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The Law & Ethics of Human Subjects Research (LAW-719R-001)
Meets 6/25-26 9AM-5PM
Research involving humans as research subjects incurs special ethical and legal responsibilities – some are voluntary, and some are mandated by law. Largely in response to notable and horrific scandals, frameworks for ethical protections for the conduct of human subjects research developed in the 20th century, and the field of research ethics has been burgeoning for the past 50 years with a vast increase in bioethical commentary. The U.S. legal system for regulating the conduct of human subjects research developed concurrently, culminating in 1991 with the current Federal regulatory structure. The U.S. Federal system of regulating human subjects research is based on ethical principles and sets the minimum legally allowable standards for the conduct of Federally funded human subjects research -- and continues to be a contentious and hotly debated regulatory scheme. This course is designed to encourage an understanding of the interrelationship of law and ethics in the protection of human subjects in research: to this end, the course will provide the historical context for the development of the discipline of research ethics; an overview of the U.S. and international codes of research ethics, with a focus on the substance and operation of current U.S. law; and a case-based exploration of controversial issues at the intersection of law and ethics. This course can be counted either towards a Pharmaceutical Law Series Certificate or a Health Care Fraud and Compliance Series Certificate. Academic credit requirement: Paper due 3 weeks after the course ends.
Textbooks and Other Materials
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First Class Readings
Not available at this time.
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