Peter MacCallum Cancer Institute has established a Tissue Bank and associated database to facilitate cancer research programs at Peter Mac and at collaborating institutions, now and in the future. The bank collects widely across 20 broad tumour categories. Breast, colon, gastric, leukaemia, lymphoma and prostate tissues are currently our focus of collection. In addition, a blood sample is obtained for each patient together with a rich clinical history. The establishment of the bank provides a co-ordinated and systematic approach to enable access by researchers to information and material from specific cancers. Ethical considerations and patient confidentiality are of paramount importance. The value of the Tissue Bank is substantial by:

Providing a co-ordinated and systematic approach enabling access by researchers to information and material from a bank of specific cancers.

Facilitating the use of innovative techniques such as DNA microarrays, which require tissue that has been freshly frozen, or alcohol fixed for RNA preservation. Formalin fixation is unsuitable.

Establishing a comprehensive clinical history for every tissue so that molecular findings can be correlated with response to treatment and outcome. Primary material can provide essential information on molecular abnormalities in human cancer and the frequency of specific genetic and biochemical changes. The value of such information is augmented greatly when combined with epidemiological, treatment and outcome data.

Tissue is only accepted from patients who have signed Information and Consent Form that address the ethical implications of our work.
Protection of privacy of participating patients is critical. Only the Tissue Bank Manager (TBM) and Assistant have access to identifying information.
Only tissue in excess to that required for pathological assessment and diagnosis is collected.

Patient consent allows for collection of tissue and blood into a central bank. Use of the tissue requires separate ethical approval via Clinical Research Committee and Ethics Committees.

Applications by researchers for material and information must be scientifically sound and make efficient use of the resources available. Where there is shared research intent the researcher must obtain a written permission from the contributor.

The Tissue Bank is not for the exclusive use of its contributors.

The operation of the PMCI Tissue Bank is provided in the attached flow chart and is under the control of the Tissue Research Management Committee (TRMC):

	Chair: Assoc. Professor Ian Campbell	Group Leader, Research (Cancer Genetics)
	Dr David Westerman	Acting Director of Pathology
	Dr Grant McArthur	Consultant Medical Oncologist, DHMO & Group Leader, Research (Molecular Oncology)
	Dr Wayne Phillips	Group Leader, Research (Surgical Oncology)
	Dr John Seymour	Director of Protocol Development in Leukaemia & Lymphoma, DHMO
	Dr Carl Sprung	Research Division
	Dr Sarah Russell	Research Division
	Dr Alvin Milner	Statistician
	Dr Izhak Haviv	Research Division
	Ms Lisa Devereux	Tissue Bank Manager

The role of the TRMC is to: Assess the scientific validity and design of research proposals using human tissue and impact on the resources of the bank. All projects are assessed by the TRMC prior to consideration by the Ethics Committee. Approval from both the TRMC and Ethics committee must be obtained before access to de-identified tissue and information is given.

Informed patient consent and patient follow up are important issues that deserve particular attention.

Patient consent allows the collection of a blood sample and tissue in excess to that required for pathological assessment and diagnosis is collected which would normally be discarded. The blood sample is likely to be valuable for a variety of investigations but the major current applications envisaged are evaluation of new serological tests and germline analysis. Consent to germline testing is outside the scope of the Tissue Bank. Blood samples, as for tumour samples, can only be accessed by researchers once they have gained CRC/Ethics approval. A patient can revoke consent at any time and their tissue/information will be discarded appropriately.

The following comments are made in support of our strategy of non-project based collection of samples for tissue banking and refer to recent recommendations made in NATIONAL STATEMENT ON ETHICAL CONDUCT IN RESEARCH INVOLVING HUMANS, Commonwealth of Australia 1999. ISBN 1864960434.

