Short Course in International Research Ethics A one-week intensive course in international research ethics is offered once per year at the Johns Hopkins Bloomberg School of Public Health. The course generally is taught in late June or early July. This course is offered through the annual Graduate Summer Institute in Epidemiology and Biostatistics. Course Title: Ethics Issues in Human Subjects Research in Developing Countries Nancy Kass and Andrea Ruff
(340.667.11) M T W Th F 1:30 p.m. - 5:00 p.m.
This course will introduce those enrolled to ethical principles and formal codes of ethics, to key ethical issues that arise in international research. Ultimately, the course will be case-based to enable course participants to work through ethical challenges posed by research conducted in developing countries. Each daily session will be divided between a formal lecture and a case discussion. Case studies will be discussed in small groups and will be based on actual research projects in developing countries, including both clinical and epidemiological/observational research. The course is geared towards U.S. and international faculty, researchers, government officials and students who conduct or fund research in developing country settings and to those who sit on IRBs/research ethics boards. Student evaluation is based on case study exercises and class participation. (2 academic credits) For additional information and application procedures please visit: http://www.jhsph.edu/summerEpi (click on "courses" at the top of the page.) The course, 340.667.11 Ethics Issues in Human Subjects Research in Developing Countries, can be found under One-week courses. Course Topics
Introduction to ethical principles and analysis; history of research ethics; all relevant codes, declarations of human rights, guidelines and regulations both from American and developing world settings. This will include discussion of the purpose of ethics codes, the history of why they were thought necessary and what function they currently serve. In the accompanying case discussions, we will analyze 1-2 research examples against different codes of ethics and human rights to determine the codes' current relevance, appropriateness, and limitations. Cultural relativism, pluralism and moral disagreement. Here we will discuss whether or to what degree ethics are universal and the relevance of local customs, traditions, and norms to an understanding of what constitutes moral behavior. We will examine cases that raise the question of when differing cultural norms ought to change researchers' practices with regard to procedures for gaining consent and/or data collection; we also will consider case examples that raise the question of whether different economic background conditions in addition to differing cultural backgrounds change what is ethically required for researchers. Informed consent. Here we will explore the history, elements, and requirements of informed consent. The focus will be on the importance of an informed consent process rather than informed consent documents. Included will be discussions of the purpose and function of an informed consent process and why first person or third party consent generally is necessary but not sufficient in and of itself to achieving ethical research. We will look at various alternative methods of obtaining informed consent, sensitive to different cultural norms, including community consent. Justice and exploitation. Here we will discuss why research is targeted to certain populations rather than others and what, ethically, must be in place to justify choosing a particular population as the subject of one's research. We will examine under what circumstances it is appropriate for U.S. researchers to conduct research in non-U.S. settings. Further, we will consider what types of benefits must be offered to a relatively disadvantaged population in order for the research to be ethical as well as what types of inducements may be excessive from an ethics perspective. Related to this, we will discuss what types of promises of future care or relationships ought to be in place, if any, before research should be allowed to go forward. Authority, oversight, and responsibility for the ethics of research. Here we will discuss the formal review process through which all U.S.-funded research must pass before being conducted, including U.S. and non-U.S. Research Ethics Review Boards. Related, we will describe a process for creating an IRB or Research Ethics Board in another country if one does not yet exist. We will also spend considerable time on the roles investigators, sponsors, and collaborators each have in conforming to and maintaining high ethical standards. We will examine the role of study subjects or community members in determining what are ethical and appropriate research practice and study procedures. Ethics issues in the choice of research design. Here we will discuss the human subjects implications of different types of research designs. We will spend considerable time on whether and when randomization and the use of placebos are ethical, and how to balance scientific and public health needs with ethics requirements in choosing a study design. AFFILIATED FACULTY Nancy Kass, ScD
Phoebe R. Berman Professor of Bioethics and Public Health
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health
And Deputy Director for Public Health, Berman Institute of Bioethics Andrea Ruff, M.D.
Associate Professor
Department of International Health, Division of Infectious Diseases
Director, Baltimore Pediatric AIDS Clinical Trials | 
