Solutions to the Crisis in Human Subjects Research: From Pillar to Post?

Wednesday, October 29, 2003 - 12:30pm to 2:00pm

Mississippi Room, Coffman Memorial Union

Three pillars support the current system for protecting the rights and interests of human subjects in research: responsible investigators and funders, oversight by Institutional Review Boards (IRBs), and informed consent. However, experience using this system of pillars and changes in the research enterprise suggest that the current system is inadequate. For example, investigators and funders may face conflicts of interests that can challenge their fiduciary obligations to participants; some empirical information suggests that IRBs may not be functioning in a uniform and optimum manner; and data indicate that informed consent needs improvement. Given these problems, a variety of solutions have been offered, including disclosing conflicts of interests to potential research subjects, centralizing and accrediting IRBs, and abbreviating consent documents. Nevertheless, since it is unclear whether these measures work, efforts should be taken to test them in controlled settings before making major policy changes. 


Prof. Jeffery Kahn, PhD, MPH
Center for Bioethics, University of Minnesota

Prof. Cathy Jordan, MD, LP
Department of Pediatrics and Neurology, University of Minnesota

Jeremy Sugarman, MD, MPH, MA is the founding Director of the Center for the Study of Medical Ethics and Humanities in the Duke University School of Medicine. After finishing college, medical school and residency training in internal medicine at Duke, he obtained a Masters of Arts in philosophy from Georgetown University as well as a Masters in Public Health from the John Hopkins University School of Hygiene and Public Health. He has served as Senior Policy and Research Analyst for the Advisory Committee on Human Radiation Experiments and as a consultant to the National Bioethics Advisory Commission. He conducts theoretical and empirical research in medical ethics, concentrating on informed consent, research ethics, and the ethical issues associated with emerging technologies. In addition to publishing numerous papers in peer-reviewed journals, he is co-editor of Beyond Consent: Seeking Justice in Research (1998), Ethics of Research with Human Subjects: Selected Policies and Resources (1998), and Methods in Medical Ethics (1998), as well as editor of Ethics in Primary Care. He is a contributing editor for IRB, a member of the Institutional Review Board for Family Health International, a member of the Board of Directors of the American Society of Bioethics and Humanities, and serves on the editorial boards of Accountability in Research and the American Journal of Bioethics. At Duke, he teaches medical ethics to undergraduates, medical students, and house staff. 

October 29, 2003