Article

Biobanking past, present and future: Responsibilities and benefits

University of California, San Francisco, San Francisco, California, United States
AIDS (London, England) (Impact Factor: 5.55). 11/2012; 27(3). DOI: 10.1097/QAD.0b013e32835c1244
Source: PubMed
ABSTRACT
This review explores the field of biobanking as it has evolved from a simple collection of frozen specimens to the virtual biobank. Biorepository and biospecimen science has evolved in response to the changing landscape of external regulatory pressures, the advances made in the biological sciences, and the advent of the computer chip. Biospecimen banking is a growing enterprise crucial to health science research and other biological sciences. In this review we discuss the history of biobanking, highlight current and emerging issues, discuss demands and responses, and describe an example of a biobank, the UCSF AIDS Specimen Bank that has functioned for 30 years.

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Available from: Yvonne De Souza, Jan 07, 2015
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EDITORIAL REVIEW
Biobanking past, present and future:
responsibilities and benefits
Yvonne G. De Souza and John S. Greenspan
The review explores the field of biobanking as it has evolved from a simple collection of
frozen specimens to the virtual biobank. Biorepository and biospecimen science has
evolved in response to the changing landscape of external regulatory pressures, the
advances made in the biological sciences, and the advent of the computer chip.
Biospecimen banking is a growing enterprise crucial to health science research and
other biological sciences. In this review we discuss the history of biobanking, highlight
current and emerging issues, discuss demands and responses, and describe an example
of a biobank, the University of California, San Francisco AIDS Specimen Bank that has
functioned for 30 years.
ß 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins
AIDS 2013, 27:303312
Keywords: AIDS specimen bank, biological specimen bank, biorepos itory,
human biobank
Introduction
The term biobank covers collections of plant and animal,
including human specimens. For the purposes of this
discussion, we focus on human biobanks. A biobank is a
biorepository that accepts, processes, stores, and dis-
tributes biospecimens and associated data for use in
research and clinical care. The field of biobanking has
changed tremendously over the past 30 years. It started
with small, predominantly university-based repositories
that were developed for the research needs of specific
projects. There gradually evolved institutional and
government-supported repositories, commercial (for
profit) biorepositories, population-based biobanks, and
most recently, virtual biobanks. The data associated with
stored biospecimens have increased in complexity from
basics, such as date of collection and the diagnosis, to
extensive information sets encompassing many aspects of
participant or patient phenotype, now rapidly extending
into genetic, proteomic, and other ‘omics’ information.
Population-wide biobanks have been developed in several
countries, including Iceland, UK, Sweden, Denmark,
Lativa, Estonia, Canada, South Korea, Japan, Singapore,
and USA. These large-scale repositories have been
created in order to collect, analyze, and store phenotypic
and genetic information on representative samples of
their source populations. Virtual biobanks are developed
to assist investigators locate biospecimens for testing
and data mining from multiple biobanks in dispersed
locations. Such virtual biobanks are accessed using
specialized software or web portals designed to connect
biobanks and investigators throughout the world.
The field of biorepository and biospecimen science has
evolved in response to the changing needs of investigators
and projects using specimen banking, as well as to external
regulatory and related pressures. This changing environ-
ment can be attributed in part to emerging fields such as
proteomics, genomics, and per sonalized medicine as well
as to the increasing precision of the associated fields of
Department of Orofacial Sciences and the AIDS Research Institute, University of California San Francisco, San Francisco,
California, USA.
Correspondence to Yvonne De Souza, Department of Orofacial Sciences, UCSF, 513 Parnassus Ave., Box 0422, San Francisco, CA
94143-0422, USA.
E-mail: yvonne.desouza@ucsf.edu
Received: 22 October 2012; accepted: 30 October 2012.
DOI:10.1097/QAD.0b013e32835c1244
ISSN 0269-9370 Q 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins
303
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
science. This process has increased the demand for high-
quality specimens with accurate, reliable, standardized
clinical and laboratory data. Thus, optimum collection,
processing, storage, tracking, and shipment of biospeci-
mens are key to the outcome of a multitude of studies.
The field of Biorepository and Biospecimen Science has
emerged [1]. The journal, Cancer Epidemiology, Biomarkers
& Prevention is based on this emerging field. Further issues
that have affected the field of biobanking include
regulatory requirements, such as Health Insurance
Portability and Accountability Act (HIPAA), Institutional
Review Board (IRB), and consent documentation,
whereas the area of genetics and biobanking has addressed
serious ethical and legal issues [2].
