Raw mRNA expressions

Leeds Melanoma Cohort gene expression Data Access Agreement

This Agreement is made between: (1)The University of Leeds, incorporated by Royal Charter with registered number RC000658 and having its registered address at Woodhouse Lane, Leeds LS2 9JT, United Kingdom ("Leeds"); and (2) [Insert Name], having its [registered / administrative] address at [insert details] ("User Institution"), [(3) [Insert further party names if more than one party will receive Data for the same Project; if the rights granted are identical each can be a "User Institution", but if they differ they will need different names] Each a "Party" and together the "Parties". Definitions Authorised Personnel: The individuals at the User Institution to whom Leeds grants access to the Data. This includes the User, the individuals listed in Appendix II and any other individuals for whom the User Institution subsequently requests access to the Data and whom Leeds approves as Authorised Personnel. Details of the initial Authorised Personnel are set out in Appendix II. Data: The managed access datasets to which the User Institution has requested access. Details of the Data are set out in Appendix I. Data Producers: Leeds and the collaborators listed in Appendix I responsible for the development, organisation, and oversight of the Data. External Collaborator: A collaborator of the User, working for an institution other than the User Institution. Project: The project for which the User Institution has requested access to the Data. A description of the Project is set out in Appendix II. Publications: Includes, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. Research Participant: An individual whose data form part of the Data. Research Purposes: Research that is seeking to advance the understanding of genetics and genomics of melanoma and work on statistical methods that may be applied to such research. The ethical framework under which the Data were generated is that the purpose of the research is to investigate the causes of melanoma and factors (both genetic and environmental) which govern relapse and survival. Use of the Data is therefore limited to addressing these purposes. User: The principal investigator for the Project at the User Institution as specified in Appendix I. The Parties agree that the Data is made available subject to the following terms:- 1. The User Institution agrees to only use the Data for the purpose of the Project (described in Appendix II) and only for Research Purposes. The User Institution further agrees that it will only use the Data for Research Purposes which are within the limitations (if any) set out in Appendix I. 2. The User Institution agrees to preserve, at all times, the confidentiality of the Data. In particular, it undertakes not to use, or attempt to use the Data to compromise or otherwise infringe the privacy of, or the confidentiality of information on, Research Participants. Without prejudice to the generality of the foregoing, the User Institution agrees, as a minimum, to use the measures set out in Appendix I to protect the Data. 3. The User Institution agrees to protect the confidentiality of Research Participants in any research papers or publications that they prepare by taking all reasonable care to limit the possibility of identification. 4. The User Institution agrees not to link or combine the Data to other information or archived data available in a way that could re-identify the Research Participants, even if access to that data has been formally granted to the User Institution or is freely available without restriction. 5. The User Institution agrees only to transfer or disclose the Data, in whole or part, or any material derived from the Data, to the Authorised Personnel. Should the User Institution wish to share the Data with an External Collaborator, the External Collaborator must complete a separate application for access to the Data. 6. The User Institution agrees that the Data Producers, 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; 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 and; c) bear no responsibility for the further analysis or interpretation of the Data. 7. The User Institution agrees to follow the Fort Lauderdale Guidelines (http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtd003207.pdf ) and the Toronto Statement (http://www.nature.com/nature/journal/v461/n7261/full/461168a.html). This includes but is not limited to recognising the contribution of the Data Producers and including a proper acknowledgement in all reports or publications resulting from the use of the Data. 8. The User Institution agrees to follow the Publication Policy in Appendix III. This includes (where applicable) respecting the moratorium period for the Data Producers to publish the first series of peer-reviewed reports describing and analysing the Data. 9. The User Institution agrees not to make intellectual property claims on the Data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of the Data, or conclusion drawn directly from the Data. 10. The User Institution can elect to perform further research that would add intellectual and resource capital to the Data and decide to obtain intellectual property rights on these downstream discoveries. In this case, the User Institution agrees to implement licensing policies that will not obstruct further research and to follow the U.S. National Institutes of Health Best Practices for the Licensing of Genomic Inventions (2005) (https://www.icgc.org/files/daco/NIH_BestPracticesLicensingGenomicInventions_2005_en.pdf ) in conformity with the Organisation for Economic Co-operation and Development Guidelines for the Licensing of the Genetic Inventions (2006) (http://www.oecd.org/science/biotech/36198812.pdf ). 