ChIP_3PEAKS

Data access policy of “Uterine leiomyoma: DNA methylation, chromatin activity and gene expression” (EGAS00001004499)

EGA DATA ACCESS AGREEMENT (“Agreement”) This Agreement is made effective on its last date of signature by and between the following parties: University of Helsinki (“UH”), Faculty of Medicine Business ID: FI0313471-7 Address: Yliopistonkatu 3 (P.O. Box 4) 00014 University of Helsinki, Finland and; “User Institution” Business ID number / equivalent if available Address: [ADD ADDRESS] The terms and conditions of this Agreement govern access to the managed access datasets (the details of which are set out in Appendix 1) to which User Institution has requested access. User Institution agrees to be bound by the terms and conditions of this Agreement. 1. Definitions “Authorized Personnel” The individuals at User Institution to whom UH grants access to Data, including the User, the individuals listed in Appendix 2 and any other individuals for whom the User Institution subsequently requests access to Data. Details of the initial Authorized Personnel are set out in Appendix 2. “Controller” As defined in Article 4(7) GDPR. “Data” The managed access datasets to which the User Institution has requested access as specified in Appendices 1 and 2. “Data Producers” UH and the collaborators listed in Appendix 1 responsible for the development, organization, and oversight of these Data. “External Collaborator” A collaborator of the User, working for an institution other than the User Institution. “GDPR” EU General Data Protection Regulation (2016/679). “Personal Data” Personal Data as defined in GDPR Article 4(1) that is included in Data. “Personal Data Breach” A breach of User Institution’s security leading to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, Personal Data transmitted, stored or otherwise processed by User Institution. “Project” The project for which User Institution has requested access to Data, the description of which is provided in Appendix 2. “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 these Data, including that individual’s Personal Data. “Research Purposes” Non-commercial research conducted in the public interest that seeks to advance the understanding of genetics and genomics, including the diagnosis, treatment and monitoring of disorders, as well as work on statistical methods that may be applied to such research. Non-commercial research as meant above does not include research: (a) that is conducted or commissioned by, or on behalf or for the sole benefit of, a commercial entity; (b) that is conducted with the primary motivation of generating: i) profit or ii) data or intellectual property rights to be used to generate such profit; or (c) in which the results are not at any stage intended to be presented in Publications due to commercial considerations. Notwithstanding the above, non-commercial research includes research in which the primary motivation is to further public interest as detailed above, but in which commercial considerations arise (e.g. intellectual property rights are generated and commercialized) as a byproduct of the research. “User” The principal investigator for the Project at the User Institution. 2. Use of Data by User Institution 2.1. User Institution agrees to only use Data: (a) for the sole purpose of conducting the Project (described in Appendix 2); (b) solely within that Project; (c) for Research Purposes; and (d) subject to the limitations (if any) set out in Appendix 1. 2.2. User Institution agrees only to transfer or disclose Data, in whole or part, or any material derived from Data, to Authorized Personnel. User Institution shall not share Data with an External Collaborator. For clarity, an External Collaborator’s may only access Data subject to that External Collaborator completing a separate application and entering into a separate data access agreement with UH. 2.3. User Institution agrees to permanently destroy 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. 3. Confidentiality & Prohibition of Re-identification 3.1. User Institution shall preserve, at all times, the confidentiality of these Data in the manner specified in this Article 3. In particular, it undertakes not to use, or attempt to use Data to disclose or compromise information pertaining to Research Participants, unless otherwise provided in this Agreement. User Institution shall ensure the confidentiality of Data by using measures that are at least equivalent to those by which User Institution protects its own confidential information. Without prejudice to the generality of the foregoing, User Institution agrees to use at least the measures set out in Appendix 1 to protect these Data. 3.2. User Institution shall protect the confidentiality of any information relating to Research Participants in any research papers or Publications by undertaking best reasonable measures to limit the possibility of both direct and indirect identification of Research Participants. 3.3. User Institution shall not link or combine these Data with other information or archived data available in a way that could result in the re-identification of Research Participants, even if access to such additional data has been formally granted to the User Institution or is freely available without restriction. 4. GDPR Compliance 4.1. User Institution acknowledges that upon receipt of Data that includes or constitutes Personal Data, User Institution constitutes a party that has determined the means and purposes of the processing of such Personal Data. 4.2. As a Controller, User Institution shall comply with the terms and conditions set out in the Controller-Controller Standard Contractual Clauses appended to this Agreement as Appendix 4. In case of discrepancy between the provisions of Appendix 4 and any other document included in this Agreement and/or its appendices, the provision included in Appendix 4 shall prevail. 