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.