Regulating organoid research

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

Quick Start Guide
Join the Final Online Workshop
microscope

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.

challenge-image
key-concepts-image

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.

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.

Τarget Groups

Project roadmap

Timeline

2021
June 15

1st stage Explore attitudes

WP1, WP2, WP3: Mapping activities

WP4: Engagement activities

WP5, WP6: Main outcomes

WP7: Coordination with SwafS-29

2022
June 15

2nd stage Consultation and co-creation

WP4: Engagement activities

WP5, WP6: Main outcomes

WP7: Coordination with SwafS-29

2023
June 15

3rd stage Assessment and validation

WP4: Engagement activities

WP5, WP6: Main outcomes

WP7: Coordination with SwafS-29

Consortium