Variants from a subset of genes from WES of adult AML patient samples

Terms and conditions that govern access to the study: Variants from a subset of genes from WES of adult AML patient samples

Data Access Agreement Parties UniSA University of South Australia ABN 37 191 313 308 Address 55 North Terrace, Adelaide SOUTH AUSTRALIA 5000 Australia E-mail Address research.contracts@unisa.edu.au Attention Jodieann Dawe Director Research and Innovation Services UQ The University of Queensland ABN 63 942 912 684 Address The University of Queensland, Brisbane QUEENSLAND 4072 Australia E-mail Address director.partnerships@research.uq.edu.au Attention Director Research Commercial Management User Institution INSERT NAME ABN INSERT ABN Address INSERT ADDRESS E-mail Address INSERT CONTACT EMAIL ADDRESS Attention INSERT CONTACT PERSON TO RECEIVE NOTICES Background A. These terms and conditions govern access to the managed access dataset (details of which are set out in Appendix I) to which the User Institution has requested access. The User Institution agrees to be bound by these terms and conditions. B. In consideration of the access to the Data provided by the Universities to the User Institution, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows: Agreed terms Definitions and interpretation Authorised Personnel means the individuals at the User Institution to whom the Universities grant 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. Data means the managed access datasets to which the User Institution has requested access. Data Producers means the Universities’ employees and collaborators listed in Appendix I responsible for the development, organisation, and oversight of the Data. External Collaborator means a collaborator of the User, working for an institution other than the User Institution. Privacy Laws means: (a) the Privacy Act 1988 (Cth); (b) the Australian Privacy Principles under the Privacy Act 1988 (Cth), regardless of whether the Australian Privacy Principles would apply but for this Agreement; (c) the General Data Protection Regulation (Regulation (EU) 2016/679); and (d) the data protection and privacy laws of applicable in the User Institution’s country. Project means the project for which the User Institution has requested access to the 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 means an individual whose data form part of the Data. Research Purposes means 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 means the principal investigator for the Project. User Institution(s) means the Institution that has requested access to the Data. The Universities means UniSA and UQ, the institutions who generated and own the Data. Terms 1. The User Institution agrees to only use the 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 the Data for Research Purposes which are within the limitations (if any) set out in Appendix I. Any proposed use of the Data beyond the scope of the Project will require a separate application for access to the Data and a will require the User Institution to enter into a separate agreement with the Universities. 2. The User Institution agrees to preserve, at all times, the confidentiality of the Data. In particular, the User Institution undertakes not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality and privacy of information relating to the Research Participants. The User Institution will keep the Data secure from misuse, interference, loss, unauthorised access, unauthorized modification and disclosure, and will implement and maintain best practice safeguards to protect the Data. 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. 3. The User Institution agrees to protect the confidentiality of Research Participants in any research papers or Publications that it prepares by taking all reasonable care to limit the possibility of identification of the Research Participants. 4. The User Institution agrees not to attempt to identify the Research Participants or 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 Institution or is freely available without restriction. 5. The User Institution agrees to transfer or disclose the Data, in whole or part, or any material derived from the Data, only to the Authorised Personnel. Should the User Institution 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 Institution agrees that the Data Producers, and all other parties involved in the creation, funding or protection of the Data: 6.1 bear no responsibility for the accuracy, quality or comprehensiveness of the Data or that the Data corresponds with a particular description or is fit for a particular purpose; 6.2 make no warranty or representation, express or implied as to the accuracy, quality or comprehensiveness of the Data or that the Data corresponds with a particular description or is fit for a particular purpose; 6.3 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 and/or the Authorised Personnel that may arise (whether directly or indirectly) in any way whatsoever from the User Institution’s and/or the Authorised Personnel’s use of the Data or from the unavailability of, or break in access to, the Data for whatever reason; and 6.4 bear no responsibility for the further analysis or interpretation of the Data. 7. The User Institution agrees to indemnify the Research Participants and the Data Producers against all liabilities, demands, damages, expenses and losses arising out of the User Institution’s use of the Data for any purpose, and/or arising out of any breach by the User Institution of the terms and conditions of this agreement. 8. The User Institution agrees to follow the Fort Lauderdale Guidelines (https://www.genome.gov/Pages/Research/WellcomeReport0303.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 verbal or written reports or Publications resulting from the use of the Data. Without limitation, the User Institution may use the following acknowledgement: “The results published here are in whole or part based upon data provided by the University of South Australia and The University of Queensland. The data used for this analysis are available at The European Genome-phenome Archive (https://ega-archive.org), accession number, e.g. EGAS00000000029.” 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 acknowledges that the Data is owned by the Data Producers and protected by copyright, database rights and other intellectual property rights owned by the Data Producers. The User Institution agrees that it shall not reproduce or copy the Data, except as reasonably required for the purpose of the Project and for no other purpose, and nor shall it sell all or any part of the Data in any circumstances. 11. 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. The User Institution acknowledges that nothing in this agreement shall operate to transfer to the User Institution any ownership or intellectual property rights relating to 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 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 ). 