Mini-organs, maximizing value: A study of the ethics and governance of organoid medicine

Abstract

Organoid research is currently rapidly emerging as a valuable tool for numerous applications in biomedicine. These developments are well-aligned with the current broader movement aimed at tailoring healthcare to the specific characteristics of the recipient, which is known as ‘precision medicine’. Because ofthe synergy between organoid technology and precision medicine, there is currently a rapid rise in clinical and biomedical applications of organoid technology, which I refer to throughout this dissertation as organoid medicine. The field of Cystic Fibrosis (CF) care serves as an archetypical recent testimony to the enormous clinical value of organoid medicine: intestinal organoids or ‘mini-guts’ have been successfully grown from the cells of individual people with CF, and subsequently validated as reliable screening tools to test the efficacy of treatment. While organoid medicine is promising for biomedical research and clinical care, it also raises several unique ethical and practical challenges related to 1) the characteristics of organoids as complex tissue entities, 2) the storage and exchange among public and private parties via (‘living’) biobanks, and 3) the specific context in or purpose for which they are utilized (i.e. research purpose, clinical care). At the moment of writing, many different types of organoids have already been successfully cultivated with increasing complexity, including lung, gastric, intestinal, liver, pancreas, kidney, prostate, brain organoids or ‘cerebroids’, and even ‘embryoids’ – cell structures resembling early stages of embryonic development. These developments are raising moral questions, such as what kind of entities organoids are, what this means for how organoids and the people providing the material should be handled, and how these considerations are affected by different kinds of technological developments and market dynamics. Storage and distribution of organoids for research is organized via biobanks: tissue repositories in which biospecimens are stored long-term, and distributed to public and frequently also private parties for the purposes of tissue research, but also (large-scale) data-sharing and analysis. Biobanks operate at the intersection of research and commercial interests, and clinical or public interests, where participants provide biological material and data and biobanks are expected to manage these samples and data in socially, ethically, and legally sound ways. In other words, biobanks have to navigate between the values and rights of the participants and the potential commercial and scientific value of the samples and data, while they are simultaneously dependent on a feasible business model that will ensure their own sustainability. Organoid medicine has great potential for healthcare and research, but also challenges established practical guidelines, ethics and governance frameworks, and regulatory policies. Since the specific ethical implications of organoid medicine currently have not or are not adequately addressed, this highlights the need for additional guidance. In order to identify the conditions required to ensure this balance, it is necessary to obtain a thorough understanding of the ethical and practical implications of organoid medicine. These conditions can serve as focal points for the development of governance models to ensure a responsible future for the field.