11. The User Institution agrees to destroy/discard the Data held, once it is no longer used for the Project, unless obliged to retain the data for archival purposes in conformity with audit or legal requirements (in which case the Data will be held only for these purposes and only for the period required by applicable law(s) or regulation(s)). 12. The User Institution will notify the University of Leeds within 30 days of any departures of Authorised Personnel. Replacements for, or additions to, Authorised Personnel may not access or use the Data until approved by Leeds in writing. 13. The User Institution will notify Leeds prior to any significant changes to the protocol for the Project. 14. The User Institution will notify the University of Leeds as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. The University of Leeds may terminate this agreement at any time and for any (or no) reason by written notice to the User Institution. If this agreement terminates for any reason, the User Institution will be required to destroy any Data held, including copies and backup copies. This clause does not prevent the User Institution from retaining the Data for archival purpose in conformity with audit or legal requirements in accordance with the terms of clause 11 above. 16. The User Institution accepts that it may be necessary for the Data Producers to alter the terms of this agreement from time to time. As an example, this may include specific provisions relating to the Data required by Data Producers other than the University of Leeds. In the event that changes are required, the Data Producers or their appointed agent will contact the User Institution to inform it of the changes and the User Institution may elect to accept the changes or terminate the agreement. 17. If requested, the User Institution will allow data security and management documentation to be inspected to verify that it is compliant with the terms of this agreement. 18. The User Institution agrees to distribute a copy of these terms to the Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this agreement. 19. 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 exclusive jurisdiction of the English courts (save that Leeds may seek injunctive relief in any relevant jurisdiction to protect the confidentiality of the Data). 20. The User Institution agrees to comply with all applicable laws relating to data protection including, within the European Economic Area, the General Data Protection Regulation 2016/679 and any legislation enabling, supplementing or replacing the same in any relevant jurisdiction. Where the Data is being transferred outside the European Economic Area, the User Institution will also execute the EU Model Clauses contained in Appendix IV without modification, unless an exception to this obligation applies (for example, the User Institution is located in a country which is subject to a European Commission decision of adequacy regarding its data protection laws). Agreed on behalf of User Institution Signature: Name: Title: Date: Principal Investigator I confirm that I have read and understood this Agreement. Signature: Name: Title: Date: Agreed on behalf of Leeds Signature: Name: Title: Date: APPENDIX I - DATASET DETAILS APPENDIX II - PROJECT DETAILS APPENDIX III - PUBLICATION POLICY APPENDIX IV - EU MODEL CLAUSES FOR DATA SHARING - CONTROLLER TO CONTROLLER APPENDIX I - DATASET DETAILS Dataset reference (EGA Study ID and Dataset Details) The Data are comprised of gene expression data generated from formalin fixed primary melanomas using the Illumina Whole Genome DASL array. Metadata supplied are, sex, age at diagnosis, stage at diagnosis and time to melanoma specific death. The nature of the consent obtained from participants was that their samples could be used to generate data to be used for the purposes of understanding the cause of melanoma and the factors governing survival from melanoma. This work might include that designed to identify biomarkers for melanoma prognosis or survival. The Data cannot therefore be used for other purposes. Name of project that created the dataset The Leeds Melanoma Cohort; otherwise known as Melanoma Follow-up and Case-Control Family Study REC reference number 01/03/057. Names of other data producers/collaborators Data from the Office of National Statistics and more recently NHS Digital were used to derive the time to melanoma death data. Specific limitations on areas of research The ethical approvals obtained require that the data may only be used to carry out research into genetic variation associated with the cause of melanoma or the determinants of relapse and therefore survival. The data should not be passed on to other parties: those seeking to access the data should complete this form and apply to the Data Access Committee. Data Access Committee The Data Access Committee for the data comprises the following persons:- Professor Julia Newton-Bishop j.a.newton-bishop@leeds.ac.uk Professor D Tim Bishop D.T.Bishop@leeds.ac.uk Dr Mark Harland M.Harland@leeds.ac.uk Barbara Hartley (lay member, provisional) Minimum protection measures required File access: Data can be held in unencrypted files on an institutional compute system, with Unix user group read/write access for one or more appropriate groups but not Unix world read/write access behind a secure firewall. Laptops holding the Data should have password protected logins and screenlocks (set to lock after 5 min of inactivity). If held on USB keys or other portable hard drives, the