Thursday, January 24
Kalmanovitz Appellate Courtroom, room 1001
12:00 PM – 1:00 PM
Alexander Capron is a globally recognized expert in health policy and medical ethics. He teaches Public Health Law, Torts, and Law, Science, and Medicine. He also teaches at the USC Keck School of Medicine and is co-director of the Pacific Center for Health Policy and Ethics, a campus-wide interdisciplinary research and education center. He returned to USC Law in fall 2006 after four years on leave as director of Ethics, Trade, Human Rights and Health Law at the World Health Organization in Geneva.
Informed Consent has been described as the "ethical cornerstone" of human experimentation and a "central tenet" of biomedical research. In the words of Jay Katz, "the concept of informed consent has been accepted in case and commentary as a cardinal principle for judging the propriety of research with human beings." Yet the actual role of informed consent in contemporary research with human subjects is frequently assumed rather than critically appraised. Such an appraisal suggests that "thoroughgoing self-determination" has been replaced by rules that allow a lot of research without consent and disallow some research for which willing subjects exist. Why has this happened?
First, the results of empirical studies of decision-making by research subjects (especially those who are also patients) have undermined confidence in the reality of informed, voluntary consent; second, the slow progress of research on important health matters has spurred efforts to make conducting research easier, with incursions on informed consent being one consequence; and third, the changing relationship between the human beings whose bodies, cells, and behavior are the object of scientific study and the research investigation and the scientists carrying it out has affected our view of the duties owed and the rights possessed by these human beings. At the beginning of the modern era of medical research, the tribunal at Nuremberg saw the inmates of the Nazi concentration camps as "subjects" and articulated the duty of researchers to obtain their voluntary informed consent before involving them in any studies, whereas fifty-five years later, when the National Bioethics Advisory Commission issued its report on Ethical and Policy Issues in Research Involving Human Participants (2001), most of the commissioners accepted the view that the human beings studied by scientists are "participants" in research.
Over the past decade, with the growth of longitudinal research and especially the storage of data and material in "biobanks," terminology has evolved to the point where the term "partner" is now used to describe the people whose records and samples are made available for future research. As the expectations for consent evolve along with this change in vocabulary-and the conceptual alterations that it signals-it is time to rethink research informed consent. The intention of the US Department of Health and Human Services to revisit and revise the Common Rule (seen in the 2011 ANPRM), makes this the right time for OHRP to question whether the regulatory bodies-particularly local IRBs-are aware, and prepared to deal with the consequences, of the silent paradigm shift in research ethics. If not, then what structures could be envisioned to ensure that all actors (subjects, investigators, sponsors, IRBs and federal officials) have made the needed adjustments in light of the changing (apparently diminishing) role of informed consent. The paper ends by examining whether the alternative means of fulfilling the functions previously served by informed consent are adequate to the task and, more basically, whether we wish to abandon or modify any of the goals themselves.
Lunch will be served.
For more information, please contact Lisa Ikemoto at firstname.lastname@example.org