Regulating organoid research
Embedding a comprehensive ethical dimension to organoid-based research and related technologies.
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HYBRIDA operational guidelines
The HYBRIDA Operational Guidelines regarding organoids and organoid-related technologies aim to help researchers and are designed to streamline certain working procedures according to best practices. Their recommendations are designed to ensure reliable research, development and production work on organoids and related technologies, as well as advice on assessment and evaluation, while making provision for flexibility in the event of unforeseen circumstances and for the rapid development of this blooming field.
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Code of Responsible Conduct
The HYBRIDA Code of Responsible Conduct for Researchers provides ethical standards of good practice to guide institutions and researchers in the field of organoids and organoid-related technologies, in compliance with the principles of the European Code of Conduct (ECoC): Accountability, Honesty, Reliability and Respect. This Code is a companion document to the HYBRIDA Operational Guidelines for Organoids and related fields (OGLs) and its focus is to develop and support research integrity within an ethical research ecosystem.
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Amendment to the European Code of Conduct
In order to complete the criteria for appropriate behavior in research, quality and robustness of research HYBRIDA has an addition to the ECoC relating to the responsibilities of researchers with regard to human biological samples and associated data, one of the fundamental principles of which is respect for the donor and his consent. Our proposed amendment would be inserted in Chapter 2 Good Research Practices.
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The three-stage engagement scheme
We achieved our results by executing the following engagement activities
Stage 1
EXPLORATION OF PUBLIC ATTITUDES
3 deliberative workshops with lay people (51 participants in total)Stage 2
CONSULTATION & CO-CREATION
- Two expert co-creation & consultation workshops (28 participants in total)- 15 expert interviews
Stage 3
ASSESSMENT & VALIDATION
6 Focus Group consultation with leading experts (35 participants in total)
Key concepts
A basis of regulations, moral codes and ethics which protects the biomedical research’s participants and research activity itself.
Ethical and scientific criteria and standards for carrying out biomedical research. These standards help to ensure the dignity, right, safety and the well - being of research participants and research credibility and integrity.
Any action that compromises research integrity including mistreatment of research materials or subjects and intentional modification of research files.
A system of administrative rules and standards of good practices through which biomedical research is managed and is conducted in a manner that protects participants and ensures accountability.
Consortium