4.3. The Parties acknowledge that User Institution’s use Personal Data in the Project is for Research Purposes alone. Further, such use is compatible with the purposes for which the Data was originally collected by Data Producers in a manner which: (a) has a strong link between the original purpose and the use of such Data in the Project, as both are conducted for Research Purposes; (b) is compatible with the context in which the Personal Data was collected, as the Research Participants have been informed of the possibility of their Personal Data being used for further Research Purposes; (c) Is in line with the reasonable expectations of Research Participants; (d) Takes into account the nature of the Personal Data; (e) Does not cause marked risks or harm to Research Participants in terms of the consequences of processing of Personal Data by User Institution; and (f) Is subject to pseudonymization and other applicable safeguards in both the original purposes for which the Personal Data were collected and the Project. Consequently, if the User Institution is subject to the provisions of the GDPR, the Parties acknowledge that the User Institution’s processing of Personal Data in the Project constitutes compatible use (as provided in GDPR Article 6(4)) and therefore User Institution does not require a separate basis for processing Personal Data (as meant in GDPR Articles 6(1) and 9(2)) in the Project. 4.4. Upon UH’s request, User Institution shall without undue delay provide UH with additional information pertaining to the processing of Personal Data in the Project in order to allow UH to comply with its obligations as the original Controller of Personal Data. In such an eventuality, the information to be provided by User Institution to UH consists of, at a minimum, the information specified in GDPR Articles 13, 14 and 30(1) (as applicable). 4.5. UH or its representative may at any moment inform User Institution of a Research Participant withdrawing their participatory consent or exercising their rights as a data subject under the GDPR. User Institution shall perform all reasonable actions specified by UH in order to fulfil the rights of the Research Participant. 4.6. In the event of a Personal Data Breach, User Institution shall, after having become aware of such Personal Data Breach, notify UH of the Personal Data Breach without delay from becoming aware of it. Such notification shall be made in writing and additionally by any other reasonable and prompt manner (e.g. by phone). 5. Publications 5.1. The User Institution agrees to follow the Publication Policy provided in Appendix 3.1. This includes respecting the moratorium period for the Data Producers to publish the first peer-reviewed report describing and analyzing these Data. 5.2. User Institution agrees to follow the Toronto Statement (as attached in Appendix 3.2) and the Fort Lauderdale Guidelines (as attached in Appendix 3.3). This includes but is not limited to recognizing the contribution of the Data Producers and including a proper acknowledgement in all reports or publications resulting from the use of these Data. 6. Intellectual Property Rights 6.1. User Institution agrees that it shall not make or attempt to make any intellectual property claims on these Data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of these Data. 6.2. Within the context of the Project’s Research Purposes, User Institution may perform research that would add intellectual and resource capital to these Data and decide to obtain intellectual property rights on these downstream discoveries and inventions. User Institution shall own such intellectual property rights. However, User Institution agrees to implement licensing policies that will not obstruct further non-commercial research activities, with such policies conforming with the Organisation for Economic Co-operation and Development Guidelines for the Licensing of the Genetic Inventions (2006) (as appended as Appendix 3.4.). 7. Liability, Representations & Warranties 7.1. User Institution assumes all liability for damages, actions, claims, proceedings, losses (including but not limited to loss of profit), costs, awards damages and payments made by User Institution that may arise (whether directly or indirectly) in any way whatsoever from User Institution’s use, storage or disposal of these Data, or from the unavailability of or break in access to these Data for whatever reason. For clarity, UH is not liable to User Institution for any loss, claim or demand made by User Institution, or made against the User Institution by any third party, arising from the use, storage or disposal of Data. 7.2. User Institution acknowledges that Data Producers, and all other parties involved in the creation, funding or protection of Data: (a) make no warranty or representation, express or implied, as to the accuracy, quality or comprehensiveness of these Data; (b) bear no responsibility for the further analysis or interpretation of these Data. 7.3. Notwithstanding the above, User Institution is not responsible for claims arising from or related to the gross negligence or willful misconduct of UH or its officers, agents or employees. 8. Notification Obligations 8.1. User Institution shall notify UH within 30 days of any changes or departures of Authorized Personnel. 8.2. User Institution shall notify UH prior to any significant changes to the protocol for the Project. 8.3. User Institution shall promptly notify UH should it become aware of a breach of the terms or conditions of this Agreement. 8.4. User Institution shall distribute a copy of these terms to the Authorized Personnel. User Institution is responsible for ensuring that the Authorized Personnel comply with the terms of this Agreement. 9. Termination 9.1. Either Party may terminate this Agreement for any reason by providing thirty (30) days prior written notice to the other Party. If this Agreement terminates for any reason, User Institution shall destroy any Data held, including copies and backup copies. 