The Collaborative IRB Training Initiative (CITI)

Summary

Questionable practices in the protection of human subjects in research studies is a hot and visible national topic. One solution is an increased emphasis on education to develop a better understanding of good ethics and practices. To ensure that DOE activities meet the level of knowledge required now by the Department of Health and Human Services and the Veterans Administration (VA), the Collaborative Institutional Review Board (IRB) Training Initiative (CITI), a modular 13-part web site tutorial developed by experts in the “IRB community” and maintained at the University of Miami, is being customized for DOE and will soon be available for use. Each module focuses on a different aspect of bio-ethics and human subjects research, and concludes with a quiz that is scored at the completion of the course. The program allows each participating institution to post specific material of importance on their web page. The DOE version will contain topical areas that are directly applicable to DOE sites, such as: history and ethical principles; regulations and process; informed consent; social/ behavioral research; records-based research; genetics research; definition of research with vulnerable subjects; community consultation and IRB review; research with investigational drugs, devices and biologics; and research in the workplace.