The NH&MRC guidelines generally require re-consent of patients when samples, consented and collected for a specific project, are to be used for a new projects. However, re-consent must consider the psychological harm that follow up may cause patients or their relatives, and the difficulty of obtaining consent from patients who had cancers with high mortality rates, such as gastric, pancreatic, ovarian, neurological cancers. Collection and consent based on specific projects greatly limits the potential utility of stored samples for future studies. If patients must be consented for each new project as it arises, we must accept that many studies that new findings or technologies suggest in the future will not be possible or will be greatly delayed if only prospective collection for defined studies is allowed.

We argue that to obtain maximum benefit from the use of tissue samples a two step process is adopted, where patients are consented for collection without specifying in detail a given project and, at the outset, they consent to institutional ethics committees regulating use of the material. This arrangement has precedent in the guidelines, where paragraphs 16.10 j, 16.12 and 16.16 describe specific provisions that allow for storage of samples for future use. Our experience is that patients who consent to sample collection are very keen to see that the maximum benefit can be obtained from their tissue.

There may be circumstances where use of tissue bank material yields results that affect patient treatment or are of significance to the patient's family. The patients are asked to consent to follow up and also to provide a nominee if they can't be contacted. Specific projects that make use of the tissue bank material can only proceed if processes for feedback are in place, as part of the ethical approval of the project.

Investigators are required to report their findings to the tissue bank management committee (TBMC) at the conclusion of a study, or at any time they become aware of results that have implications for individual patients. Any findings that the TBMC feels have implications for patients will be forwarded to both the ethics committees to decide on next steps. The TBMC will provide scientific input on any findings of patient health significance. If it decides it is clear that information has been obtained that the patient or their family may wish to learn more about, the Ethics Committee would advise the doctor and provide an appropriate letter for the patient. The investigator may be asked to continue keep the Ethics Committee informed, if additional supportive evidence is deemed necessary before further action is taken. Publication or intention to publish findings will provide a useful guide to the veracity of the findings.

Patients notified of potentially important results would be counselled in a family cancer clinic, prior to the provision of the feedback, as allowed for in the Guidelines (16.16). If information of relevance to family members is obtained, we propose to adopt the principle outlined in the Guidelines, whereby consent to contact family members will be first obtained from the patient providing the tissue sample. In cases where the patient has died we will contact the patient's nominee.

The Tissue Bank Manager liases with participating surgeons and is notified when tissue is available for collection. The Tissue Bank Assistant will collect the material at surgery or at the pathology department. Clinical information will be provided from patient records by surgeons and pathologists. The TBM will coordinate collection and entry of the information into the Tissue Bank Database.

Fresh tissue (tumour and normal) and a 20ml EDTA blood sample are processed as shown in the flow chart.

The Tissue Bank database has been developed using MS Access. The database computer is a Microsoft Windows 2000 Server with directory level security implemented to provide protection both from the network and unauthorised local access. Only the Tissue Bank Manager and Assistant have access to identifying information in the database. A web interface will allow researchers to view de-identified data.

Access the Tissuebank Database here ...

Applications by researchers for material and information must be scientifically sound and demonstrate that the material will be used efficiently. Applicants must describe the proposed research in detail and demonstrate availability of funds for the proposed research. If the proposed work has not achieved grant support through a peer reviewed process, the TBMC will forward the report for external peer review.

Applications are submitted to the TBM and scientifically reviewed by the TBMC. The committee will assess whether the application comprises a scientifically justifiable, feasible and high priority use of the material currently available. The TBMC will not circumvent the normal CRC and Ethical Committee approval process. Access to material from the bank will require approval of the CRC and Ethics committees and the applicant must seek this ethical approval. Where required, permission to use material will be obtained from the contributor by the TBM.

On approval, the Tissue Bank Manager provides the researcher with tissue. Researchers may already have an ethics approved protocol to collect and analyse tumour material that predates the establishment of the Tissue Bank. In such cases the researcher must obtain ethics committee consent to use this protocol for material collected into the central bank.

Researchers must provide a research report on the use of the Tissue Bank to the TBM, who produces the annual newsletter.

View Application Form -(PDF Document)