data must be encrypted. APPENDIX II - PROJECT DETAILS (to be completed by the User / User Institution) Brief abstract of the Project in which the Data will be used (500 words max) All Individuals who the User Institution to be named as Authorised Personnel Name of Registered User Email Job Title Supervisor* All Individuals that should have an account created at the EGA Name of Registered User Email Job Title APPENDIX III - PUBLICATION POLICY Leeds intends to publish the results of their analysis of this dataset and do not consider its deposition into public databases to be the equivalent of such publications. Leeds anticipates that the dataset could be useful to other qualified researchers for a variety of purposes. However, some areas of work are subject to a publication moratorium as the Leeds research group is actively working on several aspects of the Data. The publication moratorium covers any publications (including oral communications) that describe the use of the dataset. For research papers, submission for publication should not occur until 12 months after the Data were first made available on the relevant hosting database, unless Leeds has provided written consent to earlier submission. In any publications based on the Data, the User Institution(s) should describe how the Data can be accessed, including the name of the hosting database (e.g., The European Genome-phenome Archive at the European Bioinformatics Institute) and its accession numbers (e.g., EGAS00000000029), and acknowledge its use by including the following statement (unless otherwise agreed by Leeds):- The results of this publication are based [partly] on data generated by the University of Leeds in connection with the project 'The Leeds Melanoma Cohort'; otherwise known as Melanoma Follow-up and Case-Control Family Study (REC reference number 01/03/057). This data is currently held within the European Genome-phenome Archive at the European Bioinformatics Institute (accession number EGAS00000000029). The generation of this data was funded by Cancer Research UK (award refs C588/A19167, C8216/A6129 and C588/A10721) and with the support of the National Institutes of Health (award ref. CA83115) and the European Commission Horizon 2020 Research and Innovation Programme (Ref. No. 641458). APPENDIX IV - EU MODEL CLAUSES FOR DATA SHARING - CONTROLLER TO CONTROLLER [NB. Any User Institution which receives Data and is located outside the EEA in a jurisdiction which is not subject to a decision of adequacy relating to its data protection laws must also sign at the end of this Appendix IV. At the time of drafting the European Commission has so far recognised Andorra, Argentina, Canada (commercial organisations), Faroe Islands, Guernsey, Israel, Isle of Man, Jersey, New Zealand, Switzerland, Uruguay and the US (limited to the Privacy Shield framework, i.e. the recipient must have implemented the Privacy Shield framework) as providing adequate protection. These Model Clauses cannot be modified in any way whatsoever.)] Definitions For the purposes of the clauses: (a) "personal data", "special categories of data/sensitive data", "process/processing", "controller", "processor", "data subject" and "supervisory authority/authority" shall have the same meaning as in Directive 95/46/EC of 24 October 1995 (whereby "the authority" shall mean the competent data protection authority in the territory in which the data exporter is established); (b) "the data exporter" shall mean the controller who transfers the personal data; (c) "the data importer" shall mean the controller who agrees to receive from the data exporter personal data for further processing in accordance with the terms of these clauses and who is not subject to a third country's system ensuring adequate protection; (d) "clauses" shall mean these contractual clauses, which are a free-standing document that does not incorporate commercial business terms established by the parties under separate commercial arrangements. The details of the transfer (as well as the personal data covered) are specified in Annex B, which forms an integral part of the clauses. I. OBLIGATIONS OF THE DATA EXPORTER The data exporter warrants and undertakes that: (a) The personal data have been collected, processed and transferred in accordance with the laws applicable to the data exporter. (b) It has used reasonable efforts to determine that the data importer is able to satisfy its legal obligations under these clauses. (c) It will provide the data importer, when so requested, with copies of relevant data protection laws or references to them (where relevant, and not including legal advice) of the country in which the data exporter is established. (d) It will respond to inquiries from data subjects and the authority concerning processing of the personal data by the data importer, unless the parties have agreed that the data importer will so respond, in which case the data exporter will still respond to the extent reasonably possible and with the information reasonably available to it if the data importer is unwilling or unable to respond. Responses will be made within a reasonable time. (e) It will make available, upon request, a copy of the clauses to data subjects who are third party beneficiaries under clause III, unless the clauses contain confidential information, in which case it may remove such information. Where information is removed, the data exporter shall inform data subjects in writing of the reason for removal and of their right to draw the removal to the attention of the authority. However, the data exporter shall abide by a decision of the authority regarding access to the full