This in-depth course provides a complete understanding of U.S. and international frameworks that protect human subjects in research and the critical role of Institutional Review Boards (IRBs). Students explore the historical foundations, regulatory requirements, and real-world operations of IRBs and related oversight mechanisms.
Through a rigorous examination of U.S. federal regulations (45 CFR 46, 21 CFR 50 & 56, HIPAA, FERPA, and related agency-specific policies) and global standards such as the Declaration of Helsinki and ICH-GCP, learners gain the practical knowledge to design, oversee, and audit research involving human participants. Special emphasis is placed on ethics, risk assessment, vulnerable populations, data protection, and emerging issues such as AI-driven research, genetic data, and global collaborations.
This course equips research compliance officers, IRB administrators, principal investigators, clinical trial managers, and attorneys with the legal know-how and operational tools to ensure research integrity and protect human subjects.
Course Objectives
By the end of the course, participants will be able to:
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Explain the legal and ethical foundations of human subjects research, including key historical cases and international standards.
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Interpret and apply federal regulations such as the Common Rule (45 CFR 46), FDA human subject regulations (21 CFR 50 & 56), and HIPAA Privacy Rule requirements.
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Design and manage IRB operations—protocol review, continuing oversight, reporting, and audits.
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Evaluate and mitigate risks for vulnerable populations and complex study designs, including international and multi-site studies.
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Address contemporary challenges in data privacy, biospecimen use, AI, genomic research, and global collaboration.
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Respond to noncompliance and enforcement by federal oversight bodies such as OHRP and FDA, including corrective action planning.
