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

Cindy L. Ortega Ramos, Alexa Sengupta
K&L Gates LLP
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K&L Gates LLP

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.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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