Abraham P. Schwab, Ph.D. is a Senior Fellow in the Institute for Ethics of the Ethics Group of the American Medical Association. He received his MA in Applied Philosophy and his PhD in Philosophy from Loyola University Chicago. His research interests range perhaps too broadly into the intersections of epistemology, cognitive psychology and bioethics. As Senior Fellow he has had the privilege of working on several Reports and Opinions for the Council of Ethical and Judicial Affairs and published several articles in Virtual Mentor, the online ethics journal of the AMA. For the last several years he has also been working to identify policy guidelines for ethically acceptable medical research. This work has been informed by his work on the University of Illinois-Chicago's IRB, as well as his interest in conditions that foster or hamper good decision-making in the clinic.

Presentation: International Standards of Research

This presentation will work at clarifying the factors that determine ethically acceptable international research. Research trials are often designed in response to certain beliefs (or hypotheses) about the clinical effectiveness of new techniques or products, which are then subject to review regarding justice (i.e., the AZT trials in Africa) and patient/subject appropriateness (via informed consent). This process has yet to coherently address concerns about the exploitation of research subjects in third world countries. Rather than suggest more rigorous review or supervision, I springboard from work by Alex John London on "standards of care" to suggest that the design process for international medical research should respond to the conditions under which the research will be performed. Specifically, evaluations of three context specific outcomes must precede the execution of any research project. These outcomes are: clinical effectiveness, cost effectiveness, and likely side-effects. These three conditions are of special import in international research because of the likely differences in clinical effectiveness and side-effects across ethnically and culturally divergent populations. Further, the gaping disparities in wealth across national borders demands attention to cost-effectiveness or risk blatant exploitation (e.g., research of one population for application in another). The evaluation of clinical effectiveness, side-effects, and cost-effectiveness leads to a context sensitive evaluation of a proposed research trial. In turn, this determines the ethical acceptability of a research trial specific to the research-subject population in question. To illustrate the utility of evaluating these outcomes, I will explain how these three outcomes would be evaluated in a few cases (including the AZT trials in Africa). Further, I will briefly sketch the outcomes that justify a trial.