The Centre for Oncology Education and Research Translation (CONCERT) Biobank

The CONCERT Biobank was established as an open-access, multiple collection site biorepository designed to collect, process, store, retrieve and disseminate biological samples and health information for research projects following informed consent from participants diagnosed with cancer. Informed consent is obtained prior to surgery by either the nursing, medical or biobank staff. Tissues for biobanking are examined within the diagnostic anatomical pathology department of the participating hospital by qualified pathologists and tissues deemed in excess of diagnostic requirements are stored securely and anonymously by the biobank in anticipation of current and future research needs for broad and as yet unspecified cancer research nationally.

The CONCERT Biobank was established as an open-access, multiple collection site biorepository designed to collect, process, store, retrieve and disseminate biological samples and health information for research projects following informed consent from participants diagnosed with cancer. Informed consent is obtained prior to surgery by either the nursing, medical or biobank staff. Tissues for biobanking are examined within the diagnostic anatomical pathology department of the participating hospital by qualified pathologists and tissues deemed in excess of diagnostic requirements are stored securely and anonymously by the biobank in anticipation of current and future research needs for broad and as yet unspecified cancer research nationally.

Bioresource citation
Any research work that will use the presently described bioresource in journal articles should conform to the CoBRA guideline [5] and be cited as follows: More details at www.equator-network.org/ reporting-guidelines/cobra

Project description
The CONCERT Biobank was established and implemented in the South West Sydney and Illawarra Shoalhaven Local Health Districts, NSW, Australia, which previously had lacked any comprehensive cancer biobanking facilities to support their growing translational research programs.
The overarching aim of the CONCERT Biobank is to assist researchers in conducting large, population-based studies investigating the genetic, lifestyle and environmental factors associated with cancer and to aid in building and enabling research in daily clinical practice. This in turn will allow more rapid translation of research findings for the clinical benefit of patients. The CONCERT Biobank is also focussed on developing strategies for the establishment and maintenance of biobanks and assisting in the implementation of more effective policies and procedures to embed biobanking into routine hospital practices [1].
The CONCERT Biobank policies and procedures have been formed and formulated according to the ISBER Best Practices for Repositories Guidelines [2], the OECD Best Practice Guidelines for Biological Resource Centres, the National Health and Medical Research Council Biobanks Information Paper [3], the Cancer Institute NSW A Comprehensive Review of Cancer-Related Biobanks in New South Wales Report and the Australian Breast Cancer Tissue Bank [4] Best Practice Guidelines.

Species
Human.

Classification (2)
Biological samples and associated data.

Context Spatial coverage
The CONCERT Biobank is a non-profit entity, which is part of the CONCERT Translational Cancer Research Centre (TCRC). The CONCERT TCRC is a large multi-institutional consortium of universities (WSU, UNSW, and University of Wollongong), medical research institutes (Ingham Institute for Applied Medical Research and Illawarra Health and Medical Research Institute), hospitals and local health districts (South West Sydney and Illawarra/Shoalhaven), with many collaborative links spanning across NSW.
CONCERT Biobank collection centres include: The CONCERT Biobank arranges packaging and shipping of the biospecimens with the courier, and arranges for the invoice to be sent and paid for by the researcher.

Quality assurance measures
The quality assurance measures that have been implemented by the CONCERT Biobank include: • Implementation of standard work procedures (SWPs) • Personnel training; documented and updated, if required, on a periodic basis • Documentation of modifications or revisions of SWPs and risks assessments (RAs) • Maintenance of records pertaining to biospecimens, equipment, and consumables The quality control measures implemented by the CONCERT Biobank include: • Verification of biospecimens by a pathologist, with tumour type, grade and cellular homogeneity routinely reported. • Validation of processing methods of biospecimens via literature reviews, end user feed-back and/or laboratory quality control results • Internal audits, including pre-audit checklists

Source of associated data
Sources of associated data include: • Hospital medical and pathology records • Local health district and NSW Cancer registries • Attending clinicians consult rooms • Participants

Ethics Statement
Ethics approval (HREC/14/LPOOL/152) was obtained from the South Western Sydney Local Health District HREC, NSW, Australia, 01 November 2012. All collection sites have site specific ethics approvals. Ethics approval for the collection, processing and storage of biospecimens is indefinite.

Constraints
Current constraints include the lack of long-term funding.

Bioresource name
The Centre for Oncology Education and Research Translation Biobank.

Clinical diagnosis of patients/source
Cancer.

Pathology diagnosis
• All cancer types • ICD50

Control samples
Normal adjacent tissue.

Biospecimen type
A summary of the biospecimen characteristics is provided below ( Table 1).

Release date
The date at which biospecimens have been available for applications is 2014.

Access criteria
Biospecimens collected by the CONCERT Biobank are made available to researchers on the provision that use of specimens are for scientifically valid and ethically approved research projects.
Researcher access entails search facilities which allow for researchers to search biospecimen type and availability stored in the CONCERT Biobank using a link from the CONCERT TCRC website to the Biobank's database, which is currently still under development. All biospecimens and information are stored securely and de-identified however they are reidentifiable to CONCERT Biobank personnel who have signed confidentially agreements. Search facilities on the database protect all identifiable information of the participant.
Currently, as the CONCERT Biobank is still in the progress of developing and implementing its database, researchers can request the use of biospecimens by contacting the CONCERT Biobank manager through the Ingham Institute for Applied Medical Research's Biobank page, https:// inghaminstitute.org.au/content/concert-biobank.
Researchers seeking to use CONCERT Biobank specimens are required to formally apply using a prescribed application form. The application form, along with the researcher's institutional Ethical approval for the project, is submitted to the CONCERT Biobank manager who forwards the application to the CONCERT Biobank's scientific advisory committee (SAC) for assessment. The SAC committee rates all proposals based on its scientific aims, feasibility of study, credentials in type of research, justification for amount of material requested and overall scientific merit. If the application is approved by the SAC then a Material Transfer Agreement (MTA) is issued to the researcher.
An MTA is entered into in order to transfer CONCERT Biobank material to another organisation (commonly another university or research institution) for the purposes of that organisation's own research. The MTA governs the transfer of material, including data, between the organisations and defines the rights and obligations of each in relation to custodianship; use of the biospecimens; and data arising from such use and any modifications or derivatives of the material. The CONCERT Executive Committee reviews all MTAs received by the CONCERT Biobank. No biospecimens are sent until the MTA has been approved by the CONCERT Executive Committee and signed by both organisations. Once receipt of the signed MTA has been received by the CONCERT Biobank, then the biospecimens will be packaged and shipped to the researcher, at the researcher's expense.

(4) Reuse potential
The CONCERT Biobank does not request return of biospecimens other than research results. Validated research results arising from the use of biobank specimens such as expression levels of cancer biomarkers or emerging cancer proteins are requested to be reported back to the biobank and are recorded in the database to be made available to future researchers to reference and access.