Children's Health Defense
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.”
Clinical researchers no longer have to obtain informed consent from human subjects when their research poses “no more than minimal risk,” the U.S. Food and Drug Administration (FDA) ruled last week.
The new rule amends FDA regulations to implement a provision of the 21st Century Cures Act, which was intended to accelerate medical product development and “bring new innovations and advances to patients who need them faster and more efficiently.”
The final rule “allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects.”
It also allows an institutional review board (IRB) “to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.”
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