Researcher FAQs - Ontario Tumour Bank

Researcher FAQ

About Products and Services

What de-identified clinical information comes with the biospecimen?

Ontario Tumour Bank can collect data on more than 400 clinical elements and collects follow-up data for each case at six-twelve months, three years and five years. Follow-up data (e.g., progression, vital status) can be quickly obtained by request.

The basic level of de-identified clinical information that accompanies the specimen includes: age at time of collection (suppressed to 5-year range), biological sex, the pathological diagnosis, histopathology data and staging.

Additional clinical information can be requested about a patient donor given the availability of this data. The basic data set can be supplemented with: patient history, family history, outcome information, systemic therapy, radiotherapy, comprehensive surgical data and toxicity.

May I request a copy of Ontario Tumour Bank’s Standard Operating Protocols (SOPs)?

Researchers are welcome to request a copy of a specific SOP to ensure that the materials are processed and stored in a manner that is compatible with their intended experimental procedures.

Ontario Tumour Bank has, from time to time, also shared full SOPs with other biobanks to share knowledge and best-practices. For full access to biobanking SOPs, we would also like to suggest that biobankers seek out the excellent resources at www.biobanking.org and www.ctrnet.ca.

What is Ontario Tumour Bank?

See “About the OTB.”

Ontario Tumour Bank (OTB) is a biorepository and databank comprised of four (4) member hospitals in Ontario (London Health Sciences Centre, St. Joseph’s Healthcare Hamilton, The Ottawa Hospital, and Unity Health Toronto). OTB provides human tissue, peripheral blood, and derivative products with de-identified clinical data to academic and industry-based researchers around the world. OTB is a program of the Ontario Institute for Cancer Research which is funded by the Government of Ontario.

How does Ontario Tumour Bank manage quality?

See “Quality Measures.”

Ontario Tumour Bank has a long-standing commitment to quality and is certified under the Canadian Tumour Repository Network (CTRNet) certification program. Operations are consistent with international best practices (ISBER Best Practices 4th Ed.), with audit systems in place to ensure compliance and regular testing to assure quality. Dedicated staff control the process, from obtaining consent to collection, storage and data management. This enables Ontario Tumour Bank to bank consistently high-quality samples and clinical data while protecting patient-donor safety and privacy. Stringent quality control over samples and data is continuously enforced. Moreover, personnel at the collection centres are trained monthly on technical updates.

What types of human biospecimens are available?

See “What We Offer” and “Products and Services.”

Sample Types and Preparation:

Fresh frozen tumour tissue and normal-adjacent tissue (~250 mg/vial, of the regions immediately surrounding tumours);
Slides, wax sections and paraffin-embedded tissue blocks;
Cryopreserved plasma (1 ml/vial), cell-free plasma (1 ml/vial) and buffy coat (~250µl/vial).

Note that Ontario Tumour Bank does not provide cells or cell cultures, pediatric biospecimens, or “control” biospecimens from healthy volunteers.

Did the people whose tissue is stored in Ontario Tumour Bank provide consent to banking their tissue?

Yes. All of Ontario Tumour Bank’s donors participate through informed consent.

What types of derivative products or services are available?

See “What We Offer” and “Products and Services.”

DNA from paraffin sections (by request);
DNA from buffy coat (blood);
RNA from fresh frozen tissue (by request);and
Tissue microarrays (sections or whole block) (pre-made or custom by request).

Does Ontario Tumour Bank have research ethics approval to collect and store biospecimens?

Yes. Ontario Tumour Bank maintains ongoing approval from the research ethics boards at each of the participating hospitals.

How are the frozen biospecimens obtained to preserve quality?

As part of our standard tissue procurement protocol, samples are typically flash-frozen within 30 minutes after surgical resection and stored in the vapour-phase of liquid nitrogen below minus 180^oC. Fat and necrotic regions are avoided. All common pre-analytical variables are accurately recorded for each sample, so that researchers can select precisely the right samples for their study.

How long do you fix your samples? What fixative do you use?

Fixed samples are preserved in formalin using routine clinical protocols at each of our member hospitals. When excess tissue is available after we have banked a fresh frozen sample, tissue can be fixed then processed and embedded in paraffin to form cassettes.

Can I confirm histology before I request a sample?

Yes. Ontario Tumour Bank stores a high-resolution Aperio scan of an H&E slide for each case, which is available to researchers who wish to confirm histology of the biospecimen as part of the biospecimen selection process.

How are blood samples collected and processed?

Blood is drawn into a standard lavender-top EDTA vial and processed within 24 hours. Plasma, CNA (circulating nucleic acid) plasma and buffy coat blood fractions are stored in the vapour-phase of liquid nitrogen below minus 180^oC.

What types of human biospecimens are available from OTB?

Sample Types and Preparation

Fresh frozen tumour tissue and normal-adjacent tissue (~250 mg/vial, of the regions immediately surrounding tumours);
Slides, wax sections and paraffin-embedded tissue blocks;
Cryopreserved plasma (1 ml/vial), cell-free plasma (1 ml/vial) and buffy coat (~250µl/vial).