Biobank taxonomy
There are several types of biobanks, including those that
are disease-centric, population-based, genetic or DNA/
RNA, project-driven, tissue versus multiple specimen
type, commercial, and virtual biobanks. Watson and
Barnes [3] emphasized the importance of properly
classifying biobanks. Table 1 lists some examples of
biobank types with their websites. Upon review of these
websites one can appreciate the complexity of these
biobanks and the amount of support they provide their
research base.
Evolution of the biobank and its diverse
activities
Human specimens have been collected and stored at
institutions in the US and elsewhere for over 100 years
[4]. Specimen banks have advanced in their activities from
small operations based on the needs of a specific study, in
which record keeping was confined to a laboratory
notebook and specimen storage was in one or a few
freezers. This modest style of banking has become a far
more complex enterprise. Technological advances,
notably procedure automation, computerization, and
the Web, have revolutionized the management of
biobanks. Specimen annotation and location can now
be maintained in a computerized database and biobanks
that have sufficient funding are able to invest in robotics to
expedite specimen processing and sampling. The internet
has expanded communication with clients and also
facilitates the establishment of virtual biobanks. Software
companies are developing packages that support biobanks
in tracking inventory, expenses, consent documentation,
and the handling of clinical and laboratory data.
Biorepositories encompass collections including those
from epidemiological cohorts, clinical trials, diagnostic
and etiopathogenesis studies. Large-population biobanks
have become common over the past two decades. In
these, robotic devices handle the processing of specimens,
304 AIDS 2013, Vol 27 No 3
Table 1. Examples of biobank types and their websites.
Name of bank Biobank type Website and/or reference
Adolescent and Young Adult Biorepository Disease-specific biobank http://www.ohsu.edu/xd/health/services/cancer/
outreach-programs/programmatic-outreach/
how-is-young-adult-cancer-uniq.cfm
Australia Breast Cancer Bank Disease-specific biobank http://www.abctb.org.au/abctbNew2/
AboutUs.aspx
Cancer Human Biobank caHUB NCI-sponsored national biobank http://cahub.cancer.gov/ [9]
Cincinnati Biobank Pediatric biobank http://www.cincinnatichildrens.org/research/
cores/biobank/default/
Coriell Cell Repositories Cell culture biobank http://ccr.coriell.org
Danish National Biobank Population-based biobank http://www.biobankdenmark.dk/
Duke Institute for Genome Sciences & Policy
Biospecimen Repository
Centralized biobank for Duke
University Investigators
http://www.genome.duke.edu/cores/
biorepository
Estonian Biobank Population-based biobank http://www.itfom.eu/partners/associate-
partners/18-associate-partners/198-
estonian-genome-center-university-
of-tartu-estonia
Kaiser Permanente Research Program on Genes,
Environment, and Health (RPGEH)
Kaiser member-based biobank http://www.dor.kaiser.org/external/DOR
External/rpgeh/index.aspx
Northwest Biobank at Kaiser Permanente Partnership between Oregon
Health & Science University
and the Kaiser Permanente Center
http://www.ohsu.edu/xd/research/centers-
institutes/octri/funding/nw-biobank.cfm
SeraCare Life Sciences Commercial biobank http://www.seracarecatalog.com/default.aspx
Specimen Central Virtual biobank http://specimencentral.com/about-us.aspx
Thyroid Biobank Pasteur Hospital, Nice, France Organ-specific biobank [12]
Tissue Solutions Virtual biobank http://www.tissue-solutions.com/
Tumour Tissue Repository Cancer biobank http://www.bccrc.ca/dept/ttr
UCSF AIDS and Cancer Resource Disease-specific biobank http://acsr.ucsf.edu/
UCSF AIDS Specimen Bank Disease-specific biobank http://ari.ucsf.edu/programs/asb.aspx [8]
UK Biobank Population-based biobank http://www.ukbiobank.ac.uk/ [6,27]
Univ. of Minnesota Tissue Procurement Facility Centralized biobank for Univ. of
Minn. investigators
http://www.bionet.umn.edu/tpf/hone.html
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
whereas terabytes of data are collected and stored. In 2012,
the Danish National Biobank [5] opened as a collaboration
between the public and private sectors. Such national
biorepositories make it possible to study populations
throughout the lifespan and in this example plan to provide
more than 15 million biospecimens to investigators. The
UK biobank [6,7] was created after a decade of careful
planning with the goal of improving the prevention,
diagnosis, and treatment of a wide range of serious and life-
threatening illnesses, including cancer, cardiovascular
disease, diabetes, osteoporosis, depression, and forms of
dementia. UK Biobank has reported recruiting 500 000
people aged 4069 years during 20062010.
