Livrables
Operational guidelines consist of a set of instructions to help researchers carry out laboratory work aiming at fabrication characterization validation and exploitation of organoids They will concern assessment of origin of biological material including donors informed consent efficiencyreproducibility quality output size morphogenesis cellular composition and reliability while reducing miscommunication precise and documented description of materials and methods failure to comply with safety security RI and research misconduct
EventsA deliverable on events will report foreseen significant events of the project M3 M12 M24 M36
Complete amended HTA to assess organoids as health technologiesAmend the HTA methodology to better address the particularities of organoids as well as to address conceptual ethical and regulatory aspects Based on the results in T23 perform a complete health technology assessment HTA to assess organoids as health technologies
Different forms of conceptual uncertainty relating to organoids, chimeric entities and hybrids in scientific literature .In the scientific literature chimeras and hybrids are used both as metaphors and as termini technici for certain organoids and certain forms of organoid research For these reasons also an analysis of the use of these terms in the scientific literature with a view to uncovering conceptual uncertainty is warranted A representative sample of scientific papers on organoid researchfrom 34 high impact scientific journals from the last 5 yearswill be selected and a semantic analysis carried out
Quality Assurance PlanThe structure of the consortium is organized on the level of WPs managed by the partners with the higher experience in the relevant area The Coordinator will be responsible for the reporting to the EC The Coordinator will collect technical and financial status reports every 6 months and will send a Progress Report to the EC and to all partners Every 18 months the Coordinator will send a Review Report to the EC This report will include a short overview of the progress and deviation from plans as well as future work planned and action to be taken if any The structure of the consortium is organized on the level of WPs managed by the partners with the higher experience in the relevant area The Coordinator will be responsible for the reporting to the EC The Coordinator will collect technical and financial status reports every 6 months and will send a Progress Report to the EC and to all partners Every 18 months the Coordinator will send a Review Report to the EC This report will include a short overview of the progress and deviation from plans as well as future work planned and action to be taken if any
Map report of normative, RE and RI frameworksGather relevant results from accomplished and running relevant SwafSprojects its main aim is to funnel relevant knowledge to HYBRIDA that will be used by WP5 and 6 A search for publicly available results either public reports or publicly available deliverables through the projects websites will be carried out and b contact with the projects coordinators will be made to seek additional input that may be confidential Table 12 presents the SwafSprojects the specific input we plan to obtain from each one of them and the HYBRIDA task it is bound to fertilize We will also search for and draw relative results from the Embassy of Good Science EoGS which at the start of HYBRIDA is expected to be up an running as an Open semantic wiki platform HYBRIDA partners are already consortium members in several SwafSprojects see Table 12 and have contributed to the enrichment of the EoGS databaseCollect and elaborate on the debates that have occurred in the past and are still ongoing regarding the regulatory ethical and integrityrelated dimensions ofthe abovementioned technologies A mixed methods approach will be applied which includes a desk study and systematic literature review as well as interaction with experts within the selected technologies The systematic literature review will include selection of relevant published sources sorting and analysis of various ethical dimensions as well assynthesis of relevant findings The interaction with experts will be accomplished via 10 interviews of external experts
Newsletters and leafletsNTUA will collect input from all HYBRIDA partners in order to produce newsletters and leaflets on a biannual base They will be available online from the projects website and in printedhard copy form in order to be distributed conferences workshops and public outreach eventsNewsletters and leaflets M12 M18 M24 M30 M36
Protocol for WP4D41 Protocol for WP4 M8 AU
Policy brief 1NTUA together with UiO will prepare two short policy briefs M12 M36 as a concise and comprehensive summary of the outcomes of the mapping of the engagement activities of HYBRIDA ie being firmly anchored to the projects extensive empirical study These policy briefs will primarily target research and government policy makers as well as other stakeholders with the potential to influence policy and provide them the best policy options and recommendationsThe 1st policy brief M12 will situate HYBRIDA in the ongoing policy context and report on insights and lessons learned from the first 12 project months
