EGAD00010000704

THE UK Warfarin Consortium DATA ACCESS AGREEMENT

This agreement governs the terms on which access will be granted to the phenotype and genotype data generated by the UK Warfarin Consortium as part of the research study ‘Variability in response to warfarin: A prospective analysis of pharmacogenetic and environmental factors’. In 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 the User’s Institution (as defined below). The terms User Institution and User referred to within the agreement as “You” and “Your” shall be construed accordingly. Definitions: Consortium means the ‘UK Warfarin Consortium’, a group of researchers included in the primary publication of which can be found here http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330749/Data means all and any phenotype and genotype data obtained from the Consortium. 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 who is employed by the User Institution and is bound by confidentiality and non-use obligations in respect of Data and who has signed this Data Access Agreement and has received acknowledgment of its acceptance.User Institution means the organisation at which the User is employed, affiliated or enrolled.Publications means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. 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 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, to others, except as necessary for data/safety monitoring or programme management. Should You wish to share the Data with a collaborator, the third party must make a separate application for access to the Data. 6.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. 7.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.8.You acknowledge that the Consortium shall incur costs in providing the Data to You, including but not limited to administrative costs and the cost of obtaining appropriate data storage devices. You agree to pay, on the request of the Consortium, such reasonable costs as the Consortium may incur in providing the Data, within thirty (30) days of the Consortium making such a request for payment.9.You agree to share all computer code, statistical scripts and similar material developed while using the Data with the Consortium user community, through the channels the Consortium make available for this purpose. 10.You understand that no data, results, or any product derived from the data, may be copied, by any means and for any purposes, from the Consortium system without it having first been submitted for approval by the Consortium Data Access Committee. 11.You accept that a collaboration proposal will be required between You and the Consortium if Your research question infringes unpublished Data held by the Consortium.12.You agree to abide by the terms outlined in the Consortium ‘Publications Policy’ as set out in Schedule 1.13.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 the Consortium and the relevant primary collectors and their funders. Suitable wording is provided in the Publications Policy given in Schedule 1.14.You accept that the Consortium, the original data creators, depositors or copyright holders, or the funders 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.15.You agree that You and Your collaborators agree to make any reasonable changes to the products of Your work involving the Data, as requested by the Consortium. The Consortium Data Access Committee will only request such changes if, in its opinion, Your work infringes the spirit of the agreement or the principles of collaboration that the Consortium has with its data provider organisations. 16.You agree that you will submit a report to the Consortium Data Access Committee, if requested, on completion of the agreed purpose. The Consortium 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.17.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.18.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.19.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.20.You accept that it may be necessary for the Consortium or its appointed agent to alter the terms of this agreement from time to time in order to address new concerns. In this event, the Consortium 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.21.You accept that the Data is protected by and subject to international laws, including but not limited to the UK Data Protection Act 1998, and that You are responsible for ensuring compliance with any such applicable law. The Consortium 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.22.This 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 non-exclusive jurisdiction of the English courts.SCHEDULE 1Publications Policy Authors who use data from the project must acknowledge the Consortium using the following wording "This study makes use of anonymised data generated by the UK Warfarin Consortium. A full list of the investigators who contributed to the generation of the data is available from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330749/. Funding for the project was provided by the UK Department of Health" and cite the relevant primary Consortium publication (details of which can be found here http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330749/). Users should note that the Consortium bears no responsibility for the further analysis or interpretation of these data, over and above that published by the Consortium. Unless the Consortium has participated in the preparation of the finished report, it must be stated that the responsibility for the interpretation of the information supplied is the authors’ alone. The staff involvement from the Consortium which meets international guidelines for authorship must be suitably included in outputs. Copies of publications (abstracts, papers and posters etc) using data from the Consortium must be sent to the Consortium Data Access Committee on acceptance for publication.For and on behalf of User:Name of applicant(s):Signature of applicant(s):For and on behalf of the User Institution:Signature of institutional or administrative authority:Print name:Position within institute:User institution:Date:WHEN SUBMITTING THIS DOCUMENT PLEASE INCLUDE ALL PAGES OF THEAGREEMENT WITH THIS SIGNATURE PAGE