An example of a disease-centric biobank is the University
of California, San Fr ancisco (UCSF) AIDS Specimen
Bank (ASB). The ASB was star ted in December 1982 in
response to the early challenges of the AIDS epidemic
[8]. At the time, the causative agent for AIDS was not
known. Investigators from disciplines such as infect ious
diseases, epidemiology, oncology, pediatrics, dentistry,
and pathology came togeth er and developed a small
biobank for the processing, storage, and dissemination of
specimens. Three decades later, it is a major resource for
investigators at UCSF and throughout the world (s ee
below).
The National Cancer Institute (NCI) announced in late
2009 the establishment of the US National Cancer
Human Biobank, caHUB [9]. The creation of this
biospecimen resource was in response to a survey sent out
in 2002 to investigators funded by NCI, to members of
other federal agencies, cancer centers, industry, and
advocacy groups concerning needs for human biospeci-
mens. The responses revealed that a lack of standardized,
high-quality biospecimens with well annotated data has
slowed the prog ress of cancer research. The goal of
caHUB is to improve and modernize the field of
biobanking by creating evidence-based Standard Oper-
ating Procedures (SOPs) and biospecimen quality
standards. Describing caHUB, Vaught et al. [10] state
that collection strategies and standardized protocols for
the collection, processing, and annotation of specimens
would be developed. There would be centralized quality
control and analysis of every specimen. On July 2012,
caHUB released their first set of SOPs [11] on genome
tissue expression protocols (see also below).
A virtual biobank is an electronic database of biological
specimens and other related in formation, regardless of
where the actual specimens are stored. The University
College London (UCL) biobanks [6], one based at the
Royal Free Hospital (RFH ) and the other based at
Bloomsbury supporting Pathology and the Cancer
Institute, act as physical repositories for collections of
biological samples and data from patients consented at
UCL Partners Hospitals and external sources. The UCL
Virtual Biobank incorporates collections of existing and
new biospecimens. Their virtual biobank wi ll even-
tually be a data repository for biospecimen collections
across the health sciences center. The founders are in
the process of developing a software system to house
sample and phenotype data for UCL studies, with a
powerful se arch engine to view information across all
collections.
Best practices
The goal of a biobank/biorepository is to collect, store,
and disseminate specimens and related data. In order to
provide high-quality biospecimens with well character-
ized data, the management team must insure that they
follow ‘best practices’. Factor s to be considered in the
design and development of a biobank are discussed in a
number of best practice publications, notably those of
International Society of Biological and Environmental
Repositories (ISBER) and NCI. Publications that review
these and other aspects of bank design and operation are
listed in Table 2.
International Society of Biological and
Environmental Repositories
In 2000 the International Society of Biological and
Environmental Repositories (ISBER) was formed
(http://www.isber.org/). Investigators, biobank man-
agers and director s, NIH institute representatives,
bioinformatic managers, patient advocates, lawyers, and
others with interest in biobanking meet yearly to share
knowledge in the field. This group of biobankers includes
those working with human, animal, plant, and environ-
mental repositories. Each year the attendance at ISBER
annual meetings grows and new working g roups are
formed to address areas such as biospecimen science,
informed consent, informatics, rare diseases, and
Responsibilities and benefits of biobanking De Souza and Greenspan 305
Table 2. Selected publications on bank design and operations.
