cfDNA exercise - methylation array

• NCU DUO:0000046 (version: 2021-02-23)non-commercial use onlyThis data use modifier indicates that use of the data is limited to not-for-profit use.

plasma cfDNA - methylation array

DATA ACCESS AGREEMENT This DATA ACCESS AGREEMENT (this “Agreement”) made and entered into on _________202_ between The Hebrew University of Jerusalem, represented by the Authority for R&D, Edmond J. Safra Campus, Jerusalem 91390, Israel (the "Provider Institution"), on behalf of Prof. Tommy Kaplan and Prof. Yuval Dor (the “Provider Scientist”); and between __________________ with offices at ____________________ (the “User Institution”) on behalf of Prof./Dr._______________ (the “User”), relating to the access by the User of certain data deposited by the Provider Scientist at the European Genome-phenome Archive (“EGA”) for use in a study. These terms and conditions govern access to the datasets detailed in Appendix I to which the User Institution has requested access on behalf of the User. The User Institution agrees to be bound by these terms and conditions. Definitions “Authorised Personnel”: The individuals at the User Institution to whom the DAC grants access to the Data. This includes the User, the individuals listed in Appendix II and any other individuals for whom the User Institution subsequently requests access to the Data. Details of the initial Authorised Personnel are set out in Appendix II. “DAC”: The data access committee established by Provider Institution for METHATLAS as registered at EGA . DAC ID EGAC00001003196. “Data”: The datasets to which the User Institution has requested access. “Data Producers”: The Provider Scientist and the collaborators listed in Appendix I responsible for the development, organisation, and oversight of these Data at the Provider Institution. “External Collaborator”: A collaborator of the User, working for an institution other than the User Institution. “Project”: The project for which the User Institution has requested access on behalf of the User to the Data. A description of the Project is set out in Appendix II. “Provider Scientist”: for the purposes of this Agreement, refers to the principal investigator of the Provider Institution in relation with the Data. “Publications”: Includes, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. “Data Subject” or “Data Subjects”: An individual or the individuals whose data form part of the Data. “Research Purposes”: Shall mean non-commercial or non-for-profit research conducted under the Project. “User”: The User Institution’s principal investigator for the Project. “User Institution”: The Institution that has requested access to the Data. Institution: ______________________________________________________ Address: ______________________________________________________ Contact Person: _____________________ Position: ________________________ Contact Phone: ______________ Contact e-mail: ________________ Terms and Conditions 1. For the purposes of this Agreement, the Provider Institution is the data controller and the User Institution is the data processor. 2. The User Institution agrees to only use the Data for the purpose of the Project (as described in Appendix II) and only for Research Purposes. The User Institution further agrees that it will only use the Data for Research Purposes which are within the limitations (if any) set out in Appendix I. 3. The User Institution agrees to preserve, at all times, the confidentiality of the Data. In particular, it undertakes 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. 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 the Data. 4. The User Institution agrees to protect the confidentiality of the Data Subjects in any Publications that they prepare by taking all reasonable care to limit the possibility of identification of the Data Subjects. 5. 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 approved by the User Institution’s ethics body and formally granted to the User Institution or is freely available without restriction. 6. The User Institution agrees only to transfer or disclose the Data, in whole or part, or any material derived from the Data to the Authorised Personnel. Should the User Institution wish to share the Data with an External Collaborator, the External Collaborator must complete a separate data access agreement with the Provider Institution for access to the Data. 7. The User Institution agrees that the Provider Institution and the Data Producers: a) make no warranty or representation, express or implied as to the accuracy, quality or comprehensiveness of the Data; b) accept no liability for indirect, consequential, or incidental damages or losses arising from use of the Data; and c) bear no responsibility for the further analysis or interpretation of the Data over and above that published by the Provider Institution. 8. The User Institution agrees to follow the Fort Lauderdale Guidelines on sharing data from large-scale biological research projects (https://wellcome.ac.uk/sites/default/files/wtd003207_0.pdf) and the Toronto Statement (https://www.nature.com/articles/461168a.pdf) on prepublication data sharing. 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 the Data. 9. 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 analysing the Data. 10. The User Institution agrees to submit a report to the DAC, if requested, on completion of the Project. The DAC agrees to treat the report and all information, data, results, and conclusions contained within such report as confidential information belonging to the User Institution. 11. Nothing in this Agreement shall operate to transfer to the User Institution any intellectual property rights to the Data. 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. 12. The User Institution 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 Institution agrees to implement licensing policies that will not obstruct further research following the OECD Guidelines for the Licensing of the Genetic Inventions (http://www.oecd.org/science/biotech/36198812.pdf , OECD 2006). 13. 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. 14. The User Institution will notify the DAC within 30 days of any changes or departures of Authorised Personnel. Appendix III of this Agreements shall be amended in writing by the parties accordingly. 