CITI Program's Human Subjects Research (HSR) content includes two tracks, one with a biomedical focus, and another designed for the social, behavioral, and educational disciplines, each of which covers the historical development of human subjects protections as well as current information on regulatory and ethical issues.
Basic HSR modules are suitable for all persons involved in research studies involving human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including institutional review boards. These modules are typically assembled into a basic course, which is the learner's first exposure to the content. Refresher modules, which can be assembled into refresher courses presented to learners at intervals defined by the institution, are designed to provide continuing education in human subjects research issues.
HSR module topics include: basics of IRB regulations and the review process, assessing risk to participants, avoiding group harms, conflicts of interest, cultural competence, FDA-regulated research, genetic research, HIPAA-regulated research, informed consent, international research, Internet research, IRB member responsibilities, IRB chair responsibilities, records-based research, research in schools, research with protected populations, research with vulnerable subjects, unanticipated problems and reporting, and students in research.
For a listing of available HSR modules and standard course configurations, download the Human Subjects Research Catalog (PDF file).
For recommendations on using the HSR series, download Using CITI Program Content: Human Subjects Research (PDF file).
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