OTB does not currently provide cells or cell cultures or pediatric biospecimens.

Request Process and Terms of Use

What is the request process and how long does it take?

See “How Do I Request Samples?”

The process is:

Detailed sample search based on your study requirements (1 – 2 days, or rarely 1-2 weeks if the request is complex);
Submission of sample request application, research ethics board approval letter and a signed Material Transfer Agreement (timing is researcher-dependent);
Review by Ontario Tumour Bank (OTB) through the Material Access Review Committee . If there are any questions that arise from the review, they will be returned to the researcher promptly to address (1-3 weeks);
Selection of samples by researcher based on review of online slide images from paraffin blocks (researcher-dependent);
Shipment of de-identified clinical data followed by couriered shipment of samples (48 hours and 1 week). Processing of derivative products may require additional time, though is typically completed on a priority basis within one month.

If you are applying for funding for a research project, OTB can provide a non-binding report on availability and/or a Letter of Understanding for inclusion in your submission.

Do I need ethics approval?

All research requests must be compliant with ethics regulations and standards. This typically means that research applications for biospecimens and clinical data must be accompanied by research ethics board approvals of the research study. While Ontario Tumour Bank has research ethics approval for the collection and storage of biospecimens, further approval specific to each individual project is required to permit OTB to transfer custody of the biospecimens to the recipient researcher. This is a requirement per the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, version 2 (TCPS2) available here.

Obtaining ethics approval from your institutional research ethics board (REB) should be straightforward and quick. As there is no further or direct contact with the donor patients and the data is de-identified (i.e., “codified”), the review is categorised as “minimal risk”. Such REB applications are typically reviewed through an “expedited delegated review” as opposed to a “full board review”. It has been our experience that well prepared REB applications can obtain ethics approval in as little as one to three weeks.

If the research project takes longer than one year to complete, proof on ongoing renewal of research ethics approval is required.

What is MARC?

All research applications are subject to further review and approval by an internal Material Access Review Committee (MARC). MARC is comprised of volunteer committee members with expertise in pathology, clinical science, translational science, and statistics who review research proposals for scientific robustness to ensure best use of Ontario Tumour Bank’s (OTB) biospecimens. This is a requirement under OTB’s existing research ethics approval.

What if I want to use the left-over biospecimens in another project?

Sometimes there are materials left-over from a research project that may be useful in a second project by the same researcher. Because this is a new project, the researcher will need to provide new proposal for review and valid ethics approval letter for the new project.

What if I need more biospecimens for the same project?

Researchers requesting additional samples from their initial application must submit a letter on institutional letterhead addressing the need and justification for additional samples and is subject to approval by Ontario Tumour Bank. Ethics approval and the MTA may also require amendments.

Can I transfer biospecimens and/or data to an external collaborator?

Yes, under certain conditions and with permission from OTB. Collaborators at institutions external to yours will not be covered under your research ethics approval and will be required to submit their own. This is a requirement found in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, version 2 (TCPS2). A different Material Transfer Agreement structure will be used specific to the nature of the collaborator relationship.

Can I transfer biospecimens and/or data to a third-party service provider?

Yes, under certain conditions. A different Material Transfer Agreement structure will be used specific to the nature of the third-party relationship. Please note: If the third party would potentially be included as an author on any publications or patents arising from the research, then the third party is a “collaborator” as opposed to a “third-party service provider” and is subject to different conditions (see above).

May I link data I receive from Ontario Tumour Bank with other clinical data about the patients?

Proposed data linkages must be included in the research plan (i.e., application form) and approved by the research ethics board, the privacy officer, and Ontario Tumour Bank in order to minimise the risk of creating a data-set that could be used to potentially re-identify individuals.

What happens if a donor chooses to withdraw from the tumour bank program?

If a participant wishes to withdraw from the study and no longer wants their tissue and data retained by Ontario Tumour Bank (OTB), any remaining tissue and/or blood samples in OTB’s inventory will be returned to the pathology department of the participating hospital, where they will be destroyed along with any paper and electronic data that accompany it. No further information will be collected. However, data or samples that have already been distributed to researchers cannot be recalled.

Do I need to acknowledge Ontario Tumour Bank in publications?

Yes. While researchers are not required to include Ontario Tumour Bank (OTB) as authors on publications, OTB must be acknowledged in all publications and presentations of studies utilizing the biospecimens and to provide a copy of all publications and/or abstracts of presentations to OTB as a courtesy. Researchers are required to use the following wording: Biological materials were provided by Ontario Tumour Bank, which is supported by the Ontario Institute for Cancer Research through funding provided by the Government of Ontario.

Costs and Shipping

Who pays for shipping?

The recipient researcher is responsible for all shipping charges. Ontario Tumour Bank can use either your carrier’s account number or can use its own and provide an invoice for the charges.

