- What is Ontario Tumour Bank?
- How much tissue and blood will be taken if a patient volunteers to participate?
- What type of PHI does OTB collect and from whom is this information collected?
- How does OTB use PHI? Why is this information required?
- How is patient privacy protected and the confidentiality of PHI maintained?
- How does Ontario Tumour Bank support cancer research? To whom and for what purposes will the samples and de-identified clinical data be released?
- How are the samples and the de-identified clinical data obtained by researchers?
- Can patients decide not to participate in OTB? Will this affect their care and treatment?
- If a breakthrough in cancer research is made as a result of OTB will the participants benefit personally?
- Where can I get more information about the Ontario Tumour Bank?
- Will participants have the results of their samples returned to them?
- Whom can I speak to if I have questions about OTB’s information practices and privacy program?
- Who owns and operates Ontario Tumour Bank?
- Which hospitals are participating in the recruitment of participants and in the collection of samples and personal health information (PHI) for OTB?
Ontario Tumour Bank (OTB) was established in response to a growing need for a provincial tissue and data bank to support cancer research. OTB is a multi-centred program that collects blood and tissue samples as well as personal health information (PHI) from consenting volunteer participants.
OTB is a source of high quality samples and data for researchers to conduct cancer research. The outcomes of the research studies are expected to contribute to the provision of health care for cancer patients by providing information that may lead to an increased understanding of the disease, and the development of new diagnostic tools and therapies.
Generally when cancer surgery is performed, the tumour tissue that is removed is examined by a doctor (pathologist) who prepares a report to assist with the diagnosis of the disease and to plan for future treatment. Only a portion of the tissue that is removed is required for examination. If a patient agrees to be a donor for the tumour bank, a small sample of the tissue is collected for OTB. Only excess, leftover tissue that typically would be discarded is collected for OTB. The blood sample that is collected is up to three tablespoons of blood. If possible, this will be collected at the same time as other routine blood tests are being conducted.
OTB collects PHI via patient consent at participating hospital collection centres, which are classified as ‘health information custodians’ (HICs) under the Personal Health Information Protection Act, 2004 (PHIPA). PHI that is collected from the patient health record includes demographic information (e.g., age, sex), details of the cancer diagnosis (e.g., type of cancer, grade, stage), treatment details, patient and family history of cancer and other risk factors, and outcome information concerning the progression of the disease or the disease-free status.
OTB does not perform research and therefore does not use, disclose or retain PHI or de-identified data for its own research purposes. The use, disclosure and retention of personal health information that is collected by OTB, is for the stated purpose, which is to maintain a high quality registry of patient-donated biospecimens and accompanying clinical data for the facilitation of cancer research. To fulfill this purpose, OTB may disclose PHI to Cancer Care Ontario (CCO) for the purpose of linking the PHI collected at the participating hospitals to additional information that is in the custody and control of CCO (e.g., data within the Ontario Cancer Registry, the provincial cancer registry). This disclosure is permitted under s. 49 of the Act and allows for more accurate and comprehensive information to be provided to researchers. CCO is designated as a ‘prescribed entity’ under PHIPA and therefore this disclosure by OTB to CCO of the PHI that it collects is permitted under PHIPA.
The OTB maintains one data holding of PHI, which is housed at OICR. OICR considers all PHI in its custody and control to be highly sensitive and implements appropriate safeguards to protect the privacy of individuals whose PHI is received and to maintain the confidentiality of that information. Steps are taken to protect PHI against theft, loss, and unauthorised use or disclosure, and to protect records of PHI against unauthorised copying, modification or disposal.
The safeguards in place include:
- Administrative safeguards: e.g., privacy and information security policies and procedures, privacy and information security training for staff, access to PHI on a “need to know” basis, disclosures of de-identified clinical data only (no PHI) for research purposes;
- Technical safeguards: e.g., firewalls, separation of networks, secure servers, password/account user authentication, data encryption, audit logs, backup and recovery systems;
- Physical safeguards: e.g., secure facilities with monitored access, secure work areas.
