Rare germline variants of acute myeloid leukemia patients

Acute myeloid leukemia germline Data Access Committee Data Access Agreement

This agreement governs the terms on which access will be granted to the filtered exome sequencing data of AML germlines (details of which are set out in Appendix I) generated by the Acute myeloid leukemia germline Data Access Committee at the University of Helsinki. In signing this agreement the applicant agrees to be bound by these terms and conditions. The terms of access set out in this agreement apply both to Applicant and Applicant Institution. Definitions Authorised Personnel: The individuals to whom Acute myeloid leukemia germline Data Access Committee grants access to the data. This includes the Applicant, the individuals listed in Appendix II and any other individuals for whom the applicant 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 Applicant has requested access. Data Producers: and the collaborators listed in Appendix I responsible for the development, organisation, and oversight of these Data. External Collaborator: A collaborator of the Applicant, working for an institution other than the Applicant’s institution. Project: The project for which the Applicant 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. Applicant: The principal investigator for the Project. Applicant Institution(s): The Institution that has requested access to the Data. Acute myeloid leukemia germline Data Access Committee: DAC of the Data Terms and Conditions: In signing this Agreement: 1. The Applicant Institution agrees to only use these Data for the purpose of the Project (described in Appendix II) and only for Research Purposes. The Applicant Institution further agrees that it will only use these Data for Research Purposes which are within the limitations set out in Appendix I. 2. The Applicant 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 and their right to privacy. Without prejudice to the generality of the foregoing, the Applicant Institution agrees to use at least the measures set out in Appendix I to protect these Data. 3. The Applicant 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 Applicant 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 Applicant Institution or is freely available without restriction. 5. The Applicant 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 Applicant Institution wish to share these Data with an External Collaborator, the External Collaborator must complete a separate application for access to these Data. 6. The Applicant Institution agrees that the 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. The Applicant Institution agrees to follow the Fort Lauderdale Guidelines (http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtd003207.pdf ) and the Toronto Statement (http://www.nature.com/nature/journal/v461/n7261/full/461168a.html). This includes but is not limited to recognising the contribution of the Data Producers and including a proper acknowledgement in all reports or publications resulting from the use of these Data. 8. The Applicant Institution agrees to follow the Publication Policy in Appendix III. This includes respecting the moratorium period for the Data Producers to publish the first peer-reviewed report describing and analysing these Data. 9. The Applicant 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 Applicant 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 Applicant Institution agrees to implement licensing policies that will not obstruct further research and to follow the U.S. National Institutes of Health Best Practices for the Licensing of Genomic Inventions (2005) (https://www.icgc.org/files/daco/NIH_BestPracticesLicensingGenomicInventions_2005_en.pdf ) in conformity with the Organisation for Economic Co-operation and Development Guidelines for the Licensing of the Genetic Inventions (2006) (http://www.oecd.org/science/biotech/36198812.pdf ). 11. The Applicant 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 Applicant Institution will notify Acute myeloid leukemia germline Data Access Committee within 30 days of any changes or departures of Authorised Personnel. 13. The Applicant Institution will notify Acute myeloid leukemia germline Data Access Committee prior to any significant changes to the protocol for the Project. 14. The Applicant Institution will notify Acute myeloid leukemia germline Data Access Committee as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. Acute myeloid leukemia germline Data Access Committee may terminate this agreement by written notice to the Applicant Institution. If this agreement terminates for any reason, the Applicant Institution will be required to destroy any Data held, including copies and backup copies. This clause does not prevent the Applicant Institution from retaining these data for archival purpose in conformity with audit or legal requirements. 16. The Applicant Institution accepts that it may be necessary for the Data Producers 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 Data Producers other than Acute myeloid leukemia germline Data Access Committee. In the event that changes are required, the Data Producers or their appointed agent will contact the Applicant Institution to inform it of the changes and the Applicant Institution may elect to accept the changes or terminate the agreement. 17. If requested, the Applicant 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 Applicant Institution agrees to distribute a copy of these terms to the Authorised Personnel. The Applicant Institution will procure that the Authorised Personnel comply with the terms of this agreement. 19. This agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this agreement or its formation) shall be construed, interpreted and governed by international laws. APPENDIX I – DATASET DETAILS Dataset reference (EGA Study ID and Dataset Details) EGAS00001002760 Filtered sequencing data of 68 germline exomes (AML patients) covering two gene panels. Name of project that created the dataset Germline alterations of acute myeloid leukemia Names of Data Producers/other collaborators Outi Kilpivaara Ulla Wartiovaara-Kautto Elina Hirvonen Specific limitations on areas of research The Data cannot be used for commercial purposes. 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 5 min of inactivity). If held on USB keys or other portable hard drives, the data must be encrypted. APPENDIX II – PROJECT DETAILS (to be completed by the Requestor) Details of dataset requested i.e., EGA Study and Dataset Accession Number Brief abstract of the Project in which the Data will be used All Individuals to be named as registered users All Individuals that should have an account created at the EGA When submitting this document, please include all pages of the agreement with the signature page APPENDIX III – PUBLICATION POLICY Acute myeloid leukemia germline Data Access Committee intends to publish the results of their analysis of this dataset and do not consider its deposition into public databases to be the equivalent of such publications. Acute myeloid leukemia germline Data Access Committee anticipates that the dataset could be useful to other qualified researchers for a variety of purposes. However, some areas of work are subject to a publication moratorium. The publication moratorium covers any publications (including oral communications) that describe the use of the dataset. In any publications based on these data, please 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 Applicant Institution with Acute myeloid leukemia germline Data Access Committee.