Sequencing of IRIS cohort of young children with severe RSV infection

DATA ACCESS AGREEMENT This Data Access Agreement (hereinafter referred to as the “Agreement”), effective as of [date] (hereinafter referred to as the “Effective Date”) is made by and between: TWINCORE, Zentrum für Experimentelle und Klinische Infektionsforschung GmbH (hereinafter referred to as “TWINCORE”), a research institution based in 30625 Hanover, Germany, Feodor-Lynen-Str. 7. and, […] (hereinafter “referred to as the “User Institution”), a [nationality] company/institution/organization with tax registration number […], based in [city], [country], [address], represented by Ms/Mr. […] that acts in his/her capacity as […]. Dr. […] (hereinafter referred to as the “User”) is employee of the User Institution. RECITALS I. Whereas the User Institution and the User are interested in accessing to the managed access datasets, details of which are set out in the corresponding Application form attached as Appendix. II. Whereas TWINCORE is willing to grant the User and User Institution access to the requested datasets. Now therefore, in consideration of the mutual promises, covenants and conditions set forth herein, the parties agree as follows: 1. Definitions: “Authorized User” refers to employees, affiliated or enrolled staff of the User Institution to whom TWINCORE grants access to the Submitted Data. This includes the individuals listed in the Appendix and any other individuals for whom the User Institution subsequently requests access to the Submitted Data. Details of the initial Authorised Users are set out in Appendix. “Data Subject” refers to the person whose sample has been used to generate Submitted Data. “Project” refers to the research project for which the User Institution has requested access to the Submitted Data. “Submitted Data” refers to the data obtained by TWINCORE and made available to the Authorized User. “Publications” refers to, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. “Research Group” refers to the Research Group Experimental Virology of the TWINCORE. “Research Purposes” refers to 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” refers to the principal investigator who has successfully applied for access to Submitted Data. “User Institution” refers to the organization with which the User is employed, affiliated or enrolled. “Data Access Committee” refers to a body of one or more individuals, named by TWINCORE, granting data release to external requestors. 2. Terms and Conditions of the DAA: This Agreement governs the terms on which access will be granted to the Submitted Data generated by TWINCORE. By signing this Agreement, User and User Institution agree to be bound by the terms and conditions of access set out in this Agreement, as follows: 1. User and User Institution agree to use Submitted Data only for Research Purposes. 2. User and User Institution agree not to use, and not to allow use of, Submitted Data or any part thereof for the creation of products or services for sale or for any commercial purpose, whether sale by User, User Institution or by third parties. 3. User and User Institution acknowledge that the Submitted Data received is anonymized and that the Research Group will under no circumstances provide User and User Institution with any means to identify any Data Subject. User and User Institution agree not to use Submitted Data to identify or contact individual Data Subjects. User and User Institution agree to preserve, at all times, the confidentiality of information and Submitted Data. In particular, User and User Institution undertake not to use, or attempt to use Submitted Data to compromise or otherwise infringe the confidentiality of information on Data Subjects and their right to privacy. 4. User and User Institution agree to ensure that any Authorized Users who have access to Submitted Data comply with all obligations of the present Agreement. User agrees to disclose Submitted Data only to the Authorized Users, who are bound by a duty of confidentiality which is at least as strict as provided for in this Agreement. User and User Institution agree to be responsible for all breaches of confidentiality and of the terms of this Agreement by the Authorized Users. Any change in the User or Authorized Users shall be notified to TWINCORE within 30 days. 5. User and User Institution agree to store Submitted Data on a computer system with adequate security controls that prevent unauthorized access to or loss of Submitted Data and to maintain appropriate control over the Submitted Data. User and User Institution represent and warrant to have in place, and agree that will keep having in place, state of the art technical and organizational security measures preventing unauthorized access and loss of Submitted Data or other forms of unlawful processing of Submitted Data, including without limitation, physical security measures, access controls, security and privacy technologies, security checks in relation to personnel, security incident response management and audit arrangements. User and User Institution agree to notify forthwith the TWINCORE of any violations of the foregoing. 6. User and User Institution represent and warrant without limitation that all required ethico-legal approvals, restrictions and commitments, data subject consent and approval of the pertinent ethical review board, for the proposed use of the Submitted Data have been obtained and adhered to. 7. In the event the Submitted Data is issued to User and User Institution subject to any Data Subject’s restrictions, User and User Institution hereby assume the obligation to abide by these restrictions as their own obligation towards the Data Subject. User and User Institution agree that a Data Subject who has suffered damage(s) as a result of any violation by User and User Institution of pertinent provisions in this Agreement or of applicable legislation, is entitled to receive compensation from User and User Institution for the damage(s) suffered. In the event of such a violation, the Data Subject is also entitled to bring an action before a court within the Data Subject’s jurisdiction. 