DOE Human Subjects Resources

Collaborative IRB Training Initiative (CITI) Human Subjects Training Program

In order to ensure that every laboratory and individual involved in human subjects research has the appropriate training, DOE has collaborated in developing an educational module that provides an understanding of the rules, ethics, and practices that are required in order to conduct research with human subjects. The intent of this educational activity is to enhance the quality of these research projects and forestall any potential problems with research on human subjects that is being conducted at DOE sites.

The Collaborative IRB Training Initiative (CITI) Human Subjects Training Program was founded in March 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a Web-based training program in human research subjects protections. The collaboration was expanded to include content experts from 10 institutions who provided the material for the first 12 biomedical modules. In addition to the "Basic" content, the CITI model provides the opportunity for institutions to post additional instructional materials specific to their institution. Later, the CITI Course site was made available to institutions by subscription.

The CITI Program now includes "basic" courses in the Protection of Human Research Subjects for Biomedical as well as for Social / Behavioral Research. CITI also offers case-based and abbreviated "refresher” courses for those institutions that need a Web-based alternative for re-certification purposes.

A multi-language site, targeting international researchers was also made available. As of August 2004, the CITI Program was used by over 400 participating institutions and facilities from around the world. Over 125,000 people had registered for one of the CITI courses.

CITI is DOE’s preferred and supported system for expectations and requirements for Institutional Review Board, management, and research staff education. However, DOE sites have been given the option of using other supplementary or alternative well-designed training tools/modules such as their own in-house programs, National Institutes of Health, Health Insurance Portability and Accountability Act, Responsible Conduct of Research training, and others.

This course is intended for use by those involved in the design and conduct of biomedical and behavioral research involving human participants, including principal investigators, associate investigators, and nurse coordinators.

Collaborative Institutional Training Initiative (CITI). A history of the CITI program and its current status is provided. The Program began developing new educational content in the area of human subjects protection soon after the Department of Health and Human Services (DHHS) announced its human subjects protection education mandate in June 2000. The co-founders recruited experts in research ethics and ethics committee procedures to write 10 modules for a new web-based course.

Content reviewed: November 12, 2013