15. The User will notify the DAC prior to any significant changes to the protocol for the Project. Appendix II of this Agreements shall be amended in writing by the parties accordingly. 16. The User Institution will notify the DAC as soon as it becomes aware of a breach of the terms or conditions of this agreement. In particular in case of a breach of security which leads to disclosure of Data, the User Institution must report this to Provider Institution within 72 hours maximum, and follow any relevant rule as provided by any applicable law and the Provider Institution. 17. This Agreement will terminate immediately upon any breach by the User Institution, and the User Institution is required destroy any Data held by it, and upon request, provide written certification of such destruction. The Provider Institution may terminate this agreement by written notice to the User Institution. If this agreement terminates for any reason except for a breach by the User Institution, the User Institution will be allowed to retain the Data for archival purpose in conformity with audit or legal requirements. For the avoidance of doubt Articles 8, 9, 11, 12, and 21 shall survive the termination of this Agreement for any reason. 18. The User Institution accepts that it may be necessary for the Data Producers to alter the terms of this Agreement from time to time in order to address new concerns. In the event that changes are required, the DAC will contact the User Institution to inform it of the changes and the User Institution may elect to continue to use the Data by entering into a new version of this Agreement or terminate this Agreement. 19. 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. 20. The User Institution agrees to distribute a copy of these terms to the Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this Agreement. 21. The parties will make their best efforts to amicably settle all disputes arising out of or in connection with this Agreement. In the event of any dispute, controversy or claim arising under, out of or relating to this Agreement and any subsequent amendments of this Agreement, including, without limitation, its formation, validity, binding effect, interpretation, performance, breach or termination, as well as non-contractual claims, cannot be solved amicably, they shall be submitted to a competent court. SIGNATURES IN THE FOLLOWING PAGE IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized officers or representatives. Agreed by User Institution Signature: ______________________________________ Name: ______________________________________ Title: ______________________________________ Date: _____________ User Scientist I have read, understood and agree to abide by the terms and conditions stipulated in this Agreement. Signature: ______________________________________ Name: ______________________________________ Title: ______________________________________ Date: _____________ Provider Institution Signature: ______________________________________ Name: Hani Ben-Yehuda Title: Acting Director. The Authority for Research and Development Date: _____________ Provider Scientist I have read, understood and agree to abide by the terms and conditions stipulated in this Agreement. Signature: _____________________ Signature: _____________________ Name: Tommy Kaplan Name: Yuval Dor Title: Professor Title: Professor Date: _____________ Date: _____________ Provider DAC Signature: _____________________ Signature: _____________________ Name: Tommy Kaplan Name: Yuval Dor Title: Professor Title: Professor Date: _____________ Date: _____________ Please return a signed electronic pdf copy of this Agreement to Prof. Tommy Kaplan (tommy.kaplan@mail.huji.ac.il) and to Mr. Gustavo Fuchs, Coordinator Intellectual Property and Technology, The Hebrew University of Jerusalem, the Authority for R&D (gustavof@savion.huji.ac.il). APPENDIX I – DATASET DETAILS (To be completed by the Provider Scientist) 1. Dataset reference 1.1. Dataset Identification Dataset Name: cfDNA exercise - methylation array 1.2. Dataset Details ¬¬¬¬¬¬ DNA methylation of human plasma cfDNA after exercise 2. Name and description of project that created the dataset ¬¬¬¬¬¬ DNA methylation of human plasma cfDNA after exercise 3. Specific limitations 3.1. User Institution agree to use the Data only for the advancement of medical and scientific research, according to this Agreement. 3.2. User Institution agree not to use the Data for the creation of products for sale or for any commercial or for-profit purpose. 3.3. Other limitations by the Provider Scientist ___na_________________________________ 4. 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 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 User) 1. Details of dataset requested __________________________________________________________________________________________________________________________________________________________________________________________________________________ 2. Brief abstract of the Project in which the Data will be used (500 words max) Please include a clear description of the Project, its stakeholders, its main question and its relevance to the research domain addressed, its specific aims, and duration. Note that any use of the Data, if approved, must fall under the framework of the described Project. 3. All Individuals in the User Institution who will use the Data Name of User Email Job Title Supervisor 4. All Individuals that should have an account created at the EGA Name of Registered User Email Job Title APPENDIX III – PUBLICATION POLICY The Provider Scientist intend 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. The Provider Scientist 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. For research papers, submission for publication should not occur until __na___ months after these data were first made available on the relevant hosting database, unless the Provider Scientist and the Provider Institution have provided written consent to earlier submission. In any Publications of the User based on the Data (as defined in this Agreement), the User shall describe how the data can be accessed, including the name of the hosting database and its accession numbers, and acknowledge properly the User Institution and the Data Producers.