QUAlity biobanking iNvesTigating Urological Malignancies (QUANTUM)

Before applying to the QUANTUM Biobank to access samples, please read and review our sample access policy and Terms and Conditions for Sample Access below. Following the Sample Access Policy are a set of FAQs which serve to simplify the process and act as a guide for applicants.

QUANTUM Sample Access Policy 

QUANTUM Biobank supports studies undertaken by researchers in the University of Oxford and Oxford University Hospitals NHS Foundation Trust, as well as other academic and commercial healthcare institutions across the UK and internationally with QUANTUM Tissue Access Committee approval. For requests from commercial bodies, we would give preference to projects which are carried out in collaboration with an academic centre. Anyone wishing to access samples from the Biobank should in the first instance approach:

• the QUANTUM Biobank CI or 
• the Module Lead Clinician; or
• the Biobank Management team (via email: QUANTUM@nds.ox.ac.uk).

An Application for Access to Samples form can then be completed and sent to the Biobank Administrator. 

A summary of the process is shown in Figure 1. below.

Figure 1. Process of obtaining access to QUANTUM Biobank samples

Download a PDF version of Figure 1. 

QUANTUM Biobank will process applications for access according to written procedures. All applications to use samples must be documented, including those instances where permission to use the samples has not been granted.  Review of applications is made by the QUANTUM Governance Committee which will meet four times per annum (every three months).  Applications must be received 10 working days prior to a Meeting in order to be considered for that meeting.  Late applications will be deferred to the following meeting.  Meeting dates will be advertised on-line on the Nuffield Department of Surgical Sciences website or can be obtained by contacting the Biobank Administrator.  Applicants will be informed of the outcome of the Review within 10 working days of the Committee meeting.

Applicants may only be granted access to samples if:

• The proposed research is covered by the scope of the patient consent covering the uses of the biological samples.
• The requested samples are available. 
• The research is sufficiently funded and resourced. 
• The use of samples is appropriate and statistically justified.
• The researcher’s organisation(s) will agree to a Material Transfer Agreement with QUANTUM Biobank that governs the transfer and use of biological samples supplied.

Other considerations may include:

• Whether the research project funded by peer-reviewed funding sources.
• Whether the specific project deemed to be of high priority in situations where there is competition for access to limited tissue resources.
• If the research is of a particularly sensitive nature, whether the use of patient samples is appropriate and justified.
• Whether the research will render the samples depleted.
• Whether the project truly collaborative with respect to assignment of intellectual property and publication rights favouring the Biobank (particularly for commercial or industry access requests).
• For commercial/ industry-sponsored projects: whether are these in collaboration with an academic centre or research group?
• For non-peer-reviewed proposals, the QUANTUM Governance Committee will assess the quality of the proposal based on scientific merit (including appropriate statistical calculations) and the public benefit of the research.  The Governance Committee may co-opt external experts to review such proposals if it considers that Governance Committee members do not have the necessary expertise to do so.

The QUANTUM Governance Committee reserves the right to request applicants to provide evidence, in addition to information supplied in the application form, such as evidence of collaborations, specific ethical approval (if required), scientific peer review and funding.

Valid proposals will be submitted to the QUANTUM Governance Committee for review, prioritisation and approval. The Committee may co-opt or seek external review as appropriate. Samples may only be released after approval is granted.

Specific NHS Research Ethics Committee approval of research projects

The Biobank programme covers a wide area of research and most proposals will not require specific REC approval if their projects fall within the remit of QUANTUM’s REC approval. However, specific NHS REC approval may be required at the discretion of the Designated Individual and/or QUANTUM Governance Committee. In general, researchers must supply evidence of REC approval prior to sample release if it is not a component of the Biobank’s ethically approved research programmes. 

Applications from researchers within and outside the named Oxford establishments will be processed via the same mechanism.  In order to be considered for inclusion under QUANTUM Biobank’s generic ethical approval, the proposed research must be both collaborative (involve a researcher based within the institutions (including tissue collection centres) supporting QUANTUM Biobank) and be in keeping with these institutions’ own ethically approved research programmes. 

Collaboration policy

Anonymised samples and data may be shared with both Academic and Commercial partners in research projects which are subject to peer review and approval by the QUANTUM Governance Committee. 

