Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative (...) approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)

In his interesting commentary, Joshua Shepherd raises two points—one related to epistemology, the other to ethics—about our article on human cerebral organoids.1 2 From the epistemological standpoint, he calls into question the need for a theory of consciousness. A theory of consciousness, for him, is not necessary because of the lack of consensus about the very nature of consciousness. Shepherd suggests that ‘given widespread disagreement, applying a theory of consciousness may not be helpful when attempting to diagnose the presence of (...) consciousness in cerebral organoids’. In Shepherd’s view, it would be better to transfer ‘concepts already under development in work on the presence and structure of consciousness in difficult marginal cases involving traumatic brain injury’.2 We could not agree more on this last point; detecting a minimal capacity for consciousness in the brain of comatose patients is a very similar challenge to inferring the presence of consciousness in cerebral organoids. Every day, as a by-product of saving many lives, intensive care medicine artificially produces thousands of brains that may remain isolated, split or fragmented; in the worst case, cortical islands, or an archipelago of islands, may survive while being disconnected from the outside world. Can these islands host some form of consciousness? That is, does it feel like anything to be a large piece of human cortex? Addressing this difficult question requires the development of general, objective brain-based indices of consciousness that are independent of sensory processing, executive functions and motor outputs.3 Consider, for example, a patient showing reflexive spontaneous behaviour, no response to command and no ability to communicate. In her brain, afferent pathways are damaged, thereby impairing the recruitment of cortical areas in response to sensory stimulation; basal ganglia, as well as other frontal structures supporting executive functions, are impaired. However, resting metabolism and significant electroencephalography …. (shrink)

Organoids are three-dimensional biological structures grown in vitro from different kinds of stem cells that self-organise mimicking real organs with organ-specific cell types. Recently, researchers have managed to produce human organoids which have structural and functional properties very similar to those of different organs, such as the retina, the intestines, the kidneys, the pancreas, the liver and the inner ear. Organoids are considered a great resource for biomedical research, as they allow for a detailed study of the development and pathologies (...) of human cells; they also make it possible to test new molecules on human tissue. Furthermore, organoids have helped research take a step forward in the field of personalised medicine and transplants. However, some ethical issues have arisen concerning the origin of the cells that are used to produce organoids and their properties. In particular, there are new, relevant and so-far overlooked ethical questions concerning cerebral organoids. Scientists have created so-called mini-brains as developed as a few-months-old fetus, albeit smaller and with many structural and functional differences. However, cerebral organoids exhibit neural connections and electrical activity, raising the question whether they are or will one day be somewhat sentient. In principle, this can be measured with some techniques that are already available, which are used for brain-injured non-communicating patients. If brain organoids were to show a glimpse of sensibility, an ethical discussion on their use in clinical research and practice would be necessary. (shrink)