Serial Number:OMB-F 042 / Version Number:6.0
Version Approver:Gareth Bicknell / Version Approval Date:03/03/2014
Version Author:Lucy Roche (Laboratory Scientist), Gareth Bicknell (QM) / Version Effective:One week from release

OMB ACCESS REQUEST

The Oxford Musculoskeletal Biobank (OMB) is permitted to supply human tissue and data to research projects, provided that they fulfil the criteria for tissue release under Oxford REC C 09/H0606/11. It may also supply tissue for the purposes of performance assessment and quality assurance under the terms of HTA Licence 12217. The OMB Access and Development Committee reserves the right to decide whether requests fulfil the appropriate criteria.

AMaterial Transfer Agreement (MTA) will be required between the University of Oxford and external institutions. Institutions outside the United Kingdom will be required to provide a full protocol to ensure compliance with standards and the terms of the OMB Protocol.

PROJECT DETAILS
Short title / Nickname for the request
Full title / Full title for the request
Area of research / What area of research will be helped by this access/storage request?
e.g. “biomarkers of osteoarthritis”
APPLICANT DETAILS
Primary contact / Your name
Primary contact’s email / Your email
Principle Investigator / Who is the supervisor responsible for adherence to ethics?
Principle Investigator’s email / Supervisor’s email
Associated clinical staff / Please list the names of clinical staff who will remove material from patients, or whose clinics/theatre lists will be involved. If not all involved with the same patient groups, please indicate which staff are needed for which patients groups.
NB – This is necessary so that OMB can ensure all clinical staff are aware of OMBand have agreed to contribute under the conditions imposed by the Protocol/Licence. OMB recommends approaching staff with a higher case volume.
Co-applicants / Please list the names of all other associates, including those who will be using the material released.
NB – Updates are welcome, but they will need formal acknowledgment from OMB and a signed declaration from the additional co-applicants. This is necessary so that OMB can ensure the conditions imposed by the Protocol/Licence are not breached.
Associated institutions / Please give the departmental/full addresses (as relevant) of all parties external to NDORMS
NB – It is a University requirement that all parties external to the University/OUH NHS Trust must sign a formal agreement with Research Services. It is an OUH NHS Trust requirement that researchers must seek additional permission to transfer NHS data to parties outside the EEA.
SUMMARY OF REQUEST / AMENDMENTS
Summary of request / Please summarise your access/storage request in lay language of <200 words. Summaries will be used by the REC and released to public/patients, so please ensure that commercially-sensitive details are worded in a suitably generic format.
Commercially sensitive / Is this request commercially sensitive?
Summary and impact of latest amendment / If amending an existing approved access/storage request, please summarise the latest changes to it, and indicate any significant impact that your amendments may have
Service type / Please mark the services that you require
Prospective acquisition of OMB samples/data using OMB ethics
Access to banked OMB samples/data covered by OMB ethics
Storage of samples/data by OMB covered by your own active ethics
Adoption of samples/data from your biobank/expiring ethics by OMB
Non-research access - only for the purpose of technique development, product testing, and quality control
Historic connections / With which existing OMB request reference numbers (or historic OMB collection reference numbers) does this request link?
NB – Please do not refer a request to itself, or to the OMB Protocol
