Ethical and Regulatory Aspects of Clinical Research Lectures
Presentation Slides for 2009 course
NB: Instructions on how to print multiple slides on one sheet of paper from the pdfs below are available.
- Session 1:History, Guidance, and Framework for Ethical Clinical Research
- What Makes Clinical Research Ethical? presented by Ezekiel Emanuel
- History, Scandals, and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest presented by Susan Lederer
- Which Codes Apply to My Reseach? presented by Jerry Menikoff
Session 2: IRB Review, Conflicts of Interest, and Fair Subject Selection - The Purpose and Function of IRBs presented by Barbara Karp
- Conflict of Interest and Clinical Re$earch presented by Cary Gross
- Fair Subject Selection presented by David Wendler
Session 3: Recruitment, Research with Pregnant Women, and Mock IRB - Coercion and Undue Inducement in Research presented by Alan Wertheimer
- Sample Protocol and Mock IRB presented by Christine Grady
Session 4: Research with Children and the Cognitively Impaired, and Informed Consent - Ethical "Hot Spots" in the Additional Protections for Children in Research presented by Robert M. Nelson
- Enrolling Decisionally Impaired Adults in Research presented by Dan Rosenstein
- Informed Consent presented by Christine Grady
Session 5: Risks and Benefits, Stored Samples - Ethical Issues in the Use of Stored Samples presented by Sara Hull
- The Ethics of Risk/Benefit Judgments presented by David Wendler
Session 6: Study design, Randomization, Placebos - Ethics of Placebo Controlled Trials presented by Franklin Miller
- Ethical Conflicts in Randomized Controlled Trials presented by Robert Truog
- Session 7: Ethical Issues in International Research
- Exploitation in Clinical Research presented by Alan Wertheimer
- Ancillary Care and Post-trial Access presented by Joseph Millum
- Post-trial Obligations in International Research presented by Seema Shah