WE appreciate the 3 thoughtful commentaries on our response to the report of the National Bioethics Advisory Commission (NBAC) and we comment on each in turn.
Miller and Fins agree with our concerns about the impediments to psychiatric research that could result if new regulations emerged based on the NBAC's recommendations to establish only 2 categories of research risk. Regarding our concerns about the stigmatizing nature of the scope of the report, they suggest that we do not provide "any explicit, cogent argument," adding that in their view the recommendations are not stigmatizing if they provide appropriate protections for the research participants in question. We certainly agree that appropriate protections are not stigmatizing, and we argued that such protections should apply to all incapacitated subjects. Miller and Fins, however, then describe how the NBAC's recommendations might indeed be stigmatizing, eg, by requiring independent capacity assessment for research in the more than minimal risk category that involves persons with mental disorders that may affect decision-making capacity, since, as they say, "[i]t is far from clear which mental disorders, or what level of disease severity, would fall within the scope of NBAC's recommendations." We agree with this argument, and we stated a similar concern. Furthermore, we argued that by establishing only 2 risk categories, the NBAC recommendations would create inappropriate obstacles for low (but not minimal) risk research that would, unfairly, only apply to the mentally ill component of incapacitated individuals.
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