FDA Proposed Rule Allows Waiver of Informed Consent If IRB Finds Risk Is Minimal

By Jeffrey K. Shapiro — The informed consent requirements in drug and device trials are important for subject protection. But there are trials where it is not possible (or difficult) to obtain consent, and the risk to subjects is minimal. Until recently, these trials could not go forward. In the 21st Century Cures Act, Congress stepped in.  Section 3024 amends drug and device provisions in the Federal Food, Drug, and Cosmetic Act that require informed consent for clinical studies to allow a waiver, if the testing poses “no more than minimal risk” to the subjects and/or the investigator and has “appropriate safeguards.” It is left to FDA to fill out the details. FDA has just announced a proposed rule. As the FDA Commissioner, Scott Gottlieb, M.D., explains: Over the years, we’ve received feedback from sponsors and investigators that they were not able to move forward in conducting important clinical investigations where there would be…

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