Topic Reference
Community-based hospital biorepository [12]
Epidemiological issues in design and use of
biological specimens
[13]
Epidemiological research and public health [14]
Human tissue monitoring and specimen banking [15]
ISBER 2012 best practices for repositories [16]
Interdisciplinary clinical research [17]
NCI best practices for biospecimen science [18]
Prospective thyroid biobank [19]
Sample storage management [20]
Sample management [21]
Single-investigator biobanks [22]
Stakeholder analysis [23]
Standard preanalytical coding for biospecimens [24,25]
Technological and administrative factors
implementing a virtual biobank
[26]
UCSF AIDS specimen bank (ASB) [8]
UK Biobank sample handling [27]
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automated repositories, to name a few. One of the most
important publications of ISBER is Best Practices for
Repositories, first published in 2005 [28] and revised in
2008 [29] and 2012 [16]. This is the first ‘handbook’ for
biobankers. Topics such as cost recovery, facilities,
equipment, safety, quality assurance and quality control,
shipping, ethical issues, specimen collection, processing,
and retrieval, training, specimen culling, and many more
are discussed. ISBER’s journal, Biopreservation and
Biobanking (formerly Cell Preservation Technology) is the
first journal to provide a forum for peer-reviewed
communication on recent advances in the emerging and
evolving field of biospecimen procurement, processing,
preservation, and banking.
National Cancer Institute office of
biorepositories and biospecimen
High-quality biospecimens for molecular applications are
essential in order to produce reliable and consistent results.
Moore et al. [30] reported evidence indicating that multiple
factors in the handling of biospecimens can affect the
detection of molecular analytes in downstream appli-
cations. They also repor ted that among NCI-supported
biorepositories, most programs collected frozen biospeci-
mens for genomic and proteomic research. However, there
were no common SOPs or quality assurance and quality
control measures, and the programs lacked a common
database. NCI established the Office of Biorepositories
and Biospecimen Research (OBBR) in 2005 and the
Biorepository Coordinating Committee (BCC), which
has an advisory role to OBBR. The mission of the BCC is
to coordinate efforts to improve the availability and quality
of human specimens needed for research supported by
the NCI. OBBR’s mission is to facilitate cancer and
biomedical research by improving the quality and
consistency of human biospecimens. In 2005 [31] the
NCI developed the First-Generation Guidelines for NCI
Funded Biorepositories. These guidelines were posted
for public comment prior to final release. Subsequently
revised versions were released in 2007 [32] and 2011
[18] and renamed the NCI Best Practices for Biospecimen
Resources.
Rand Corporation
The Rand Corporation was the first to publish
information on stored tissue samples in the US [4]. At
the time of the publication, they estimated that there were
more than 307 million specimens from more than 178
million individuals stored in the US. In 2003, the Rand
Corporation published [33] Best Practices’ for a Biopsecimen
Resource for the Genomic and Proteomic Era. This
monograph addressed biospecimen collection, proces-
sing, annotation, storage, and distribution; bioinfor-
matics; consumer, and user needs; business plans and
operations; privacy, ethical concerns, and consent issues;
intellectual property rights and legal issues; and public
relations, marketing, and education.
University of California, San Francisco
Institutional Review Board
In 2005, members of UCSF IRB, the Medical Center
Associate Privacy Officer, the ASB co-director, the
Cancer Center Tissue Core manager, and faculty
members prepared a guidebook for investigators and
staff on research with human biological specimens [34].
Biospecimen science
Biospecimen research in recent years has focused on
preanalytical variables, defined as any variation taking
place between the moment of specimen collection and
the moment of specimen analysis [35]. Preanalytical
variables can be grouped broadly under three categories:
physiological, specimen collection, and influence or
interference factors [36]. Examples of preanalytical
variables are collection, blood tube selection, order of
blood draw, centrifugation speeds, storage and processing;
all affect the consistency and molecular composition of
biospecimens [3739]. The ISBER Biospecimen Work-
ing Group has compiled a more extensive list of
publications on biospecimen research that can be found
at http://www.isber.org/wg/bs.html.
Moore et al. [30] emphasize that to improve the quality of
research utilizing human biospecimens, it is critical that
information regarding how the biospecimens were
handled be reported in an accurate and standardized
system. This reporting system is identified as the
Biospecimen Reporting for Improved Study Quality or
BRISQ. The authors suggest that this reporting tool will
help to strengthen biospecimen-related studies.
Legal and ethical issues
The evolving regulatory landscape affects biobanks.
HIPAA, also known as ‘The Privacy Rule’, set new
standards and regulations to protect patients from
inappropriate disclosures of their ‘protected health
information’ (PHI) that may affect a patient’s access to
insurance, employability, and privacy. Specimen bankers
and investigators who manage specimen data and other s
who have access to it are legally and ethically obligated to
protect data that are considered private information. At
UCSF, institutional oversight of banking of human
specimens for research requires approval by several
regulatory committees, including biosafety, radiation
safety, animal safety, human research, and sponsored
research.