8. User and User Institution agree not to attempt to link Submitted Data to other information or archive data available for the data sets provided under this Agreement, even if access to that data has been formally granted to User and User Institution, or it is freely available without restriction, without the required consents and approvals. User and User Institution agree to retain control over Submitted Data, and not to distribute Submitted Data provided under this Agreement, in any form, to any third party. 9. The Submitted Data were collected in the framework of the study entitled “Die Rolle genetischer Determinanten des Interferonsystems bei der komplizierten RSV-Infektion im Kindesalter” (“The role of genetic determinants of the interferon system in complicated RSV infection in early childhood”). The purpose of this study was to investigate, by means of genetic analyses and virological characterisation, whether specific genetic factors in the interferon system contribute to the occurrence and severity of respiratory syncytial virus (RSV) infections in children up to five years of age, and to explore associations with clinical outcomes of such infections (“Purpose”). User and User Institution acknowledge and agree that the Submitted Data may only be used for research activities that are within and compatible with this defined Purpose. 10. User and User Institution agree not to transfer, share or disclose Submitted Data, in whole or in part, to or with anybody else, whether or not he or she is affiliated with the User Institution. 11. User and User Institution agree to use Submitted Data only for the Purpose and Project as described in the application form approved by the Data Access Committee. Use of the data for a different project or by another researcher will require a new application and approval. Substantive modification of the original application requires submission of an amendment to the original application. 12. User and User Institution agree to, when analyses result in the discovery of new variants at an individual level that may be associated with a severe course of RSV infection, submit these new variables for archiving with the Research Group. This should be done no later than that the related paper will be submitted for publication. 13. User and User Institution accept that Submitted Data will be reissued from time to time, with suitable versioning. Research Group will inform User and User Institution when a new version of Submitted Data is available. If the reissue is at the request of sample donors and/or subject to other ethical scrutiny, User and User Institution will destroy earlier versions of the Submitted Data. 14. User and User Institution understand and acknowledge that Submitted Data may be protected by copyright, database right and other intellectual property and proprietary rights, and that duplication, sale, licensing or any other form of disposing or distribution or making available, of all or part of the Submitted Data on any media is not permitted. 15. User and User Institution acknowledge that the Submitted Data are made available under this Agreement on the title of un-assignable and non-exclusive access. User and User Institution recognize that nothing in this Agreement shall operate to transfer any rights, including but not limited to intellectual property rights and database rights, in or relating to Submitted Data. If any new intellectual property rights are created through, arising from, or as a result of the use of the Submitted Data by User or Authorised Users, ownership of these intellectual property shall be determined in good faith depending on each party’s relative contribution. TWINCORE will be granted a non-exclusive, royalty-free licence to use such new intellectual property rights for research purpose activities. 16. User and Authorised Users agree to acknowledge in any work based in whole or in part on Submitted Data, the published paper from which the Submitted Data derives, the version of the data, the role and /or contribution of the Research Group and the relevant primary collectors and their funders. Specifically, it needs to acknowledge the funding party RESIST “Funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) under Germany's Excellence Strategy - EXC 2155 - project number 390874280”. User and Authorised Users agree to respect in any publication the mention of the inventors or authors according to applicable Law and commonly accepted conventions for scientific publications. Notwithstanding the foregoing, prior to any disclosure, User and Authorised Users shall submit to TWINCORE, at least thirty (30) days in advance, all intentions to publish or to otherwise disclose the results. TWINCORE shall report in writing, within those thirty (30) days, if it is of the opinion that the protection of the results might be threatened and/or its commercial interests are likely to be prejudiced by the aforementioned publication or disclosure (it shall be understood that the lack of reply in the 30-days period is a tacit approval of the disclosure). In case of prejudice, TWINCORE may request User and Authorised Users to omit confidential information and/or to delay the publication or disclosure to allow proper protection of the results to be disclosed. Such delay shall sufficiently be motivated in writing and shall not exceed sixty (60) additional days, except if otherwise agreed between the parties. 17. User and User Institution agree to destroy the Submitted Data after the resulting paper has been published. Upon destruction of data a written confirmation will be sent to TWINCORE. 18. User and User Institution accept that TWINCORE, the Research Group, the original Submitted Data generators and the funders of the Submitted Data: a) bear no legal responsibility whatsoever for the accuracy, completeness or comprehensiveness of the Submitted Data; and b) accept no liability for direct, indirect, consequential or incidental, damages or losses arising from any use of Submitted Data by anyone, including without limitation any clinical use and any commercial use thereof, or arising from the unavailability of, or break in access to, the Submitted Data for whatever reason. 