An FDA rule change published on December 21, 2023 solidifies that scientists are allowed to conduct human experiments without informed consent, as long as the research poses “minimal risk” and includes “appropriate safeguards to protect the rights, safety, and welfare of human subjects.” Investigation by ICAN’s legal team revealed that efforts to undermine informed consent protections have long been in the works, going back to at least 1962. ICAN has filed a FOIA request to dig deeper into this violation of one of our most basic human rights.
Informed consent is one of the bedrocks of human rights. It requires that (1) you be fully informed of the risks and benefits of any intervention or procedure and (2) that you consent to participate without coercion of any kind. Unfortunately, it turns out that Congress and our federal health authorities have been working to weaken informed consent protections for over 60 years!
On the heels of FDA’s new draft guidance which further weakens the already paltry clinical trial requirements for vaccine approval, FDA is once again implementing rules that take aim at informed consent protections. On December 21, 2023, FDA issued a final rule that “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.”
An investigation by ICAN’s attorneys revealed that back in 1962, Congress passed an amendment to the Food, Drug, and Cosmetics Act which directed HHS to create regulations that required researchers to “obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings.” (Emphasis added.)
In 1981, both the FDA and HHS issued updated federal regulations regarding “The Protection of Human Subjects.” HHS’s regulations for example “exempt[ed] broad categories of research which normally present little or no risk of harm to subjects,” such as “study of data, documents, records and specimens.”
Hellbound and Down 