Whole exome sequencing data of germline and two independent primary leukemias of five patients

Radboud Pediatric Cancer Consortium Data Access Agreement

Radboud Pediatric Cancer ConsortiumData Access Agreement This agreement governs the terms on which access will be granted to the genotype data generated by the Radboud Pediatric Cancer Consortium. In signing this agreement, the undersigned, viz., the scientist(s) (“User”) and the institution acting as the User’s employer (“User Institution”) are agreeing to be bound by the terms and conditions of access set out in this agreement. For the sake of clarity, the terms of access set out in this agreement apply both to the User and the User’s Institution (as defined below). User Institution and User are referred to within the agreement as “You” and “Your” shall be construed accordingly. Definitions: Consortium means the Radboud Pediatric Cancer Consortium.Data means all and any human genetic data obtained from the Consortium, including the Data Subjects’ age, sex and tumour pathology. Explicitly, Data does not include samples or biological materialsData Subject means a person, who has been provided informed consent for the use of biologic material for research. User means a researcher whose User Institution has previously completed this Data Access Agreement and has received acknowledgement of its acceptance. Publications means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. User Institution means the organization at which the User is employed, affiliated or enrolled. Terms and Conditions: In signing this Agreement: 1. You agree to use the Data only for the advancement of medical research, according to the consent obtained from sample donors.2. You agree that You are a laboratory head, principal investigator or departmental chair and take responsibility for the distribution restrictions defined in Section 4 of this Agreement, and use and, protection of the Data by your laboratory. 3. You agree not to use the data from the Consortium or any part thereof for the creation of products for sale or for any commercial purpose. 4. You agree to preserve, at all times, the confidentiality of information and Data pertaining to Data Subjects. In particular, You undertake not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Data Subjects and their right to privacy. 5. You agree not to attempt to link the Data provided under this agreement to other information or archive data available for the data sets provided, even if access to that data has been formally granted to you, or it is freely available without restriction, without specific permission being sought from the relevant access committees.6. You agree not to transfer or disclose the Data, in whole or part, or any identifiable material derived from the Data, to others, including other investigators and laboratories in your institution, except as necessary for data/safety monitoring or program management. Should You wish to share the Data with a collaborator within or outwith the same Institution, the third party must make a separate application for access to the Data. 7. You agree that you have the computation infrastructure and expertise to analyze the Data. 8. You agree to use the data for the approved purpose and project described in your application; use of the data for a new purpose or project will require a new application and approval. 9. You agree that the Data are made available for one (1) year. You agree to destroy the Data after one (1) year. You must re-apply to access the Data after this period. 10. You accept that Data will be reissued from time to time, with suitable versioning. If the reissue is at the request of sample donors and/or other ethical scrutiny, You will destroy earlier versions of the Data. 11. You agree to abide by the terms outlined in the Consortium publication policy (Schedule 1). By signing this agreement, you are agreeing that you will not use the Consortium data in a public presentation or publication for 9 months from the time of data release, or until the data is published by the Consortium, whichever occurs first. 12. You agree to acknowledge in any work based in whole or part on the Data, the published paper from which the Data derives, the version of the data, and the role of the Consortium and relevant primary collectors and their funders. Suitable wording is provided in the Publications Policy given in Schedule 1. 13. You accept that the Consortium, the original data creators, depositors or copyright holders, or the funders of the Data or any part of the Data supplied: a) bear no legal responsibility for the accuracy or comprehensiveness of the Data; and b) accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the Data, or from the unavailability of, or break in access to, the Data for whatever reason. 14. You understand and acknowledge that the Data is protected by copyright and other intellectual property rights, and that duplication of the Data, except as reasonably required to carry out Your research with the Data, or sale of all or part of the Data on any media is not permitted. 15. You recognize that nothing in this agreement shall operate to transfer to the User Institution any intellectual property rights relating to the Data. The User Institution has the right to develop intellectual property based on comparisons with their own data. 16. You accept that this agreement will terminate immediately upon any breach of this agreement by You and You will be required to destroy any Data held. 17. You accept that it may be necessary for the Consortium or its appointed agent to alter the terms of this agreement from time to time in order to address new concerns. In this event, the Consortium or its appointed agent will contact You to inform You of any changes and You agree that Your continued use of the Data shall be dependent on the parties entering into a new version of the Agreement. 18. You agree that you will submit a report to the Radboud Pediatric Cancer Data Access Committee, on completion of the agreed purpose. The Radboud Pediatric Cancer Data Access Committee agrees to treat the report and all information, data, results, and conclusions contained within such report as confidential information belonging to the User Institution. You further agree to provide a copy of any publications arising from the use of the Data to the Radboud Pediatric Cancer Data Access Committee within thirty (30) days of its publication. 19. You accept that the Data is protected by and subject to international laws, including but not limited to the Netherlands Data Protection Act (Wet Bescherming Persoonsgegevens), and that You are responsible for ensuring compliance with any such applicable law. The Radboud Pediatric Cancer Data Access Committee reserves the right to request and inspect data security and management documentation to ensure the adequacy of data protection measures in countries that have no national laws comparable to that which pertain in the European Union. 20. This agreement shall be construed, interpreted and governed by the laws of The Netherlands and shall be subject to the jurisdiction of the competent court in the District of Arnhem, The Netherlands. SCHEDULE 1 Publications Policy The primary purpose of the Radboud Pediatric Cancer Consortium is to identify inherited and tumor-acquired (somatic) genome sequence and structural variants influencing the development and behavior of childhood tumors. Additional objectives include, but are not limited to, the acquisition and analysis of additional genomic data, including epigenetic and gene expression data, data integration, and the development and validation of informatics and analytical solutions appropriate to the scale and nature of the project, as well as use of the data generated to answer important methodological and biological questions studies of tumor biology in general, and specifically related to childhood malignancies. The Radboud Pediatric Cancer Consortium anticipates that data generated from the project will be used by others, such as required for developing new analytical methods, validation of results, and the identification of additional genetic variations and alterations in the data. Authors who use data from the project must acknowledge the Radboud Pediatric Cancer Consortium using the following wording "This study makes use of data generated by the Department of Human genetics at the Radboud University Medical Center. Funding for this project was provided by the KiKa foundation project 127" and cite the relevant primary publication. Users should note that the Radboud Pediatric Cancer Consortium bears no responsibility for the further analysis or interpretation of these data, over and above that published by the Consortium.  For and on behalf of UserEBI Dataset ID: _____________________________________ (*Please note that you need one application per dataset) Name of Applicant(s)*:_____________________________________ _____________________________________ * Must include Laboratory Head, Principal Investigator or Departmental Chair Signature of Applicant(s):___________________________________ _____________________________________ E-mail address of Applicant(s): _____________________________________ _____________________________________ Telephone number Applicant(s):_____________________________________ _____________________________________ Date: _____________________________________  For and on behalf of User InstitutionName of the Information Technology Director of the Institution: ______________________________________ Signature of Institutional or Administrative Authority**: ______________________________________ ** The Institutional or Administrative Authority is equivalent to the individual with the organizational authority to sign for a grant application, otherwise known as the Authorized Organizational Representative (AOR) or the Signing Official Print name: ______________________________________ User Institution:______________________________________ Date:________________________________