ProstOmics - DNA methylation v2

• HMB DUO:0000006 (version: 2021-02-23)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.
• COL DUO:0000020 (version: 2021-02-23)collaboration requiredThis data use modifier indicates that the requestor must agree to collaboration with the primary study investigator(s).
• IRB DUO:0000021 (version: 2021-02-23)ethics approval requiredThis data use modifier indicates that the requestor must provide documentation of local IRB/ERB approval.
• TS DUO:0000025 (version: 2021-02-23)time limit on useThis data use modifier indicates that use is approved for a specific number of months.
• PS DUO:0000027 (version: 2021-02-23)project specific restrictionThis data use modifier indicates that use is limited to use within an approved project.
• IS DUO:0000028 (version: 2021-02-23)institution specific restrictionThis data use modifier indicates that use is limited to use within an approved institution.

NTNU Data Access Policy for “ProstOmics: spatial and bulk multi-omics of prostate cancer” datasets archived in Federated EGA Norway

1. Data Access Committee A Data Access Committee (DAC) is a body of one or more named individuals who are responsible for data release to external requesters based on consent and/or National Research Ethics terms. Each dataset submitted by the Norwegian University of Science and Technology (NTNU) for archival and controlled access sharing in Federated EGA Norway, has a DAC appointed by NTNU to govern controlled access to the dataset according to this Data Access Policy. Multiple datasets may be affiliated to a single DAC. NTNU as an institution has the overall data controller responsibility, and has appointed a DAC based on proper internal procedures that ensures involvement of institutional functions such as Data Protection Officer, legal control, etc. 2. Data use conditions To advise any would-be requester on how the data can be used, Data Use Ontology codes (DUO) is associated to each dataset, providing the requester more insights into which terms for sharing and use of the data that applies, and that needs to be addressed as part of the communication with the DAC in a data access request. No access to a NTNU dataset deposited in FEGA Norway can be granted to a requester before all applicable conditions and requirements for the use and management of the data have been agreed upon in a signed Data Access Agreement. All research projects that include information from ProstOmics must comply with the EU’s General Data Protection Regulation (GDPR). This means that the processing must have approval from the Regional Committee for Medical Research in Norway (REC). Furthermore, the processing needs legal basis according to GDPR Article 6 and 9. The applicant must have considered the need for a Data Protection Impact Assessment (DPIA) according to GDPR article 35. The applicant must prove that these requirements have been met before the data can be made available. Disclosure of information to countries outside the EU requires that the conditions in GDPR are met. 3. Data Access Agreement The Data Access Agreement (DAA) will include requirements specific for both the dataset and the management of the data in the hands of the requester applying for access, and will thus be an individual DAA for each case of granted access to a dataset. As a rule, a DAA for a NTNU dataset will take the form of a Data Transfer Agreement. 4. Processing of requests for access The overall data access approval process at NTNU can be summarized as follows: · DAC for an NTNU dataset is contacted by a potential data requester · DAC continues communication with requester to understand the purpose of use, i.e. research setting the dataset is envisioned for by requester, to identify if data sharing is possible directly under current conditions for the dataset, or actions such as updating ethical approvals or new patient consent is needed to accommodate the proposed research setting/data use. · A Data Access Agreement is jointly formulated and agreed upon, with the DAC following internal NTNU procedure to include the Data Protection Officer and Division for research support. · When a completed DAA has been signed between the parties, and archived at NTNU, the DAC will provide the requester with access by either instructing the FEGA Norway node to release the data to the requester or by facilitating access to analyzing the data in HUNT Cloud).