Multi-platform genome sequencing of families with rare disease

The Jackson Laboratory Data Access Agreement --Non-negotiable-- This Data Access Agreement (“Agreement”) governs the terms on which access will be granted to the Data, which are available through the European Genome-phenome Archive (EGA) under study EGAS50000001464 and provided by The Jackson Laboratory. In acknowledging and signing this Agreement, You and the User Institution are agreeing to be bound by the terms and conditions of access set out in this Agreement. User Institution and User are referred to within the Agreement as “You” and “Your”. DEFINITIONS: • “Data” means the managed access datasets made available by Data Provider to which the User and User Institution have requested access through the EGA. • “Data Subject” means a person whose data is being shared with informed consent/ethical approval by the relevant ethics commission or institutional review board. • “Data Provider” means The Jackson Laboratory. • “EGA” means the European Genome-phenome Archive, a permanent archive of controlled access data generated for biomedical research and deposited to enable data sharing. The EGA is described on the website http://www.ebi.ac.ukl/ega. • “Project” means the project for which the User and User Institution have requested access to the Data. A description of the Project is set out below. • “Research Purposes” shall mean internal non-commercial 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(s)” means a researcher(s) who, with their User Institution, has executed this Data Access Agreement and has received acknowledgement of its acceptance from The Jackson Laboratory. • “User Institution” means the organization at which the User is employed, affiliated or enrolled. Terms and Conditions: In acknowledging and signing this Agreement: 1. You agree to use the Data only for internal non-commercial Research Purposes in furtherance of the Project. 2. 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. For example, You agree not to undertake any efforts to identify the Data Subjects. Data may be held in unencrypted files on an institutional computer system, behind a secure firewall, with Unix user group read/write access for one or more appropriate groups, but not Unix world read/write access. Laptops holding the Data should have password protected logins and screen-locks (set to lock after 5 min of inactivity). If held on USB keys or other portable hard drives, the Data must be encrypted. 3. The User Institution agrees to protect the confidentiality of Data Subjects in any research papers or publications that they prepare by taking all reasonable care to limit the possibility of identification. The User Institution agrees not to link or combine the Data to other information or archived data available in a way that could re-identify the Data Subjects, even if access to that data has been formally granted to the User Institution or is freely available without restriction. 4. You agree not to transfer or disclose the Data, in whole or part, or any identifiable material derived from the Data, to others, except as necessary for data/safety monitoring or program management. Should You wish to share the Data with a collaborator outside Your Institution, the third party collaborator must make a separate application for access to the Data and sign this Agreement. 5. You agree to use the Data for the approved Research Purpose and Project described in your application; use of the Data for a new purpose or project will require a new application and a new approval. 6. You acknowledge and agree that the Data Providers and the funders of the Data or any part of the Data: a) disclaim any warranties or representations, express or implied, as to fitness for a particular purpose, accuracy, quality or comprehensiveness of the Data; b) exclude and disclaim, 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 (including direct, indirect, consequential, or incidental, damages or losses of any kind) and payments made by the User or User Institution that may arise (whether directly or indirectly) in any way whatsoever from the User or User Institution’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 the Data. 7. The User Institution agrees to follow the Toronto Statement (http://www.nature.com/nature/journal/v461/n7261/full/461168a.html). This includes but is not limited to recognizing the contribution of the Data Providers and including a proper acknowledgement in all reports or publications resulting from the use of the Data. 8. The User Institution agrees 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. 9. You understand and agree that duplication, 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 prohibited. 10. 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. 11. The User Institution will notify The Jackson Laboratory within 30 days of any changes or departures of authorized Users. 12. The User Institution will notify The Jackson Laboratory prior to any significant changes to the protocol for the Project. 13. The User Institution will notify The Jackson Laboratory as soon as it becomes aware of a breach of the terms or conditions of this Agreement. 14. You understand and agree that this Agreement will terminate immediately upon any breach of this Agreement by You. Upon termination, You will be required to promptly destroy any Data held by You or Your Institution. 15. The Jackson Laboratory 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 the Data for archival purpose in conformity with audit or legal requirements. 16. You understand and agree that it may be necessary for the Data Provider or its appointed agents to alter the terms of this Agreement from time to time in order to address new concerns. In this event, the EGA 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 incorporating the changes. 17. You understand and agree that the Data may be protected by and subject to laws and regulations, including but not limited to applicable laws on the protection of personal data, and that You are responsible for ensuring compliance with any such applicable law. You understand and agree that You shall undertake to implement or have implemented adequate technical and organizational security measures to protect the Data. 18. 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. 19. The User Institution agrees to distribute a copy of these terms to the authorized User(s). The User Institution will be responsible for ensuring that the authorized User(s) comply with the terms of this Agreement. 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 the State of Maine, United States of America, and shall be subject to the exclusive jurisdiction of the federal or state courts in the State of Maine. For and on behalf of User: Project Title:_________________________________________ Project Description: ___________________________________________________ ___________________________________________________ ___________________________________________________ ___________________________________________________ ___________________________________________________ Institution full address: _____________________________________ _____________________________________ Applicant information: PhD student/ Post doc applicants must include their supervisors as a co-applicant and provide their full contact details. Name(s): Job Title(s): Email(s): Signature(s): Date: For and on behalf of User Institution: Name of Institution: _____________________________________ Name of Legal Representative: _____________________________________ Signature of Legal Representative: _____________________________________ Date: ______________________________________ WHEN SUBMITTING THIS DOCUMENT, PLEASE INCLUDE ALL PAGES OF THE AGREEMENT WITH THIS SIGNATURE PAGE. Contact for The Jackson Laboratory Data Access Committee for the study EGAS50000001464 and Data EGAD50000002109. Olivia Bart, data_access@jax.org Mark Adams, mark.adams@jax.org Melissa Kelly, melissa.kelly@jax.org The Jackson Laboratory for Genomic Medicine 10 Discovery Drive Farmington, CT 06032 USA