Course Description
Designed to introduce advanced students working in cell biology and regenerative medicine research to ethical, policy, and social issues relevant to the field, specifically stem cell research.
Athena Title
Reg Med Cell Manu and Society
Non-Traditional Format
The course combines classroom lecture and discussion. This includes live, real-time interaction with students from other campuses via videoconferencing. This will NOT be recorded; rather, online participation is designed to help students engage with students and faculty from other U.S. universities in real- time.
Semester Course Offered
Offered fall
Grading System
A - F (Traditional)
Course Objectives
1. Understand current and past legal, political, and social issues related to regenerative medicine. This includes laws and regulations, but also an understanding of clinical ethics issues, translational research and commercialization, and emerging novel techniques requiring careful ethical consideration. 2. Understand more about relations of science, the state, and public, particularly around controversial or novel innovations; and learn how best to address emerging controversies and public concerns ethically in their professional careers. 3. Learn the guidelines for the responsible conduct of research for stem cell science and cell manufacturing, where to access regulatory and oversight documents, and how to apply for research protocols with ethics oversight. 4. Gain analytical skills for addressing policy, legal, and social issues through research and writing exercises. Students will also learn analytical and professional presentation skills through classroom interactions and discussion.
Topical Outline
1. Introduction 2. Workplace issues: diversity and inclusion, successful professional conduct 3. Legal, social, and ethical backgrounds for regenerative medicine in the U.S. 4. International policy and emerging politics, social and ethical issues and law 5. Clinical issues: patients and practitioners 6. Academic-industry relations 7. Critical issues in preclinical research – Part 1: Ethical issues of methods and materials 8. Critical issues in preclinical research – Part 2 9. FDA oversight and unproven therapies 10. CRISPR-Cas9 and gene editing ethics 11. Commercialization and economics of cell therapies 12. Technology transfer, material transfer agreements, patenting, and intellectual property debates 13. Emerging social, ethical, and policy issues in cell manufacturing