APCIM_Nanostring_FAP

• 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.
• RS DUO:0000012 (version: 2021-02-23)research specific restrictionsThis data use modifier indicates that use is limited to studies of a certain research type.
• PUB DUO:0000019 (version: 2021-02-23)publication requiredThis data use modifier indicates that requestor agrees to make results of studies using the data available to the larger scientific community.
• US DUO:0000026 (version: 2021-02-23)user specific restrictionThis data use modifier indicates that use is limited to use by approved users.
• PS DUO:0000027 (version: 2021-02-23)project specific restrictionThis data use modifier indicates that use is limited to use within an approved project.

Data published within the study EGAS00001007237 (Analysis of a cohort of familial ademomatous polyposis patients bearing APC gene mutation) concerning whole blood cell gene expression are made available under controlled access. You can read the applicable conditions here. Please contact the DAC at apcim-ip@pasteur.fr to receive the policy form to be filled and submitted to the data controller (Institut Pasteur) in order to require data access.

Data Access Agreement (DAA) for Controlled Access Data Preamble: Institut Pasteur uses the services of the European Genome-phenome Archive (hereafter “EGA”) system, in order to store and share data resulting from the research called “Cohorte prospective de sujets sains et maladies pour l’étude du Système Immunitaire de ses determinants Génétiques et Environnementaux” (hereafter the “COSIMMGEN Research”). Its purpose is to study the human immune system, its genetic and environmental determinants, in healthy people or people with specific pathologies. It is made up of six arms representing sub-cohorts, including the “ancillary cohort F” (hereafter the “Initial Research”). This cohort is comprised of patients with familial adenomatous polyposis and carrying a mutation of the Adenomatous Polyposis Coli tumor suppressor gene. That arm has been set up to carry out a pilot phase on the role of APC mutations on anti-tumoral immune response. During the Initial Research, data have been collected from individuals whose consent agreements authorised their distribution for the purposes of the Initial Research. The object of this Data Access Agreement (hereafter “DAA”) is to frame the access of the Data Recipient to these data stored on the EGA.   Table of Content Section I: Contacts Information 3 Section II: Definitions 5 Section III: Obligations of the Data Recipient 7 Section IV: Obligations of Institut Pasteur 10 Section V: Miscellaneous provisions 11 Signatures 12 Appendix n°1 _ Description of the Research Project 13 Appendix n°2 _ Description of the Data 15   Section I: Contacts Information A. Data Recipient (including contact details) Please ensure that a full postal address and a valid Institutional email address are included Name: Legal Name: Institutional Postal Address: Institutional E-mail Address: Website of the Institution: B. Authorised Representative of the Data Recipient Name: Position: Affiliation: Institutional Postal Address: Institutional E-mail Address: C. Authorised Personnel of the Data Recipient Name: Position: Affiliation: Institutional Postal Address: Institutional E-mail Address: D. Data protection specialists contacts of the Data Recipient Data Protection Officer (DPO) E-mail Address : Postal Address:   E. Institut Pasteur (including contact details) Please ensure that a full postal address and a valid Institutional email address are included Name: Data Access Committee Institution’s Legal Name: Institut Pasteur Institutional Postal Address: 28 rue du Docteur Roux, 75015 Paris, France Institutional E-mail Address: apcim-ip@pasteur.fr Website of the Institution: F. Authorised Representative of Institut Pasteur Name: Dr. Vincenzo Di Bartolo Position: Doctor - Members of the Data Access Committee Affiliation: Immunoregulation Unit - Data Access Committee of Institut Pasteur Institutional Postal Address: 28 rue du Docteur Roux, 75015 Paris, France Institutional E-mail Address: apcim-ip@pasteur.fr G. Data protection specialists contacts of the Institut Pasteur Data Protection Officer (DPO) E-mail Address : dpo@pasteur.fr Postal Address: Institut Pasteur – Direction juridique, 28 rue du Docteur Roux, 75724 Paris Cedex 15   Section II: Definitions For the purposes of this Data Access Agreement, the following capitalized terms shall have the following meanings, being specified that any reference to the singular shall include the plural and vice versa. Unless otherwise stated, the following definitions shall also apply to Appendixes and potential amendments: Authorised Personnel: designates the individual(s) for whom the Data Recipient subsequently requests access to the Data. DAA: means the present Data Access Agreement. Data: refers to pseudonymized controlled access data to which the Data Recipient has requested access, and which constitute Personal Data. The Data disclosed are detailed in Appendix 2. Data Access/Transfer: means the Data Recipient and its Authorised Personnel’s right to request access to the Data and retrieve them from the EGA system subject to having fulfilled the conditions set out in article 4. Data Access Committee (DAC): refers to data access-granting organisation created by Institut Pasteur. It is made up of one or more appointed persons who examine the Data Recipient’s request for access to the Data. Data Controller: means, as defined in GDPR Article 4 (7), the natural or legal person, public authority agency or other body which, alone or jointly with others, determines the purposes and means of the processing of Personal Data. As part of this DAA, Institut Pasteur is Data Controller for the processing carried out as part of the Initial Research. The Data Recipient is Data Controller for the re-use of the Data as part of their Research Project. Data Processor: means, as defined in GDPR Article 4 (8), the natural or legal person, public authority, agency or other body which