RRBS data of 48 individuals of the Dutch Hunger Winter Families Study

Access policy Dutch Hunger Winter Families Study

Human data access agreement for institutions between:(1) Academisch Ziekenhuis Leiden, also acting under the name Leiden University Medical Center, having its principal place of business at Albinusdreef 2, 2333 ZA Leiden, The Netherlands, in this case acting through its Division 4, duly represented by its manager, hereinafter referred to as “LUMC”;(2) [INSERT INSTITUTION DETAILS] , hereinafter referred to as “Recipient”.WHEREAS LUMC has performed research known as the Dutch Hunger Winter Families Study within which scope Data (as defined below) were generated;WHEREAS Recipient has made a request for access to the Data;WHEREAS LUMC is prepared to grant such access to Recipient under the conditions as set out in this Agreement.LUMC and the Recipient agree as follows:1 Definitions1.1 “Dutch Famine Study” (“DFS”) shall mean the project undertaken at the Leiden University Medical Center in Leiden in cooperation with researchers at Columbia University in New York to identify molecular differences relevant to the development of adult disease in humans exposed to the Dutch Hunger winter and unexposed siblings;1.2 “Data” shall mean all and any human genetic data obtained from the DFS. Explicitly, data does not include samples or biological materials;1.3 “Data Subject” shall mean the person (irrespective of state of health) to whom Data refers and who has been informed of the purpose for which the Data is held and has given his/her informed consent thereto;1.4 “Intellectual Property” means (i) patents, designs, trade marks and trade names (whether registered or unregistered), copyright and related rights, database rights, know-how and confidential information; (ii) all other intellectual property rights and similar or equivalent rights anywhere in the world which currently exist or are recognised in the future; and (iii) applications, extensions and renewals in relation to any such rights;1.5 “Registered User” shall mean 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 and visiting academics provided that any such individual is bound by confidentiality and nonuse obligations no less onerous than those binding the Recipient’s employees;1.6 “Research” shall mean academic research that is seeking to advance the understanding and treatment of diseases, and work on statistical methods that may be applied to such research;1.7 “Researcher(s)” shall mean an individual or individuals carrying out Research who:(a) in the case of an individual seeking access to Data, has authored a relevant peer-reviewed article that the LUMC can locate on PubMed and who is still working in the field; or(b) in the case of an individual seeking access to Data held as part of a wider consortium, is a successful applicant to the consortium data access committee.2 PurposeThe Recipient agrees to use Data only for the Research.3 ConfidentialityThe Recipient agrees to preserve, at all times, the confidentiality of Data pertaining to identifiable Data Subjects. In particular, the Recipient undertakes not to use, or attempt to use the Data to deliberately compromise or otherwise infringe the confidentiality of information on Data Subjects and their right to privacy.4 Data Protection4.1 The Recipient agrees that it, and its Registered Users, are covered by and shall comply with the obligations contained in the Dutch Personal Data Protection Act (Wet Bescherming Persoonsgegevens) as amended from time to time, or equivalent national provisions no less onerous than those contained in the European Data Protection directive 95/46. In particular, the Recipient and its Registered Users understand their duties under such legislation in relation to the handling of Data and the rights of Data Subjects.4.2 The Recipient agrees that it, and its Registered Users, shall not analyse or make any use of the Data in such a way that has the potential to (a) lead to the identification of any Data Subject; or (b) compromise the anonymity of any Data Subject in any way.5 Access and Governance5.1 The Recipient agrees that it shall take all reasonable security precautions to keep the Data confidential, such precautions to be no less onerous than those applied in respect of the Recipient’s own confidential information.5.2 The Recipient agrees to only give access to Data, in whole or part, or any identifiable material derived from the Data, to a Registered User. The Recipient agrees that before it gives any Registered User access to Data, it shall first show the Registered User a copy of this Agreement and shall inform the Registered User that he or she must comply with the obligations contained in this Agreement and sign up to the provisions of this Agreement in the form set out at the end of this Agreement. The Recipient shall provide LUMC with a copy of the Registered User’s acceptance form within thirty (30) days of the date of acceptance by the Registered User.5.3 The Recipient agrees that it shall only give Registered Users that are not Researchers (including but not limited to students or new researchers to the field) access to the Data if they are supervised by a Researcher who will take responsibility for such Registered Users’ use of the Data.5.4 LUMC 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 pertaining in the European Economic Area (EEA).6 ErrorsThe Recipient agrees to notify the LUMC of any errors detected in the Data.7 Data reissueThe Recipient accepts that Data will be reissued from time to time, with suitable versioning. If Data is reissued at the request of sample donors and/or as the result of other ethical scrutiny, the Recipient agrees to destroy all earlier versions of the Data.8 Intellectual Property8.1 The Recipient recognises that nothing in this Agreement shall operate to transfer to the Recipient or its Registered Users any Intellectual Property rights in or relating to the Data.8.2 The Recipient and its Registered Users shall have the right to develop Intellectual Property based on comparisons of the Data with their own data.9 Publications9.1 The Recipient agrees 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 LUMC, the study principal investigators, and its funders in its distribution. The Recipient agrees to use the acknowledgement wording provided for the relevant Data in its publication. The Recipient will also declare in any such work that those who carried out the original analysis and collection of the Data bear no responsibility for the further analysis or interpretation of it by the Recipient.10 Termination of Agreement10.1 LUMC has the right to terminate this Agreement with immediate effect upon any breach of the provisions of this Agreement by the Recipient or by the Recipient’s RegisteredUsers.10.2 The Recipient accepts that the changing ethical framework of human genetic research may lead to alteration to the provisions of this Agreement, in which case the Recipient may accept such alterations or terminate this Agreement.10.3 Either party shall have the right to terminate this Agreement with immediate effect upon giving written notice of termination to the other party.10.4 In the event that this Agreement is terminated in accordance with this Clause 10 the Recipient shall upon direction of LUMC either return or destroy all Data.11 CostsThe Recipient acknowledges that LUMC may 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 LUMC, such reasonable costs as LUMC may incur in providing the Data, within thirty (30) days of LUMC making such a request for payment.12 Representations and Warranties and Indemnity12.1 The Recipient acknowledges that LUMC and all other parties involved in the creation, funding or protection of the Data:(a) make no warranty or representation, express or implied as to the accuracy, quality or comprehensiveness of the Data; and(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 waywhatsoever from the Recipient’s use of the Data, or from the unavailability of, or break in access to the Data for whatever reason.12.2 The Recipient understands that all the Data may be protected by copyright and other Intellectual Property rights, such that duplication or sale of all of or part of the Data on any media is not permitted under any circumstances, except with the prior written consent of LUMC.13 Governing Law and Competent Court13.1 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 Dutch law. 13.2 Any disputes arising out of or in connection with this Agreement, including disputes concerning the existence and validity thereof, shall be resolved exclusively by the competent courts in The Hague, the Netherlands and shall be subject to the exclusive jurisdiction of the Dutch courts.AGREED by the parties through their authorised signatoriesFor LUMC:Name:Drs G.E. de BlécourtDate:Signature:For Recipient:Name:Date:Signature: