CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.
Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .
Resultado final
HYBRIDA’s exploitation plan will include a comprehensive description of the project’s exploitation objectives, activities, and outcomes, during the project period, as well as foreseen exploitation targets of the 4 main products thereafter. The exploitation plan will provide a three level description: the systemic level, the organizational level, i.e. partner-specific, and the individual level.
Common understanding and form of the productsUiO, with its capacity as the coordinating entity, will contact the project coordinator of SwafS-29-2020, at M1 in order to inform her/him about the initiation of HYBRIDA. Within this task a plan to co-organize three interaction workshops will be made with SwafS-29-2020 beneficiaries. The implementation months should be at least similar, if not identical, for both projects, in order for the interaction workshops to have a similar impact in both projects. In order to safeguard this, UiO will contact the EC, in order to seek the possibility to get in touch with the coordinator of SwafS-29-2020 before the initiation of HYBRIDA and SwafS-29-2020.
Common structure of the 4 products of HYBRIDAand SwafS-29 projectsIn this task the joint task force will work to assimilate the products of the two projects, based on the decisions made at the 2nd interaction workshop and on the preparatory work made at the 3rd interaction workshop.
Operational guidelines for the field of organoids and organoid-related technologiesOperational 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), efficiency/reproducibility, 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
Application of the amended HTA"This report applies the methodology developed in D2.3 to assess organoids as a new and emerging technology in the clinic. The report tries to identify the possible different applications of the technology in the clinic, delineating these applications and assessing their potentialities and limitations. It does so by collecting and analysing a large material: ""visionary statements” in the field, published evidence and ongoing trials, interviews with key stakeholders. The focus is especially on the vision of using patient-derived organoids as models for personalized medicine."
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
Provision, if deemed necessary, of a supplement to the ECoCThis task aims at conducting a comparative analysis of guidelines and codes produced in T5.1 and T5.2 with existing European guidelines in the field. This will be carried out in close collaboration with WP4, WP6 and WP7. Interactions with ALLEA, the European Federation of Academies of Sciences and Humanities, which released the ECoC, are envisaged.
Report on interviews and co-creation workshopsD4.4: Report on the expert interviews and co-creation workshops (M24; AU)
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
Final report on Data ManagementProject quality management will ensure that the project satisfies the required project management standards. The quality management will be based on the Quality Assurance Plan (QAP), which will be produced in M4, and comprises the activity of quality planning and quality control. Quality management will be performed by project coordinator in collaboration with the WP leaders.
Policy brief 2NTUA, 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, i.e. being firmly anchored to the project's 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 recommendations.The second, and final policy brief (M36) will provide policy recommendations for a range of stakeholders based oin the insights and lessons learned from the preojec implementation (2nd reporting period) and finalization
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
Code of responsible conduct for organoid researchersIn addition to the operational guidelines, responsible conduct is a normative demand related not only to personal and team conduct (e.g. integrity and honesty) but also to society. In order to be accepted at the social and political levels, research on organoids should be conducted in a responsible manner. It includes transparency and benefits sharing. The Code will list these demands and will pinpoint the requirements and duties of scientists, research organizations, industries, regulatory instances and States. It will be informed by the results of Task 5.1, discussed with the different stakeholdersand articulated with existing codes in the field of stem cells and biomaterials (input from WP3).
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
Specific proposals for addressing gapsIn collaboration with WP3, WP5 and WP8 an inventory of actors will be produced of the current regulatory agencies and actors involved in regulating organoid activities, their areas of responsibility and their main mode of regulation. Special attention will be paid to regulatory actors that are primarily regulating through the promulgation of ethics and normative frameworks. Potential regulatory actors, i.e. actors that could play an active role in the regulation of organoid activities through involvement in the development of ethics and normative frameworks, but do not currently play such a role will also be identified. Based on this inventory of actors and the gaps identified, analysed and assessed in tasks 6.1-6.5 the actor or actors that are best positioned to address each important gap will be identified and a specific proposal for action developed for each gap. This will be done on the basis of regulatory theory, especially the theorization of “responsive regulation”, and on the basis of the literature on the role of ethics and normative frameworks in the implementation of RE and RI (broadly conceived).Throughout this task there will be close collaboration with WP4 to ensure stakeholder involvement in co-creation and validation of the proposals developed in WP6.
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
Report on focus group consultationD4.5: Report on the focus group consultation and validation process (M36; AU)
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
Publicaciones
Autores:
Tine Ravn, Mads P. Sørensen, Emma Capulli, Panagiotis Kavouras, Renzo Pegoraro, Mario Picozzi, Louise I. Saugstrup, Eleni Spyrakou, Vana Stavridi
Publicado en:
Stem Cell Reports, Edición 18, 2023, Página(s) 841-852, ISSN 2213-6711
Editor:
Cell Press
DOI:
10.1016/j.stemcr.2023.03.003
Autores:
Dam, Mie S.; Green, Sara.
Publicado en:
Science, Technology, & Human Values, 2022, ISSN 0162-2439
Editor:
SAGE Publications
DOI:
10.1177/01622439221143205
Autores:
Jun-ya Shoji, Richard P. Davis, Christine L. Mummery, Stefan Krauss
Publicado en:
Advanced Healthcare Materials, Edición Volume 13, Edición 21, 2024, ISSN 2192-2659
Editor:
World Scientific
DOI:
10.1002/adhm.202301067
Autores:
Maxence Gaillard, Mylène Botbol-Baum
Publicado en:
AJOB Neuroscience, Edición 21507740, 2022, Página(s) 79-80, ISSN 2150-7740
Editor:
Taylor and Francis
DOI:
10.1080/21507740.2022.2048735
Autores:
Rosario Isasi, Heidi B. Bentzen, Morris Fabbri, Antonie Fuhr, Joel C. Glover, Nancy Mah, Deborah Mascalzoni, Sabine Mueller, Stefanie Seltmann, Andreas Kurtz
Publicado en:
Stem Cell Reports, Edición 19, 2024, Página(s) 1233-1241, ISSN 2213-6711
Editor:
Cell Press
DOI:
10.1016/j.stemcr.2024.07.006
Autores:
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
Publicado en:
Journal of Medical Internet Research, Edición 25, 2023, Página(s) e47066, ISSN 1438-8871
Editor:
Journal of medical Internet Research
DOI:
10.2196/47066
Autores:
Jonathan Lewis
Søren Holm
Publicado en:
Bioethics, Edición 14678519, 2022, Página(s) 742-756, ISSN 1467-8519
Editor:
Wiley
DOI:
10.1111/bioe.13047
Autores:
Hofmann B, Zinöcker S, Holm S, Lewis J, Kavouras P
Publicado en:
Cells Tissues Organs, Edición 14226405, 2022, ISSN 1422-6405
Editor:
S. Karger AG
DOI:
10.1159/000527237
Autores:
Edward S. Dove
Publicado en:
Human organoids. Things or data?, Edición 2024, 2024, ISBN 9781003394518
Editor:
Routledge
DOI:
10.4324/9781003394518
Autores:
Sara Green, Mie S. Dam, Mette N. Svendsen
Publicado en:
Human Perspectives in Health Sciences and Technology, Personalized Medicine in the Making, 2023, Página(s) 125-146
Editor:
Springer International Publishing
DOI:
10.1007/978-3-030-74804-3_7
Autores:
Søren Holm
Jonathan Lewis
Publicado en:
AJOB Neuroscience, Edición 13(2), 2022, Página(s) 106-108, ISSN 2150-7759
Editor:
Taylor & Francis
DOI:
10.1080/21507740.2022.2048725
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