EGAD00010000492

Policy statements for EGA by CIC bioGUNE (CbG)

Human genetic Data Access Agreement for institutionsThis agreement governs the terms on which access will be granted to the sequencing data generated by CIC bioGUNE.Between:(1) CIC bioGUNE, a non-profit association for Biomedical Research, whose registered address is Technological Park of Bizkaia, Building 801-A, 48160 Derio, SPAIN, from now “CbG”; and(2) [INSERT INSTITUTION DETAILS] (the “Recipient”).Definitions:“Data” means all and any human genetic data obtained from CbG including the Data Subjects’ age, sex and tumour pathology. Explicitly, Data does not include samples or biological materials.“Data Subject” means a person, who has been informed of the purpose for which the Data is held and has given his/her informed consent thereto.“User” means a Researcher (or an individual conducting Research under the supervision of a Researcher) that is employed by the Recipient and is bound by confidentiality and non-use obligations in respect of Data and who has signed this Agreement and has received acknowledgement of its acceptance. For the avoidance of doubt, “Registered User” may also include students, visiting academics, contractors, sub-contractors or independent consultants provided that any such individual is bound by confidentiality and nonuse obligations no less onerous than those binding the Recipient’s employees;“Publications” means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research.“User Institution” means the organisation at which the User is employed, affiliated or enrolled.In response to the Recipient's request for access to the Data (as defined below), CbG and the Recipient agree to be bound by the terms and conditions of access set out in this agreement.Terms and Conditions:In signing this Agreement:1.You agree to use the Data only for the advancement of medical research, according to the consent obtained from sample donors.2.You agree not to use the data from CbG or any part thereof for the creation of products for sale or for any commercial purpose.3.You agree to preserve, at all times, the confidentiality of information and Data pertaining to Data Subjects. In particular, You undertake not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Data Subjects and their right to privacy.4.You agree not to attempt to link the data provided under this agreement to other information or archive data available for the data sets provided, even if access to that data has been formally granted to you, or it is freely available without restriction, without specific permission being sought from the relevant access committees.5.You agree not to transfer or disclose the Data, in whole or part, or any identifiable material derived from the Data, to others, except as necessary for data/safety monitoring or program management. Should You wish to share the Data with a collaborator within the same Institution, the third party must make a separate application for access to the Data.6.The Recipient acknowledges that CbG shall incur costs in providing the Data to the Recipient, including but not limited to administrative costs and the cost of obtaining appropriate data storage devices. The Recipient agrees to pay, on the request of CbG, such reasonable costs as CbG may incur in providing the Data, within thirty (30) days of CbG making such a request for payment.7.The Recipient agrees to notify CbG of any errors detected in the Data8.You agree to use the data for the approved purpose and project described in your application; use of the data for a new purpose or project will require a new application and approval.9.You accept that Data will be reissued from time to time, with suitable versioning. If the reissue is at the request of sample donors and/or other ethical scrutiny, You will destroy earlier versions of the Data.10.You agree to abide by the terms outlined in the CbG 'Publications Policy' as set out in Schedule 1.11.You agree to acknowledge in any work based in whole or part on the Data, the published paper from which the Data derives, the version of the data, and the role of CbG and the relevant primary collectors and their funders. Suitable wording is provided in the Publications Policy given in Schedule 1.12.You accept that CbG, the original data creators, depositors or copyright holders, or the founders of the Data or any part of the Data supplied: a) bear no legal responsibility for the accuracy or comprehensiveness of the Data; and b) accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the Data, or from the unavailability of, or break in access to, the Data for whatever reason.13.You understand and acknowledge that the Data is protected by copyright and other intellectual property rights, and that duplication, except as reasonably required to carry out Your research with the Data, or sale of all or part of the Data on any media is not permitted.14.You recognise that nothing in this agreement shall operate to transfer to the User Institution any intellectual property rights relating to the Data. The User Institution has the right to develop intellectual property based on comparisons with their own data.15.You accept that this agreement will terminate immediately upon any breach of this agreement by You and You will be required to destroy any Data held.16.You accept that it may be necessary for CbG or its appointed agent to alter the terms of this agreement from time to time in order to address new concerns. In this event, CbG or its appointed agent will contact You to inform You of any changes and You agree that Your continued use of the Data shall be dependent on the parties entering into a new version of the Agreement.17.You agree that you will submit a report to CbG Data Access Committee, if requested, on completion of the agreed purpose. The CbG Data Access Committee agrees to treat the report and all information, data, results, and conclusions contained within such report as confidential information belonging to the User Institution.18.You accept that the Data is protected by and subject to international laws, including but not limited to the Basque Country Legislation, and that You are responsible for ensuring compliance with any such applicable law. The CbG Data Access Committee reserves the right to request and inspect data security and management documentation to ensure the adequacy of data protection measures in countries that have no national laws comparable to that which pertain in the EAA.19.This agreement shall be construed, interpreted and governed by the laws of Basque Country and shall be subject to the non-exclusive jurisdiction of the Basque courts.SCHEDULE 1Publications PolicyOne of the purposes of CbG is to accelerate efforts to identify genome sequence variants influencing major causes of human morbidity and mortality, through implementation and analysis of large-scale genome-wide association studies. Additional objectives include the development and validation of informatics and analytical solutions appropriate to the scale and nature of the project, as well as use of the data generated to answer important methodological and biological questions relevant to association studies in general.CbG anticipates that data generated from the project will be used by others, such as required for developing new analytical methods, in understanding patterns of polymorphism and in guiding selection of markers to map genes involved in specific diseases.Authors who use data from the project must acknowledge CbG using the following wording "This study makes use of data generated by CIC bioGUNE” and must cite the relevant primary CbG publication. Funding for the project was provided by the Government of Navarra (Spain), the Government of the Basque Country (Etortek Research Programs 2010/2012) and from the Innovation Technology Department of the Bizkaia County.Users should note that CbG bears no responsibility for the further analysis or interpretation of these data, over and above that published by CbG.