19. User and User Institution accept that this Agreement will terminate immediately upon any breach of this Agreement by User and User Institution and will be required to destroy any Submitted Data held. 20. User and User Institution accept that it may be necessary to alter the terms of this Agreement from time to time in order to address new concerns. In this event, TWINCORE will inform of any changes and User and User Institution agree that the continued use of Submitted Data shall be dependent on the parties entering into a new version of the Agreement. 21. User will submit a report to the Data Access Committee, if requested, on completion of the research study of the Submitted Data. Such report will include the data resulting from the research study of the Submitted Data. The Data Access Committee agrees to treat the report and all information, data, results, and conclusions contained within such report as confidential information. 22. User and User Institution accept that Submitted Data may be protected by and subject to national and international laws. User and User Institution are responsible for ensuring compliance with any such applicable law with respect to the use and processing of the Submitted Data. The Data Access Committee reserves the right to request and inspect User Institution’s data security and management documentation to ensure the adequacy of data protection measures applied on the Submitted Data. 23. This Agreement shall be governed by and construed under the laws of Germany. With express waiver to any other jurisdiction that may correspond to the parties, any dispute or controversy in relation to, in connection with or resulting from the interpretation, performance, or execution of this Agreement that cannot be solved amicably between the parties shall be submitted exclusively to the courts of Hannover, Germany 24. This Agreement may be executed in two or more counterparts, each of which shall be considered an original instrument. The parties of this Agreement will process personal data of its signatories for the execution of this Agreement until it is in force and after that, until the applicable legal limitation periods. The parties may at any time exercise their rights of access, rectification, erasure, opposition, limitation and portability, through the address of the other party indicated above, as well as submit a claim to the supervisory authority on Data Protection. Each counterpart will be considered a valid and binding original, and all counterparts taken together shall constitute one and the same Agreement. In witness whereof, the parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date. Signed by: Name of User Institution: -------------------------------------------------------------------- Name and affiliation of User (Principal Investigator): Date: -------------------------------------------------------------------- Legal representative of User Institution: Date: (Stamp or seal of User Institution) -------------------------------------------------------------------- Signed by: XXX Name and affiliation of XXX Research Group Principal Investigator: Date: -------------------------------------------------------------------- Legal representative of XXX: Date: (Stamp or seal of XXX) -------------------------------------------------------------------- APPENDIX – APPLICATION FORM APPLICATION FOR DATA ACCESS (to be completed by the Requester) Application for access to data shall be submitted to Prof. Dr. Thomas Pietschmann (thomas.pietschmann@twincore.de) or Prof. Dr. Chris Lauber (chris.lauber@twincore.de). The Data Access Committee will consider the application according to the information received. 1. Name of applicant including affiliation and contact details Name: Institution: Address: Phone number: E-mail address: 2. Details of dataset requested EGA Study and Dataset Accession Number: Description of the specific datasets that are being requested: 3. Purpose and Project Brief abstract of the purpose and the project in which the data will be used. This should include specific details about the use of the data in the Project (500 words max): 4. Feasibility Description of your experience and expertise and how this will be applied to the proposed Project. Include up to 3 citations, major funding sources and identify any collaborator in the Project: 5. Research ethics Information about any ethical issues arising as a result of your research in the Project: 6. Users List of employees, affiliated or enrolled staff of the user institution interested in accessing to the data: Name of user 1: Job Title: E-mail address: Supervisor: EGA Registered User (Yes/No): Name of user 2: Job Title: E-mail address: Supervisor: EGA Registered User (Yes/No): The personal data you provide to the TWINCORE will be processed for considering your application of access to an EGA dataset owned by TWINCORE. Legal entity responsible for processing your data: TWINCORE, Feodor-Lynen-Str. 7, 30625 Hannover, Germany Purpose of the data processing: Management of your application. Legitimation: Activity of public interest. Recipient: Third parties with whom TWINCORE is legally obliged to provide the data. Term: TWINCORE will keep your data until your access to the EGA dataset is in force and, after that, until the applicable legal limitation periods. Rights: You can exercise your rights of access, rectification, erasure, opposition, limitation and portability through the address indicated above or by submitting a claim to the supervisory authority on Data Protection. DPO: Datenschutz@twincore.de I authorize the processing of my data for the indicated purpose by signing the present application form: Signature of the principal investigator who applies for access to the data Name: Date: Signature: [This Data Access Agreement can also be provided as a Word document upon request.]