Targeted DNA sequencing dataset for the study "Molecular profiling of EBV associated diffuse large B-cell lymphoma"

Data access policy for data in the study "Molecular profiling of EBV associated diffuse large B-cell lymphoma"

DATA ACCESS AGREEMENT between Westfälische Wilhelms-Universität Münster, represented by the Rector, Prof. Dr. Johannes Wessels, acting on his behalf, the Commercial Director of the University Hospital of Münster, Dr. Christoph Hoppenheit, Albert-Schweitzer-Campus 1, Gebäude D5, 48149 Münster, Germany Performed by: Medical Clinic A, Albert-Schweitzer-Campus 1, Gebäude A1, 48149 Münster Head of Medical Clinic A: Prof. Dr. Georg Lenz Investigator: Dr. Fabian Frontzek hereinafter collectively referred to as “MedA UKM” and <User Institution> Hereinafter referred to as “User Institution” These terms and conditions govern access to the managed access datasets (details of which are set out in Appendix I) to which the User Institution has requested access. The User Institution agrees to be bound by these terms and conditions. Definitions Authorised Personnel: The individuals at the User Institution to whom MedA UKM grants access to the Data. This includes the User, the individuals listed in Appendix II and any other individuals for whom the User Institution subsequently requests access to the Data. Details of the initial Authorised Personnel are set out in Appendix II. Data: The managed access datasets to which the User Institution has requested access. Data Producers: MedA UKM and the collaborators listed in Appendix I responsible for the development, organisation, and oversight of these 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 these Data. A description of the Project is set out in Appendix II. Publications: Includes, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. Research Participant: An individual whose data form part of these Data. Research Purposes: Shall mean research that is seeking to advance the understanding of genetics and genomics, including the treatment of disorders, and work on statistical methods that may be applied to such research. User: The principal investigator for the Project. 1. The User Institution agrees to only use these Data for the purpose of the Project (described in Appendix II) and only for Research Purposes. Data will not be used for any other purpose or for any commercial purposes. The User Institution further agrees that it will only use these Data for Research Purposes which are within the limitations (if any) set out in Appendix I. 2. The data provided is anonymized. The User Institution agrees to preserve, at all times, the confidentiality of these Data. In particular, it undertakes not to use, or attempt to use these Data to compromise or otherwise infringe the confidentiality of information on Research Participants. Without prejudice to the generality of the foregoing, the User Institution agrees to use at least the measures set out in Appendix I to protect these Data. 3. The User Institution agrees to protect the confidentiality of Research Participants in any research papers or publications that they prepare by taking all reasonable care to limit the possibility of identification. 4. The User Institution agrees not to link or combine these Data to other information or archived data available in a way that could re-identify the Research Participants, even if access to that data has been formally granted to the User Institution or is freely available without restriction. 5. The User Institution agrees only to transfer or disclose these Data, in whole or part, or any material derived from these Data, to the Authorised Personnel. Should the User Institution wish to share these Data with an External Collaborator, the External Collaborator must complete a separate application for access to these Data. The disclosure of Data to External Collaborators requires MedA UKM’s prior consent. 6. The User Institution agrees that MedA UKM, other Data Producers, and all other parties involved in the creation, funding or protection of these Data: a) make no warranty or representation, express or implied as to the accuracy, quality or comprehensiveness of these Data; b) exclude to the fullest extent permitted by law all liability for actions, claims, proceedings, demands, losses (including but not limited to loss of profit), costs, awards damages and payments made by the Recipient that may arise (whether directly or indirectly) in any way whatsoever from the Recipient’s use of these Data or from the unavailability of, or break in access to, these Data for whatever reason and; c) bear no responsibility for the further analysis or interpretation of these Data. 7. Notwithstanding User Institution`s confidentiality obligations, User Institution will have the right to publish and disclose the final results of the research based on the Data. In order to balance this right with MedA UKM`s proprietary interests, User Institution will submit for MedA UKM`s review all manuscripts, abstracts or presentations intended for publication or other public disclosure (“Publications”) at least forty-five (45) days prior to the date of submission for publication or public disclosure for the sole intent of removing any MedA UKM confidential information from the Publication. MedA UKM will provide any comments to User Institution within forty-five (45) days of receipt of the Publications. The User Institution agrees to use the Data in compliance with all applicable statutes and regulations, including Public Health Service and National Institutes of Health regulations and guidelines. 