Regulating organoid research

Embedding a comprehensive ethical dimension to organoid-based research and related technologies.

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About

HYBRIDA is a 3 year Science With and For Society (SwafS) project funded under HORIZON2020 coordinated by the University of Oslo, Norway.

The main objective is to develop a comprehensive regulatory framework for organoid research and organoid-related technologies.

Our contribution

Operational guidelines for the field.
Code of Responsible Conduct for researchers.
Enhancement of existing ethics and normative frameworks.
Supplement to the ECoC.

The challenge

The project aims to address how the conceptual, epistemological and regulatory uncertainties arise in organoid research, and to develop a conceptual and regulatory framework able to overcome the ‘persons vs things’ dualism.

From this follows also the need to communicate the potential and possible pitfalls of organoid research in ways that convey realistic- instead of hyped scenarios.

Key concepts

Chimeras and hybrids

Research ethics

Responsible research and innovation

Research integrity

Regulatory framework

A basis of regulations, moral codes and ethics which protects the biomedical research’s participants and research activity itself.

Operational guidelines

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.

Research misconduct

Any action that compromises research integrity including mistreatment of research materials or subjects and intentional modification of research files.

Research governance and policy making

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.

Epistemology

Uncertainty

Regulatory dualism

Basic objectives

1.Identify different forms of conceptual uncertainty by exploring the ontological, moral and legal status of organoids present in different cultures and knowledge traditions.

2.Reduce epistemological uncertainty in organoid research and produce improvements in impact assessment of organoïd-related technologies.

3.Explore regulatory uncertainty prevalent in existing normative and ethical frameworks pertaining to technologies similar to organoid-related technologies.

4.Understand the worries, fears and expectations of the general public, vulnerable groups, patients, donors and civil society organisations with respect to organoids.

5.Actively engage relevant stakeholders, in order to co-create and validate the 4 main products of HYBRIDA.

6.Produce a set of operational guidelines for the field of organoid research.

7.Produce a Code of responsible conduct for organoid researchers and, if needed, suggest a supplement to the ECoC.

8.Enhance existing ethics and normative frameworks with a focus on organoid research and organoid-related technologies.