Among the core competencies the Clinical Research program develops is the ability to explain, assess, and employ research ethics. All students are required to study research ethics.
CLR0700 - Professionalism and Ethical Issues in Clinical Research
Course Directors: Karin Meyers, MA and Rosamond Rhodes, PhD
This seminar will explore the complex issues raised by human subject research. The seminar will begin with a review of some of the landmark cases of unethical use of human subjects in research; the policies that shape our current understanding of the ethical conduct of research, and the mechanisms for research oversight that have been instituted. Then, through reading a broad selection of seminal articles and papers from the recent literature, seminar presentations, and discussion, we shall engage in a conceptual analysis of a number of controversial and pressing issues.
We shall be discussing the moral and public policy aspects of topics such as research design, risk-benefit assessment, informed consent, the use of “vulnerable” subjects, research without consent, confidentiality, inducements, conflicts of interests, disclosure of research findings, tissue use, vaccine development, and international research. In addition to exploring the moral landscape of this rich and provocative domain, the seminar should clarify and inform participants’ understanding of basic moral concepts such as autonomy and justice. It should also serve as a model for approaching other issues in applied ethics.
This seminar is required for students in the Masters and PhD degree programs in Clinical Research. It is an elective for medical and Public Health students.
CLR0720 - Theories of Bioethics (Bioethics, Policies and Cases)
Course Directors: Rosamond Rhodes, PhD and Ian R. Holzman, MD
Most people who consider the ethical rules that should govern the practice of medicine assume that the ethics of medicine is no different from the rest of morality. For that reason, people who write about medical ethics draw on the classical sources of ethical insight. They discuss autonomy in Kantian terms, allocation of scarce resources in utilitarian terms, access to health care in terms of rights, and professionalism in terms of virtues. This dominant view was articulated by K. Danner Clouser in his Encyclopedia of Bioethics article on “Bioethics” where he explained that “bioethics is not a new set of principles or maneuvers, but the same old ethics being applied to a particular realm of concerns.” This strategy is most prominently expounded by Beauchamp and Childress in the six editions of their Principles of Medical Ethics and further explained by Gert, Culver, and Clouser in Bioethics: A Return to Fundamentals. The authors of those volumes identify the common features of morality, and show how to apply them to the practice of medicine. This course will explore the major theoretical approaches to bioethics, including principlism, common morality, virtue theory, casuistry, and constructivist bioethics. We shall read and discuss this literature in the context of cases from the practice of medicine. Our study will be guided by two goals. First, we shall try to understand how these theories inform our thinking about medical ethics. Second, we shall try to assess whether these theories are actually appropriate to the practice of medicine. Do any of them actually identify an appropriate framework for the ethical practice of medicine? Do they provide a useful guide to the ethical practice of medicine? Do they offer helpful tools for resolving controversies within medical practice?