General – use in animals / Will samples or expanded cells ever be used in animal models?
WARNING - If YES, OMB cannot help you: the OMB Protocol does not permit use in animal models under any circumstances
General – reproductive cloning or research / Will your use of samples involve reproductive cloning or research (including that associated with pregnancy termination or contraception)?
WARNING - If YES, OMB cannot help you: the OMB Protocol does not permit this activity under any circumstances
General – genetic analysis / Will samples or expanded cells be used for genetic analysis?
NB – most genetic analysis is allowed, but anything that could be construed by an insurance company as genetic testing, or anything that would prove/disprove parentage, is not allowed
General – licence transfer / If storage involves transfer of samples to, or from, a different regulator licence number, please quote that number here
e.g. “HTA Licence xxxxx”
General – existing ethics / If you have your own REC-approved protocol covering all, or part, of your request, please quote its REC reference number here, and attach a copy, the approval letter, and (if applicable) your sponsor approval
e.g. “Ox REC C xx/xxxx/xx”
General – access under own ethics / Does the above protocol already quote OMB as a source of the samples/data being requested?
NB - this does not guarantee access, but if sufficiently detailed, your protocol may mean that the OMB Access & Development Committee does not need to consider the scientific and ethical implications of your request
FUNDING
Funding – requirement / OMB is required to recoup costs associated with consent, collection, processing, storage, and distribution. Please show that you have considered this by inserting a financial breakdown of your request.
NB – Universityof Oxford applicants should use the quote calculator published in the For Researchers section of . Others should use the quote request form published in the same section.
Funding – support / Please enter all funding sourcesthat will be used to pay for OMB costs incurred.
NB – Pleaseinclude grant or account numbers that should be quoted on invoices.
ACCESS TO PROSPECTIVE OR EXISTING SAMPLES/DATA
Complete this part if requesting access to OMB holdings
Request – primary data / Primary clinical data required
Request – other data / Other data required (confounders, stratifiers, minimal data sets)
Request – timescale / What is the timescale for sample/data acquisition?
e.g. EACH YEAR or OVER 5 YEARS. This enables OMB to avoid oversubscribing patient numbers or material requests
Request – diseased/injured inclusion criteria / Please include full inclusion criteria to enable identification of suitable diseased/injured patients or material by OMB and/or clinical staff
NB – You may need to consult with a clinician to enable the creation of clinically-meaningful inclusion criteria
Request – diseased/injured exclusion criteria / Please include full exclusion criteria to enable identification of suitable diseased/injured patients or material by OMB and/or clinical staff
NB – You may need to consult with a clinician to enable the creation of clinically-meaningful exclusion criteria
Request – diseased/injured samples / For each type of diseased/injuredsample, please specify:
  • how manypatients you need in the timeframe
  • PER PATIENT, how many WHOLE SAMPLES or ALIQUOTS
  • size, mass, or volume of each sample or aliquot (e.g. 1 ml, at least 5 mm)
  • whether FRESH, FROZEN, FIXED, FFPE BLOCKS, SECTIONS (or other specified format)
  • the type of tissue (e.g. SERUM, CARTILAGE)
  • source of the tissue (if not obvious, e.g. TIBIAL PLATEAU, FEMORAL HEAD
  • sample treatments required (e.g. GOLD tubes, PURPLE tubes, RPMI/DMEM, RNAlater, hyaluronidase)
  • any other special instructions for acquisition and processing (e.g. paired samples only, maximum acceptable warm time)

