Circular RNA characterization in functionally distinct brain regions

Circular RNA characterization in functionally distinct brain regions

DATA ACCESS AGREEMENT The Translational Genomics Research Institute (TGen) has research data hosted in the established central data repository called the European Genome-phenome Archive (EGA) at the European Bioinformatics Institute. Access to human genomic data will be provided to research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed below. It is the intent of TGen that approved users of EGA datasets recognize all restrictions on data use established by TGen. The parties to this agreement include: the Principal Investigator (PI) requesting access to the genomic study dataset (the “Approved User”), his/her home institution as represented by the Institutional Signing Official (the “User Institution”), and TGen (the “Data Producers”). The effective date of this agreement shall be the later of a) the Project Approval Date, as specified on the Data Access Committee (DAC) approval notification, and b) the date of the last signature on this Agreement. These terms and conditions govern access to the managed access datasets (details of which are set out in Appendix I) to which the Approved User and User Institution has requested access. The Approved User and User Institution agree to be bound by these terms and conditions. DEFINITIONS Approved User: The Principal Investigator for the Project. Authorized Personnel: The individuals at the User Institution to whom TGen grants access to the Data. This includes the Approved User, the individuals listed in Appendix II and any other individuals for whom the User Institution subsequently requests access to the Data (in a subsequent, separate request approved by TGen). Details of the initial Authorized Personnel are set out in Appendix II. Data: The managed access datasets to which the User Institution has requested access. Data Producers: TGen and the collaborators listed in Appendix I responsible for the development, organization, and oversight of these Data. External Collaborator: A collaborator of the Approved User, working for an institution other than the User Institution. Project: The project for which the User Institution 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 the requested 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. User Institution(s): The User Institution that has requested access to the Data. TERMS OF ACCESS 1. The User Institution agrees to only use these Data for the purpose of the Project (described in Appendix II) and only for Research Purposes. The User Institution further agrees that it will only use these Data for Research Purposes, which are within the limitations (if any) set out in Appendix I. 2. The User 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 breach the obligations of confidentiality of information on Research Participants. Without prejudice to the generality of the foregoing, the User Institution agrees to use at least the measures set out in Appendix I to protect these Data. 3. The User 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 User 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 User Institution or is freely available without restriction. 5. The User Institution agrees only to transfer or disclose these Data, in whole or part, or any material derived from these Data, to the Authorized Personnel. Should the User 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 User 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 User Institution that may arise (whether directly or indirectly) in any way whatsoever from the User Institution’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 User Institution agrees to follow the Fort Lauderdale Guidelines and the Toronto Statement. This includes but is not limited to recognizing 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 User 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 analyzing these Data. 9. The User 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 User 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 User 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) in conformity with the Organization for Economic Co-operation and Development Guidelines for the Licensing of the Genetic Inventions (2006). 11. 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. 12. The User Institution will notify TGen in writing within 30 days of any changes or departures of Authorized Personnel. 13. The User Institution will notify TGen in writing prior to any significant changes to the protocol for the Project. 14. The User Institution will notify TGen in writing as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. TGen or the User Institution may terminate this agreement at any time, and for any reason, by written notice to the other party. If this agreement is terminated, the User Institution shall destroy any Data held, including copies and backup copies. This clause does not prevent the User Institution from retaining these Data for archival purpose in conformity with audit or legal requirements. 16. The User Institution accepts that it may be necessary for the Data Producers to modify the terms of this agreement from time to time. As an example, such modifications may include specific provisions relating to the Data required by Data Producers other than TGen. In the event that changes are required, the Data Producers or their appointed agent will contact the User Institution to inform it of the changes, and the User Institution may elect to accept the changes or terminate the agreement. 17. If requested, the User Institution will allow data security and management documentation to be inspected by TGen to verify that it is complying with the terms of this agreement. 18. The User Institution agrees to distribute a copy of these terms to all Authorized Personnel and require the Authorized Personnel to 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 the laws of the state of New York, without reference to its conflicts of law provisions. Agreed for User Institution (Signatory Official) Signature: Name: Title: Date: Principal Investigator I confirm that I have read and understood this Agreement. Signature: Name: Title: Date: Agreed for TGen Signature: Name: Stephanie Buchholtz, MS Title: Director, Office of Research Compliance & Quality Mgmt Date: APPENDIX I – DATASET DETAILS APPENDIX II ––PROJECT DETAILS APPENDIX III –– PUBLICATION POLICY APPENDIX I – DATASET DETAILS Dataset reference (EGAS00001003128 and Dataset Details) EGAS00001003128 Dataset maintained by the Translational Genomics Research Institute. Name of project that created the dataset Circular RNA characterization in functionally distinct brain regions Names of other data producers/collaborators Illumina Specific limitations on areas of research No specific limitations set Minimum protection measures required The Approved User, their User Institution and all Authorized Users agree to handle the data according to the current NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy (09MAR2015). 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 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. APPENDIX II – PROJECT DETAILS (to be completed by the Approved User) Details of dataset requested i.e., EGA Study and Dataset Accession Number EGAS____________________ Dataset maintained by the Translational Genomics Research Institute. Name of Principal Investigator Email Job Title User Institution Brief abstract of the Project in which the Data will be used (500 words max) All Individuals who the User Institution requests to be named as Authorized Personnel (add rows as needed) Name of Authorized Personnel Email Job Title Supervisor* All Individuals that should have an account created at the EGA Name of Authorized User Email Job Title   APPENDIX III – PUBLICATION POLICY 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 (EGAS______________), and acknowledge its use in a form agreed by the User Institution with TGen.