Genomic and transcriptomic profiling of soft tissue sarcoma

DATA ACCESS AGREEMENT These terms and conditions govern access to and processing of the managed-access datasets described in Appendix I, to which the User Institution has requested access. The User Institution agrees to be bound by these terms and conditions and any appendices or addenda attached to this Agreement. 1. Definitions Authorised Personnel The individuals at the User Institution to whom access to the Data has been approved under this Agreement. This includes the User, the individuals listed in Appendix II, and any other individuals for whom the User Institution subsequently requests access and whose access is approved. Data The managed-access datasets described in Appendix I. Data Access Committee or DAC The committee designated from time to time by the Data Producers to review, govern, and decide whether to approve, condition, deny, suspend, or terminate access to the Data for a particular Project. The composition, procedures, and contact details of the DAC may be updated from time to time without amendment of this Agreement. Data Producers The investigators, institutions, and collaborators listed in Appendix I who are responsible for the generation, organization, stewardship, and oversight of the Data. External Collaborator A collaborator of the User working for an institution other than the User Institution. Project The project for which the User Institution has requested access to the Data, as described in Appendix II. Publications Articles, reviews, books, abstracts, posters, oral presentations, preprints, and other written or verbal disclosures of research findings. Research Participant An individual whose data form part of the Data. Research Purposes Research seeking to advance the understanding of genetics, genomics, biology, disease, or treatment, including related statistical or computational methods, in each case subject to the limitations set out in this Agreement and Appendix I. User The principal investigator for the Project. User Institution The institution that has requested access to the Data, together with its Authorised Personnel. 2. Permitted Use The User Institution shall use the Data only for the Project described in Appendix II and only for Research Purposes. The User Institution shall comply with any additional limitations on use described in Appendix I. 3. Confidentiality and Data Security The User Institution shall preserve at all times the confidentiality of the Data and shall implement appropriate administrative, technical, and organizational safeguards to protect the Data against unauthorized access, use, copying, disclosure, alteration, or loss. The User Institution shall use at least the security measures set out in Appendix I. 4. No Re-identification and No Attempt to Obtain Personal Information The User Institution shall not use, and shall not attempt to use, the Data to identify, contact, or infer the identity of any Research Participant. The User Institution shall not attempt to discover, obtain, confirm, reconstruct, or infer personal identifying information relating to any Research Participant, whether directly or indirectly, including by means of linkage, triangulation, matching, or inference. 5. No Linking for Re-identification The User Institution shall not link, combine, merge, compare, or otherwise use the Data together with any other dataset, archive, registry, record, or source of information in any manner that could reasonably be expected to re-identify a Research Participant, even if access to such other information has been lawfully obtained or is publicly available. 6. No Distribution or Onward Transfer The User Institution shall not transfer, distribute, disclose, release, transmit, sublicense, provide remote access to, or otherwise make available the Data, in whole or in part, to any person other than Authorised Personnel approved under this Agreement. If the User Institution wishes to share the Data with an External Collaborator, the External Collaborator or the collaborator’s institution must submit a separate request and receive separate approval for access. 7. Derived Materials The User Institution may generate analyses, summaries, models, and other materials derived from the Data for the approved Project. The User Institution shall not share derived materials outside the User Institution if they contain individual-level data or could reasonably be used to identify a Research Participant or reconstruct protected aspects of the Data. 8. Publications and Acknowledgment The User Institution shall protect the confidentiality of Research Participants in all Publications by taking all reasonable care to limit the possibility of identification. The User Institution shall acknowledge the Data and the Data Producers in Publications in the manner specified in Appendix III and shall describe how the Data may be accessed through the relevant managed-access repository and accession mechanism, where applicable. The User Institution shall comply with the Publication Policy in Appendix III, including any publication moratorium or pre-publication review requirements stated there. 9. No Warranty and Limitation of Responsibility The Data are provided as is. To the fullest extent permitted by applicable law, the Data Producers, the DAC, and all other parties involved in the creation, funding, stewardship, hosting, or protection of the Data make no warranty or representation, express or implied, as to the accuracy, quality, completeness, availability, or fitness for purpose of the Data, and bear no responsibility for the User Institution’s analysis, interpretation, or use of the Data. 10. Intellectual Property The User Institution shall not make intellectual property claims on the Data themselves and shall not use intellectual property protection in any way that would prevent or block access to, or use of, any element of the Data, or conclusions drawn directly from the Data. Nothing in this Agreement prevents the User Institution from seeking intellectual property rights in downstream discoveries arising from independent analysis, provided that such rights are not used to obstruct further research use of the Data. 11. Changes in Authorised Personnel The User Institution shall notify the DAC within 30 days of any additions, changes, or departures of Authorised Personnel. The User Institution shall promptly revoke access for departed personnel. 