8.The User Institution agrees to follow the Publication Policy in Appendix III. 9. The User Institution agrees not to make intellectual property claims on these Data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of these Data, or conclusion drawn directly from these Data. 10. The User Institution can elect to perform further research that would add intellectual and resource capital to these data and decide to obtain intellectual property rights on these downstream discoveries. In this case, the User Institution agrees to implement licensing policies that will not obstruct further research and agrees to notify the MedA UKM upon filing for intellectual property rights. If applicable, User Institution and MedA UKM will enter into a separate collaborative agreement to govern the terms of any such intellectual property. 11. The User Institution agrees to destroy/discard the Data held, once it is no longer used for the Project, unless obliged to retain the data for archival purposes in conformity with audit or legal requirements. 12. The User Institution will notify MedA UKM within 30 days of any changes or departures of Authorised Personnel. 13. The User Institution will notify MedA UKM prior to any significant changes to the protocol for the Project. 14. The User Institution will notify MedA UKM as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. MedA UKM may terminate this agreement by written notice to the User Institution. If this agreement terminates for any reason, the User Institution will be required to destroy any Data held, including copies and backup copies. This clause does not prevent the User Institution from retaining these data for archival purpose in conformity with audit or legal requirements. 16. The User Institution accepts that it may be necessary MedA UKM to alter the terms of this agreement from time to time. As an example, this may include specific provisions relating to the Data required by MedA UKM. In the event that changes are required, MedA UKM will contact the User Institution to inform it of the changes and the User Institution may elect to accept the changes or terminate the agreement with a period of 2 weeks after receipt of the changes. If the changes are accepted MedA UKM and User Institution will enter into a written amendment documenting such changes. 17. If requested, the User Institution will allow data security and management documentation to be inspected to verify that it is complying with the terms of this agreement. 18. The User Institution agrees to distribute a copy of these terms to the Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this agreement. 19. This agreement may be executed in separate counterparts, and delivered electronically (in .pdf format), and when so executed and delivered shall be an original and all such counterparts shall together constitute one and the same instrument. 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 UKM Signature:   Name:   Title:   Date:   I confirm that I have read and understood this Agreement. Signature:   Name:   Title:   Date:   Signature:   Name:   Title:   Date:   APPENDIX I – DATASET DETAILS APPENDIX II ––PROJECT DETAILS APPENDIX III –– PUBLICATION POLICY APPENDIX I – DATASET DETAILS Dataset reference (EGA Study ID and Dataset Details) Name of project that created the dataset Names of other data producers/collaborators N/A Specific limitations on areas of research These data are for non-profit use only. Redistributing these data to any other group is forbidden. Commercial development using these data is forbidden. Commercial entities are forbidden from access to the data. Safeguards to protect patient privacy and data redistribution must be fully described. In some instances, a protocol approved by the institutional review board may be needed to certify the use of the data. Minimum protection measures required File access: Data can be held in unencrypted files on an institutional compute system, with Unix user group read/write access for one or more appropriate groups but not Unix world read/write access behind a secure firewall. Laptops holding these data should have password protected logins and screenlocks (set to lock after 1-5 min of inactivity). If held on USB keys or other portable hard drives, the data must be encrypted. APPENDIX II – PROJECT DETAILS Details of dataset requested i.e., EGA Study and Dataset Accession Number Brief abstract of the Project in which the Data will be used (500 words max) All Individuals who the User Institution to be named as registered users | Name of Registered User | Email | Job Title | Supervisor* | All Individuals that should have an account created at the EGA | Name of Registered User | Email | Job Title | APPENDIX III – PUBLICATION POLICY In any publications based on these data, please cite this study using a reference for a journal article provided by MedA UKM and describe how the data can be accessed, including the name of the hosting database (e.g., The European Genome-phenome Archive at the European Bioinformatics Institute) and its accession numbers, and acknowledge its use in a form agreed by the User Institution with MedA UKM.