The increased demand for human specimens in genome-
wide association studies (GWAS) and data sharing raises
306 AIDS 2013, Vol 27 No 3
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
concerns of privacy, confidentiality, and human protec-
tion.
One important issue that will affect biobanks in the future
is the concept of providing research results to participants
in studies. Most biobanks are not certified by the Clinical
Laboratory Improvement Amendments (CLIA). Thus is
it not legal in the US for biobanks to provide study
participants/patients with results generated by those
proje cts [40]. Recently, the Office for Human Research
Protections (OHRP) announced an ambitious effor t to
upd ate the regulations conc erni ng research on humans
[40]. One of the changes proposed would require
consent for all research use of b iological spec imen s,
even those that have been rendered anonymous. The
general view of those in the field is that this is
impractica l, for the vast majority of bi obanks, have
neither the infrastr ucture nor financial suppor t to fulfill
such a mandate.
Another ongoing debate is the question of whether
investigators or biobanks have responsibility to report a
participant’s incidental findings or individual research
results (IRRs) generated by genetic research [41]. Both
incidental findings and IRRs are defined as a research
finding concerning an individual participant that has
potential health or reproductive significance. The
difference is that incidental findings are discovered
beyond the specific aims of a study, whereas IRRs are
findings discovered as defined by the specific aims of the
study [42]. However, in the context of GWAS, incidental
findings and IRRs are not distinct. Thus, there is
considerable debate surrounding the issue of whether
biobanks should be responsible for reporting genetic
findings. Over time there may be policies developed
regarding returning a participant’s research results due to
pressure from the participants themselves and the public
pressure [43].
In the state of California, Bill SB 1267 [44], passed, raises a
primary concern over the requirement that each speci-
men recipient, through various steps of the research
chain, must obtain authorization to use the specimens for
genetic research, even if the specimen is de-identified.
Civil and criminal penalties would apply in the case of
violation. This action sparked an immediate reaction
from the University of California, Stanford University
and other California academic institutions. The bill has
been amended to eliminate the need for consent for each
step of the research chain and is still in committee as of
August 2012.
Certification of biobanks
Standard operating procedures and quality assurance and
quality control programs are implemented in the majority
of biobanks. However, to insure that a biobank is
consistent in its practices it has been proposed that
biobanks obtain accreditation. The College of American
Pathologist (CAP) [21,45] has announced a plan for
biorepository accreditation beginning in 2012. This will
be a 3-year peer-based accreditation program.
In order to achieve consistency in specimen management,
some European biobanks are implementing a Quality
Management System (QMS) and have identified the
International Organization of Standardization Standard
9001 [46] as their system. The UK DNA Banking
Network [47] implemented ISO9001 standards to
suppor t their biobanking research infrastr ucture.
The Department of Pathology and Laboratory Medicine
at the University of California Los Angeles (UCLA) has a
2-year accredited neuropathology program. A com-
ponent of this program is a cour se on biorespository
science. Trainees are encouraged to participate in this
course because the process of collection, processing, and
storage of specimens is an essential par t of a neuropatho-
logist’s practice [48].
International Society of Biological and Environmental
Repositories is in the process of developing a global
certification program for biorespository technical pro-
fessions [49]. ISBER will collaborate with the American
Society for Clinical Pathology in the administration and
development of this program.
The process of accreditation requires dedication of staff
and resources. In order to increase the value and quality of
a biobank collection, the management team must develop
SOPS, along with a quality assurance and quality control
program. ISBER’s, NCI’s Best Practices, and Rand
Corporation’s documents are excellent resources for
those undertaking these tasks [16,18,28,29,3133] The
American Association of Tissue Banks provides a course
on tissue banking. ISBER has developed (http://
www.isber.org/sat/) a self-assessment tool [50] for
biorepositories to help identify areas that need improve-
ment. ISBER has launched a Proficiency Testing
Program for biorespositories to assess the accuracy of
their quality control programs and to identify any
problems. The four inter-laborator y testing areas are
DNA quantification and purity, RNA integrity, cell
viability, and tissue histology [51,52].
