RNA-seq data for de-methylation of FOXP3-TSDR study

Data access policy for de-methylation of FOXP3-TSDR study

Data Access Agreement This agreement governs the terms on which access will be granted to the controlled access datasets under the accession number EGAS00001004867, which were generated for and published in Frontiers in Immunology: “Targeted de-methylation of the FOXP3-TSDR is sufficient to induce physiological FOXP3 expression but not a functional Treg phenotype.” Christopher Kressler, Gilles Gasparoni, Karl Nordström, Dania Hamo, Abdulrahman Salhab, Christoforos Dimitropoulos, Sascha Tierling, Petra Reinke, Hans-Dieter Volk, Jörn Walter, Alf Hamann and Julia K. Polansky. 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 authorlist. External Collaborator: A collaborator of the User, working for an institution other than the User Institution(s). Data: The controlled access data in EGAS00001004867 and published in the mentioned study. 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 having contributed their personal data/biomaterial to the mentioned study. 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) agree to only use the 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 Application form (if so required). Use of the Data for a new purpose or project will require a new application and approval. 2. The User and the User Institution(s) agree that the Data are made available for one (1) year. The User and the User Institution(s) agree to destroy/discard any 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 Data for archival purposes in conformity with national audits or legal requirements. To extend the use of Data after the one-year period, Users and User Institution(s) must re-apply to access the data. 3. The User and the User Institution(s) agree to preserve, at all times, the confidentiality of the information and Data. In particular, they undertake not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Research Participants. 4. The User and the User Institution(s) agree 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. 5. The User and the User Institution(s) agree not to link or combine the Data provided under this agreement to other information or archived data available in a way that could re-identify the Research Participants, even if access to the data has been formally granted to the User and the User Institution(s), or is freely available without restriction. 6. The User and the User Institution(s) agree not to transfer or disclose the Data, in whole or part, or any material derived from the 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 or the User Institution(s) wish to share the Data with an External Collaborator, the External Collaborator must complete a separate application for Access to the controlled access Data. 7. The User and the User Institution(s) accept that the Data Producers, or copyright holders, or the funders of the Data or any part of the Data supplied: a) bear no legal responsibility for accuracy or comprehensiveness of the Data b) accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the Data, or from the unavailability of, interruption in Data access for whatever reason c) bear no responsibility for the further analysis or interpretation of these Data, over and above that published by the authors. 8. The User and the User Institution(s) agree that they have the secure computation infrastructure and expertise to analyse the Data. 9. The User and the User Institution(s) agree to recognize the contribution of the authors and to include a proper acknowledgement in any work based in whole or part on the Data. 10. The User and the User Institution(s) accept that the Data may be reissued from time to time, with suitable versioning. If the reissue is at the request of a Research Participant and/or other ethical scrutiny, the User and the User Institution(s) will destroy earlier versions of the data. 11. The User and the User Institution(s) agree 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 conclusions drawn directly from the Data. 12. The User and the User Institution(s) 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 and the User Institution(s) 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 User and the User Institution(s) will update the list of authorized personnel (section B in the Data Access Application form) to reflect any changes in researchers, collaborators and personnel within 30 days of the changes made. This update can be sent by email to the data access committee (DAC). 14. The User and the User Institution(s) must notify the DAC prior to any significant change to the research protocol of the User. This update can be sent by email to the DAC. 15. The User and the User Institution(s) will notify the DAC as soon as they become aware of a breach of the terms or conditions of this agreement. 16. The User and the User Institution(s) accept that this agreement may terminate upon any breach of this agreement from the User, the User Institution(s) 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 User and the User Institution(s) will be required to destroy/discard any Data held, including copies and backup copies. This clause does not prevent the User or the User Institution(s) from retaining the Data for archival purposes in conformity with national audits or legal requirements. 17. The User and the User Institution(s) accept that it may be necessary for the data producer or its appointed agent to alter the terms of this agreement from time to time. In this event, the data producer or its appointed agent will contact the User and the User Institution(s) to inform them of any changes. 18. If requested, the User and the User Institution(s) will allow data security and management documentation to be inspected to verify that they are complying with the terms of this Data Access Agreement. 