Late last year, the U.S. Food and Drug Administration (FDA) quietly introduced a regulation that may be one of the most important shifts in how nonprofit and for-profit U.S. institutions, both at home and abroad, conduct future medical and public health research. It represents an erosion of personal medical choice and threatens to undermine the public’s trust in scientific investigations in biomedicine.

At its core, the new FDA rule change allows any IRB to broadly assume the FDA’s own exemption power, dubiously granted under the 21st Century Cures Act of 2016, to grant exemptions to informed consent requirements based on “minimal risk.” Based on vague guidelines, it effectively gives thousands of IRB committees the unilateral ability to determine that researchers need not obtain true informed consent from research participants.