One of the fastest growing global markets is pharmaceutical sales. With changing political landscapes and an increased awareness of new customers worldwide, sales have increased in Eastern Europe, Asia, and especially Latin America. As researches expand into countries with poor socio-economic and political infrastructures, guidelines such as the Helsinki Declaration, the Nuremburg Code, and the Belmot principles are being challenged. Regulatory and ethical guidelines have not kept pace with the explosion of international research and the potential for such human research abuses is great. The most fundamental ethical principle of clinical research is the idea of respect for persons or the concept of autonomy. Autonomy, as used in research guidelines, must meet two criteria, that people need to be treated as autonomous agents

This patient education program explains clinical trials and answers some frequently asked questions. This is a MedlinePlus Interactive Health Tutorial from the National Library of Medicine, designed and developed by the Patient Education Institute.

Ethics of Human Subject Research (2 credits) is offered by the Department of Health Policy and Management and the Distance Education Division, Johns Hopkins Bloomberg School of Public Health and The Phoebe R. Berman Bioethics Institute, Johns Hopkins University. The course introduces students to the ethics of human subject research. Ethical theory and principles are introduced, followed by a brief history of research ethics. Topics covered in lectures and moderated discussions include informed consent for research participation, role and function of institutional review boards, just selection of research subjects, ethical aspects of study design, and privacy and confidentiality. Student evaluation will be based on participation in moderated discussions, an informed consent exercise and written case analysis.

This team taught, multidisciplinary course covers the fundamentals of magnetic resonance imaging relevant to the conduct and interpretation of human brain mapping studies. The challenges inherent in advancing our knowledge about brain function using fMRI are presented first to put the work in context. The course then provides in depth coverage of the physics of image formation, mechanisms of image contrast, and the physiological basis for image signals. Parenchymal and cerebrovascular neuroanatomy and application of sophisticated structural analysis algorithms for segmentation and registration of functional data are discussed. Additional topics include fMRI experimental design including block design, event related and exploratory data analysis methods, building and applying statistical models for fMRI data. Human subjects issues including informed consent, institutional review board requirements and safety in the high field environment are presented.

" This team-taught multidisciplinary course provides information relevant to the conduct and interpretation of human brain mapping studies. It begins with in-depth coverage of the physics of image formation, mechanisms of image contrast, and the physiological basis for image signals. Parenchymal and cerebrovascular neuroanatomy and application of sophisticated structural analysis algorithms for segmentation and registration of functional data are discussed. Additional topics include: fMRI experimental design including block design, event related and exploratory data analysis methods, and building and applying statistical models for fMRI data; and human subject issues including informed consent, institutional review board requirements and safety in the high field environment. Additional Faculty Div Bolar Dr. Bradford Dickerson Dr. John Gabrieli Dr. Doug Greve Dr. Karl Helmer Dr. Dara Manoach Dr. Jason Mitchell Dr. Christopher Moore Dr. Vitaly Napadow Dr. Jon Polimeni Dr. Sonia Pujol Dr. Bruce Rosen Dr. Mert Sabuncu Dr. David Salat Dr. Robert Savoy Dr. David Somers Dr. A. Gregory Sorensen Dr. Christina Triantafyllou Dr. Wim Vanduffel Dr. Mark Vangel Dr. Lawrence Wald Dr. Susan Whitfield-Gabrieli Dr. Anastasia Yendiki "