Artistic representations of chimeras and hybridsMythological artistic and science fiction representations of chimeras and hybrids will be studied with a view to these representations impact on the conceptual and metaphorical landscape of organoid research
Typology for artificial biological entities.A socially robust typology for artificial biological entities intra and interspecies chimeras intra and interspecies hybrids organoids and biologicaltechnical hybrids built
Report on the mini-publicD43 Report on the minipublics M14 AU
Comparative analysisIdentify relevant regulatory environments and cultures that deal with the selected technologies and gather existing knowledge on codes of conduct SOPs and guidelines regulating organoid research and the selected technologiesfamilies of technologies We will proceed with a mixed methods approach similar to the one applied in Task 31 ie a combination of literature review and expert consultations which will result in the compilation and classification of the findings in order to suggest appropriate operational guidelines draft a Code of responsible conduct for researchers as well as contribute to the existing ethics and normative frameworks WP5 and WP6 respectively
Systematic and structured gap analysisThe two mappings produced in WP2 organoid activity and WP3 regulatory landscape will be integrated into a multidimensional Super Map showing which activities are regulated in which ways and by what agenciesactors The integration will require close reading of the extant regulations using standard legal methods of statutoryregulatory interpretation The creation of the super map will enable the identification of areas of activity that are currently unregulated or underregulated gaps and areas of activity that are overregulated
Report on participant selectionD42Report on participant selection and procedures and criteria for recruitment M8 AU
Results of a traditional HTAA traditional HTA will be performed applying existing evidence for efficacy effectiveness safety and costeffectiveness to reveal the deficiencies of existing methodology
Different forms of conceptual uncertainty relating to organoids, chimeric entities and hybrids in philosophical, ethical, and legal literatureFocus will be on identifying conceptual uncertainties relating to the moral and legal status of such entities A review of relevant philosophical ethical and legal literature will be carried out using different philosophical methodologies and methods for analysis of legal texts
Map of the organoid fieldMap the types of organoids origins of cells purpose of research planned and potential translation using literature searches of both academic and grey literature cocitation analysis patent searches and searches of trade publications and business databases
WP8 will design HYBRIDAs branding implement and monitor a communication and dissemination campaign through online website and social media offline channels participations in conferences workshops and public events and printed material NTUA will be responsible for the broad dissemination of the projects threestage engagement process intermediate and final results and HYBRIDAs progress at large WP8 will also produce HYBRIDAs exploitation plan at the end of the project
Policy for Data management the project will comply with the newly imposed rules concerning data quality sharing and security A Data Management Plan DMP will be produced by M4 and will be updated at the project midterm and end The HYBRIDA consortium will ensure that research data will be easily discoverable accessible assessable and intelligible usable beyond the original purpose for which they were collected interoperable to specific quality standards whenever relevant following the FAIR data principles
Publications
Auteurs:
Tine Ravn, Mads P. Sørensen, Emma Capulli, Panagiotis Kavouras, Renzo Pegoraro, Mario Picozzi, Louise I. Saugstrup, Eleni Spyrakou, Vana Stavridi
Publié dans:
Stem Cell Reports, Numéro 18, 2023, Page(s) 841-852, ISSN 2213-6711
Éditeur:
Cell Press
DOI:
10.1016/j.stemcr.2023.03.003
Auteurs:
Dam, Mie S.; Green, Sara.
Publié dans:
Science, Technology, & Human Values, 2022, ISSN 0162-2439
Éditeur:
SAGE Publications
DOI:
10.1177/01622439221143205
Auteurs:
Maxence Gaillard, Mylène Botbol-Baum
Publié dans:
AJOB Neuroscience, Numéro 21507740, 2022, Page(s) 79-80, ISSN 2150-7740
Éditeur:
Taylor and Francis
DOI:
10.1080/21507740.2022.2048735
Auteurs:
Rosario Isasi, Heidi B. Bentzen, Morris Fabbri, Antonie Fuhr, Joel C. Glover, Nancy Mah, Deborah Mascalzoni, Sabine Mueller, Stefanie Seltmann, Andreas Kurtz
Publié dans:
Stem Cell Reports, Numéro 19, 2024, Page(s) 1233-1241, ISSN 2213-6711
Éditeur:
Cell Press
DOI:
10.1016/j.stemcr.2024.07.006
Auteurs:
Jonathan Lewis
Søren Holm
Publié dans:
Bioethics, Numéro 14678519, 2022, Page(s) 742-756, ISSN 1467-8519
Éditeur:
Wiley
DOI:
10.1111/bioe.13047
Auteurs:
Hofmann B, Zinöcker S, Holm S, Lewis J, Kavouras P
Publié dans:
Cells Tissues Organs, Numéro 14226405, 2022, ISSN 1422-6405
Éditeur:
S. Karger AG
DOI:
10.1159/000527237
Auteurs:
Søren Holm
Jonathan Lewis
Publié dans:
AJOB Neuroscience, Numéro 13(2), 2022, Page(s) 106-108, ISSN 2150-7759
Éditeur:
Taylor & Francis
DOI:
10.1080/21507740.2022.2048725
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