miRNA and mRNA transcriptome data

This Data Access policy provides access to the managed access datasets generated by Dr Carlos Perez-Sanchez, Dr Ariana Barbera Betancourt, Prof. Kenneth Smith, and Dr Paul Lyons, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ.

This Data Access Agreement governs the terms of access to the managed access datasets generated by Dr Carlos Perez-Sanchez, Dr Ariana Barbera Betancourt, Prof. Kenneth Smith, and Dr Paul Lyons, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ, UK (the “Data” as defined below). In signing this agreement, you agree to be bound by the terms and conditions of access set out therein. For the sake of clarity, the terms of access set out in this agreement apply to the User and to the User Institution(s) (as defined below). Definitions Data: The managed access datasets of the RNA-Seq component for the “miR-374a-5p regulates inflammatory genes and monocyte function in inflammatory bowel disease” project. Data Producer(s): Dr Carlos Perez-Sanchez, Dr Ariana Barbera Betancourt, Prof. Kenneth Smith, and Dr Paul Lyons University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ, UK, responsible for the development, organisation, and oversight of the Data. External Collaborator: A collaborator of the User, working for an institution other than the User Institution(s) (see below for definitions of User and User Institution(s)). 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 having contributed data for research purposes. User: An applicant (principal investigator), having signed this Data Access Agreement, whose User Institution has co-signed this Data Access Agreement, both of them having received acknowledgement of its acceptance. User Institution(s): Institution(s) at which the User is employed, affiliated or enrolled. A representative of it has co-signed this Data Access Agreement with the User and received acknowledgement of its acceptance. Terms and Conditions: In signing this agreement: 1. The User and the User Institution(s) agree to only use the Data for the objectives and analyses outlined in section G. 2. The User and the User Institution(s) agree to preserve, at all times, the confidentiality of the Data. In particular, they undertake not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Research Participants. 3. The User and the User Institution(s) agree 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 and the User Institution(s) agree not to link or combine the 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 and the User Institution(s), or is freely available without restriction. 5. The User and the User Institution(s) agree not to transfer or disclose the Data, in whole or part, or any material derived from the Data, to anyone not listed in section C “Names of authorised personnel” or D “Names of authorised students” of this application form, except as necessary for data safety monitoring, national audits or programme management. Should the User or the User Institution(s) wish to share the Data with an External Collaborator, the External Collaborator must complete a separate Application for Access to the Data. 6. The User and the User Institution(s) agree that the Data producers, and all other parties involved in the creation, funding or protection of the Data: a) make no warranty or representation, express or implied as to the accuracy, quality or comprehensiveness of the 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 the Data or from the unavailability of, or break in access to, the Data for whatever reason and; c) bear no responsibility for the further analysis or interpretation of these Data. 7. The User and the User Institution(s) agree to follow the Fort Lauderdale Guidelines included as Appendix I of this agreement and the Toronto Statement included as Appendix II of this agreement. This includes but is not limited to recognizing the contribution of the Data Producer(s) and including a proper acknowledgement in all reports or publications resulting from the User and the User Institutions use of the Data. 8. The User and the User Institution(s) agree to follow the Publication Policy available as Appendix III of this agreement. This includes respecting the moratorium period for Data Producers to publish the first peer-review report(s) describing and analyzing the Data. 9. The User and the User Institution(s) agree not to make intellectual property claims on the Data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of the Data, or conclusion drawn directly from the Data. 10. The User and the User Institution(s) can elect to perform further research that would add intellectual and resource capital to the data and decide to obtain intellectual property rights on these downstream discoveries. In this case, the User and the User Institution(s) agree 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) in conformity with the Organisation for Economic Co-operation and Development Guidelines for the Licensing of the Genetic Inventions (2006). These two policies (NIH and OECD) are included as Appendix IV and V of this agreement. 11. The Data was partly funded by the Wellcome Trust with the charitable objective of improving health. If results arising from the User and the User Institution(s) use of the Data could provide health solutions for the benefit of people in the developing world, the User and the User Institution(s) agree to offer non-exclusive licenses to such results on a reasonable basis for use in low income and low-middle income countries (as defined by the World Bank) to any party that requests such a license solely for uses within these territories. 12. The User and the User Institution(s) agree to destroy/discard the Data held, once it is no longer used for the project described in this application form, unless obligated to retain the data for archival purposes in conformity with national audits or legal requirements. 13. The User and the User Institution(s) will update the List of Authorized Personnel to reflect any changes or departures in researchers, collaborators and personnel within 30 days of the changes made. 14. The User and the User Institution(s) must notify the Data Producer(s) prior to any significant changes to the protocol of the User (as described in section I.G. “Research Project”). 15. The User and the User Institution(s) will notify the Data Producer(s) as soon as they become aware of a breach of the terms or conditions of this agreement. 16. The User and the User Institution(s) accept that this agreement may terminate upon any breach of this agreement from the User, the User Institution(s) or any authorised personnel mentioned in section C. “Names of authorised personnel” or D. “Names of authorised students” of this application document. In this case, The User and the User Institution(s) will be required to destroy/discard any Data held, including copies and backup copies. This clause does not prevent the User and the User Institution(s) from retaining the data for archival purpose in conformity with national audits or legal requirements. 17. The User and the User Institution(s) accept that it may be necessary for the Data Producer(s) or their appointed agent to alter the terms of this agreement from time to time. In this event, the Data Producer(s) or their appointed agent will contact the User and the User Institution(s) to inform them of any changes. 18. If requested, the User and the User Institution(s) will allow data security and management documentation to be inspected to verify that they are complying with the terms of this agreement. 19. The User and the User Institution(s) agree to distribute a copy of this agreement and explain its content to any person mentioned in section C. “Names of authorised personnel” and D. “Names of authorised students section of this application form. 20. 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 the laws of England and Wales and shall be subject to the exclusive jurisdiction of the English courts. I have read and agree to abide by the terms and conditions outlined in the Data Access Agreement. YES (please circle on paper copy) I have read the Appendices listed at the end of this page. YES (please circle on paper copy) Applicant: Name ____________________________(block letters) Title and position ___________________ Institution _________________________ Signature _____________________ Authorized institutional representative: (He/she should be the same person as mentioned under Section I B. Institutional Representative of this data application document): Name ____________________________(blocks letters) Title and position ___________________ Institution ________________________(name of legal entity) Signature______________________ Authorized institutional representative of the Data Producer(s): I attest that the above is in conformity with the access requirements for genotype data in Genome-wide association study of prognosis in Crohn’s disease Project: Name _____________________________ (block letters) Signature ___________________________ Approval number _____________________ Once completed and sent electronically to pal34@cam.ac.uk, a paper copy of this application must be faxed to +44-1223-336846 or mailed to Paul Lyons, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ, UK. Only the paper copy needs to be signed. Appendices do not need to be sent back.