RNA sequencing dataset of mesothelioma CONFIRM study

Southampton Clinical Trials Unit Omics Research Programme Data Access Policy POLICY DESCRIPTION This policy governs controlled access to genomic, transcriptomic, clinical and associated phenotypic datasets generated by clinical trials and translational research programmes managed through Southampton Clinical Trials Unit and deposited within the European Genome-phenome Archive (EGA). These datasets may contain human genomic and clinical information which could potentially contribute to participant re-identification if used inappropriately. Access is therefore controlled to protect participant confidentiality, comply with ethical approvals and informed consent, and satisfy applicable legal and regulatory requirements. The purpose of this policy is to define the principles, requirements and conditions under which authorised researchers may access and use these data. It establishes the criteria and process by which the Data Access Committee (DAC), acting on behalf of the relevant Trial Sponsor, Data Controller and/or Data Custodian, assesses and approves requests for access to controlled data. Access will only be granted where the proposed use is consistent with the applicable participant consent, ethical and research governance requirements, the approved research purpose, and any trial-specific data sharing commitments. Approved users must comply with the conditions of access set out in this policy and any associated Data Access Agreement, including requirements relating to confidentiality, data security, permitted use, prohibition of participant re-identification or contact, data retention and destruction, and appropriate dissemination of research findings. This policy is intended to facilitate responsible and scientifically valuable secondary research while maintaining the confidentiality, integrity and appropriate governance of participant data. DATA ACCESS APPLICATION REQUIREMENTS Applicants must provide sufficient information for the DAC to assess the proposed use of the data, including: • Full name and institutional affiliation(s). • Proposed project title and description. • Datasets requested and justification for access. • Proposed research objectives and analyses. • Names and roles of members of the research team who will access the data. • Proposed duration of access. • Confirmation of ethics approval, exemption, or other applicable governance arrangements. • Agreement to enter into and comply with any required Data Access Agreement. • Confirmation of appropriate data security arrangements. Access will only be granted to appropriately qualified researchers affiliated with a bona fide research organisation and where the proposed use of the data is consistent with the applicable participant consent, ethical approvals, research governance requirements and this Data Access Policy. EGA accounts are individual and must not be shared. Only individuals named in the approved application and authorised by the DAC may access the data. DAC REVIEW AND OVERSIGHT All applications are reviewed by the Southampton Clinical Trials Unit Omics Data Access Committee (DAC). The DAC will consider: • Whether the applicant and their institution are appropriately qualified and bona fide. • Whether the proposed research is scientifically justified. • Whether the proposed use is consistent with participant consent and the applicable ethical and governance requirements. • Whether the requested data are appropriate and proportionate to the proposed research. • Whether adequate confidentiality and data security safeguards are in place. • Whether the proposed use complies with this policy and any trial-specific data sharing requirements. The DAC may approve, approve subject to conditions, reject, or request clarification or modification of an application. Where the proposed research, intended use of the data, or membership of the research team changes substantially after approval, the changes must be submitted to the DAC for review and approval before implementation. ACCESS RESTRICTIONS AND PERMITTED USES 1. Data may only be used for the specific research purpose, objectives and analyses described in the approved data access application. 2. Applicants should request only those datasets, variables and data elements necessary to achieve the approved research objectives. 3. Data users must not attempt to identify or re-identify any participant. 4. Data must not be linked with external datasets or other information in a manner that could increase the risk of participant identification. 5. Data must not be redistributed, shared or transferred to third parties. 6. Commercial use is not permitted unless it is permitted by the applicable participant consent and explicitly approved by the DAC. 7. Data obtained through the EGA must be stored and processed using secure systems appropriate to the sensitivity of the data. Access must be restricted to authorised members of the approved research team. 8. The applicant is responsible for ensuring that all members of the approved research team comply with this policy and the applicable Data Access Agreement. 9. Data users must comply with all applicable laws and regulations including UK GDPR and the Data Protection Act 2018 where applicable. 10. Any substantial change to the proposed research purpose, methodology, research team or intended use of the data must be submitted to the DAC for review and approval before implementation. 11. Any proposed use outside the scope of the approved application requires further approval from the DAC and may require a new application. RESPONSIBILITIES OF APPROVED USERS Approved users must maintain data securely, restrict access to authorised personnel, use data only for the approved project, report suspected breaches, appropriately acknowledge originating studies, and securely delete data when access expires. DATA RETENTION AND DESTRUCTION Access to data will be limited to the period required for the approved research project. At the end of the approved access period, or where access is withdrawn, the applicant must securely delete or otherwise dispose of downloaded copies of the data in accordance with the Data Access Agreement. Where continued retention is required by applicable legislation, regulatory requirements, active publication processes, research integrity requirements or ongoing approved project activities, the data must remain securely stored and must not be used for any purpose outside those permitted under the approved data access arrangements. Retention of data for future or unrelated research purposes is not permitted without further approval from the DAC. PUBLICATION AND ACKNOWLEDGEMENT Research findings arising from the use of data accessed under this policy should appropriately acknowledge and reference the originating trial(s), Trial Sponsor, funding bodies and Southampton Clinical Trials Unit, as applicable. Where members of the originating trial team have made a substantive contribution to the research or resulting publication, authorship should be considered in accordance with applicable authorship guidance and any relevant trial-specific agreements.   Applicants should provide the Southampton Clinical Trials Unit with a copy or citation of publications and other significant public outputs arising from the approved use of the data when available.   The DAC or Southampton Clinical Trials Unit may request an opportunity to review proposed publications or other public outputs before submission or presentation where necessary to identify potential breaches of confidentiality, inappropriate disclosure, misuse of the data or failure to comply with the conditions of access. Such review will not be used to restrict the publication of scientifically valid findings. ETHICAL AND LEGAL COMPLIANCE   All data governed under this policy will have been collected under appropriate ethical approvals, participant consent processes and research governance arrangements.   Access and use of the data must remain consistent with the applicable participant consent, ethics requirements, sponsor requirements, data protection legislation, EGA governance requirements and any other applicable legal and regulatory requirements.   The applicant is responsible for ensuring that the proposed research is appropriately authorised within their own institution and jurisdiction. BREACH, SUSPENSION AND WITHDRAWAL OF ACCESS   Any actual or suspected breach of this policy or the applicable Data Access Agreement must be reported promptly to the DAC and, where applicable, the relevant Trial Sponsor, Data Controller and institutional data protection or information security contacts.   The DAC may suspend or withdraw access where there is evidence of misuse, non-compliance, a data security incident, a material change to the approved research or research team, or where continued access is no longer considered appropriate.   Where access is suspended or withdrawn, the applicant must cease use of the data and securely delete all downloaded copies. The applicant may be required to confirm destruction of the data in accordance with the Data Access Agreement and applicable requirements.