Research ethics since the Belmont Report has rested on the assumption that there is an ethically important distinction between clinical research and clinical care. This distinction has provided the foundation for analyses of numerous bioethical concepts, including clinical equipoise, the researcher-participant relationship, and therapeutic misconception, among many others. However, the lines between research and care are increasingly blurred, due to such developments as embedded pragmatic trials, decentralized research designs, expanded access programs, and increased appreciation of the situations in which no standard of care options exist for patients. We will assess what this blurring means for the research/care distinction and whether it should prompt us to reconsider its import.
N-of-1 trials share a common feature: they are single-subject study designs with the goal of determining how an individual patient responds to treatment intervention(s). These trials can take several forms, spanning different purposes and study populations, with their own distinctive advantages and challenges. The April 2023 Bioethics Collaborative focused on various ethical questions that arise in N-of-1 research: How do traditional research ethics principles and analyses, such as the concept of clinical equipoise and ‘social value,’ apply to N-of-1 research? How can the N-of-1 approach be generalized if each “trial” is unique to the individual? Is there a way to gain generalizable knowledge across several individual trials? How should costly N-of-1 research be prioritized against other research priorities? How do we decide, fairly and equitably, who has access to N-of-1 trials, particularly for rare or unique genetic conditions? How should we think about informed consent and make efforts to support it, given the potentially transformative nature of personalized interventions in particular?
Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070
An overview of the FDA’s recent final guidance on clinical decision support (“CDS”) software, with a focus on its application to clinical research settings.
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