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

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

Nashville

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

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