ࡱ> [ IRbjbjXX :ji:jiJB  4h8| \I"""""#"# #tIvIvIvIvIvIvI$MPfI#####I""I&&&#*""tI&#tI&&6lBD"FED$LC`II0IhC`P%^P8DPD##&#####IIY&^###I####P######### X b: International Centre for Genomic Medicine in Neuromuscular Diseases (ICGNMD) DATA ACCESS AGREEMENT Data collected by the MRC funded ICGNMD project has been archived at the EMBL-EGA European Genome Archive. The funder requires such data to be shared with external international researchers. To gain access, third party research organisations (referred to below as a User Institution) must first complete and submit [this] application to the ICGNMDs Data Access Committee (DAC), by emailing it to  HYPERLINK "mailto:icgnmd@ucl.ac.uk" icgnmd@ucl.ac.uk, ccing  HYPERLINK "mailto:Lindsay.Wilson@ucl.ac.uk" Lindsay.Wilson@ucl.ac.uk . The granting of access by the DAC to any ICGNMD data is subject to acceptance of the below terms by the User Institution. The terms and conditions below govern access to the managed access ICGNMD datasets (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. 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 ICGNMDs Data Access Committee. Data: The managed access datasets to which the User Institution has requested access. Data Producers: UCL and the collaborators listed in Appendix I responsible for the development, organisation, and oversight of these Data. 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 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 these 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. UCL: University College London, incorporated in the United Kingdom by Royal Charter, whose registered office is at Gower Street, London WC1E 6BT. User: The principal investigator for the Project. User Institution(s): The Institution that has requested access to the Data. Terms of Use of Data The User Institution agrees to only use these Data for the purpose of the Project (described in Appendix II) and only for Research Purposes and for the duration thereof as set out in Appendix II (Project Details). 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. 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 infringe the 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. 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. 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. The User Institution agrees only to transfer or disclose these Data, in whole or part, or any material derived from these Data, to the Authorised 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. 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 Recipient that may arise (whether directly or indirectly) in any way whatsoever from the Recipients 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. The User Institution agrees to follow the Fort Lauderdale Guidelines ( HYPERLINK "http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtd003207.pdf" http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtd003207.pdf ) and the Toronto Statement ( HYPERLINK "http://www.nature.com/nature/journal/v461/n7261/full/461168a.html" 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 clear and proper acknowledgement of the ICGNMD in all reports and/or Publications resulting from the use of these Data. The User Institution acknowledges that 911 and the other User Institutions have an obligation to handle all Data in accordance with the MRC Data Sharing Policy ( HYPERLINK "https://www.ukri.org/publications/mrc-data-sharing-policy/data-sharing-policy/" MRC data sharing policy UKRI) and the User Institution hereby agrees to follow best practice for open data sharing, to adhere to the MRC Data Sharing Policy, and not to knowingly or willingly do anything that would, or would be likely to, put 911 and/or any of the User Institutions in breach of that policy. The foundation of authorship of any Publications shall be openness, inclusiveness and goodwill. User Institution agrees and undertakes 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 these Data. 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. 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) ( HYPERLINK "https://www.icgc.org/files/daco/NIH_BestPracticesLicensingGenomicInventions_2005_en.pdf%20" 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) ( HYPERLINK "http://www.oecd.org/science/biotech/36198812.pdf%20" http://www.oecd.org/science/biotech/36198812.pdf ). The User Institution agrees to securely 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. The User Institution will notify 911ithin thirty (30) days following any changes to or departures of Authorised Personnel. The User Institution will notify UCL as soon as reasonably practicable prior to any significant changes to the protocol for the Project. The User Institution will notify UCL as soon as it becomes aware of any breach of the terms or conditions of this Data Access Agreement. UCL may terminate this Data Access Agreement for convenience, by providing written notice of such termination to the User Institution. If this Data Access Agreement expires or 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 these data for archival purpose in conformity with audit or legal requirements. The User Institution accepts that it may be necessary for the Data Producers to alter the terms of this Data Access Agreement from time to time. As an example, this may include specific provisions relating to the Data required by Data Producers other than UCL. 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 Data Access Agreement. 