
incl
udin
g pla
sma,
seru
m,
buff
y co
at. A
dditio
nal
pro
cess
es
on r
equest
not
yet
dete
rmin
ed. 2
x -8
0C
freeze
rs.
Inte
rnal
fundin
g only
.
50%
fundin
g al
loca
ted t
o
pers
onnel,
40%
equip
ment
and 1
0%
IT
reso
urc
es.
Sin
gle-s
ite
multi-ce
ntr
e
eth
ics
appro
val f
rom
St V
ince
nt’s
Hosp
ital
,
plu
s eth
ics
appro
vals a
t
par
tici
pat
ing
site
s. 0
.5 F
TE
staf
f. B
ank
perf
orm
ance
curr
ently
meas
ure
d b
y
num
ber
of sp
eci
mens
sto
red (
curr
ently
colle
cted
only
as
par
t of ongo
ing
studie
s).
Pat
ients
conse
nte
d in
vari
ous
way
s in
cludin
g
hosp
ital
sett
ings
, Can
cer
Counci
l Netw
ork
s, C
linic
al
Can
cer
Regi
stri
es.
Clin
ical
dat
a co
llect
ed v
ia p
atie
nt
quest
ionnai
re. L
inks
to
oth
er
sourc
es
pla
nned
for
late
r in
the
study.
Additio
nal
dat
a lin
kage
via
CH
eR
eL. Q
ual
ity
contr
ol
as p
er
Dept
Medic
al
Onco
logy
, St
Vin
cent’s
Hosp
ital
.
Speci
mens
are n
ot
yet
avai
lable
for
exte
rnal
rese
arch
er
acce
ss.
*T
he
Can
cer
Counci
l NSW
undert
oo
k th
e s
peci
men s
urv
ey
and P
has
e 2
Exte
nded s
urv
ey
only
, so s
om
e dat
a ar
e u
nav
aila
ble
.
Tab
le 9
.3
Design
and G
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eyed (
cont’d)
79
Abbreviations
ABN Australasian Biospecimens Network (Aus)
AGOG Australian Genomics and Clinical Outcomes of High Grade Glioma
APCC Australian Prostate Cancer Collaboration
BCTB Breast Cancer Tissue Bank (Westmead Millennium Institute)
CAPCA Canadian Association of Provincial Cancer Agencies
CBCTR Cooperative Breast Cancer Tissue Resource (US)
CCB Confederation of Cancer Biobanks (UK)
CCIA Children’s Cancer Institute Australia for Medical Research
CCR Clinical Cancer Registry
CEO Chief Executive Offi cer
CHeReL Centre for Health Record Linkage
CHTN Cooperative Human Tissue Network (US)
CHW Children’s Hospital Westmead
CIHR Canadian Institutes of Health Research
CI NSW Cancer Institute NSW
CSO Chief Scientist Offi ce (Scotland)
CTRN Canadian Tumour Repository Network
EDRN Early Detection Research Network (US)
FFPE Fresh Frozen Paraffi n Embedded
FTE Full Time Equivalent
H&E Haematoxylin and Eosin staining
HMA Healthcare Management Advisors
ISBER International Society for Biological and Environmental Repositories
kConFab Kathleen Cuningham Foundation Consortium for research into Familial Breast Cancer
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
80
MASCRI Melanoma and Skin Cancer Research Institute
NBCF National Breast Cancer Foundation
NBN National Biospecimen Network (US)
NCI National Cancer Institute (US)
NCRI National Cancer Research Institute (UK)
NEAF National Ethics Application Form
NHMRC National Health and Medical Research Council
OBBR Offi ce of Biorepositories and Biospecimen Research (US)
OECD Organisation for Economic Cooperation and Development
QIMR Queensland Institute of Medical Research
RNSH Royal North Shore Hospital
RNS Private Royal North Shore Private Hospital
RPAH Royal Prince Alfred Hospital
SMU Sydney Melanoma Unit
SOP Standard Operating Procedures
SPORE Specialise Program of Research Excellence
UNSW University of New South Wales
USMCI BSN US Military Cancer Institute Biospecimen Network
VCB Victorian Cancer Biobank
WAIMR West Australian Institute for Medical Research
WMI Westmead Millennium Institute for Medical Research
81
References
Personal Correspondence – Peter Geary, CEO 1.