text of the clauses by data subjects, as long as data subjects have agreed to respect the confidentiality of the confidential information removed. The data exporter shall also provide a copy of the clauses to the authority where required. II. OBLIGATIONS OF THE DATA IMPORTER The data importer warrants and undertakes that: (a) It will have in place appropriate technical and organisational measures to protect the personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, and which provide a level of security appropriate to the risk represented by the processing and the nature of the data to be protected. (b) It will have in place procedures so that any third party it authorises to have access to the personal data, including processors, will respect and maintain the confidentiality and security of the personal data. Any person acting under the authority of the data importer, including a data processor, shall be obligated to process the personal data only on instructions from the data importer. This provision does not apply to persons authorised or required by law or regulation to have access to the personal data. (c) It has no reason to believe, at the time of entering into these clauses, in the existence of any local laws that would have a substantial adverse effect on the guarantees provided for under these clauses, and it will inform the data exporter (which will pass such notification on to the authority where required) if it becomes aware of any such laws. (d) It will process the personal data for purposes described in Annex B, and has the legal authority to give the warranties and fulfil the undertakings set out in these clauses. (e) It will identify to the data exporter a contact point within its organisation authorised to respond to enquiries concerning processing of the personal data, and will cooperate in good faith with the data exporter, the data subject and the authority concerning all such enquiries within a reasonable time. In case of legal dissolution of the data exporter, or if the parties have so agreed, the data importer will assume responsibility for compliance with the provisions of clause I(e). (f) At the request of the data exporter, it will provide the data exporter with evidence of financial resources sufficient to fulfil its responsibilities under clause III (which may include insurance coverage). (g) Upon reasonable request of the data exporter, it will submit its data processing facilities, data files and documentation needed for processing to reviewing, auditing and/or certifying by the data exporter (or any independent or impartial inspection agents or auditors, selected by the data exporter and not reasonably objected to by the data importer) to ascertain compliance with the warranties and undertakings in these clauses, with reasonable notice and during regular business hours. The request will be subject to any necessary consent or approval from a regulatory or supervisory authority within the country of the data importer, which consent or approval the data importer will attempt to obtain in a timely fashion. (h) It will process the personal data, at its option, in accordance with: (i) the data protection laws of the country in which the data exporter is established, or (ii) the relevant provisions (of any Commission decision pursuant to Article 25(6) of Directive 95/46/EC, where the data importer complies with the relevant provisions of such an authorisation or decision and is based in a country to which such an authorisation or decision pertains, but is not covered by such authorisation or decision for the purposes of the transfer(s) of the personal data, or (iii) the data processing principles set forth in Annex A. Data importer to indicate which option it selects: ______________________________________________ Initials of data importer: _____________________________________________________________________; (i) It will not disclose or transfer the personal data to a third party data controller located outside the European Economic Area (EEA) unless it notifies the data exporter about the transfer and (i) the third party data controller processes the personal data in accordance with a Commission decision finding that a third country provides adequate protection, or (ii) the third party data controller becomes a signatory to these clauses or another data transfer agreement approved by a competent authority in the EU, or (iii) data subjects have been given the opportunity to object, after having been informed of the purposes of the transfer, the categories of recipients and the fact that the countries to which data is exported may have different data protection standards, or (iv) with regard to onward transfers of sensitive data, data subjects have given their unambiguous consent to the onward transfer. III. LIABILITY AND THIRD PARTY RIGHTS (a) Each party shall be liable to the other parties for damages it causes by any breach of these clauses. Liability as between the parties is limited to actual damage suffered. Punitive damages (i.e. damages intended to punish a party for its outrageous conduct) are specifically excluded. Each party shall be liable to data subjects for damages it causes by any breach of third party rights under these clauses. This does not affect the liability of the data exporter under its data protection law. (b) The parties agree that a data subject shall have the right to enforce as a third party beneficiary this clause and clauses I(b), I(d), I(e), II(a), II(c), II(d), II(e), II(h), II(i), III(a), V, VI(d) and VII against the data importer or the data exporter, for their respective breach of their contractual obligations, with