Italian Genome Project

GENETIC HISTORY OF ITALY: THE ITALIAN GENOME PROJECT (IGP)

POLICY DOCUMENTATIONSData Access Committee (DAC) name: HUGEFHuman Genetics Foundation – HuGeF Via Nizza 52, 10126, Torino, ItalyThis document specifies the policy for granting access to the European Genome-phenome Archive (EGA) secure Web based tools for managing data access permissions to the data stored in the EGA database. Access is granted to those Data Access Committee members named in this document by Paul Flicek, head of Genes, Genomes and Variation.Conditions of access:The account holder will abide by all current and future policies of the EBI for computer use as well as computer use policies of the European Molecular Biology Laboratory (EMBL), of which the EBI is a part. All EGA specific policies and standard operating procedures (SOPs) must also be followed. All applicable policies will be provided to the authorized users.The DAC HUGEF will evaluate any request to access the data and will approve data sharing on the basis of the specific project presented, verifying bona fide of the researchers and absence of conflict of interests. Method of access:The EBI will create a personal account for the authorized person. The account username and password together with a RSA key provide access to the secure EGA infrastructure. A separate document with detailed guidelines on how to access and use these tools is provided to each account holder. The EGA helpdesk provides training when needed.Review:All individuals access to the EGA user authorization tools will be reviewed annually by Paul Flicek. Any staff changes affecting the authorized person must be provided immediately to Paul Flicek (flicek@ebi.ac.uk).HUMAN GENETIC DATA ACCESS AGREEMENT FORMBetween:(1)HUMAN GENETICS FOUNDATION, a private no profit research Foundation registered to the Register of Legal Entities of the Piedmont Region under n. 841 (Tax code 97696250014; VAT: 10335910013) whose registered address is Via Nizza 52, Torino, Italy, operating as the “HuGeF” institution; and(2)[INSERT INSTITUTION DETAILS] (the “Recipient”).In response to the Recipient's request for access to the Data (as defined below), HuGeF and the Recipient agree as follows:1Definitions1.1“Italian Genome Project” (“IGP”) shall mean the project undertaken at the HuGeF in Torino to identify genetic sequence variants to study population stratification and complex diseases in Italy;1.2“Data” shall mean human genetic data obtained from the IGP including the Data Subjects’ macroarea of origin with reference to the paper Fiorito et al (Eur J Hum Genet. 2015 Nov 11; PMID: 26554880). 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, visiting academics, contractors, sub-contractors or independent consultants provided that any such individual is bound by confidentiality and non- use obligations no less onerous then those binding the Recipient’s employees;1.6“Research” shall mean research that is seeking to advance the understanding of the population stratification in Italy, the relationship with other European and non-European populations, 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 held control of HuGeF and the IGP, has authored a relevant control of HuGeF and the IGP, has authored a relevant peer-reviewed article that HuGeF 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.2Purpose2.1The Recipient agrees to use Data only for the Research.3Confidentiality3.1The 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.4Data Protection4.1The Recipient agrees that it, and its Registered Users, are covered by and shall comply with the obligations contained in the Data Protection Act 1998 as amended from time to time, or equivalent national provisions. 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.4.2The 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.5Access and Governance5.1The 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.5.2The 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 HuGeF with a copy of the Registered User’s acceptance form within thirty (30) days of the date of acceptance by the Registered User.5.3The 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. Should The Recipient wish to share the Data with a Researcher outwith the same Institution, the third party must make a separate application for accessing to the Data. 5.4HuGeF 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).6Errors6.1The Recipient agrees to notify the IGP of any errors detected in the Data.7Data reissue7.1The 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.8Intellectual Property8.1The 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.9Publications9.1The 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 IGP 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.10Termination of Agreement10.1This Agreement will terminate immediately upon any breach of the provisions of this Agreement by the Recipient or by the Recipient’s Registered Users.10.2The 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.10.3Either 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 return or destroy all Data at the direction of HuGeF.12Costs12.1The Recipient acknowledges that HuGeF 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 HuGeF, such reasonable costs as HuGeF may incur in providing the Data, within thirty (30) days of HuGeF making such a request for payment.13Legal statement13.1The Recipient acknowledges that HuGeF 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 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.13.2The 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 HuGeF.14Governing Law14.1This 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 Italy and shall be subject to the exclusive jurisdiction of the Italy courts.AGREED by the parties through their authorised signatories HuGeF complies with the requirements of the Data Protection Act 1998 or equivalent national provisions (particularly Italian Data Protection Code - Legislative Decree no. 196/2003) according to 4.1 with regard to the collection, storage, processing and disclosure of personal information and is committed to upholding the Act's core Data Protection PrinciplesInformation collected under the Agreement will be used for the purposes of maintaining the Agreement, and may be used for statistical reporting.