Conditions of sample and data release to researchers

A full list of Terms and Conditions to use samples and data from the QUANTUM Biobank are appended to the Sample Access Request Form. By submitting an application form for review, researchers are agreeing to these Terms and Conditions:

• The requestor agrees that the samples provided by QUANTUM will be used only for the purposes specified in their application. Further use of the same material for subsequent research must be sought independently of the original application. 
• Samples supplied may only be transferred to collaborators named at the time of the original application or in subsequent applications and specified in the Material Transfer Agreement or later amendments. This includes derivatives of the material (e.g. protein, RNA or DNA). 
• Samples will be supplied with a minimum dataset, unless additional data is available and requested. All samples are coded-linked and no donor identifiable data will be provided. The requestor agrees not to attempt to identify any individual from the materials supplied. 
• The requestor assumes all responsibility for ensuring that samples are used in accordance with: 

1. The ethical approval and host organisation / sponsor approvals, including appropriate handling of material when approvals expire; and 
2. The current requirements of the Human Tissue Authority or applicable regulations if outside England, Wales and Northern Ireland. 

• Requestors external to the University of Oxford and Oxford University Hospitals NHS Foundation Trust may be required to complete a Material Transfer Agreement before samples are released. 
• Requestors must notify QUANTUM Biobank once the project is completed and confirm sample status.  Any surplus samples must either be destroyed (with a record made of the method, reason and date of disposal), returned to QUANTUM Biobank to be destroyed or returned for inclusion in holdings. 
• If participant consent is withdrawn for issued samples, requestors will be informed of the relevant numbers and asked to destroy any unused samples and certify that they have done so. Results obtained from samples that have already been used for research need not be destroyed unless informed otherwise. The fee is non-refundable if consent is withdrawn. 
• QUANTUM will attempt to avoid providing samples that are contaminated with highly infectious agents such as hepatitis and HIV, however all samples should be treated as potentially infectious. The requestor assumes all responsibility for training personnel in the procedures for safe handling of human samples. 
• The samples are provided as a service to the research community without warranty of merchantability or fitness for a particular purpose or use or any other warranty or representation, whether express or implied. 
• The requestor will ensure that any publication or presentation that is based (in whole or in part) on any materials obtained via QUANTUM will include the following standard acknowledgement: “This research has been conducted with support from the QUANTUM (QUAlity biobanking iNvesTigating Urological Malignancies) Research Tissue Bank, which is operated by the University of Oxford supported by the John Black Foundation”. Recipients will be advised if samples have been sourced from a specific collection that must also be acknowledged. 
• Recipients must provide a copy of any publications based on samples or data provided through QUANTUM, and ideally pathologists, sub-collection managers and members of QUANTUM who have contributed significantly to delivery of a project, should be named as co-authors in publications. 
• Study titles may be published on the QUANTUM website, together with lay summaries and the names of institutions where the work is taking place (unless agreed otherwise e.g. for confidentiality purposes). 

Terms of payment 

• Services provided by QUANTUM will be charged according to the work involved. 
• An estimate will be provided upon approval of application. This estimate is valid for a period of 30 days and is exclusive of VAT. 
• The estimate price is approximate, and representative of the services requested in the application. If additional costs are anticipated once the estimate has been issued, this will be agreed with the requestor before further work is undertaken. 
• Depending upon the size and complexity of the request, QUANTUM or the requestor may request that a contract is put in place before work is undertaken. 
• Each application will incur a handling charge and this will be included on the quotation. Subsequent requests / amendments to the original application will usually incur a further handling charge. 
• No material will be provided until QUANTUM is in receipt of a Purchase Order to cover at least 50% of the estimate costs. Purchase orders should be addressed to University of Oxford, Nuffield Department of Surgical Sciences, Level 6, Rm 6607, John Radcliffe Hospital, Headington, Oxford, OX3 9DU. 
• Payment terms are strictly 30 days from receipt of invoice. Invoices will be issued by the University of Oxford

^{In certain circumstances applications to the QUANTUM Biobank which involve the collaboration with, or the contribution(s) of, third parties will be subject to the procedures for Gift-funded Intellectual Property (IP) in line with Terms and Conditions of the John Black Charitable Foundation Gift Agreement. These will be covered by a separate collaboration agreement between the University of Oxford and the third party to cover any commercial use of, or granting to any third party any exploitation rights over the results of the research.}