Human Subjects Research (HSR) content is organized into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). They are intended for anyone involved in research studies with human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs). HSR Biomed and SBE courses are offered as Comprehensive and Foundation versions.
Comprehensive courses provide an expanded training covering not only major topical areas but also many concepts that are specific to types of research, roles in the protection of human subjects, and advanced modules on informed consent topics, vulnerable populations, stem cell research, phase I research, data and safety monitoring, big data research, mobile apps research, and disaster and conflict research.
Foundations courses provide foundational training covering major topic areas in human subjects protections.
This series also include refresher course options for both the Biomed and SBE tracks. Refresher courses provide retraining for individuals who have already completed a basic course. CITI Program offers a variety of refresher courses so learners can meet retraining requirements with fresh content.
Additional modules of interest within HSR allow for exploration of several important topics and may be selected to meet organizational needs.
HSR includes additional standalone courses for different specific roles including institutional/signatory officials, IRB chairs, public health researchers, and Certified IRB Professionals (CIPs) seeking recertification credit. Topic-focused mini-courses such as Single IRB (sIRB) Use and Administration, Clinical Trial Agreements, Phase I Research, and Community-Engaged and Community-Based Participatory Research, as well as a standalone Revised Common Rule course that covers the regulatory updates to the Common Rule (45 CFR 46, Subpart A) are also available.
All HSR modules reflect the revised Common Rule (2018 Requirements). Upon request, a selection of HSR modules are available as legacy versions (reflecting the pre-2018 requirements).
These courses were written and peer-reviewed by experts.
Note: Organizations subscribing to HSR have access to all of the modules included in the courses below.
Demo of Informed Consent Case Videos:
Language Availability: English, Korean, Spanish, French
Suggested Audiences: Human Subject Protection Staff, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Administrators and Staff, IRB Chairs, Research Team Members, Researchers, Students