Business · 21/12/2023Updated: 10/17/2026 · 1 min read
FDA Issues Final Rule to Waive Informed Consent for Minimal Risk Clinical Investigations
Summary
The FDA is implementing a provision of the 21st Century Cures Act, allowing IRBs to waive informed consent for minimal risk clinical investigations with safeguards in place to protect human subjects.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →