Re-Evaluating Risks and Benefits in Human Subjects Research

Modern bioethics is grounded in four basic principles: respect for persons (i.e. autonomy), beneficence, nonmalificence and justice. In a recent presentation at the 2011 ELSI Congress, "Exploring the ELSI Universe," Malia Fullerton, a professor in the Department of Bioethics & Humanities at the University of Washington School of Medicine, noted that "respect for persons" and "beneficence" have come to be the preeminent values in bioethical review of human subjects studies, particularly in the context of IRB review. Respect for persons typically manifests in a concern for informed consent, and beneficence in a concern for weighing the potential harms and benefits of research. Fullerton argued that a more balanced consideration of the other values, particularly justice and a concern for persons not just in terms of consent but in terms of dignity, needed to be incorporated into such review.

This got me to thinking about these concepts and their deployment in current biomedical research. Beneficence has often been cast in terms of balancing costs and benefits, as though it were simply a utilitarian calculus. However, in the context of...