Canadian Tumour Repository Network (Jan 2009).
http://gemstudy.org/main/index.html (accessed Feb 2.
2009).
Mann et. al. (2006) Analysis of cancer risk and BRCA1 3.
and BRCA2 mutation prevalence in the kConFab familial
breast cancer resource. Breast Cancer Research 8(1):
R12.
The Human Genome Project http://www.ornl.gov/sci/4.
techresources/Human_Genome/home.shtml accessed
(accessed Feb 2009).
Welberry H, Edwards C, Weston A, Harvey C, Wilson 5.
CS, Böll SK, Lo M and Bishop JF. Cancer Research in NSW
2001–2006. Sydney: Cancer Institute NSW, March 2008.
Beishon M. 6. How Europe is taking on the big biobank
challenge. Cancer World: Drug Watch. May/June 2008:
20–26.
Catchpoole D, deFazio A, Devereux L, Fleming M, Hof 7.
M, Schmidt C, Thourne H, Zeps N. The importance
of biorepository networks: the Australian Biospecimen
Network – Oncology. Australian Journal of Medical
Science, Feb 2007. 28(1): 16–20.
National Biospecimen Network Blueprint, Andrew 8.
Friede, Ruth Grossman, Rachel Hunt, Rose Maria Li, and
Susan Stern, eds. (Constella Group, Inc., Durham, NC)
2003.
OnCore UK website, http://www.oncoreuk.org/index.9.
html (accessed May 2008).
Cooperative Human Tissue Network website, http://10.
chtn.nci.nih.gov/ (accessed May 2008).
Early Detection Research Network website, http://edrn.11.
nci.nih.gov/ (accessed May 2008).
Cooperative Breast Cancer Tissue Resource website, 12.
http://cbctr.nci.nih.gov/ (accessed May 2008).
Canadian Tumour Repository Network website, https://13.
www.ctrnet.ca/ (accessed May 2008).
Generation Scotland website, http://129.215.140.49/gs/14.
index.html (accessed May 2008).
Generation Scotland website, Projects page. 15.
http://129.215.140.49/gs/21cgh.htm (accessed May 2008).
Generation Scotland website, Projects page 16.
http://129.215.140.49/gs/SFHS.htm (accessed May 2008).
Spanish National Cancer Research Centre website, 17.
National Health System Support Services: Tumour Bank
page: http://www.cnio.es/ing/programas/progTumor01.
asp (accessed September 2008).
Spanish National Cancer Research Centre website, 18.
About the CNIO page, http://www.cnio.es/ing/about/
antecedentes.asp (accessed September 2008).
BioResource-Med webpage, Genome Austria Tissue 19.
Bank (GATiB) page: http://bioresource-med.at/
(accessed September 2008).
Genome Research in Austria website, the programme 20.
page: http://www.gen-au.at/content_index.
jsp?base=foerdern&lang=en (accessed September 2008).
Bioserve website, http://www.bioserve.com/company/21.
companyOverview.cfm (accessed May 2008).
Asterand website, http://www.asterand.com/Asterand/22.
index.htm (accessed May 2008).
HealthCare IT website http://www.ardais.com/index.23.
html (accessed September 2008).
Prostate SPORE National Biospecimen Network Pilot 24.
website, http://prostatenbnpilot.nci.nih.gov/default.asp
(accessed May 2008).
National Cancer Institute, Offi ce of Biorepositories 25.
and Biospecimen Research website: Frequently asked
questions: http://biospecimens.cancer.gov/basics/faqs/
(accessed May 2008).
Biobank Ireland Trust website: http://biobankireland.com/26.
default.aspx (accessed September 2008).
UK Biobank website: http://www.ukbiobank.ac.uk/ 27.
(accessed May 2008).