9.2. User Institution accepts that it may be necessary for the Data Producers to alter the terms of this Agreement from time to time. In the event that changes are required, Data Producers or their appointed agent will contact User Institution to inform it of the changes and User Institution may elect to accept the changes or terminate the Agreement. Any such changes are be implemented upon execution of a signed amendment to this Agreement. 10. Inspections 10.1. If requested, upon advance written notice, and to the extent necessary, during mutually agreeable normal administrative business hours User Institution will allow UH to inspect User Institution’s data security and management documentation (either physically or electronically, as decided by UH) to verify that User Institution is complying with the terms of this Agreement. UH shall schedule such inspections in coordination with User Institution. Inspections are subject to compliance with User Institution’s reasonable measures for confidentiality, safety and security, and are also be subject to compliance with generally applicable premises rules at User Institution (if applicable). 11. Applicable Law & Dispute Settlement 11.1. This Agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this Agreement or its formation; hereinafter “Dispute”) is construed, interpreted and governed by the laws of Finland. 11.2. All Disputes between the Parties in connection to this Agreement shall be first discussed in good faith between the Parties in order to try to find an amicable solution. 11.3. Any Dispute which cannot be solved amicably within 90 days of commencement of negotiations shall be subject to the exclusive jurisdiction of the Finnish courts. 12. Signatures This Agreement may be executed in counterparts, each and every one of which are deemed an original and all of which together constitute one and the same instrument. Each Party may execute this Agreement in Adobe Portable Document Format (PDF) sent by electronic mail, reliable electronic signature service providers (e.g., DocuSign) or as otherwise agreed between the Parties. PDF and/or electronic signatures of authorized signatories of the Parties are deemed to be original signatures, are valid and binding upon the Parties, and, upon delivery, constitute due execution of this Agreement. UNIVERSITY OF HELSINKI Signature:   Name:   Title:   Date:   UH PRINCIPAL INVESTIGATOR I confirm that I have read and understood this Agreement. Signature:   Name:   Title:   Date: [THE REMAINDER OF THIS PAGE REMAINS BLANK USER INSTITUTION SIGNATURES ON FOLLOWING PAGE] USER INSTITUTION: [ADD] Signature:   Name:   Title: Date:   USER I confirm that I have read and understood this Agreement. Signature:   Name:   Title:   Date:   APPENDICES: APPENDIX 1. Dataset Details APPENDIX 2. Project Description APPENDIX 3. Additional Requirements 3.1. Publication Policy 3.2. Toronto Statement 3.3. Fort Lauderdale Guidelines 3.4. OECD Guidelines for the Licensing of Genetic Inventions APPENDIX 4. STANDARD CONTRACTUAL CLAUSES, CONTROLLER - CONTROLLER APPENDIX I – DATASET DETAILS 1. Dataset reference (EGA Study ID and Dataset Details) [add details] 2. Name of project that created the dataset [add details] 3. Names of other data producers/collaborators [add if applicable] 4. Specific limitations on areas of research Limitations as described in the data access agreement. 5. 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 these 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. Information Security: The User Institution shall maintain an appropriate level of information security in accordance with the provisions of the GDPR, taking into account that the Data includes data that constitutes special category data under Article 9 of the GDPR. APPENDIX II – PROJECT DETAILS 1. Details of dataset requested i.e., EGA Study and Dataset Accession Number Study ID: [add details] 2. Brief abstract of the Project in which the Data will be used (500 words max) [add details] 3. All Individuals who the User Institution to be named as registered users Name of Registered User Email Job Title Supervisor* [add details] 4. All Individuals that should have an account created at the EGA Name of Registered User Email Job Title [add details] APPENDIX III – PUBLICATION POLICY UH intend 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. UH anticipate 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. 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 six months after these data were first made available on the relevant hosting database, unless UH has provided written consent to earlier submission. In any publications based on these data, please 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., EGAS00001004499), and acknowledge its use in a form agreed by the User Institution with UH. APPENDIX IV EUROPEAN COMMISSION DIRECTORATE-GENERAL JUSTICE Directorate C: Fundamental rights and Union citizenship Unit C.3: Data protection Commission Decision C(2004)5721 SET II Standard contractual clauses for the transfer of personal data from the Community to third countries (controller to controller transfers) Data transfer agreement between University of Helsinki, Faculty of Medicine, Research Programs Unit Yliopistonkatu 4 (P.O Box 3), 00014 University of Helsinki, Finland hereinafter “data exporter” and [add details] hereinafter “data importer” each a “party”; together “the parties”. 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 enquiries 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 provisions1 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 data2, or iii. the data processing principles set forth in Annex A. Data importer to indicate which option it selects: the data processing principles set forth in Annex A. 