OTB discloses de-identified clinical data and samples to researchers for the conduct of cancer research. “De-identified” means that it is not reasonably foreseeable in the circumstances that the information could be utilized, either alone or with other information, to identify an individual. As such, OTB does not permit PHI (identifying health information) to be disclosed to researchers under any circumstances. Approved researchers will be provided with samples and with de-identified clinical data to conduct their research. The outcomes of the research studies are expected to contribute to the provision of health care for cancer patients by providing information that may lead to an increased understanding of the disease, and the development of new diagnostic tools and therapies. Examples of the outcomes of research studies may include: the development of tests for the detection of cancer; the identification and role of proteins that may signify the presence of cancer; and the discovery of new therapies to treat cancer. Since research methods are evolving very quickly, it is difficult to know all of the possible future uses for the samples.
De-identified clinical data and samples are made available only to qualified researchers. No information that may directly identify the participant (such as name, date of birth, and medical record number) will be released to researchers. All researchers wishing to obtain samples and de-identified clinical data must apply to OTB with a valid research ethics board approval letter for their research study. OTB then reviews and approves the application and ensures that a Material Transfer Agreement (MTA) be signed between OICR and the researcher. This agreement includes provisions to ensure that the researcher will maintain the confidentiality of the information and will not attempt to re-identify the participant.
Participation in OTB, which includes the donation of samples and PHI, is completely voluntary. Participants who agree to participate are asked to sign a consent form. The care and treatment of patients who decide not to participate in OTB will not be affected.
Participants who sign the consent form are free to choose to limit their participation at any time, and are free to withdraw their consent without penalty or effect on their ongoing or future care or treatment.
If a participant wishes to withdraw from the study, any remaining samples will be returned to the pathology department of the participating collection centre (hospital), where they will be destroyed. All associated health information will be deleted from Ontario Tumour Bank information system and any associated paper files will be securely destroyed. No further health information will be collected. The destruction of samples and data that have already been distributed to a researcher will not be possible.
Participants will not benefit directly from participating in the tumour bank project, but participation in this project will enable researchers to conduct research that may provide new knowledge that will help cancer patients in the future.
Information about individual samples will not be provided to the participant, the participant’s family nor to health care providers.
In the rare case that information that comes from an individual sample is determined to be of medical significance, the Research Ethics Board at the collection centre (hospital) where the sample was collected may authorise the participant’s physician to contact the participant. This would be done only if there were a high likelihood of benefit to the participant or to the participant’s family.
Questions or concerns related to OTB’s information practices or privacy program should be submitted in writing and addressed to the OICR Privacy Officer, as set out below. All inquiries will be dealt with in a timely fashion.
A complaint regarding OTB’s compliance with PHIPA, 2004 and its regulation may be directed to the Information and Privacy Commissioner of Ontario:
Information and Privacy Commissioner/Ontario
2 Bloor Street East, Suite 1400
Canada M4W 1A8
Telephone: 416-326-3333 or 1-800-387-0073
OTB is one of several programs of the Ontario Institute for Cancer Research (OICR), a not-for-profit corporation that is funded by the Ontario Government. OICR is an innovative cancer research institute with a focus on prevention, early detection, diagnosis and the treatment of cancer.
Under section 39(1)(c) of the Personal Health Information Protection Act, 2004 (PHIPA), the Ministry of Health and Long-Term Care has prescribed OICR in respect of OTB as a registry of personal health information. To fulfill this role, OICR has implemented policies, procedures and practices to protect the privacy of individuals whose personal health information it receives and to maintain the confidentiality of that information. These policies, procedures and practices are subject to review and approval by the Office of the Information and Privacy Commissioner of Ontario (IPC) every three years.
Hospital Collection Centres:
- Kingston Health Sciences Centre (Kingston, Ontario);
- London Health Sciences Centre (London, Ontario);
- St. Joseph’s Healthcare Hamilton (Hamilton, Ontario);
- The Ottawa Hospital (Ottawa, Ontario).