Readiness for First-In-Human Neuromodulatory Interventions.

BACKGROUND: Novel neurointerventions present innovative therapeutic approaches to a range of treatment-refractory disorders. We sought to characterize factors that inform and define translational readiness for first-in-human (FIH) neuromodulatory trials. METHODS: We used a two-part methodology involving a scoping review of the biomedical literature on the readiness of FIH trials for both neurological and non-neurological applications, and semi-structured interviews with stakeholders about decision-making for neuromodulation using magnetic resonance-guided focused ultrasound as a case example. RESULTS: One hundred and thirty factors relevant to FIH readiness were identified in the scoping review. Trial design, adequacy of preclinical evidence, and risk were ubiquitous across biotechnologies. Target organ, target function, and inadequacy of animal models were dominant in the neurointervention literature. Interview results on the relative importance of these factors reveal divergent values, priorities, and understandings both between patients and clinicians and between patients affected by different conditions. CONCLUSION: Readiness of neurotechnology for FIH trials is defined by a multitude of interacting factors that pertain to clinical and nonclinical priorities, perceptions, and values.

Owning Ethical Innovation: Claims about Commercial Wearable Brain Technologies.

The wearable neurotechnology market targets consumers with promises of cognitive benefit and personal wellness. Scientific evidence is essential to substantiate claims about utility, safety, and efficacy and for informed choice and public trust.

Ethics of mobile phone surveys to monitor non-communicable disease risk factors in low- and middle-income countries: A global stakeholder survey.

Active public health surveillance has traditionally been carried out through face-to-face household surveys or contact with providers, which can be time and resource intensive. The increasing ubiquity of mobile phones and availability of phone survey platforms provide an opportunity to explore the use of mobile phone surveys (MPS) for active disease and risk factor surveillance, including for non-communicable diseases (NCDs). Scholars are increasingly examining the ethics implications of mobile health (mHealth), but few have focused on the ethics of mHealth in low- and middle-income countries (LMICs), and even fewer on mHealth for active surveillance. Given that little is known about ethics-related attitudes and practices of stakeholders invested in the conduct and oversight of mHealth in LMICs, we undertook a cross-sectional global stakeholder survey of ethics-related issues implicated by active observational MPS, with a contextual frame of monitoring NCD risk factors in LMICs. We analyse these findings with an organising focus on ethical issues that arise before, during and after conduct of an MPS including defining the activity; anticipating harms and benefits; obtaining consent; data ownership, access, and use; and ensuring sustainability. Finally, we present a set of empirical, conceptual, and normative considerations that arise from this analysis and merit further consideration.