This course introduces the foundations of human research protections and the Common Rule. It explains how the regulations define “research” and “human subjects,” as well as exemptions from the Common Rule requirements. Learners will explore the role of and membership requirements for Institutional Review Boards (IRBs), the criteria for IRB review and approval, and the responsibilities of research institutions and IRBs in ensuring compliance and participant protection.
This course is ideal for learners who only need a foundational overview of human research protection. CITI Program’s Biomedical and Social-Behavioral-Educational Foundations courses provide more in-depth information and topic-specific modules.
Note: This course is only available for subscribing organizations who utilize the HSR series. The course is available at no additional charge.
Disclaimer: The U.S. Department of Health and Human Services (HHS)’s Office for Human Research Protections (OHRP) has developed a series of trainings on their regulations at 45 CFR part 46 (including the Common Rule at subpart A) for the research community to access freely on the OHRP website. This course is a faithful, unchanged (other than reformatting to fit this platform) duplication of these materials available at no charge at https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/index.html. While the CITI Program and the OHRP Trainings are identical in substantive content, OHRP is not responsible for the accuracy of the content reproduction, operation, or record keeping related to the trainings on the CITI Program’s learning system and does not endorse CITI Program or any of its products or services.
Language Availability: English
Suggested Audiences: Research Personnel, Researchers, Students, Those working in an area related to human subjects research
Organizational Subscription Price: Included with Human Subjects Research series, available as part of an organizational subscription package or for $1,000 per year/per site for government and non-profit organizations; $1,200 per year/per site for for-profit organizations
Independent Learner Price: N/A