NB – If available at the time, OMB may collect other samples. These can be made available to you by application/amendment
Request – control inclusion criteria / If different from above, please include full inclusion criteria to enable identification of suitable control patients or material by OMB and/or clinical staff
NB – You may need to consult with a clinician to enable the creation of clinically-meaningful criteria
Request – control exclusion criteria / If different from above, please include full exclusion criteria to enable identification of suitable control patients or material by OMB and/or clinical staff
NB – You may need to consult with a clinician to enable the creation of clinically-meaningful criteria
Request – control samples / For each type of controlsample, please specify:
  • how manypatients you need in the timeframe
  • PER PATIENT, how many WHOLE SAMPLES or ALIQUOTS
  • size, mass, or volume of each sample or aliquot (e.g. 1 ml, at least 5 mm)
  • whether FRESH, FROZEN, FIXED, FFPE BLOCKS, SECTIONS (or other specified format)
  • the type of tissue (e.g. SERUM, CARTILAGE)
  • source of the tissue (if not obvious, e.g. TIBIAL PLATEAU, FEMORAL HEAD
  • sample treatments required (e.g. GOLD tubes, PURPLE tubes, RPMI/DMEM, RNAlater, hyaluronidase)
  • any other special instructions for acquisition and processing

NB – if available at the time, OMB may collect other samples. These can be made available to you by application/amendment
Request – end of recruitment / Please indicate the anticipated end of recruitment or sample/data acquisition phase, if there is one
Resources – prospective OMB consent / Will you need OMB Core Staff to take prospective OMB consent?
If providing your own staff for prospective OMB consent, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin consent duties
Resources – prospective sample acquisition / Will you need OMB Core Staff to attend sample retrieval (e.g. in theatre), to pick up samples (e.g. from clinic), and/or to check samples into OMB systems?
If providing your own staff for sample acquisition, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin acquisition duties
Resources – sample processing in the OMB laboratory / Will you need OMB Core Staff to perform any sample processing before transfer to researchers, or before storage in OMB facilities?
If providing your own staff for sample processing, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin processing duties
Resources – OMB storage / Will you need OMB Core Staff to place samples physically into OMB’s storage facilities?
If providing your own staff for OMB storage, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin storage duties
Resources – sample transfer / Will you need OMB Core Staff to check samples out from OMB systems and release them to your researchers?
If providing your own staff for sample transfer, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin release duties
Resources – prospective data acquisition / Will you need OMB Core Staff to collect data (either by direct contact with the patient, or indirectly via identifiable questionnaires or clinical records)?
If providing your own staff for data acquisition, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin data acquisition duties
Resources – data release / Will you need OMB Core Staff to anonymise and release data to your researchers?
If providing your own staff for data anonymisation and release, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin data release duties
APPLICATION UNDER OMB PROTOCOL
Complete this part if your own REC-approved protocol does not specifically quote OMB as a source of the samples/data being requested
OMB ADC – project background / Please summarise the background to this access request
OMB ADC – research hypotheses / Please summarise the research hypotheses you wish to address with this access request
OMB ADC – research questions / Please summarise the research questions you wish to answer with this access request
OMB ADC - outcomes / Please indicate the primary and (if relevant) secondary outcome variables of this access request
OMB ADC - statistics / Please state if this is intended as a pilot project, or else provide details of your proposed analytical approach and the power calculations supporting your requested number of samples/patients.
Advisors are published at in the For Researchers section
OMB ADC – own staff consent / If consenting using your own staff under the OMB Protocol, please indicate how you intend to address the following components of consent within the limits of the OMB Protocol:
  • liaising with the clinical care team to identify patients from the NHS pool
  • ensuring the Patient Information Leaflet is received>24h ahead of consent
  • approaching patients and dealing with their questions
  • avoiding the stress reported by patients when consented immediately before transfer to theatre

NB – if consenting only via NOC POAC, simply stating “NOC POAC” is sufficient, because it is a well-established mechanism
OMB ADC – other processing / If not specified elsewhere, please detail any special processing that you require OMB Core Staff to perform before release of samples to you, or before storage in OMB’s facilities
OMB ADC – downstream methods / Please detail methods and model systems you intend to use once samples have been transferred to you
e.g. expansion in cell culture, ELISA, flow cytometry
OMB ADC – downstream storage location / After transfer to you, where will samples be stored?
e.g. -80 monitored freezer in the Botnar Research Centre
OMB ADC – downstream storage administration / Please detail how you intend to track and ensure security of samples/data transferred to you, so that you may accurately submit Annual Reports to OMB
OMB ADC – downstream transfer / Please detail any third parties to whom you might subsequently wish to transfer samples/data, and why
e.g. provision of analytical service, collaboration
NB - parties outside the University or Trust will require an MTA if performing a service. Parties wishing to retain samples for research will also need to submit a separate OMB request in order to fulfil ethical, IP, and financial requirements
OMB ADC – first manuscript / Please indicate an anticipated date of first manuscript
OMB ADC – key references / Please provide key references supporting your hypotheses
STORAGE-ONLY SERVICE
Complete this part if requesting OMB to store material under your own active protocol
Service – storage-only / Please indicate how you envisage the number of samples being stored
IN TOTAL – number of samples stored is the total number
PERIODIC – number of samples stored is the number at any random moment
Service – storage-only samples / For each type of sample to be stored by OMB for you under your active protocol, please specify in the timeframe indicated above:
  • roughly how many
  • WHOLE SAMPLES or ALIQUOTS
  • size, mass, or volume of each sample or aliquot (e.g. 1 ml, at least 5 mm)
  • whether FRESH, FROZEN, FIXED, FFPE BLOCKS, SECTIONS (or other specified format)
  • the type of tissue (e.g. SERUM, CARTILAGE)