How much do biospecimens cost?

See “Researcher Overview” for details. The cost of samples and data depends on the type of specimen preparation and the depth of clinical data required, and the category of researcher (e.g., commercial vs. academic, local vs. international). Access fees for academic researchers are deeply subsidized to below cost. Please contact Ontario Tumour Bank directly for pricing details and/or a detailed quote customized to your research needs.

How is the data transferred and how is patient privacy protected?

Data is transferred securely to recipient researchers electronically. A link to a data portal is provided by email accessible with a unique password.

Ontario Tumour Bank (OTB) has technical, administrative and physical safeguards in place to protect personal health information (PHI). Modern security technologies and controls are used to protect the privacy and integrity of information during transfer, storage and use. Data is encrypted during transmission and stored on secured servers. The Ontario Institute for Cancer Research (OICR) has extensive privacy and security policies in place that limit access and disclosure of data. All PHI is de-identified before it is made accessible to researchers. De-identified PHI is provided to researchers who have a valid research ethics board approval for their research study and only if their application is approved by the OTB. Researchers who access the samples and data must agree that they will not attempt to re-identify the participant.

What couriers does Ontario Tumour Bank use?

Physical materials are shipped to researchers by FedEx and FedEx Priority Alert, WorldCourier or Cryoport. The carrier choice is dependent on the nature of the biospecimens included in the shipment and the geographic location of the recipient.

Non-Ontario Researchers

Does Ontario Tumour Bank serve researchers outside of Ontario?

Yes. Ontario Tumour Bank provides samples to researchers worldwide.

What are the costs to non-Ontario researchers?

See “Researcher Overview.”

Fees are typically subsidised to below-cost for academic researchers worldwide; however, they are not as subsidised as much as for Ontario researchers. Please contact Ontario Tumour Bank directly for pricing details and/or a detailed quote customised to your research needs.

Do I need ethics approval?

Yes. Even if ethics approval would not be required in your own region, because the biospecimens originate from Ontario patients, Canadian and Ontario regulation and standards apply.

Canadian academic researchers can obtain ethics approval through their research ethics board (REB) or institutional review board (IRB).

If your country does not have an established research ethics process in place, you may obtain research ethics review through a private commercial research ethics review board. Please contact us if you require assistance.

Obtaining ethics approval should be straightforward and quick. As there is no further or direct contact with the donor patients and the data is de-identified (i.e. “codified”), the review is categorized as “minimal risk”. Such REB or IRB applications are typically reviewed through an “expedited delegated review” as opposed to a “full board review”. It has been our experience that it can take as little as one to three weeks to obtain ethics approval with a well prepared application.

If the research project takes longer than one year to complete, proof on ongoing renewal of research ethics approval is required.

How is shipping managed internationally?

Samples held at room-temperature (i.e., FFPE sections) are shipped via FedEx.

Frozen materials are shipped via WorldCourier, which has excellent cold-chain procedures to ensure the materials stay frozen for the full duration of shipping.

Alternatively, samples may be shipped on request with Cryoport, in liquid-nitrogen dry-shippers.

How are your frozen samples procured?

As part of our standard tissue procurement protocol, samples are typically flash-frozen within 30 minutes after surgical resection and stored in vapour-phase liquid nitrogen (VPLN).

Commercial Researchers

Does Ontario Tumour Bank serve commercial researchers?

Yes. Ontario Tumour Bank serves industry researchers and commercially funded researchers.

Is my information kept confidential?

Yes. Ontario Tumour Bank (OTB) will not share details about your research project or transaction with any outside organization. All staff and affiliates of OTB, e.g., Material Access Review Committee members, are bound through a non-disclosure confidentiality agreement to the Ontario Institute for Cancer Research (OICR). If further protection is needed, a confidentiality agreement between OTB/OICR and your organization may be obtained.

What are the costs to commercial researchers?

See “Researcher Overview.”

Access fees extended to commercial researchers are not subsidised. Please contact the Ontario Tumour Bank directly for pricing details and/or a detailed quote customized to your research needs.

Do I need ethics approval?

Yes. Because the biospecimens originate from a Canadian academic institution, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, version 2 still applies. A research ethics review can be obtained through a private commercial research ethics review board. Please contact us if you require assistance.

Obtaining ethics approval should be straightforward and quick. As there is no further or direct contact with the donor patients and the data is de-identified (i.e., “codified”), the review is categorized as “minimal risk”. Such research ethics board REB or institutional review board (IRB) applications are typically reviewed through an “expedited delegated review” as opposed to a “full board review”. It has been our experience that it can take as little as one to three weeks to obtain ethics approval with a well prepared REB (or IRB) application. Applications through a private REB or IRB can take as little as three days.

If the research project takes longer than one year to complete, proof on ongoing renewal of research ethics approval is required.

How much do samples cost?

The cost of samples and data depends on the type of specimen preparation and the depth of clinical data required. For an estimate, please contact OTB directly.