FrAmework for ClInicaL trIal participants daTA reutilization for a fully Transparent and Ethical ecosystem

Project Information

FACILITATE

Grant agreement ID: 101034366

DOI

10.3030/101034366

EC signature date 11 October 2021

Start date 1 January 2022

End date 31 December 2025

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 7 562 151,00

EU contribution

€ 3 260 000,00

Coordinated by

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Italy

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (14)

Ethical standards and guidelines No. 2

Ethical standards and guidelines

EDC(B) workshop to discuss and align with DP authorities

EDC(B) workshop to discuss and align with DP authorities, draft harmonized template compatible across countries for all the above deliverables

Consortium handbook

Consortium handbook, to provide important information about the structure of the project, the governing structure, relevant tools for financing and managing activities.

Ethical framework

Ethical framework, first draft for the return of trial data to patients and stakeholder informed strategies for the secondary use of data

Outcome of consultations with local DP authorities

Outcome of consultations with local DP authorities, final harmonized template compatible across countries discussed

Report of the stakeholders involvement plan results No. 2

Report of the stakeholders involvement plan results, periodic report concerning the archived results of the activities

Expert Decision Committees establishment and management rules

Expert Decision Committees establishment and management rules, to define the rules of each Committee and its composition

Communication, dissemination, and exploitation plan

Communication, dissemination, and exploitation plan, detailed plan where to define the strategy according to EU rules

Report on stakeholders' needs and potential barriers

Report on stakeholders’ needs and potential barriers for adoption of the process and associated tools developed through the FACILITATE project

Report of the stakeholders involvement plan results No. 3

Report of the stakeholders involvement plan results, periodic report concerning the archived results of the activities

Ethical standards and guidelines No. 1

Ethical standards and guidelines

Report of the stakeholders involvement plan results No. 1

Report of the stakeholders involvement plan results, periodic report concerning the archived results of the activities

Legal clauses

Legal clauses (M32), to be inserted in investigators contracts to allow the returning of data

Scientific Advisory Board establishment and management rules

Scientific Advisory Board establishment and management rules, to define the rules of the Board and its composition

Websites, patent fillings, videos etc. (1)

FACILITATE Website

FACILITATE Website, to define the structure of the website

Publications

Peer reviewed articles (5)

The nexus of social alliances and diverse moral domains: a bedrock for participatory clinical research

Author(s): Johanna M. C. Blom, Veronica Rivi, Fabio Tascedda and Luca Pani
Published in: Frontiers in Medicine, Issue 10:1250247; 02 October 2023 Sec. Regulatory Science Volume 10 - 2023, 2023, Page(s) 01-04, ISSN 2296-858X
Publisher: Frontiers
DOI: 10.3389/fmed.2023.1250247

Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

Author(s): Deborah Mascalzoni; Roberto Melotti; Cristian Pattaro; Peter Paul Pramstaller; Martin Gögele; Alessandro De Grandi; Roberta Biasiotto
Published in: European Journal of Human Genetics, Issue Eur J Hum Genet 30, 1391–1397 (2022). https://doi.org/10.1038/s41431-022-01160-4, 2022, Page(s) 1391–1397, ISSN 0967-0912
Publisher: Institute of Materials
DOI: 10.1038/s41431-022-01160-4

Ethical and social reflections on the proposed European Health Data Space

Author(s): Ciara Staunton, Mahsa Shabani, Deborah Mascalzoni, Signe Mežinska and Santa Slokenberga
Published in: European Journal of Human Genetics, Issue 32, pages 498–505 (2024), 2024, Page(s) 498-505, ISSN 1018-4813
Publisher: Natue Publishing Group
DOI: 10.1038/s41431-024-01543-9

Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants

Author(s): Ciara Staunton, Johanna M. C. Blom, Deborah Mascalzoni, null null
Published in: Frontiers in Medicine, Issue 11, 2024, Page(s) 01-08, ISSN 2296-858X
Publisher: Frontiers
DOI: 10.3389/fmed.2024.1408600

Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries

Author(s): Roberta Biasiotto, Jennifer Viberg Johansson, Melaku Birhanu Alemu, Virginia Romano, Heidi Beate Bentzen, Jane Kaye, Mirko Ancillotti, Johanna Maria Catharina Blom, Gauthier Chassang, Dara Hallinan, Guðbjörg Andrea Jónsdóttir, Aníbal Monasterio Astobiza, Emmanuelle Rial-Sebbag, David Rodríguez-Arias, Nisha Shah, Lea Skovgaard, Ciara Staunton, Katharina Tschigg, Jorien Veldwijk, Deborah Masca
Published in: JOURNAL OF MEDICAL INTERNET RESEARCH, Issue J Med Internet Res 2023, vol. 25, e47066, 2023, Page(s) 01-16, ISSN 1438-8871
Publisher: Journal of medical Internet Research
DOI: 10.2196/47066

Conference proceedings (1)

Need for Speed: Leveraging the Power of Functional Encryption for Resource-Constrained Devices

Author(s): Eugene Frimpong, Alexandros Bakas, Camille Foucault and Antonis Michalas
Published in: Cryptology ePrint Archive, Paper 2024/231, 2024, Page(s) 13
Publisher: Cryptology ePrint Archive