Hyperpolarized carbon-13 MRI for very early response assessment of neoadjuvant chemotherapy in breast cancer patients

• HMB DUO:0000006 (version: 2019-01-07)health or medical or biomedical researchThis data use permission indicates that use is allowed for health/medical/biomedical purposes; does not include the study of population origins or ancestry.
• RU DUO:0000014 (version: 2019-01-07)research use onlyThis data use limitation indicates that use is limited to research purposes (e.g., does not include its use in clinical care).

Policy for access to transcriptomic data for hyperpolarized 13C MRI in breast cancer

Guidelines for Access to Gene Expression Data 1. General principles The Data Access Committee for this study will consider applications for access to anonymised expression data generated as a result of the study named “Imaging metabolic heterogeneity in breast cancer using hyperpolarized 13C-MRI”. Access to data will be granted to qualified researchers for appropriate use. A qualified researcher refers to a scientist who is employed, or a student enrolled at, or legitimately affiliated with an academic, non-profit or government institution, or a commercial company. The data are deposited in the European Genome-Phenome Archive (EGA) and access will be granted by application to the Data Access Committee (DAC) for this study. Access to data will be granted to researchers for appropriate use and will be governed by the provisions laid out in the associated informed consent for each cohort or collection, and the terms contained in the Data Access Agreement. The Data Access Committee is concerned only with access to the core, anonymised, expression data generated by this study. The associated clinical/phenotypic information has been provided in the publication (Gallagher et al. Imaging breast cancer using hyperpolarized carbon-13 MRI. Proc Natl Acad Sci U S A 2019). Access is conditional upon the signed agreement by the researcher(s) and the responsible employing Institution to abide by policies related to publication, data disposal, ethical approval and confidentiality. 2. Application procedure Applicants requesting access to data from “Imaging metabolic heterogeneity in breast cancer using hyperpolarized 13C-MRI” will be asked to complete a basic application form and to agree to the terms and conditions laid out in the Data Access Agreement (DAA). The DAA must be signed by the applicant and the relevant Head of Department, Head of Institute, or equivalent. Successful applicants who have access to data will be designated "Registered Users" and will be issued with a username and password by the EGA to enable access to the database. The Committee will consider applications that include named collaborators, but each Institution must sign a separate Data Access Agreement. Should you wish to share the data with additional collaborators not previously approved, they must make a separate application for access to the Data. Applicants agree to use the data for the approved purpose and project described in the application; use of the data for a new purpose or project will require a new application and approval. 3. Membership of the Data Access Committee Carlos Caldas, University of Cambridge and Cancer Research UK Ferdia Gallgher, University of Cambridge, UK Jean E Abraham, University of Cambridge, UK Ramona Woitek, University of Cambridge, UK 4. Assessment Criteria Each application will be assessed to determine if: • It has been submitted by a qualified researcher or researchers, embedded in a recognised research institution that can provide institutional responsibility for appropriate research governance • The project described constitutes 'biomedical research' in the context of the consent process, and is likely to be understood as such by the sample donors • It breaches any of the ethical permissions or restrictions in the consent forms for any component cohort or collection • It has the potential to produce information that will enable identification of individual participants • That PhD students include details of their research supervisors In considering applications, the DAC have clarified their policies in regard to specific data access requests. The Committee has agreed that: • DAC does NOT attempt to peer review the scientific quality of proposals. However, it does ask for a brief summary of the research to be undertaken, in order to judge whether it falls within the scope of the consents. It also considers that grossly inadequate research is ethically questionable, and reserves the right to refer back for clarification those requests that do not appear to attain even a minimal standard of competence • Unless specifically restricted in the consent documents for a particular collection or cohort, the use of data by commercial companies for commercial purposes is permissible. 5. Data Available Please visit www.ebi.ac.uk/ega to view the datasets available