The prospect of using cell-based interventions to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause (...) for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment. (shrink)

Much of the legal and social interest in new neuroimaging techniques stems from the belief that they can deliver on the materialist understanding of the relationship between the brain and the mind. This article looks at predictions about the future both of scientific advances and of social reactions to those predictions. It looks at the likely technical limits on neuroscience-based mindreading, then at the likely limits in how the law might use such technologies. It describes three kinds of technical barriers (...) to detailed and useful mindreading: the likely impossibility of making a complete and accurate model of a human brain in light of its incredible complexity, the problems of interpersonal and intrapersonal plasticity, and the problem of trying to read, now, someone's past mental state. The potential changes to the operation of the law, through the use of mindreading as evidence of pain, deception, or bias, among other things, could be extremely important. (shrink)

In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act . We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive (...) research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research. (shrink)