Projects that use the resource fall into two general categories: i) Projects initiated by members of the Manitoba Breast Cancer Research Group and other academic researchers in Manitoba, ii) Projects initiated by external academic users in Canada, in the USA, and in Europe. For both categories access to the MBTB involves
three phases described below. Local academic users receive first priority. However, the MBTB design and philosophy has ensured that for over more than a decade of operation, external users have almost equivalent access.
Process
- Formal applications for access are required for all users. The application form includes a) the investigator CV, b) sources of funding, c) description, design and justification of study, d) techniques to be used, e) the type and extent of data (histological, pathological and clinical) requested, f) evidence or plan for ethical review board approval, g)
commitment to terms and conditions for use of material. Applicants are encouraged to discuss and refine project details (such as specific case selection criteria and assay protocols to maximize efficient use of invaluable tissue samples) with the director, prior to submission.
- Applications are reviewed by the MBTB Access Review Committee Committee that comprises the principal investigators of the University of Manitoba Breast Cancer Research Group and individuals with medical, and surgical oncology expertise. Review also encompasses the Pathology Access to Tissue Committee (PACT) on all applications that access paraffin blocks, and from the Cancer Care Manitoba Data Access committee on all applications that access clinical data. Criteria for review include the background and credentials of the investigator, evidence of peer reviewed and preferably national funding, high scientific quality and merit, and evidence of
appropriate ethical review. The MBTB review panel considers ethical and confidentiality issues with respect to appropriate justification and equitable use of a rare resource donated by patients. However in accordance with TCPS and local REB policies, all applications are subject to documentation of appropriate and expert institutional REB approval. Projects are rated as supportable, supportable with reservations, or unsupportable.
- After review all applicants are notified of the panel decision and those that are supportable are asked to provide i) institutional and investigator signatures attesting to commitment to the terms of support, which include conditions on the secondary use of materials provided and recognition of MBTB support in publications arising from use of the material (see application form in appendix) and ii) documentation of appropriate institutional Research Ethics Board (REB) approval for the project.
- Prior to release of selected study materials, users are then sent a small test batch of tissues in the appropriate assay format (eg sections in tubes or on coated slides) to test courier mail ‘connections’ and the capability of the laboratory to successfully conduct their assays on MBTB material. Only after confirmation of successful receipt and performance of the relevant assay(s) on MBTB material is the study set finally sectioned and released in batches. Cases are identified only by an anonymous MBTB number. No clinical or demographic information (eg that concerns patient or family history or treatment center) that might compromise anonymity is released.
|