A Comprehensive Review of Cancer-Related Biobanks in New South Wales
82
Ontario Tumour Bank website, http://www.28.
ontariotumourbank.ca/?gclid=CNDn48aJuZMCFRGYggo
dIUdZBg (accessed September 2008).
The Confederation of Cancer Biobanks website, http://29.
www.ncri.org.uk/ccb/index.html (accessed May 2008).
National Cancer Institute website, Offi ce of 30.
Biorepositories and Biospecimen Research page, http://
biospecimens.cancer.gov/ (accessed May 2008).
The Australasian Biospecimens Network website, http://31.
www.abrn.net/default.htm (accessed May 2008).
NCI Specimen Resource Locator website, http://pluto3.32.
nci.nih.gov/tissue/default.cfm (accessed May 2008).
Confederation of Cancer Biobanks website, Biosample 33.
Search Portal page, http://www.walescancerbank.com/
explorer/ccb.php (accessed May 2008).
Australasian Biospecimens Network website, Tissue 34.
Specimen Locator page, http://www.abrn.net/AbnWeb/
OncologySearchPage.aspx (accessed May 2008).
Dan Catchpoole, Tissue Bank Manager, Children’s 35.
Hospital at Westmead. Personal Correspondence,
October 2008.
Standards Australia AS 8000-2003, Australian 36.
StandardTM Good Governance Principles. Prepared
by Committee MB-004, Business Governance for the
Council of Standards Australia, June 2003.
Dr Nikolajs Zeps, Researcher: St John of God Pathology: 37.
Radiation Oncology, Sir Charles Gairdner Hospital;
School of Surgery, University of Western Australia; and
Notre Dame medical school. Personal Correspondence,
October 2008.
St John of God Pathology website: http://www.sjog.38.
org.au/portal/page?_pageid=454,1&_dad=portal&_
schema=PORTAL&p_division= (accessed September
2008).
Grizzle W, Sexton K and Bell W. Quality Assurance in 39.
Tissue Resourcing supporting Biomedical Research. Cell
Preservation Technology. 2008. 6: 113–118.
Western Australian Genetic Epidemiology Resource 40.
webpage: http://www.wager.org.au/home.html (accessed
September 2008).
Paul White, Manager WAGER. Personal 41.
Correspondence, October 2008.
Western Australian Data Linkage Information website, 42.
Facts and Questions page: http://www.datalinkage-
wa.org/go/data-linkage/facts-and-questions (accessed
September 2008).
BioGrid Australia webpage: http://www.biogrid.org.au/43.
pages/index.php (accessed May 2008).
Centre for Health Record Linkage (CHeReL) website: 44.
http://www.cherel.org.au/about_Us.html (accessed
May 2008).
http://www.isber.org/Pubs/BestPractices2008.pdf 45.
(accessed May 2008).
http://biospecimens.cancer.gov/global/pdfs/NCI_Best_46.
Practices_060507.pdf (accessed May 2008).
http://www.abrn.net/pdf/ABN_SOPs_Review_Mar07_47.
fi nal.pdf (accessed May 2008).
National Health and Medical Research Council 48.
(NHMRC), the Australian Research Council and the
Australian Vice-Chancellors’ Committee. National
Statement on Ethical Conduct in Human Research.
Australian Government. 2007. Section 2.2.14.
National Health and Medical Research Council 49.
(NHMRC), the Australian Research Council and the
Australian Vice-Chancellors’ Committee. National
Statement on Ethical Conduct in Human Research.
Australian Government. 2007. Section 3.2.
Eisman, Bloom, Brower et al, Case Studies of Existing 50.
Human Tissue Repositories, ‘Best Practices’ for a
biospecimen resource for the genomic and proteomic
era. Prepared for the National Cancer Institute National
Dialogue on Cancer. Published by Rand, 2003.
Confederation of Cancer Biobanks, Human Research 51.
Tissue Banks/ Resources / Biobanks Guiding Principles.
http://www.ncri.org.uk/includes/What_We_Do/facilities/
CCBDocs/Principles.pdf (accessed May 2008).
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