Abstract

The title question serves as the framework for a clinical research ethics inquiry having both regulatory and clinical implications. The overall structure of the inquiry is shaped by an hypothesis gleaned from the works of Paul Ramsey. That hypothesis states that acceptable risk in medical practice can become conflated for purposes of "minimal risk" in research practice involving children. The result of such conflation is that risk justified by therapeutic benefit may become analogized to research risk justified on the basis of social aims. The project as a whole utilizes historical and comparative methods to press Ramsey's notion in regard to the RCI Exemplar Question. ;The dissertation is divided into two parts. Chapters I--IV explore the political roots of informed consent. Risk-minimizing philosophy inherent in early consent theory provides historical access to a paradigm focused upon managing transference between medical authority over therapeutic risk and medical authority over risk/benefit analysis in research practice. That paradigm is the Nuremberg Code. Historical material regarding the Nuremberg Doctors' Trial is distilled, leading to the Nuremberg Method, a descriptive methodology. I conclude Part I by demonstrating the qualitative measures possible when using the Method to elucidate development of World Medical Association ethics codes from 1949 to 1996, particularly as it reveals the reclamation of medical authority over research practice. ;Part II is formulated as a regulatory and clinical analysis of research involving children. Current U.S. human subjects protections regulations are reviewed, critiqued by way of the Method, and then considered for their practical significance . The RCI exemplar is tested for risk conflation by means of case analysis using recent research published in the Journal of the American Medical Association . I conclude that the National Commission's assignment of the RCI exemplar undermines special protections for research involving children and is thus unacceptable