regard to his personal data, and accept jurisdiction for this purpose in the data exporter's country of establishment. In cases involving allegations of breach by the data importer, the data subject must first request the data exporter to take appropriate action to enforce his rights against the data importer; if the data exporter does not take such action within a reasonable period (which under normal circumstances would be one month), the data subject may then enforce his rights against the data importer directly. A data subject is entitled to proceed directly against a data exporter that has failed to use reasonable efforts to determine that the data importer is able to satisfy its legal obligations under these clauses (the data exporter shall have the burden to prove that it took reasonable efforts). IV. LAW APPLICABLE TO THE CLAUSES These clauses shall be governed by the law of the country in which the data exporter is established, with the exception of the laws and regulations relating to processing of the personal data by the data importer under clause II(h), which shall apply only if so selected by the data importer under that clause. V. RESOLUTION OF DISPUTES WITH DATA SUBJECTS OR THE AUTHORITY (a) In the event of a dispute or claim brought by a data subject or the authority concerning the processing of the personal data against either or both of the parties, the parties will inform each other about any such disputes or claims, and will cooperate with a view to settling them amicably in a timely fashion. (b) The parties agree to respond to any generally available non-binding mediation procedure initiated by a data subject or by the authority. If they do participate in the proceedings, the parties may elect to do so remotely (such as by telephone or other electronic means). The parties also agree to consider participating in any other arbitration, mediation or other dispute resolution proceedings developed for data protection disputes. (c) Each party shall abide by a decision of a competent court of the data exporter's country of establishment or of the authority which is final and against which no further appeal is possible. VI. TERMINATION (a) In the event that the data importer is in breach of its obligations under these clauses, then the data exporter may temporarily suspend the transfer of personal data to the data importer until the breach is repaired or the contract is terminated. (b) In the event that: (i) the transfer of personal data to the data importer has been temporarily suspended by the data exporter for longer than one month pursuant to paragraph (a); (ii) compliance by the data importer with these clauses would put it in breach of its legal or regulatory obligations in the country of import; (iii) the data importer is in substantial or persistent breach of any warranties or undertakings given by it under these clauses; (iv) a final decision against which no further appeal is possible of a competent court of the data exporter's country of establishment or of the authority rules that there has been a breach of the clauses by the data importer or the data exporter; or (v) a petition is presented for the administration or winding up of the data importer, whether in its personal or business capacity, which petition is not dismissed within the applicable period for such dismissal under applicable law; a winding up order is made; a receiver is appointed over any of its assets; a trustee in bankruptcy is appointed, if the data importer is an individual; a company voluntary arrangement is commenced by it; or any equivalent event in any jurisdiction occurs then the data exporter, without prejudice to any other rights which it may have against the data importer, shall be entitled to terminate these clauses, in which case the authority shall be informed where required. In cases covered by (i), (ii), or (iv) above the data importer may also terminate these clauses. (c) Either party may terminate these clauses if (i) any Commission positive adequacy decision under Article 25(6) of Directive 95/46/EC (or any superseding text) is issued in relation to the country (or a sector thereof) to which the data is transferred and processed by the data importer, or (ii) Directive 95/46/EC (or any superseding text) becomes directly applicable in such country. (d) The parties agree that the termination of these clauses at any time, in any circumstances and for whatever reason (except for termination under clause VI(c)) does not exempt them from the obligations and/or conditions under the clauses as regards the processing of the personal data transferred. VII. VARIATION OF THESE CLAUSES The parties may not modify these clauses except to update any information in Annex B, in which case they will inform the authority where required. This does not preclude the parties from adding additional commercial clauses where required. VIII. DESCRIPTION OF THE TRANSFER The details of the transfer and of the personal data are specified in Annex B. The parties agree that Annex B may contain confidential business information which they will not disclose to third parties, except as required by law or in response to a competent regulatory or government agency, or as required under clause I(e). The parties may execute additional annexes to cover additional transfers, which will be submitted to the authority where required. Annex B may, in the alternative, be drafted to cover multiple transfers. Dated: _____________________________________ ___________________________________________ FOR DATA IMPORTER Name: Position: ___________________________________________ FOR DATA EXPORTER Name: Position: