Topic. Ethical Conduct in Research

Introduction: Background Videos

1. IPPCR 2016: Research with Vulnerable Patients
2. Research Ethics Involving Human Subjects
3. An Ethical Framework for Learning Health Systems

Assigned Reading

1. Review this PPT and the notes. I have attached  as PowerPoint
2. Vaughn, Chapter 6  I have attached this book as PDF
3. FOUNDATIONAL DOCUMENTS
4. United States Office of Human Research Protections, “The Belmont Report. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.”
5. Emanuel, E.J., Wendler, D., & Grady, C. “What Makes Clinical Research Ethical?” Journal of the American Medical Association 283 (2000); pp. 2701-2711.
6. The Declaration of Helsinki 
7. The American Medical Association Code of Medical Ethics’ Opinions on Clinical Research 
8. Code of Federal Regulations (Review the Subparts which describe rules for research on vulnerable populations). 
9. THERAPEUTIC MISCONCEPTION
10. Enrolling Research Participants in Private Practice: Conflicts of Interest, Consistency, Therapeutic Misconception, and Informed Consent, December 2015
11. The AMA Code of Medical Ethics’ Opinions on Physicians’ Participation in Clinical Research, April 2014
12. CLINICAL EQUIPOISE
13. The Question of Clinical Equipoise and Patients’ Best Interests
14. INTERNATIONAL CONTEXT 
15. Nuffield Council on Bioethics Summary 
16. Comparison of International Guidelines

Discussion Questions after reading

What ethical principles and concepts stood out to you as important to consider when ensuring that research is conducted in an ethical manner? Do you believe that it is possible to conduct an ethical clinical trial that includes a placebo? Explain your answer. 

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