Phenotype-modifier genes in FHHNC

• HMB DUO:0000006 (version: 2021-02-23)health or medical or biomedical researchThis data use permission indicates that use is allowed for health/medical/biomedical purposes; does not include the study of population origins or ancestry.
• NPUNCU DUO:0000018 (version: 2021-02-23)not for profit, non commercial use onlyThis data use modifier indicates that use of the data is limited to not-for-profit organizations and not-for-profit use, non-commercial use.
• IRB DUO:0000021 (version: 2021-02-23)ethics approval requiredThis data use modifier indicates that the requestor must provide documentation of local IRB/ERB approval.

Data access agreement for datasets of the VHIR Renal Physiopathology Group

Data access agreement for institutions for the study “______________” This agreement governs the terms on which access will be granted to the genotype data generated by the founder researcher Dr.__________________________ (P.I), from Fundació Hospital Universitari Vall d’Hebron – Institut de Recerca – VHIR-, Barcelona, Spain. In response to the Recipient's request for access to the Data (as defined below), VHIR and the Recipient agree as follows: 1 Definitions 1.1 “Data” shall mean all and any human data obtained from the Study. Data include samples or biological materials. 1.2 “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; 1.3 “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; 1.4 “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, visiting academics, contractors, sub-contractors or independent consultants provided that any such individual is bound by confidentiality and nonuse obligations no less onerous then those binding the Recipient’s employees; 1.5 “Research” shall mean research that is seeking to investigate the genotype / phenotype and work on statistical methods that may be applied to such research. Related topics are also possible; 1.6 “Researcher(s)” shall mean an individual or individuals carrying out Research who:(a) in the case of an individual seeking access to Data held solely under the control of P.I and the project, 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 Purpose 2.1 The Recipient agrees to use Data only for the Research. 3 Confidentiality 3.1 The 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 Protection 4.1 The Recipient agrees that it, and its Registered Users, are covered by and shall comply with the obligations contained in the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data. 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. 4.3. The Recipient and Registered Users won’t be able to communicate the data to third parties located in third states that don’t comply with security measures comparable to european ones. In this case, the communication will require the express agreement of the PI/VHIR. 5 Access and Governance 5.1 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 will not communicate personal data to third parties, unless it has the express authorization of P.I/VHIR, in the legally admissible cases. 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 will communicate to the P.I/VHIR, within a maximum period of 30 days, the name of the Registered Users. 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 P.I/VHIR 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 Union (EU). 6 Data Security Breaches The Recipient will notify P.I/VHIR, without undue delay, and in any case before the maximum period of 12 hours, and through e-mail, of the breach of security of personal data in charge of that it has knowledge, together with all the relevant information for the documentation and communication of the incident. Notification will not be necessary when it is unlikely that this security breach constitutes a risk to the rights and freedoms of natural persons. The notification must at least: a) Describe the nature of the breach of security of personal data. b) Communicate the name and contact details of the data protection officer or other contact point where more information can be obtained. c) Describe the possible consequences of the breach of security of personal data. d) Describe the measures adopted or proposed to remedy the breach of security of personal data, including, where appropriate, the measures adopted to mitigate the possible negative effects. 7 Errors 7.1 The Recipient agrees to notify the P.I of any errors detected in the Data. 8 Data reissue 8.1 The 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. 9 Intellectual Property 9.1 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. 9.2 The Recipient and its Registered Users shall have the right to develop Intellectual Property based on comparisons with their own data. The Recipient and Registered Users don’t have the right to transfer the data to third parties, commercialize or distribute it, in whole or in part, without the prior and express authorization of the P.I/VHIR 10 Publications 10.1 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 Study 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. 11 Termination of Agreement 11.1 This Agreement will terminate immediately upon any breach of the provisions of this Agreement by the Recipient or by the Recipient’s Registered Users. 11.2 The Recipient accepts that the changing ethical framework of human genetic research may lead to: (i) alteration to the provisions of this Agreement, in which case the Recipient may accept such alterations or terminate this Agreement; or (ii) the withdrawal of this Agreement in extreme circumstances. 11.3 Either party shall have the right to terminate this Agreement with immediate effect upon giving written notice of termination to the other party. 11.4 In the event that this Agreement is terminated in accordance with this Clause 11 the Recipient shall return or destroy all Data at the direction of P.I/VHIR. 12 Legal statement 12.1 The Recipient acknowledges that P.I and all other parties involved in the creation, 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 way whatsoever 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 is 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 P.I/VHIR. 13 Jurisdiction This Agreement shall be subject to Spanish legislation and in order to resolve any discrepancy which could arise with regard to the application or interpretation of the provisions of this Agreement, the Parties submit, with an express waiver of any jurisdiction to which they could be entitled, to the jurisdiction of the courts and tribunals of Barcelona. The Registered Users acknowledge the contents of this Agreement and agree to comply with the obligations herein. P.I. of Fundació Hospital Universitari Vall d’Hebron – Institut de Recerca – VHIR- comply with the requirements of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data with regard to the collection, storage, processing and disclosure of personal information. Information collected under the Agreement will be used for the purposes of maintaining the Agreement, and may be used for statistical reporting. Passeig Vall d’Hebron 119-129, Central Building, Barcelona (08035). From VHIR Legal Unit, all doubts, complaints, clarifications, suggestions will be resolved through the email lopd@vhir.org