Donors of cells used to create induced pluripotent stem cells (iPSCs) and brain organoids may not understand what brain organoids are, how they will be used, or the long-term implications of the research. Informed consent documents (ICDs) often contain highly technical language and are written at reading grade levels higher than those attained by the target population. Our goal was to evaluate informed consent documents used for brain organoid research. We compared 20 currently active, IRB-approved consent documents to published templates/guidelines for iPSC research consent. Analyzed ICDs adhered to guidelines in explaining risks and benefits, de-identification, commercial potential, storage, and results sharing. However, descriptions of current and future use were lacking in detail, and the average reading level of ICDs far exceeded that of the general population. Our findings suggest additional transparency in ICDs would assist participants in making an informed choice about participation in iPSC and brain organoid research.
Neurotechnologies such as brain-computer interfaces (BCIs) and deep brain stimulation (DBS) raise distinctive concerns about human agency. A recent proposal by Schönau et al. identifies four dimensions along which neurotechnologies may threaten agency: responsibility, privacy, authenticity, and trust. The Schönau et al. framework valuably maps how neurotechnologies affect users and has inspired qualitative assessment tools. Yet although it acknowledges interconnections among the four dimensions, it does not explain what structurally unifies them. This represents a key gap in the view. Assessment instruments modeled on the framework, such as their Qualitative Agentive Competency Tool (Q-ACT), evaluate each dimension independently, risking fragmented assessments that miss the integrated nature of agential harm. I argue that agential self-trust unifies these four dimensions. Each tracks a distinct way that neurotechnologies can erode the self-trust constitutive of planning agency: confidence in one's control over action (responsibility), in the boundaries of one's deliberative life (privacy), in one's psychological continuity (authenticity), and in one's sensory and evaluative capacities (trust). This carries concrete policy implications. Current informed consent procedures for neurotechnology trials enumerate risks along separate dimensions without flagging the cumulative threat to a user's capacity for agential self-trust. Likewise, assessment instruments should include integrative measures that track agential self-trust across domains. As neurotechnology governance develops at the international level, a unified account of agential harm within this dimensional framework can guide both consent design and longitudinal monitoring.
For children with severe physical and cognitive disabilities (e.g. iatrogenic neurologic injury, congenital myelopathy, or quadriplegic cerebral palsy), there are limited therapeutic options. Scientific and clinical developments in implantable brain-computer interface (BCI) technology are in clinical trials in adults. The ethical issues around implantable BCI research in adults have recently been examined, but to date, only limited literature is available on the ethical issues that are attendant with implantable pediatric BCI research. Here, we summarize the ethical issues, focusing on (1) whether invasive BCI research should proceed in children, (2) regulatory considerations, (3) study design considerations, (4) pediatric recipient selection for invasive BCI trials, (5) special problems regarding informed consent in this context, and (6) related psychosocial and public perception considerations. We conclude with specific recommendations regarding ethically informed design of invasive pediatric BCI trials.
Bioprediction uses biomedical data, biomarkers, and algorithmic tools to forecast future physiological states or impairments. As predictive technologies increasingly enable individuals to anticipate loss of cognitive capacity before it occurs, they raise a fundamental ethical question: how should moral responsibility be assessed when impairment becomes foreseeable in advance of its onset? We argue that biopredictive technologies can alter both the epistemic and control conditions that ground moral responsibility. In some cases, this generates obligations to respond to predictive warnings of cognitive decline; in more limited circumstances, it may also ground obligations to acquire and use biopredictive technologies where these represent a proportionate and least restrictive means of risk reduction. We further argue that emerging individual responsibilities generate corresponding obligations for states. Where access to biopredictive technologies is necessary to meet morally significant expectations of risk management, fairness, and legitimacy require attention to affordability, accessibility, and institutional support.
