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.

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