D4.5. Report on Focus Group Consultation concerning an Ethical and Legal Framework for Organoid-based Technologies: HYBRIDA. Embedding a comprehensive ethical dimension in organoid-based research and resulting technologies

Tine Ravn; Mette Lindhart Falkenberg; Mads P. Sørensen

D4.5. Report on Focus Group Consultation concerning an Ethical and Legal Framework for Organoid-based Technologies: HYBRIDA. Embedding a comprehensive ethical dimension in organoid-based research and resulting technologies

Tine Ravn, Mette Lindhart Falkenberg, Mads P. Sørensen

Research output: Book/anthology/dissertation/report › Report › Research › peer-review

Abstract

The report presents the main results from a focus group consultation
concerning an ethical and legal framework for organoid technologies. Six
focus group interviews were conducted, wherein experts were consulted to
help validate issues related to the latest version of the HYBRIDA Operational
Guidelines for the Field of Organoids and Organoid-Related Technologies
(Chneiweiss et al. 2023) and a regulatory framework for the field (Lewis and
Holm 2022). In all, 35 key experts in the field participated in the consultation
process, with representation from the research community, industry, patient
organizations, biobank networks, stem cell registries, donor organizations,
European agencies, research ethics committees, and research integrity
offices. The experts represented 17 different European countries. The report
addresses the following main topics and provides several recommendations
to be addressed for the ethical and legal guidelines produced in HYBRIDA: i)
the overall set of Operational Guidelines; ii) Informed Consent; iii) Existing Cell
Lines and Ownership; iv) Classification and Regulation of Organoids for
Medical Use; and v) Embryo Models and Neural Organoids.

Original language	English

Place of publication	EU Commission
Number of pages	99
Publication status	Published - Jan 2024

Cite this

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title = "D4.5. Report on Focus Group Consultation concerning an Ethical and Legal Framework for Organoid-based Technologies: HYBRIDA. Embedding a comprehensive ethical dimension in organoid-based research and resulting technologies",

abstract = "The report presents the main results from a focus group consultationconcerning an ethical and legal framework for organoid technologies. Sixfocus group interviews were conducted, wherein experts were consulted tohelp validate issues related to the latest version of the HYBRIDA OperationalGuidelines for the Field of Organoids and Organoid-Related Technologies(Chneiweiss et al. 2023) and a regulatory framework for the field (Lewis andHolm 2022). In all, 35 key experts in the field participated in the consultationprocess, with representation from the research community, industry, patientorganizations, biobank networks, stem cell registries, donor organizations,European agencies, research ethics committees, and research integrityoffices. The experts represented 17 different European countries. The reportaddresses the following main topics and provides several recommendationsto be addressed for the ethical and legal guidelines produced in HYBRIDA: i)the overall set of Operational Guidelines; ii) Informed Consent; iii) Existing CellLines and Ownership; iv) Classification and Regulation of Organoids forMedical Use; and v) Embryo Models and Neural Organoids.",

author = "Tine Ravn and Falkenberg, {Mette Lindhart} and S{\o}rensen, {Mads P.}",

year = "2024",

month = jan,

language = "English",

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D4.5. Report on Focus Group Consultation concerning an Ethical and Legal Framework for Organoid-based Technologies: HYBRIDA. Embedding a comprehensive ethical dimension in organoid-based research and resulting technologies. / Ravn, Tine; Falkenberg, Mette Lindhart; Sørensen, Mads P.
EU Commission, 2024. 99 p.

Research output: Book/anthology/dissertation/report › Report › Research › peer-review

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AU - Falkenberg, Mette Lindhart

AU - Sørensen, Mads P.

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