RNA-seq for IgA BMPC project

Data access policy for IgA BMPC project

IgA expressing bone marrow plasma cells (IgA BMPC) Data Access Agreement This agreement governs the terms on which access will be granted to the controlled access datasets generated by the IgA BMPC project. By signing this agreement, you are agreeing to be bound by the terms and conditions of access set out in this agreement. For the sake of clarity, the terms of access set out in this agreement apply both to the User and to the User’s Institution (as defined below). Definitions: Data Producer: A member of the IgA BMPC project. External Collaborator: A collaborator of the User, working for an institution other than the User Institution(s). IgA expressing bone marrow plasma cells Data: The controlled access data of generated within the IgA BMPC project. Human Donor: Individuals having contributed their personal data/biomaterial to IgA BMPC project. Publications: Includes, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. User: An applicant (principal investigator), having signed this Data Access Agreement, whose User Institution has co-signed this Data Access Agreement, both of them having received acknowledgment of its acceptance. User Institution(s): Institution(s) at which the User is employed, affiliated or enrolled. A representative of it has co-signed this data Access Agreement with the User and received acknowledgment of its acceptance. Terms and Conditions: In signing this Agreement: 1. The User and the User Institution(s) (from here on referred to as “the Users”) agree to only use the IgA BMPC data for the objectives and analyses outlined in section E “Scientific abstract” and as approved by their ethics committee(s) in the letter requested in section I “Research ethics” of the Data Access. Use of the IgA BMPC data for a new purpose or project will require a new application and approval. 2. The Uses agree that the IgA BMPC data are made available for one (1) year. The Users agree to destroy/discard any IgA BMPC data held once it is no longer used for the project described in section E “Scientific abstract” of the Data Access Application Form or after the end of the granted time-period of one year unless obligated to retain the IgA BMPC data for archival purposes in conformity with national audits or legal requirements. To extend the use of IgA BMPC data after the one-year period, Users must re-apply to access the data. 3. The Users agree to preserve, at all times, the confidentiality of the information and IgA BMPC data. In particular, they undertake not to use, or attempt to use the IgA BMPC data to compromise or otherwise infringe the confidentiality of information on Human Donors including any attempt to re-identify the donors. 4. The Users agree to protect the confidentiality of Human Donors in any research papers or publications that they prepare by taking all reasonable care to limit the possibility of identification. The Users agree to comply with the donors’ rights according to GDPR (DS-GVO) $15 ff. that any data stemming from the donors are to be deleted if desired. 5. The Users are not to link or combine the IgA BMPC data provided under this agreement to other information or archived data available in a way that could re-identify the Human Donors, even if access to the data has been formally granted to the Users or is freely available without restriction. 6. The Users agree not to transfer or disclose the IgA BMPC data in whole or part, or any material derived from the IgA BMPC data, to anyone not listed in sections A “Name of applicant (principal investigator), including affiliations and contact details“ and B “Name of authorized personnel within your institution, including affiliations and contact details.“ of the Data Access Application form, except as necessary for data safety monitoring, national audits or program management. Should the User wish to share the IgA BMPC data with an External Collaborator, the External Collaborator must complete a separate application for Access to the IgA BMPC data. 7. The Users accept that the original Data Producers, or copyright holders, or the funders of the IgA BMPC data or any part of the IgA BMPC data supplied: a) bear no legal responsibility for accuracy or comprehensiveness of the IgA BMPC data b) accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the IgA BMPC data, or from the unavailability of, interruption in IgA BMPC data access for whatever reason c) bear no responsibility for the further analysis or interpretation of these IgA BMPC data, over and above that published by the Data Producers. 8. The Users agree that they have a secure infrastructure and the expertise to analyze the IgA BMPC data. This includes authorized data access only and a secure computation infrastructure. 9. The Users agree to recognize the contribution of the Data Producers and to include a proper acknowledgement, e.g. citation in the references or in the acknowledgement section, in any work based in whole or part on the IgA BMPC data. 10. The Users accept that IgA BMPC data may be reissued from time to time, with suitable versioning. If the reissue is at the request of ethical scrutiny, the Users destroy earlier versions of the data. 11. The Users agree not to make intellectual property claims on the IgA BMPC data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of the IgA BMPC data, or conclusions drawn directly from the IgA BMPC data. 12. The Users can elect to perform further research that would add intellectual and resource capital to the IgA BMPC data and decide to obtain intellectual property rights on these downstream discoveries. In this case, the Users agree to implement licensing policies that will not obstruct further research and to follow a national guideline that is in conformity with the OECD, “Guidelines for the Licensing of the Genetic Inventions”. 13. The Users must notify the IgA BMPC DAC prior to any significant change to the research protocol of the User. This update can be sent by email to the DAC. 14. The Users will notify the IgA BMPC DAC as soon as they become aware of a breach of the terms or conditions of this agreement. 15. The Users accept that this agreement may terminate upon any breach of this agreement from the Users or any authorized personnel mentioned in section B “Name of authorized personnel within your institution, including affiliations and contact details“ of the Data Access Application form. In this case, the Users will be required to destroy/discard any IgA BMPC data held, including copies and backup copies. This clause does not prevent the Users from retaining the IgA BMPC data for archival purposes in conformity with national audits or legal requirements. 16. The Users accept that it may be necessary for the Data Producers or its appointed agent to alter the terms of this agreement from time to time. In this event, the Data Producers or their appointed agent will contact the Users inform them of any changes. 17. If requested, the Users will allow data security and management documentation to be inspected to verify that they are complying with the terms of this Data Access Agreement. 18. The Users agree to distribute a copy of this agreement and explain its content to any person mentioned in section B “Name of authorized personnel within your institution, including affiliations and contact details“ of the Data Access Application form. 0 I have read the policies and guidelines of the IgA BMPC project. Applicant: Name: Signed: Date: Authorized institutional representative: Name: Signed: Date: The completed agreement must be sent by email to the DAC (thomas.doerner@charite.de).