Abstract

Clinical trial informed consent is one of the most pressing issues of research ethics. As the Western world moves toward a harmonization of clinical research practices, scholars and clinical researchers have begun to discuss methods that can adequately assure a more valid clinical research informed consent process. ;One resource for insight and guidance on the issue of clinical trial informed consent is the theologically trained medical ethicist. Because of the theological and philosophical explications on love and justice that are emphasized in their training, such individuals are uniquely qualified to address the institutional and individual parameters inherent in the clinical trial informed consent process. These parameters are grounded in the clinical trial informed consent paradigm categories of recruitment of potential subjects, the "stranger" or "outsider" status of the potential subject, and the notion of clinical trials as endeavors of human experimentation. The argument for a unique qualification in this field relies upon the affinity found between these component categories of the clinical trial informed consent paradigm and the love and justice explications of Paul Ramsey and John Rawls. Specifically, these explications are concerned with the notions of care for the stranger and justice in institutional structures.