FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

<p class="MsoNormal">In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.</p>