University of California, San Francisco
AIDS Specimen Bank: 30 years of
experience
In its infancy, ASB was a small laboratory with single
ultra-low and liquid nitrogen freezers. Data collected on
Responsibilities and benefits of biobanking De Souza and Greenspan 307
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
specimens was recorded in a notebook, then a word
processor, and ultimately a computerized database. In
December 1982, ASB received 25 specimen deposits,
now ASB has received over 463 000 specimens and has
shipped over 500 000 vials or other forms of biospecimens
worldwide (see Fig. 1). ASB supports the UCSF HIV
research community by providing a wide variety of high
quality biospecimens to investigators; offers consultation
and training in specimen acquisition and handling for
early-career investigators and research staff, and fosters
collaboration among HIV investigators involved in
multidisciplinary translational research. ASB processes
and stores specimens from both HIVand non-HIV studies
(see Fig. 2). The workflow processes are summarized in
Figs 3 and 4.
The essentials of specimen banking at ASB: processing,
storage, and providing high-quality specimens linked to
clinical information remain constant. However, new and
improved services and technologies that support an
evolving user base, investigating new domains of science,
demand the evolution of the biorepository. High impact
and reproducible basic science or translational research
demands the availability of stringently collected speci-
mens that have been properly labeled, processed, and
stored. ASB supports new investigators’ insights into
specimen-related issues through a training program.
Workshops are developed for researchers interested in
designing a biorepository or those that seek to understand
the process of specimen collection, processing, and
storage. The workshops provide instruction in the proper
collection and processing crucial for downstream
applications for which the specimen will be used. The
goal is to reduce the number of preanalytical variables that
maybe introduced during the collection, shipping,
processing, and storage phases of a biospecimen.
To maintain biospecimen integrity, ASB has developed
str ingent quality assurance and quality control (QC)
programs. The quality ass urance and quality control
programs are an on-going process th at requires the d aily
attention of ASB staff. These programs are reviewed
annually at staff meeting to insure all members take
‘ownership’ of the process. ASB participates in the Adult
AID S Clinical Trials Group (ACTG) Immunology
Quality Assessment Program (IQA). Cryopreserved
peripheral blood mononuclear cells (PBMCs) are
shipped quar terly to the IQA to te st for viability and
viable cell recover y. This a rigorous national monitor ing
effort in which ASB ha s successfully par ticipated for
8years.
The IQA reports that ASB’s viable recovery ranges from
70 to 120% and their PBMC viability is usually above
90%. ASB provides the UCSF Immunology Core
laboratory with frozen PBMCs for quality control
purposes. This collaboration provides another source of
quality control testing of the viability of ASB PMBC
preparations. To date, the Immunology Core Director
reports that PBMCs are of the highest quality with a
viability of more than 90% and are essential to their
quality control program. The efficient operations of ASB
allow other UCSF Cores and major research programs to
avoid the costs and risks of maintaining separate,
redundant, and perhaps lower-quality specimen reposi-
tories.
308 AIDS 2013, Vol 27 No 3
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10 000
20 000
30 000
40 000
50 000
60 000
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
Aug-12
Year
Deposits and withdrawals
Number of specimens
Deposits
Fig. 1. UCSF AIDS Specimen Bank deposits and withdrawals during December 1982 to August 2012.
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
AIDS Specimen Bank’s policies and procedures require
that all specimens processed and/or stored must have IRB
approval. Personal identifiers are not entered in ASB’s
database, any PHI remains with the depositing investi-
gator. ASB’s specimens are assigned a unique accession
number that is linked to the study identification of the
participant. Recipients of ASB’s processed specimens
only have the bar coded accession number as the
identifier. Within the UCSF research community, ASB
facilitates new collaborations among investigators from
academic institutions and private sector. Innovative
research collaborations arise, given the availability of
specimens at ASB and the caliber of UCSF investigators
who contribute these specimens.
AIDS Specimen Bank’s 25 ultra-low and 14 liquid
nitrogen freezers are monitored by a wireless, web-
enabled alarm monitoring system (Opto-Solutions Inc.),
which monitors all units both on and off campus. This
alarm system has improved the quality assurance program
within ASB by providing accurate recordkeeping of each
freezer’s temperature.
