The ethical primacy of autonomy and informed consent for human genomic-related screening, testing and research.

摘要

This dissertation examines how genomics impacts on the relationship between individual and group interests from the perspective of the autonomous choice model of informed consent. Specifically, this work evaluates whether individual informed consent for genomic-related screening, testing, and research is sustainable in light of competing ethical values and interests of others.; For the analysis, a four-step approach is used throughout the dissertation. First, four theoretical formulations of informed consent are identified: individual express consent; substituted judgment; best-interests; and research consent. Second, each formulation is refined by adding relevant ethical, authority, guidance, and intervention principles. This results in the construction of four 'ideal' informed consent models. Third, genomic-related screening, testing, and research scenarios are applied to these ideal models. For those situations where the elements of the informed consent model are not being satisfied due to conflicts, the analysis proceeds to the final step. Fourth, the overriding justification framework is employed to determine whether individual informed consent deserves ethical primacy over the competing interests of others.; Eight genomic-related activities are analyzed using the four-step approach. When the material is synthesized, it suggests three conclusions. First, individual autonomy---through the doctrine of informed consent---is entitled to ethical primacy at the present time. Second, and perhaps more importantly, personal autonomy is not absolute; individual ethical interests may be overridden when five justificatory conditions are met: effectiveness, proportionality, necessity, least infringement, and transparency. Finally, there is need for great care when evaluating informed consent in an age of genomic medicine: it requires case-by-case assessment in a morally responsible manner. To this end, a flexible approach to informed consent is proposed---one which is derived from the dissertation analysis.