Garvan/St Vincent’s Prostate Cancer Tissue and Data

Garvan/St Vincent’s Prostate Cancer Tissue and Data policy

The Tissue/Data Access Committee (TDAC) consists of seven members, including researchers, pathologists, a consumer representative, and a data expert. The committee Manager will be the secretary to the committee and will be the contact person for receiving applications and distributing them to the committee. The committee will meet monthly (either in person or by zoom) to review the Tissue/Data Access application forms (circulated by email) to consider requests. Quorum for decision-making will be a minimum of 4 members and include at least one of the chief Investigators and one Garvan member. Decisions will be made by consensus. Any member of the Committee directly involved in the application, or having a COI with applicants, can provide a view on the application but will not vote or take part in decision-making. Application Procedures The TDAC will consider requests for biospecimens and/or clinical data from all researchers. Biospecimens and associated clinical data from the Database/Tissue Bank will only be released to researchers who can provide a statement of ethics approval from the Clinical Investigation I Human Research Ethics Committee of their host institution in order to safeguard patient rights. The following information will be requested in applications for Data/Tissue access: • The applicant's name, institution, email address and telephone number • The research question/hypotheses to be tested • List of biospecimens or clinical data required • Statistical justification for the number and types of cases required (where applicable) • Brief description of the technical approach (for biospecimen I TMA release) • Evidence of the proposed technical approach's prior successful use (where applicable) • HREC approval number (and copy of approval if requested) to conduct proposed research (external applicants) Before submitting a request/release form, applicants will be encouraged to confer with the Database/Tissue Bank Manager and/or authorized representative to discuss the appropriateness of the biospecimens and/or clinical data for the proposed study and the feasibility of the request. Decision-making The TDAC will make decisions on approval of access to tissue/data using the following criteria: 1. The availability of tissue 2. The track record of the applicants in the technical approach and likelihood of significant outcomes from the research proposed 3. Non-overlap with projects being undertaken by the Prostate Group (except with compelling justification) 4. Alignment of the research purpose with patient’s informed consent and ethics approval (eg restrictions as to commercial research, or other requirements needing additional approval) 5. Any other restrictions or conditions that may apply to the uses or disclosures of the relevant tissue/data The TDAC can impose certain restrictions on all approvals, and/or specific restrictions on particular approvals, as follows: 1. No transfer to third parties allowed (all) 2. Acknowledgment of the Database/Tissue Bank in publications/presentations (all) 3. A report of the results of the research to be provided to TDAC after completion (or when requested) 4. Researchers can freely utilize the tissue/data for non-commercial research, but not for commercial purposes without the approval of TDAC and Garvan’s BD office (all) 5. Approval will not be given that excludes other researchers from accessing tissue/data (all) 6. Approval might be time-limited exclusive rights for a particular research development (particular) After approval by the TDAC, the Database/Tissue Manager will organize for the data and/or biospecimens to be sent de-identified to the researchers. Responsibilities It is the responsibility of the applicants to: • Provide a research proposal that justifies the request for tissue and/or data (adequate preliminary data) • Consult with a researcher on the Tissue/Data Access Committee prior to making an application • Submit a request/release form to the delegated Manager of the Database/Tissue Bank. • Obtain appropriate HREC approval/authorization for the use of tissue/data. It is the responsibility of Tissue/Data Access Committee to: • Review applications and approve the release of tissue and/or data based on the scientific value of the research proposal and the availability of the resource • Coordinate pre-exit examination of biospecimens and/or clinical data • Coordinate biospecimen and/or clinical data release • Review the completed data and publication