Periodic Reporting for period 1 - HYBRIDA (Embedding a comprehensive ethical dimension to organoïd-based research and resulting technologies)
Reporting period: 2021-02-01 to 2022-07-31
The HYBRIDA project investigates three types of uncertainty in relation to organoid research and technology development in order to be able to co-develop guidance for researchers and regulators. Since Roman law, all entities have been categorized and regulated either as persons or as things (subjects or objects). However, this conceptual, epistemological and regulatory dualism is currently being challenged by disruptive research and innovation, among which organoid research is a prominent example. The dualistic normative framework pertaining to health and life science research are disrupted by three different kinds of uncertainty. First, conceptual uncertainty (ontological uncertainty): how should one conceive of entities that cannot be categorized as either persons or things? What are they? Second, epistemological and methodological uncertainty: How do we know the characteristics of these entities called organoids? How do we address forms of uncertainty that cannot be evaluated through the use of statistical methods, i.e. risk? Epistemological uncertainty comes in two kinds, which can be categorized as qualitative, or strict, uncertainty and ignorance or non-knowledge. In order to develop ethically and socially robust ways of assessing the effects of organoid research and related technologies, there is a need to include these additional forms of uncertainty in the Health Technology Assessment (HTA). Third, regulatory uncertainty: this uncertainty emerges because parts of regulatory frameworks concerning the rights and duties of persons have been merged with elements of regulation dealing with the stewardship of objects or things. These forms of uncertainty are of particular importance. This project aims to address how these uncertainties arise in organoid research and develop a conceptual and regulatory framework able to overcome this 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.
In this reporting period the work has focused on analysis of the conceptual uncertainties, reducing epistemological uncertainty, exploring regulatory uncertainty, engaging with the public and stakeholders, and the initial work laying the ground for creating operational guidelines, a code of responsible conduct, and enhancing existing ethics and normative frameworks.
The activity in the organoid field has been mapped in detail and a Health Technology Assessment of organoid use in clinical medicine has been performed.
The activity in the organoid field has been mapped in detail and a Health Technology Assessment of organoid use in clinical medicine has been performed.
The in-depth mapping of the organoid field has not been done before. It provides a good evidence base for the co-development of guidelines for organoid researchers and for enhancing existing normative frameworks and regulations. Co-developing and validating these guidelines with engagement of the public and other stakeholders is the main task of the second period of the project.