ResolveCRPS study - Transcriptomics

For access to DNA- or RNA sequencing data from human biosamples for research purposes. The original research involved human subjects, human material, or human data. In accordance with the Declaration of Helsinki, the use of the biopsy samples was done after consideration and approval by the institutional ethics committee of the Julius-Maximilians University of Würzburg, Bavaria, Germany. DATA ACCESS AGREEMENT These terms and conditions govern access to the managed access datasets 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 corresponding author grants access to the data. This includes the User, the authors and any other individuals for whom the User Institution subsequently requests access to the Data. Data: The managed access datasets to which the User Institution has requested access. Data Producers: The authors 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. 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. User: The principal investigator for the Project. User Institution(s): The Institution that has requested access to the Data. 1. The User Institution agrees to only use these Data for the purpose of the Project and only for Research Purposes. The User Institution further agrees that it will only use these Data for Research Purposes. 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 infringe the confidentiality of information on Research Participants. Without prejudice to the generality of the foregoing, the User Institution agrees to protect the original 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 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. 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 Recipient that may arise (whether directly or indirectly) in any way whatsoever from the Recipient'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 Toronto Statement http://www.nature.com/nature/journal/v461/n7261/full/461168a.html, https://doi.org/10.1038/461168a) about 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 these Data. 8. The User Institution agrees to follow the Publication Policy. This includes respecting the moratorium period for the Data Producers to publish the first peer-reviewed report describing and analysing these Data. 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 12 months after these data were first made available on the relevant hosting database, unless the corresponding author 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 the corresponding author. 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) (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 ). 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 the corresponding author within 30 days of any changes or departures of Authorised Personnel. 13. The User Institution will notify the corresponding author prior to any significant changes to the protocol for the Project. 14. The User Institution will notify the corresponding author as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. The corresponding author 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 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 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. 17. 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, as further described in Annex 1. 18. 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. ANNEX 1 Annex 1 to Data Transfer Agreement of Human Data for Research Purposes IT Security Access to Data covered by this Data Transfer Agreement is a procedure that entails legal and ethical obligations. We require that you and your institution has adequate information technology (IT) policies in place that meet industry standards and include, in particular, the following items: Should personal data be automatically processed or used, this shall be organized within the agency or company to ensure that it meets data protection requirements. Depending on the type of personal data or data categories to be protected, the measures taken shall, 1. Deny unauthorized access to data processing facilities in which personal data is processed or used (physical access controls), 2. Prevent unauthorized persons from using data processing systems (access controls), 3. Ensure that authorized users only have access to the data to which they have access rights, and that personal data cannot be read, copied, modified or deleted by unauthorized persons during processing or use, and after storage (user-access control), 4. Ensure that personal data cannot be read, copied, modified or deleted by unauthorized persons during electronic transmission or during their transport or their storage on data carriers, and that it can be verified and established at which points a transmission of personal data by data transmission equipment (transmission control) is foreseen, 5. Ensure that it can be subsequently verified and established whether and by whom personal data are entered, modified or deleted in the data processing systems (input control), 6. Ensure that personal data which are processed on behalf of clients can be processed only in accordance with the instructions of the client (job control), 7. Ensure that personal data are protected against accidental destruction or loss (availability control), 8. Ensure that data collected for different purposes can be processed separately. One measure, in particular, to be taken in compliance with paragraph 2, numbers 2-4, is the use of state-of-the-art encryption methods. In the event that the Recipient becomes aware that there has been a breach or suspected breach of the agreement, the Recipient shall immediately notify the corresponding DAC.