This advanced course provides a comprehensive understanding of the U.S. research compliance framework that governs federally funded and privately sponsored research in universities, hospitals, government labs, and private industry. It dives into federal and state regulations, agency requirements, institutional review processes, and enforcement mechanisms, giving learners practical, real-world insights into how compliance protects research integrity, participants, and institutions.
From human subjects protection and animal research to export controls, conflict-of-interest policies, data management, and financial stewardship, students will gain a full-spectrum view of compliance obligations. The course blends legal requirements, agency guidance, and practical implementation strategies to prepare participants for roles such as research compliance officers, principal investigators, administrators, or counsel supporting research enterprises.
Course Objectives
By the end of the course, participants will be able to:
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Understand the legal landscape of U.S. research compliance, including federal statutes, regulations, and key agencies (e.g., HHS, NSF, DoD, DOE, FDA).
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Identify and manage compliance risks related to human subjects, animal care, conflicts of interest, data integrity, financial oversight, and export controls.
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Implement institutional compliance programs, including IRBs, IACUCs, data security policies, and research integrity offices.
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Navigate enforcement actions and mitigate penalties from agencies such as the Office for Human Research Protections (OHRP), Office of Research Integrity (ORI), and the Department of Justice (DOJ).
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Integrate best practices for training, auditing, reporting, and continuous improvement of research compliance systems.
