FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies

“A ruling issued last week by the U.S. Food and Drug Administration — to implement a provision of the 21st Century Cures Act, signed into law in December 2016 — makes it legal for clinical researchers to conduct research on human subjects without obtaining informed consent when the research poses ‘no more than minimal risk.’”

“Critics — including Robert F. Kennedy Jr., chairman-on-leave of Children’s Health Defense — said the move opens the door to dangerous testing on people without their knowledge or permission, beyond what U.S. citizens already endured during the rollout of experimental COVID-19 vaccines.”

FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies • Children’s Health Defense (childrenshealthdefense.org)

Published by markskidmore

Mark Skidmore is Professor of Economics at Michigan State University where he holds the Morris Chair in State and Local Government Finance and Policy. His research focuses on topics in public finance, regional economics, and the economics of natural disasters. Mark created the Lighthouse Economics website and blog to share economic research and information relevant for navigating tumultuous times.

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