The Era of INFORMED Consent is OVER

… HHS and FDA issued a final ruling

… amend a provision of the 21st Century Cures Act

… “an exception from the requirement to obtain informed consent

when a clinical investigation poses no more than a minimal risk to the human subject

… went into effect on January 22nd, 2024

… means it’s already standard practice across America

… the 21st Century Cures Act enacted in January 2016

… designed to “accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes

… he Act supported: High-risk, high-reward research  [ Sec. 2036 ]

… Novel clinical trial designs  [ Sec. 3021 ]

… Encouraging vaccine innovation  [ Sec. 3093 ]

… the NIH legal protection to pursue high-risk, novel vaccine research

… necessary architecture required for much of the evil that transpired over the past four years

… under Section 3024 was the provision to develop an “informed consent waiver or alteration for clinical investigation

… just 77 years after Nuremberg

… the door has once again opened for state-sanctioned medical experimentation

on potentially uninformed and unwilling citizens

… the state alone … will decide what is considered a “minimal risk”

… will determine: appropriate safeguards to protect the rights, safety, and welfare of human subjects

subjects, not patients, persons, individuals, or citizens

… the term subjects also serves to dehumanise

… a critical component of Nazi human experimentation

… the histories of pharmacology and medicine are plagued with clinical investigations and interventions that were thought to pose no more than minimal risk to humans

… went on to cause immeasurable pain, suffering, and death

… represents merely a first tentative step as the US government

… Given the lack of attention … the government is likely to feel emboldened to widen its scope

… this decision represents the beginning of a chilling revisionism in Western medical history

… patient autonomy is again forsaken

… is another step toward a dystopian future unimaginable just five years ago


                      Final ruling – FDA HHS


                    21st Century Cures Act