Problems and successes
AIDS Specimen Bank has had its share of the problems
and successes that occur in biobanking. ASB had a policy
of not accepting specimens that were previously thawed
and aliquoted. An investigator was not pleased with this
policy and was requesting that a collaborator from an
external laboratory must return previously thawed and
sub-aliquoted specimens to ASB. After much discussion
with the ASB Advisory Committee, it was agreed that if
specimens were to be returned the external laboratory
must supply sufficient documentation and SOPs before
specimens were returned to ASB. This is to assure
Responsibilities and benefits of biobanking De Souza and Greenspan 309
Translational research
Genomics, Proteomics, Therapy, Diagnosis
Specimen collection
Biospecimen dissemination
(a)
(b)
(c)
(f)
(e)
(d)
Biospecimen processing and storage
Fig. 2. Biobanking work processes. These are the steps involved in a typical biobank. (a) Specimen collection (consent has been
obtained prior to collection). (b) Centrifugation of specimens for processing. (c) Serum (red top blood tubes) and 50 ml conical
containing peripheral blood mononuclear cell layer sitting on ficoll after centrifugation. (d) Sub-aliquoting specimens under a
biosafety laminar flow cabinet. (e) Putting specimens into long-term storage. (f) Specimens will be shipped to investigators for
translational research.
Page 7
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
compliance with minimum acceptable standards in
specimen handling and operations. The requesting
principal investigator was financially responsible for each
specimen being returned to ASB. To date, ASB has
received no additional request for previously thawed
specimens to be returned.
Another issue that arose for ASB was when two faculty
members were co-investigators on a study. They left the
University and both claimed ownership of the data
and specimens. The Director of ASB contacted the
University’s legal department for consultation. An
agreement was drawn up stating that the specimens
would remain with ASB and the data remained with the
department in which the investigators had appointments.
It was agreed that the co-investigators may contact ASB
or their department for specimens or data as long as they
had IRB approval and funds to support the transfer of
specimens or data.
AIDS Specimen Bank’s success as a biobank lies partly in
the fact that since 1982, ASB has provided specimens that
have been stringently collected, labeled, processed, and
stored for investigators involved in high impact and
reproducible basic, translational, clinical, and populations
sciences. During the early days of the AIDS epidemic,
ASB provided specimens that contributed to the
identification of the agents that cause AIDS and Kaposi’s
sarcoma. ASB also collaborated with biotech firms
developing rapid diagnostic kits for HIV. ASB serves as
a resource for investigators new to HIV research and for
the active UCSF HIV research community. ASB’s success
relies on its ability to process, store, and provide well
characterized specimens to researchers worldwide.
310 AIDS 2013, Vol 27 No 3
ASB contacted for
repository services
Depositor submits IRB
approved protocol to ASB
Study protocols are reviewed
Study site and ASB coordinate
delivery of specimens
Specimen packaged for
delivery by standardized
protocol
ASB receives specimen from
study site
Specimen information entered
into data base
Specimens processed by
study protocol
Specimen(s) require
real-time testing
Specimen(s) sent
to clinical lab for
testing
Specimen inventoried into
storage and entered into
database
Quality assurance
of
specimens
1. Packaging
2. Storage conditions
3. Patient ID
4. Specimen match
Check/verify protocols
and procedures
Study site notified
of protocols and
procedures failure
No
No
No
Yes
Yes
Yes
1. IRB approved protocol.
2. Specimen banking is part of IRB approved
protocol.
3. Consent forms - patients are informed of
disposition of specimens.
4. Specimen processing protocol is reviewed.
5. Budget and protocol is approved by ASB
director and co-director and client.
ASB reviews
ASB
End
Fig. 3. UCSF AIDS Specimen Bank specimen accessioning, processing and storage workflow.
Page 8
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Acknowledgements
Both authors have contributed to the preparation of this
manuscript. We would like to acknowledge UCSF AIDS
Specimen Bank staff for their hard work and dedication
to our investigators for their support and to the study
participants.
The comments of this manuscript are solely the respon-
sibility of the authors and do not represent the official views
of NIH, NIDCR, NIAID, NCCAM, NHLBI.
This work was supported in part by awards, from National
Institutes of Health (NIH (P30AI027763), NIH, Natio-
nal Heart Lung & Blood Institute (NHLBI) and National
Institute of Dental Craniofacial Research (NIDCR) (N01
DE326636), NIH, National Institute of Allergy and
Infectious Diseases (NIAID) (AI34989 and 1P01
A1071713), NIH and National Center for Complemen-
tary & Alternative Medicine (NCCAM) (P01 AT005013),
and NIH, NIAID and NIDCR (U01 AI68636).