12. Changes to the Project The User Institution shall notify the DAC before implementing any significant change to the Project, including substantial changes in aims, methods, collaborating institutions, or scope of analysis. Continued use of the Data for a materially changed Project requires prior approval. 13. Breach Notification The User Institution shall notify the DAC promptly upon becoming aware of any actual or suspected breach of this Agreement, unauthorized access, unauthorized disclosure, loss of Data, security incident, or attempted re-identification involving the Data. 14. Termination The DAC may terminate or suspend this Agreement by written notice if it reasonably believes that the User Institution has breached this Agreement or is using the Data outside the approved scope. The User Institution may terminate this Agreement by written notice and discontinuation of use of the Data. 15. Destruction or Retention of Data Once the Data are no longer required for the Project, or upon termination of this Agreement, the User Institution shall securely destroy or delete all copies of the Data in its possession or control, including backup copies to the extent reasonably practicable, unless retention is required for archival, audit, legal, or regulatory purposes. Upon request, the User Institution shall certify destruction or explain the basis for any permitted retention. 16. Changes to Terms The User Institution acknowledges that the Data Producers or the DAC may reasonably amend the terms applicable to access to the Data from time to time to reflect legal, ethical, regulatory, scientific, governance, or security requirements. If material changes are required, the User Institution shall be informed and may elect to accept the revised terms or terminate this Agreement. 17. Compliance Verification If reasonably requested, the User Institution shall provide documentation reasonably sufficient to verify compliance with this Agreement, including documentation relating to data security, access controls, personnel authorization, and destruction or retention practices. 18. Distribution of Terms to Authorised Personnel The User Institution shall provide a copy of this Agreement to all Authorised Personnel and shall ensure that Authorised Personnel comply with its terms. 19. Governing Law This Agreement shall be governed by the laws of [insert governing law]. Any dispute arising out of or in connection with this Agreement shall be subject to the exclusive jurisdiction of the courts of [insert jurisdiction], unless otherwise required by applicable law or agreed in writing by the parties. 20. Signatures Agreed for User Institution Signature Name Title Date Principal Investigator I confirm that I have read and understood this Agreement. Signature Name Title Date Agreed for the Data Access Committee, on behalf of the Data Producers Signature Name Title Date ________________________________________ APPENDIX I – DATA DETAILS Dataset reference EGA Study ID and Dataset accession number(s): [insert] Description of Data The Data are comprised of sequencing data, process metrics, and de-identified clinical and related research data, as further described in the applicable repository records and associated study documentation. Data Producers [insert names of institutions, investigators, and collaborators] Data Access Committee Access requests shall be reviewed and decided by the Data Access Committee acting on behalf of the Data Producers. Current DAC composition and contact details may be updated from time to time without amendment of this Agreement. DAC contact [insert stable DAC email address] Specific limitations on areas of research The DAC may specify additional limitations on areas of research or categories of use with respect to the Data from time to time. The User Institution shall be informed of any such limitations and may elect to accept them or terminate this Agreement. Minimum security requirements The User Institution shall maintain role-based access controls, limit access to Authorised Personnel, use secure institutional systems or equivalently protected environments, and implement reasonable safeguards against unauthorized copying, onward transfer, or disclosure. ________________________________________ APPENDIX II – PROJECT DETAILS Details of Data requested EGA Study and Dataset accession number(s): [insert] Project title [insert] Brief abstract of the Project [insert] Authorised Personnel Name Email Job Title Institution Supervisor [insert table] ________________________________________ APPENDIX III – PUBLICATION POLICY The Data Producers intend to publish analyses of these Data and do not consider deposition of the Data into a managed-access repository to be equivalent to such publication. The Data may be useful to other qualified researchers for a variety of purposes. However, certain areas of work may be subject to a publication moratorium, as follows: No Publication, poster, oral presentation, or other public disclosure describing the use of the Data or results of the Project shall be submitted, posted, or presented until [insert period, e.g. eighteen (18) months] after these Data and analyses derived from them are first made public in manuscript by the Data Producers, unless the DAC has provided prior written consent to earlier submission or presentation. Any Publication based on the Data shall describe how the Data can be accessed, including the name of the hosting database and the applicable accession numbers, and shall include appropriate acknowledgment of the Data and the Data Producers. Where required by the DAC, proposed Publications based substantially on the Data shall be provided to the DAC for confidential review for acknowledgment, compliance with the publication policy, and protection against disclosure of identifying information, within [insert number] days before submission.