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

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Date: 12 October 2023
Triage
By: Alexa Sengupta, Cindy L. Ortega Ramos

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.

Alexa Sengupta
Alexa Sengupta
Nashville
Cindy L. Ortega Ramos
Cindy L. Ortega Ramos
Chicago
Find more items tagged as: Health Care and FDA, Health Care Fraud and Abuse (U.S.), Health Care Payor-Provider Disputes (U.S.), Health Care Sector, Health Care Transactions, Hospitals and Health Systems, Policy and Regulatory
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