13. The User Institution agrees that the Data may be reissued from time to time, with suitable versioning. If the reissue is at the request of the Research Participants and/or other ethical scrutiny, the User Institution will destroy earlier versions of the Data, and, upon request from the Data Producers, provide written certification of such destruction. 14. 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. 15. The User Institution will notify the Universities within 30 days of any changes or departures of Authorised Personnel. 16. The User Institution will notify the Universities prior to any significant changes to the protocol for the Project. 17. The User Institution will notify each of the Universities as soon as it becomes aware of a breach of the terms or conditions of this agreement. In the event of a breach of the terms or conditions of this agreement, 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. 18. Either (or both) UniSA and UQ 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. 19. 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 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. 20. If requested, the User Institution will allow data security and management documentation to be inspected by the UniSA, UQ, and/or their employees or agents to verify that the User Institution is complying with the terms of this agreement. 21. The User Institution agrees to distribute a copy of these terms to the Authorised Personnel. The User Institution will ensure that the Authorised Personnel comply with the terms of this agreement. 22. The User Institution acknowledges that the Data is protected by and subject to applicable international laws. The User Institution will comply with the Privacy Laws. 23. The User Institution will maintain a person with responsibility for monitoring and ensuring the User Institution’s compliance with this agreement (“Privacy Officer”). The User Institution will ensure that the Privacy Officer provides reasonable co-operation to the Data Producers as may be required for the purposes of clause 24. 24. The User Institution will notify the Data Producers of any unauthorised or accidental access to, or disclosure, alteration, loss, or destruction of, the Data, or any action that prevents the User Institution from accessing the Data on either a temporary or permanent basis as soon as reasonably practicable after becoming aware that such event has occurred. The User Institution will provide all assistance and information reasonably required by the Data Producers to enable the Data Producers to meet their obligations (if any) under the Privacy Laws. 25. The User Institution may not assign, transfer or otherwise dispose of any of its rights or obligations under this agreement except with the prior written consent of the Data Producers. 26. No amendment to this agreement will be effective unless in writing and signed by the each of the parties. 27. If a party fails to exercise, or delays or holds off exercising, a power or right under this agreement, that is not a waiver of the power or right. A single or partial exercise of such a power or right does not preclude further exercises of that power or right or any other. 28. If part of this agreement is indefinite, invalid, illegal or otherwise voidable or unenforceable, that part may be severed and the balance of this agreement will continue in full force and effect. 29. 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 and regulatory requirements of the State of South Australia and the Parties agree to submit to the exclusive jurisdiction of the Courts of that State and the courts of appeal from them.   Executed for and on behalf of UNIVERSITY OF SOUTH AUSTRALIA ABN 37 191 313 308 by an officer duly authorised in accordance with the Vice- Chancellor’s authorisations: Signature of witness Signature of Officer Name of Witness Name of Officer Date Executed for and on behalf of THE UNIVERSITY OF QUEENSLAND ABN 63 942 912 684 by its duly authorised representative in the presence of: Signature of witness Signature of authorised representative Name of Witness Name of authorised representative Date Executed for and on behalf of USER INSTITUTION ABN by its duly authorised representative in the presence of: Signature of witness Signature of authorised representative Name of Witness Name of authorised representative Date Signed by the Principal Investigator who confirms that they have read and understood this Agreement. Signature of Principal Investigator Name of Principal Investigator Date   Appendix I Dataset Details Dataset reference (EGA Study ID and Dataset Details) Variants from a subset of genes from WES of adult AML patient samples Name of project that created the dataset Identification and characterisation of novel FLT3-ITD co-operating mutations (HRECs: CALHN HREC/12/RAH/152, UNISA 0000031791) Names of other data producers/collaborators Prof Richard D’Andrea, Prof Thomas Gonda, A/Prof Paul Leo. Specific limitations on areas of research The User Institution agrees to use the Data only for the proposed/approved Project (Appendix II). Use of the Data for a new purpose or project will require a new application and approval. Minimum protection measures required The User Institution agrees: - to take all reasonable physical and digital security precautions to keep the Data confidential; - that Data placed on shared systems must be secured and limited to those Authorised Personnel for which the Data has been requested; and - that the Data must not be posted on any web server or ftp server. The User Institution will maintain an up to date, best practices information technology (IT) policy that must include, at a minimum, the following items: - Logging and auditing of access to the Data and to the computer network; - Password protection to the computer network and/or strong data encryption; - Virus and malware protection to computers on the computer network; and - Secure back up procedure. File access: Data can be held in unencrypted files on an institutional computer 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 the 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 (500 words max) All Individuals who the User Institution to be named as registered users Name of Registered User Email Job Title Supervisor* All Individuals that should have an account created at the EGA Name of Registered User Email Job Title   Appendix III Publications Policy In any publications based on the 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 (e.g., EGAS00000000029), and acknowledge its use as per clauses 8 and 9 of this Agreement. The User Institution agrees to a moratorium on publishing global analyses of the Data until the Data Producers have published their own global analyses or twelve months have passed from the time the Data were deposited with the European Genome-phenome Archive, whichever occurs first.