19. The User and the User Institution(s) 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. Applicant: Name: Signed: Date: Authorized institutional representative: Name: Signed: Date: Data Access Application form for Controlled Access Data under the accession number EGAS00001004867, published in Frontiers in Immunology: “Targeted de-methylation of the FOXP3-TSDR is sufficient to induce physiological FOXP3 expression but not a functional Treg phenotype.” Christopher Kressler, Gilles Gasparoni, Karl Nordström, Dania Hamo, Abdulrahman Salhab, Christoforos Dimitropoulos, Sascha Tierling, Petra Reinke, Hans-Dieter Volk, Jörn Walter, Alf Hamann and Julia K. Polansky. This application form is for requests for access to controlled data under the accession number EGAS00001004867. To receive access the entire following application form must be completed. Applications for access to data can be submitted at any time. The Data Access Committee (DAC) will review applications on a rolling basis and aim to provide a decision within 20 days of receipt. The application will be checked for conformity with the goals and policies of the International Human Epigenome Consortium (see http://ihec-epigenomes.org/about/policies-and-guidelines/). If your application is refused it remains possible to re-apply in the future. A. Name of applicant (principal investigator), including affiliations and contact details Enter the primary e-mail correspondence address you would like to use E-mail address: Please ensure that a full postal and email address is included. Name: Title: Position: Affiliation: Institutional e-mail address: Website of the institution: Mailing address: B. Name of authorized personnel within your institution, including affiliations and contact details Include names of all investigators, collaborators*, research staff and PhD students who will have access to the controlled data. PhD student applicants must include their supervisors as a co-applicant. Name: Title: Position: Affiliation: Institutional e-mail address: *Collaborators at other institutions will have to submit a full separate application for access to the controlled data. C. Name of the authorized institutional representative, including affiliations and contact details Please ensure that a full postal and email address is included. Name: Title: Position: Affiliation: Institutional e-mail address: Website of the institution: Mailing address: D. Title of the Project If available, please provide also the address of the project website. E. Scientific abstract Please provide a clear description of the project and its specific aims in no more than 750 words. This should include specific details of what you plan to do with the data and key references. F. Feasibility Please describe fully your experience and expertise, and that of your collaborators, and how this will be applied to the proposed study. Include a list of relevant publications of which you were an author or coauthor. A publication list MUST be provided for the applicant, co-applicants and PhD supervisors where PhD students have applied. The committee needs assurance of competence in handling datasets of this size and nature. G. Lay summary of the project Please provide a short description of the project in no more than 200 words. H. Datasets Requested I. Research ethics Do you foresee any ethical issues arising as a result of your research? If so, how do you plan to address such issues? My country/region does not require my project to undergo ethics review. My country requires my project to undergo ethics review. The project has been approved by the responsible institutional review board or research ethics committee, and the approval letter is attached. The DAC is not responsible for the ethics approval and monitoring of the applicant’s research projects and bears no responsibility for the applicant’s failure to comply with local/national/international ethical requirements. IT security assessment In order to avoid inadvertent disclosure of the private data of patients/donors to unauthorized individuals, the DAC asks you to observe basic information security practices. If you make local copies of Controlled Access Data, you must minimize the risk that this information might be disclosed to individuals who have not agreed to the patient privacy protection conditions. Acceptable practices include: • Physical security: Controlled data will be maintained on physically secure computer systems, such as in a locked office. If the data is stored on a laptop computer, it must be encrypted to avoid its disclosure in case of loss or theft. • Access security: Only individuals who are listed on the data access request should have access to Controlled Access Data. If copies of the data are stored locally on a shared computer or a file server, then it should be password or encryption protected so that only the individuals named in the request have access to it. If the computer that holds Controlled Access Data is backed up, the backup media should either be encrypted or stored in a physical secure location. • Network security: If Controlled Access Data is stored on a network-accessible computer, there should be controls in place to prevent access by computer “hackers”, or contamination by viruses and spyware. Network security is usually implemented by your institution’s IT department and will consist of some combination of network firewalls, network intrusion monitoring, and virus scanning software. • End of project: After finishing the project for which you are requesting access, you must destroy all local copies, including backups. However, if necessary, you can still keep the Controlled Access Data for archival purpose in conformity with national audits or legal requirements. • Training: Everyone who will use controlled data should be trained in the responsible use of patient confidentiality information, familiarized with the terms and conditions of the Data Access Agreement and briefed on the security plans you describe here. Access to Controlled Access Data is a procedure that entails legal and ethical obligations. We require that you and your institutions have a modern, up to date, information technology (IT) policy in place that must include the following items: • Logging and auditing of access to data and to computer network • Password protection to computer network • Virus and malware protection to computers on computer networks • Auditable data destruction procedure, when necessary • Secure data backup procedure, when necessary • Strong encryption on any portable device which may store or provide access to the controlled access data You must agree to the following procedures in order to have access to the Controlled Access Data: 1. I will keep all computers on which Controlled Access Data reside, or which provide access to such data, up to date with respect to software patches and antivirus file definitions (if applicable). Yes 2. I will protect Controlled Access Data against disclosure to unauthorized individuals. Yes 3. I will monitor and control which individuals have access to Controlled Access Data. Yes 4. I will destroy all copies of Controlled Access Data in accordance with the terms and conditions of the Data Access Agreement. Yes 5. I will familiarize all individuals who have access to controlled datasets with the restrictions on its use. Yes 6. I agree to swiftly provide a copy of both my institutional and project related IT policy documents upon request from a DAC representative. Yes I have read, completed and returned the Data Access Agreement (provided separately). Applicant: Name: Signed: Date: Authorized institutional representative: Name: Signed: Date: The completed application must be sent by email to julia.polansky-biskup@charite.de