The following is an excerpt from The Defender.
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.”
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.
The FDA said it expects the change will create “benefits in the form of healthcare advances,” as studies that would otherwise not be performed if consent were required can now be undertaken.
Read more here.
The Lemonade Mermaid Store
Unique gifts for Land or Sea Mermaids, Mer-pets and Little Mermaids!
Left: Pastel Beach Necklace $16