Human Research Protections & Regulatory Compliance

1.5 Credit Hours

This course explores the critical regulatory and ethical frameworks governing biomedical and social-behavioral human research protections. The current system of regulations was established to mitigate risks in response to historical research abuses involving human subjects. Research institutions navigate a complex landscape of human research participant protections that are overseen by multiple federal agencies, including the Food and Drug Administration (FDA) and the US Department of Health and Human Services (DHHS). Though the intersections of regulation and research can be complex, building knowledge of the applicability and structure of this content helps to balance research innovation with integrity. This course will cover the authorization of clinical investigations and the legal marketing of new drugs and devices in the US. Through a combination of asynchronous readings, discussions, and synchronous activities, students will gain a deep understanding of how, when, and why regulations are applied to evolving research.