2.8 - Summary

In this second lesson, Ethics of Clinical Trials, we learned:

• 3 internationally recognized conditions necessary to justify conducting a medical experiment in humans.
• The condition that is required to justify randomizing a patient to a treatment.
• To differentiate between ethical and unethical use of placebo control.
• Requirements for IRB approval of human research studies involving any product regulated by the U.S. FDA.
• U.S requirements for investigators to report financial interests that may affect design, conduct or reporting of research regulated by the U.S. Public Health Service.