Conflicts of interest
There are no conflicts of interest.
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312 AIDS 2013, Vol 27 No 3
Page 10
  • Source
    • "A human tissue Biobank is a biorepository that accepts, processes, stores and distributes biospecimens. It associates data for use in research and clinical care [16]. Biobanks can provide researchers a reliable and organised source of human tissue for RNA-based analysis. "
    [Show abstract] [Hide abstract] ABSTRACT: Medical research projects become increasingly dependent on biobanked tissue of high quality because the reliability of gene expression is affected by the quality of extracted RNA. Hence, the present study aimed to determine if clinical, surgical, histological, and molecular parameters influence RNA quality of normal and tumoral frozen colonic tissues. RNA Quality Index (RQI) was evaluated on 241 adenocarcinomas and 115 matched normal frozen colon tissues collected between October 2006 and December 2012. RQI results were compared to patients' age and sex, tumor site, kind of surgery, anastomosis failure, adenocarcinoma type and grade, tumor cell percentage, necrosis extent, HIF-1α and cleaved caspase-3 immunohistochemistry, and BRAF, KRAS and microsatellites status. The RQI was significantly higher in colon cancer tissue than in matched normal tissue. RQI from left-sided colonic cancers was significantly higher than RQI from right-sided cancers. The RNA quality was not affected by ischemia and storage duration. According to histological control, 7.9% of the samples were unsatisfactory because of inadequate sampling. Biobanked tumoral tissues with RQI ≥5 had lower malignant cells to stromal cells ratio than samples with RQI <5 (p <0.05). Cellularity, necrosis extent and mucinous component did not influence RQI results. Cleaved caspase-3 and HIF-1α immunolabelling were not correlated to RQI. BRAF, KRAS and microsatellites molecular status did not influence RNA quality. Multivariate analysis revealed that the tumor location, the surgical approach (laparoscopy versus open colectomy) and the occurrence of anastomotic leakage were the only parameters influencing significantly RQI results of tumor samples. We failed to identify parameter influencing RQI of normal colon samples. These data suggest that RNA quality of colonic adenocarcinoma biospecimens is determined by clinical and surgical parameters. More attention should be paid during the biobanking procedure of right-sided colon cancer or laparoscopic colectomy specimen. Histological quality control remains essential to control sampling accuracy.
    Full-text · Article · Apr 2016 · PLoS ONE
  • Source
    • "Our studies on the place of oral lesions in the natural history of HIV/AIDS began with patients in our own clinic, referred by our dental school colleagues, local dentists, or physicians working in UCSF and other San Francisco AIDS/Infectious Disease clinics (Greenspan et al, 1987). At about the same time, the UCSF AIDS Specimen Bank (Greenspan et al, 1991; De Souza and Greenspan, 2013) was established in response to the need for a biospecimen processing and storage facility to support the growing number and types of investigations in the field. The connections we thus made opened for us many opportunities for collaboration. "
    [Show abstract] [Hide abstract] ABSTRACT: Well into the fourth decade of the HIV/AIDS pandemic, we can look back on the early years, the initial discoveries, and the broad sweep of the progress of our understanding of the nature, causes, and significance of the oral lesions seen in those infected with the virus. Prominent among these is oral hairy leukoplakia (HL), a previously unknown lesion of the mouth associated with Epstein-Barr virus (EBV) and initially seen only in people with AIDS, in the then-recognized risk groups, or those shown to be HIV positive. Subsequently, it became clear that the distribution of HL extends well beyond the HIV spectrum. In this brief review, we consider the clinical and histological features of HL, discuss how it was discovered, explore its cause, diagnosis, relationship with AIDS, pathogenesis, significance in EBV biology, options for management, and how it changes with HIV/AIDS therapy.
    Preview · Article · Apr 2016 · Oral Diseases
  • Source
    • "106 genetic profile we have complete personal information useful for understanding specific disorders by integration of test results with clinic history [13]. DNA is strategic for genetic studies, so its quality must be tested through different methods and this also for rna [14]. Infact, over time, the requirement of genetic biobanks which collect samples (dna and/or rna) for biomedical research, referred to different fields like rare diseases or specific conditions, was great [15]. "
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