Service – storage-only pre-processing / Please detail what pre-processing of samples, if any, you may require OMB to perform before storage under your own active protocol
PLEASE REMEMBER to attach your current protocol, approval letter, and (if applicable) sponsor approval
Resources – sample processing in the OMB laboratory / Will you need OMB Core Staff to perform any sample processing before transfer to researchers, or before storage in OMB facilities?
If providing your own staff for sample processing, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin processing duties
Resources – OMB storage / Will you need OMB Core Staff to place samples physically into OMB’s storage facilities?
If providing your own staff for OMB storage, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin storage duties
Resources – sample transfer / Will you need OMB Core Staff to check samples out from OMB systems and release them to your researchers?
If providing your own staff for sample transfer, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin release duties
ADOPTION SERVICE
Complete this part if requesting OMB to adopt samples/data from your biobank/expiring ethics
Service – adoption of samples / For each type of sample to be adopted by OMB, please specify:
  • how many
  • WHOLE SAMPLES or ALIQUOTS
  • size, mass, or volume of each sample or aliquot (e.g. 1 ml, at least 5 mm)
  • whether FRESH, FROZEN, FIXED, FFPE BLOCKS, SECTIONS (or other specified format)
  • the type of tissue (e.g. SERUM, CARTILAGE)
  • source of the tissue (if not obvious, e.g. TIBIAL PLATEAU, FEMORAL HEAD)
  • sample treatments used (e.g. GOLD tubes, PURPLE tubes, RPMI/DMEM, RNAlater, hyaluronidase)

PLEASE REMEMBER to attach your current protocol, approval letter, and (if applicable) sponsor approval
Service – adoption further release / Once adopted, samples become part of the OMB collection. Do you wish to be consulted about the samples’ further release to researchers?
Resources – OMB storage / Will you need OMB Core Staff to place samples physically into OMB’s storage facilities?
If providing your own staff for OMB storage, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin storage duties
NON-RESEARCH REQUESTS
Complete this part if requesting samples for technique development or quality assurance
Non-research – samples / For each type of sample, please specify:
  • how many
  • WHOLE SAMPLES or ALIQUOTS
  • size, mass, or volume of each sample or aliquot (e.g. 1 ml, at least 5 mm)
  • whether FRESH, FROZEN, FIXED, FFPE BLOCKS, SECTIONS (or other specified format)
  • the type of tissue (e.g. SERUM, CARTILAGE)
  • source of the tissue (if not obvious, e.g. TIBIAL PLATEAU, FEMORAL HEAD
  • any other special instructions for handling before storage or transfer

Non-research – intended use / Please provide details of any procedures, techniques and/or equipment that the samples will be used to improve/validate/develop
Non-research – disposal / For how long do you require the samples, and how will they be disposed of?
Non-research – special instructions / If not specified elsewhere, please detail any special handling required before release of samples to you, or before storage
Resources – prospective OMB consent / Will you need OMB Core Staff to take prospective OMB consent?
If providing your own staff for prospective OMB consent, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin consent duties
Resources – prospective sample acquisition / Will you need OMB Core Staff to attend sample retrieval (e.g. in theatre), to pick up samples (e.g. from clinic), and/or to check samples into OMB systems?
If providing your own staff for sample acquisition, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin acquisition duties
Resources – sample processing in the OMB laboratory / Will you need OMB Core Staff to perform any sample processing before transfer to researchers, or before storage in OMB facilities?
If providing your own staff for sample processing, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin processing duties
Resources – OMB storage / Will you need OMB Core Staff to place samples physically into OMB’s storage facilities?
If providing your own staff for OMB storage, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin storage duties
Resources – sample transfer / Will you need OMB Core Staff to check samples out from OMB systems and release them to your researchers?
If providing your own staff for sample transfer, please list their names
The OMB Protocol/Licence requires these staff to be trained and signed off by OMB before they begin release duties

DECLARATION

All individuals involved in your request must sign the following declaration