European platform for neurodegenerative disorders

Risultati finali

Among other work and research carried out in WP2/T2.1, The White Paper will also incorporate the work of the ELSI Officer (T2.4), who will assemble the relevant ELSI documentation before the start of each case study (ethics review approvals/amendments, information sheets and consent forms, incidental findings policies, material transfer agreements etc.) A clear statement on the ethics of the case studies explicitly confirming verification/documentation of consent, incidental findings, and ethics review confirmations will be included in the annual reports of the ELSI Officer. These reports will incorporate the following related to HUMANS: 1. Detailed information on the informed consent procedures that will be implemented for the participation of humans (including the follow-up of the cohorts and the consultation to the stakeholders) must be provided. These will be kept on file and provided to IMI JU upon request. 2. If applicable, details on incidental findings policy must be provided. 3. The concerned consortium members must confirm that opinions/approvals by ethics committees and/or competent authorities for the research with humans have been obtained prior to the start of the research in T5.6 and are kept on file. They must be provided to IMI JU upon request. the annual reports of the ELSI Officer will also incorporate the following related to HUMAN CELLS (all of the information/documentation will be provided to IMI JU upon request):1. In case human cells/tissues are obtained within the project, details on cell/tissue types must be kept on file. The concerned consortium members must confirm that the specific approval has been obtained prior to the start of the research activity raising ethics issue and that it is kept on file. 2. In case human cells/tissues are obtained from another project, details on cell/tissue types must be kept on file. The concerned consortium members must confirm that authorisation has been obtained from the primary owner of cells/tissues (including references to ethics approval) prior to the start of the research activity raising ethics issue and that it is kept on file. 3. In case human cells/tissues are obtained from a biobank, details on the cell/tissue types and on the biobank and access to it, must be kept on file prior to the start of the research activity raising ethics issue. 4. The concerned consortium members must confirm that they have obtained all the relevant documents for using, producing or collecting human cells or tissues (e.g., ethics approval, import licence, accreditation/designation/authorisation/licensing) prior to the start of the research activity raising ethics issue and that they are kept on file.

SOP minimal dataset for data glossary

SOP minimal dataset for data glossary from T33 SOP minimal dataset

Framework design & roadmap of the EPND Platform node of ADWB defining standards, biobank facilities, federated components, roles and time plan

Framework design roadmap of the EPND Platform node of ADWB defining standards biobank facilities federated components roles and time plan

Data Management Plan

The Data Management Plan DMP will report on the following data protection requirements partner verification and confirmation of any special derogations of data subject rights in crossborder contexts international transfers partner declarations of compliance with national frameworks transparent DPO contact information and GDPR role assignments Verification and documentation will be carried out by the ELSI Officer as part of T242 The Officer will review a checklist of each of these elements as part of assisting cohorts in implementing the consortium materialdata transfer agreement templates The DMP will also incorporate data protection issues especially sections 4 Data security and 5 Ethics of the DMP template1 The concerned consortium members must check and confirm to IMI JU if special derogations pertaining to the rights of data subjects or the processing of genetic andor health data have been established under the national legislation of the country where the research takes place and provide a declaration of compliance with respective national legal frameworks2 If applicable if case personal data are transferred from the EU to a nonEU country or international organisation confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPR must be provided3 The consortium members must confirm that contact details of the Data Protection Officer DPO were made available to all data subjects involved in the research For the members of the consortium not required to appoint a DPO under the General Data Protection Regulation a detaileddata protection policy for the project must be elaborated and kept on file It must be provided to IMI JU upon request4 The role of controllerjoint controller and data processor among consortiums partners must be clarified In particular in case of joint controllership the consortium must clarify if and how Article 26 of the GDPR will be implemented also concerning the agreement referred to in paragraph 1 of that provision

Data Protection Impact Assessment
Report on kick-off meeting

Report on kickoff meeting

Online publication EPND glossary, core data models and metadata specifications as a FAIR implementation profile
EPND Cohort Classification Scheme
Roadmap and tools for stakeholder engagement

Roadmap and tools for stakeholder engagement as part of Task 6.2

Project management tools for project tracking and reporting
SOP for biomarker validation

SOP for biomarker validation from T34 SOP validation

Phase 1 Evaluation
"General Assembly (GA) meeting #1: minutes and decisions"

General Assembly GA meeting 1 minutes and decisions

Best practices for biobanking

Best practices for biobanking from T31 Best practices for biobanking

SOP body materials collection

SOP body materials collection from T32 SOP body materials collection

Pubblicazioni

Data and sample sharing as an enabler for large-scale biomarker research and development: The EPND perspective

Autori: Niranjan Bose1, Anthony J. Brookes, Phil Scordis and Pieter Jelle Visser, on behalf of the EPND Consortium
Pubblicato in: Frontiers in Neurology, Numero November 2022, 2022, Pagina/e online, ISSN 1664-2295
Editore: Frontiers Research Foundation
DOI: 10.3389/fneur.2022.1031091

Risultati finali

Pubblicazioni

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