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 Data Access Agreement. The User Institution agrees to distribute a copy of the terms of this Data Access Agreement to the Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this Data Access Agreement. The User Institution acknowledges that the Data Access Committee has appointed and authorised UCL to countersign this Data Access Agreement on behalf of itself and each of the relevant Data Producers. This Data Access 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. Agreed for User Institution Signature:Name:Title:Date: Principal Investigator I confirm that I have read and understood this Agreement. Signature:Name:Title:Date: Agreed for University College London Signature:Name:Title:Date: APPENDIX I DATASET DETAILS APPENDIX II PROJECT DETAILS APPENDIX III PUBLICATION POLICY APPENDIX I DATASET DETAILS [Note: to be edited by Requestor and checked by UCL] Dataset reference (EGA Study ID and Dataset Details) [Note: to be edited by Requestor and checked by UCL] Name of project that created the dataset The International Centre for Genomic Medicine in Neuromuscular Diseases (ICGNMD) Names of other data producers/collaborators [Note: Full list below to be edited by UCL post-application] United Kingdom: University College London University of Cambridge University of Newcastle upon Tyne Brazil: Fundao de Apoio ao Ensino, Pesquisa e Assistncia do Hospital das Clnicas da Faculdade de Medicina de Ribeiro Preto da Universidade de So Paulo (FAEPA), So Paulo India: All India Institute of Medical Sciences (AIIMS), Delhi Nizams Institute of Medical Sciences (NIMS), Hyderabad National Institute for Mental Health and Neurosciences (NIMHANS), Bangalore CSIR-Centre for Cellular and Molecular Biology (CSIR-CCMB), Hyderabad Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad The Netherlands: Leiden University Medical Centre, Leiden South Africa: University of Pretoria, Pretoria North-West University, Potchefstroom University of Cape Town, Cape Town Stellenbosch University, Cape Town Turkey: Izmir Biomedicine and Genome Centre, Izmir Specific limitations on areas of research DUO codes for ICGNMD datasets Study ID PrefixDAC conditionDAC conditionDAC conditionDAC conditionDAC conditionDAC conditionSite specificSite specificSite specificSite specificAIIMSIC_AIMDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000015DUO:0000044NIMSIC_NIMDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000006DUO:0000044NIMHANS NaliniIC_NANDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000006DUO:0000044DUO:0000046DUO:0000020NIMHANS GayathriIC_NASDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000006DUO:0000044DUO:0000020FAEPAIC_BAPDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000015DUO:0000044LUSAKAIC_UTHDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000015DUO:0000044DUO:0000018ANKARAIC_TANDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000006DUO:0000044DUO:0000020IZMIRIC_TIMDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000006DUO:0000044DUO:0000020STELLENBOSCHIC_SABDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000044PRETORIAIC_SPRDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000044CAPE TOWN RCCHIC_SRCDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000044CAPE TOWN GSHIC_SGSDUO:0000019DUO:0000021DUO:0000025DUO:0000026DUO:0000027DUO:0000028DUO:0000007 (NMDs)DUO:0000044 Continued next page KEY TO TERMSDUO:0000019*This requirement indicates that requestor agrees to make results of studies using the data available to the larger scientific community.DUO:0000021This requirement indicates that the requestor must provide documentation of local IRB/ERB approval.DUO:0000025This requirement indicates that use is approved for a specific number of months.DUO:0000026This requirement indicates that use is limited to use by approved users.DUO:0000027This requirement indicates that use is limited to use within an approved project.DUO:0000028This requirement indicates that use is limited to use within an approved institution.DUO:0000006*This primary category consent code indicates that use is allowed for health/medical/biomedical purposes; does not include the study of population origins or ancestry.DUO:0000007This primary category consent code indicates that use is allowed provided it is related to the specified disease.DUO:0000015*This secondary category consent code indicates that use includes methods development research(e.g., development of software or algorithms) only within the bounds of other use limitations.DUO:0000018This requirement indicates that use is limited to not-for-profit organizations.DUO:0000020*This requirement indicates that the requestor must agree to collaboration with the primary study investigator(s).DUO:0000044*This data use modifier indicates use for purposes of population, origin, or ancestry research is prohibited.DUO:0000046This data use modifier indicates that use of the data is limited to not-for-profit use. Minimum protection measures required 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 these 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. All encryption solutions must meet current standards, including FIPS 140-2 and FIPS 197. Only Authorised Personnel shall have access to the data. Location of data storage must be recorded and shared with UCL and, following expiry or termination of this Data Access Agreement, the Data must be securely destroyed by the User Institution in accordance with clause 16. 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) Expected duration of the Project (the term during which the Data will be used) All Individuals who the User Institution to be named as registered users Name of Registered UserEmailJob TitleSupervisor* All Individuals that should have an account created at the EGA Name of Registered UserEmail Job Title APPENDIX III PUBLICATION POLICY UCL and other Data Producers 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. UCL and other Data Producers anticipate 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 (or any part of it). For research papers, submission for publication should not occur until 01 June 2026, unless the ICGNMDs Data Access Committee has provided written consent to earlier submission. 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 (e.g., EGAS00000000029), and acknowledge its use in a form agreed by the User Institution with UCL on behalf of itself and the other Data Producers. The minimum requirements are: (i) to state in the publication Acknowledgements This study includes data [insert EGA accession numbers here] from the MRC strategic award to establish an International Centre for Genomic Medicine in Neuromuscular Diseases (ICGNMD) MR/S005021/1; and (ii) to refer to use of this data in the body of the publication, including the reference Wilson et al 2023 (doi: 10.1093/brain/awad254, PMID: 37516995). Please notify project lead Michael Hanna ( HYPERLINK "mailto:m.hanna@ucl.ac.uk" m.hanna@ucl.ac.uk) of any Publications making use of ICGNMD data, prior to each such Publication being published. Where ICGNMD data is to be used as part of a formal training research project, work to be published must adhere to this policy and to the Academic Rules of the respective institutions where students are registered.     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