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MED HIST 545

ETHICAL AND REGULATORY ISSUES IN CLINICAL INVESTIGATION

1 credit.

Explores and examines the ethical issues central to clinical research, regulations governing clinical investigation, and the role of good clinical practice for clinical trials.

Prerequisites & course information

Requisites: Consent of instructor Course Designation: Core GenEd - Social & Behavioral Science Level - Advanced L&S Credit - L&S Liberal Arts and Science Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Know the basic elements of the federal regulations for human subjects research (“The Common Rule”). Audience: Both Grad & Undergrad 2. Provide examples of a conflict between the Common Rule and ethical principles guiding human subjects research. Audience: Both Grad & Undergrad 3. Develop a skeptical attitude about conventional wisdom on ethical and legal issues in human subjects research. Audience: Both Grad & Undergrad 4. Write a critical analysis of an ethically complex research study. Audience: Graduate Learning Outcomes: 1. Know the basic elements of the federal regulations for human subjects research (“The Common Rule”). Audience: Both Grad & Undergrad 2. Provide examples of a conflict between the Common Rule and ethical principles guiding human subjects research. Audience: Both Grad & Undergrad 3. Develop a skeptical attitude about conventional wisdom on ethical and legal issues in human subjects research. Audience: Both Grad & Undergrad 4. Write a critical analysis of an ethically complex research study. Audience: Graduate

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