Southern African Prostate Cancer Study (SAPCS) 70 whole bloods

SAPCS Data Access Committee The SAPCS Data Access Committee (DAC) consists of eight members, including clinicians, pathologists, researchers, local community and consumer representatives. The SAPCS-DAC is under management of a manager. Members will meet monthly (by zoom, when required) to consider requests. Quorum for decision-making will be a minimum of five members and include at least two of the SAPCS Directors. Decisions will be made by consensus. Application Procedures The SAPCS-DAC will consider requests for published data from all researchers. Data will only be released to researchers who can provide a statement of ethics approval from the IRB I Human Research Ethics Committee (HREC) of their host institution to safeguard patient rights. Before submitting a request, applicants are encouraged to confer with the main contact Prof. Hayes to discuss the appropriateness of the data for the proposed study and the feasibility of the request. The following information will be requested in applications for Data access: (i) The applicant's name, institution, email address, (ii) The research question/hypotheses to be tested, (iii) List of data required, (iv) Statistical justification for the number and types of cases required (where applicable), (v) Brief description of the technical approach, (vi) Evidence of the proposed technical approach's prior successful use (where applicable), (vi) IRB/HREC approval number (and copy of approval if requested) to conduct proposed research (external applicants). Decision-making As all data has been generated through peer-reviewed funding mechanisms, research projects may well be underway to address relevant questions, as such, priority will need to be given to already funded SAPCS research efforts. The SAPCS-DAC will make decisions on approval of access to data using the following criteria: (i) The track record of the applicants in the technical approach and likelihood of significant outcomes from the research proposed. (ii) Non-overlap with projects being undertaken by the SAPCS team (except with compelling justification). (iii) Alignment of the research purpose with patient’s informed consent and ethics approval (e.g., restrictions as to commercial research, or other requirements needing additional approval). (iv) Any other restrictions or conditions that may apply to the use or disclosure of the relevant data. The SAPCS-DAC can impose certain restrictions on all approvals, and/or specific restrictions on approvals, as follows: (i) No transfer to third parties allowed (all). (ii) Acknowledgment of the SAPCS in publications/presentations (all). (iii) A report of the results of the research to be provided to DAC after completion (or when requested). (iv) Researchers cannot utilize the data for commercial purposes (all). (v) Approval will not be given that excludes other researchers from accessing data (all). (vi) Approval might be time-limited exclusive rights for a particular research development (particular). After approval by the DAC, the Database Manager will organize for the data to be sent de-identified to the researchers or allow access through an established database. Responsibilities It is the responsibility of the applicants to: (i) Provide a research proposal that justifies the request for data (adequate preliminary data); (ii) consult with a SAPCS Director prior to making an application; (iii) submit an email request to SAPCS-DAC Manager; (iv) obtain appropriate IRB/HREC approval for the use of the data; (v) appropriately acknowledge SAPCS in publications using relevant data. It is the responsibility of Data Access Committee to: (i) Review applications and approve the release of data based on the scientific value of the research proposal that is not in conflict with current SAPCS approved/funded studies; (ii) coordinate data release, (iii) review the completed data and publication.