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 ………………………………………….. ………………………………………….. …………………………………………. ………………………………………….. Dated: FOR DATA EXPORTER ………………………………………….. ………………………………………….. …………………………………………. ………………………………………….. ANNEX A DATA PROCESSING PRINCIPLES 1. Purpose limitation: Personal data may be processed and subsequently used or further communicated only for purposes described in Annex B or subsequently authorised by the data subject. 2. Data quality and proportionality: Personal data must be accurate and, where necessary, kept up to date. The personal data must be adequate, relevant and not excessive in relation to the purposes for which they are transferred and further processed. 3. Transparency: Data subjects must be provided with information necessary to ensure fair processing (such as information about the purposes of processing and about the transfer), unless such information has already been given by the data exporter. 4. Security and confidentiality: Technical and organisational security measures must be taken by the data controller that are appropriate to the risks, such as against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, presented by the processing. Any person acting under the authority of the data controller, including a processor, must not process the data except on instructions from the data controller. 5. Rights of access, rectification, deletion and objection: As provided in Article 12 of Directive 95/46/EC, data subjects must, whether directly or via a third party, be provided with the personal information about them that an organisation holds, except for requests which are manifestly abusive, based on unreasonable intervals or their number or repetitive or systematic nature, or for which access need not be granted under the law of the country of the data exporter. Provided that the authority has given its prior approval, access need also not be granted when doing so would be likely to seriously harm the interests of the data importer or other organisations dealing with the data importer and such interests are not overridden by the interests for fundamental rights and freedoms of the data subject. The sources of the personal data need not be identified when this is not possible by reasonable efforts, or where the rights of persons other than the individual would be violated. Data subjects must be able to have the personal information about them rectified, amended, or deleted where it is inaccurate or processed against these principles. If there are compelling grounds to doubt the legitimacy of the request, the organisation may require further justifications before proceeding to rectification, amendment or deletion. Notification of any rectification, amendment or deletion to third parties to whom the data have been disclosed need not be made when this involves a disproportionate effort. A data subject must also be able to object to the processing of the personal data relating to him if there are compelling legitimate grounds relating to his particular situation. The burden of proof for any refusal rests on the data importer, and the data subject may always challenge a refusal before the authority. 6. Sensitive data: The data importer shall take such additional measures (e.g. relating to security) as are necessary to protect such sensitive data in accordance with its obligations under clause II. 7. Data used for marketing purposes: Where data are processed for the purposes of direct marketing, effective procedures should exist allowing the data subject at any time to “opt-out” from having his data used for such purposes. 8. Automated decisions: For purposes hereof “automated decision” shall mean a decision by the data exporter or the data importer which produces legal effects concerning a data subject or significantly affects a data subject and which is based solely on automated processing of personal data intended to evaluate certain personal aspects relating to him, such as his performance at work, creditworthiness, reliability, conduct, etc. The data importer shall not make any automated decisions concerning data subjects, except when: a) i. such decisions are made by the data importer in entering into or performing a contract with the data subject, and ii. the data subject is given an opportunity to discuss the results of a relevant automated decision with a representative of the parties making such decision or otherwise to make representations to that parties. or b) where otherwise provided by the law of the data exporter. ANNEX B DESCRIPTION OF THE TRANSFER (To be completed by the parties) Data subjects The personal data transferred concern the following categories of data subjects: Research subjects, clinical sample donors. Purposes of the transfer(s) The transfer is made for the following purposes: For the purposes of conducting the research activities specified in Appendix 2 of the Data Access Agreement to which these Standard Contractual Clauses have been appended. Categories of data The personal data transferred concern the following categories of data: [add details] Access Agreement. Recipients The personal data transferred may be disclosed only to the following recipients or categories of recipients: The recipients of the data are specified in Appendix 2 of the Data Access Agreement to which these Standard Contractual Clauses have been appended. Sensitive data (if appropriate) The personal data transferred concern the following categories of sensitive data: [add details] The data has been further specified in Appendices 1 and 2 of the Data Access Agreement. Data protection registration information of data exporter (where applicable) [add details] Additional useful information (storage limits and other relevant information) Duration of the processing as provided in Section of 2.3 of the Agreement. Contact points for data protection enquiries Data importer Data exporter [add details] Data Protection Officer: Lotta Ylä-Sulkava [add details] tietosuoja@helsinki.fi tel. 02941 911 (switchboard)