processes personal data on behalf of the Data Controller. Data Subject: Refers to any individual who is the source of any Data covered by this DAA. Data Recipient (‘You’): Refers to the Institution who requests Access to the Data through this DAA. European Genome-phenome Archive (EGA): it is a service for permanent archiving and sharing of Data generated for the purposes of the Initial Research. GDPR: means Regulation (EU) 2016/679 (General Data Protection Regulation) of the European Parliament and of the Council on the protection of individuals with regard to the processing of Personal Data and on the free movement of such data. Information: refers to the documents produced by the Data Recipient to enable the Data Subject to be fully aware of the re-use that will be made of his/her Data as part of the Research Project, and of his/her right to oppose to such re-use. Personal Data shall mean any information relating to an identified or identifiable natural person(s) considered as personal data included in the Data as defined in RGPD included in the Data. The Personal Data disclosed are detailed in Appendix 2. Publications: Refers, without limitation, to any and all articles published in print journals, electronic journals, reviews, books, posters, and other written and verbal presentations of Research Project. Supervisory authority: means, as defined in GDPR Article 4 (21), the independent public authority which is established by a Member State pursuant to GDPR Article 51. In France, the Regulatory authority is the Commission Nationale de l'Informatique et des Libertés (“CNIL”). Research Project: The Project for which You have requested Access to the Data, and which is specified in Appendix 1.   Section III: Obligations of the Data Recipient In signing this Data Access Agreement: 1. You, the Data Recipient, acknowledge that Institut Pasteur is subject to the French law and European law, and that the Data Subjects are French. 2. As legally responsible for the Research Project, You undertake to comply with all the legislative and regulatory provisions relating to the implementation of the Research Project, and in particular with the provisions of the Regulations relating to Personal Data applicable to it, and to have obtained all the necessary authorisations and/or completed all the necessary formalities with the competent administrative authorities. In particular, You undertake to have taken the steps required by the French law relating to data processing, data files and individual liberties (“LIL”) with the CNIL, competent supervisory authority in France, precisely, to have obtained authorisation or to comply with reference methodology no. 4 . In this respect, You undertake to provide Institut Pasteur with proof of compliance with this article 2. 3. You undertake to use the Data only for the purposes of carrying out the Research Project and in accordance with the applicable laws and regulations and solely in compliance with the obligations set out in this DAA. No subsequent use of the Data may be made without the prior written consent of Institut Pasteur. If You wish to use the Data for other projects, Institut Pasteur will be notified in writing for its prior written agreement and, where appropriate, a new agreement may be drawn up. 4. Institut Pasteur will grant You Data Access subject to the following cumulative conditions: a. You have sent your Data Access request to the DAC at apcim-ip@pasteur.fr for review and have received its authorisation, which has been formalised by the signature of the present DAA, b. You have fulfilled the formalities described in article 2. 5. In the meantime, you acknowledge that Institut Pasteur, Sponsor of the Initial Research, will need to re-inform individually each Data Subject about the re-use of the Data for the conduct of your Research Project, based on the Information you would have provided to Institut Pasteur to pass on to the Data Subject. You acknowledge that from the moment the Data Subject receives the said information, data access will not be possible before a minimum period of reflection of one (1) month has elapsed, giving the Data Subject the opportunity to object to the re-use of the Data relating to him/her individually. On this point, you agree that Institut Pasteur cannot undertake that the Data Subject will not object to the re-use of his/her Data, and that Institut Pasteur cannot be held liable for this opposition. 6. You agree to use the Data solely for the Purpose of the Research Project and for the duration of the Research Project described in Appendix 1. Any use of the Data for another Research Project will need to be approved by the DAC and will require a new DAA to be signed with Institut Pasteur. 7. You agree to preserve, at all times, the confidentiality of information and Data. You undertake not to use or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Data Subjects and his/her right to privacy. 8. You agree not to attempt to identify Data Subjects. 9. You recognize that nothing in this DAA shall operate to transfer to You any intellectual property rights to the Data. 10. You agree 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. 11. You agree that Institut Pasteur 1) bears no legal responsibility for the accuracy, quality or comprehensiveness of the Data; 2) excludes, 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 Data Recipient that may arise (whether directly or indirectly) in any way from the use of suck Data by the Data Recipient, or from the unavailability or break in access to these Data for whatever reason and; 3) bears no responsibility for the further analysis or interpretation of these Data. 12. You agree to hold the Data Subject and Institut Pasteur harmless and to defend and indemnify all these parties against all liabilities, demands, damages, expenses, and losses arising out of your use for any purpose of the Data. 13. You agree to a moratorium on publishing global analyses of the Data until such time as Institut Pasteur has published its own global analysis or six (6) months, whichever occurs first, have elapsed since the Data were deposited. 14. You agree to acknowledge the contribution of Lymphocyte Cell Biology Unit of Institut Pasteur, as well as the publication “Cuche et al., Frontiers in Immunology, 2023” in all oral and written presentations, disclosures, and Publications resulting from all analyses of the Data, and You undertake to send Institut Pasteur a copy of such Publications. 15. You agree that this DAA, except for article 14, does not grant You or Institut Pasteur any right to use the name, trademarks, logo or any other distinctive sign belonging to either of them without prior written consent of You or Institut Pasteur. Any authorised use of the name, brand, logo or other distinctive sign of either You or Institut Pasteur must comply with your graphic charter or Institut Pasteur’s graphic charter. You may not transfer the Data itself to anyone outside the institution unless Institut Pasteur has approved such transfer and its terms in writing, 16. You may not transfer any information included in the Data to anyone else except to your Authorised Personnel listed out in Section I. article C. In this case, You Authorised Personnel must be bound by a contract that you have signed with them, and whose obligations are at least as binding as those set out in this DAA. 17. Should You wish to share the Data with an external collaborator, You must obtain prior written authorisation of Institut Pasteur and You must sign with the external collaborator a contract whose obligations will be at least as restrictive. 18. In case of a breach of security resulting from accidental use of Data by You and/or your Authorised Personnel, which leads to disclosure of Data, You must report this to Institut Pasteur within 72 hours maximum, and follow any relevant rule as provided by the GDPR. The contact details are mentioned in Section I. article F.   Section IV: Obligations of Institut Pasteur 19. Institut Pasteur assists You in fulfilling your obligation to respond to requests from Data Subject to exercise their rights of access, rectification, erasure and objection, restriction of processing and any other rights they have in relation to their Data. 20. Institut Pasteur undertakes to inform You of any request from Data Subject to exercise their right immediately after becoming aware of it, together with the date of the request, to the address mentioned in Section I. article F. 21. Institut Pasteur will not respond to any request directly except to confirm that the request concerns You if this is the case. Institut Pasteur guarantees that it will help You to process these requests in accordance with the regulations and in compliance with the deadlines set by these regulations.   Section V: Miscellaneous provisions 22. This DAA will be terminated either in the event of breach of this DAA by You, or upon written notice from Institut Pasteur to You, or at the end of the Research Project. 23. In case of termination of this DAA for any reason, You will be required to destroy any Data held. 24. The applicable law is French law. 25. Institut Pasteur and the Data Recipient both shall attempt in good faith to settle any disputes relating to this DAA, its interpretation or enforceability. Should this attempt fail to be amicably settled within three (3) months from the notification of the dispute by the more diligent party to the other, such dispute shall be submitted to the French Courts.   Signatures Except where prohibited by law, Institut Pasteur and the Data Recipient expressly acknowledge and accept that the DAA may be signed in two or more original copies, or in electronic form (by facsimile, pdf or any other electronic means), each of the copies being deemed to be an original and all, taken together, to be considered as constituting one and the same amendment. Consequently, Institut Pasteur and the Data Recipient recognise that the dematerialised signed DAA is proof of the content of the said rider, of the identity of the signatory and of his consent to the obligations and consequences of fact and law arising from the dematerialised signed DAA. I have read, understood and agree to abide by the terms and conditions stipulated in this Data Access Agreement. Data Recipient or Authorised Representative of the Data Recipient: Name: Title and position (if applicable): Affiliation (if applicable): Signature: _____________________________________Date: _____________________ Institut Pasteur or Authorised Representative of the Institut Pasteur: Name: Title and position (if applicable): Affiliation (if applicable): Signature: _____________________________________Date: ______________________ Authorised Personnel of the Data Recipient: Name: Title and position (if applicable): Affiliation (if applicable): Signature: _____________________________________Date: ______________________ Appendix n°1 _ Description of the Research Project A. Title of the Proposed Research Project B. Research Project (Scientific Abstract): Please provide a clear description of the Research Project: - its stakeholders, - its main question and its relevance to the research domain addressed, - its specific aims, - and duration. Note that any use of the Data, if approved, must fall under the framework of the described Research Project (300 words max): C. Research Credentials Please provide a list of three Publications, relevant to the Research Project description, of which the Data Recipient is author or co-author, and, also, attach their (Data Recipient’s) short CV. If the Data Recipient has not authored or co-authored three relevant Publications, please describe their relevant expertise or experience in no more than 150 words; also, notify how the Research Project will be carried out (e.g. available funding, infrastructure and so on).   Appendix n°2 _ Description of the Data Within the frame of the Initial Research, Institut Pasteur collected and stored on EGA the following Data object of the present Data Access Agreement: Please write down a list of the Data you wish to have access to: