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.
This is a direct violation of the Nuremberg Code.
— Robert F. Kennedy Jr (@RobertKennedyJr) January 30, 2024
This opens the door for testing of new “medicines” via the water supply or aerosolized spraying. It wouldn’t be the first time. To name one example of many, the U.S. army tested germ warfare dispersion in the NYC subway in 1966. https://t.co/qyJursaU0F
— Robert F. Kennedy Jr (@RobertKennedyJr) January 30, 2024
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.
FDA codifies law passed in 2016
Scientist James Lyons-Weiler, Ph.D., called the FDA ruling “wrong in every way possible when it comes to the culture of informed consent and human rights and medical rights.”
Although the FDA’s ruling is new, he said, its language comes from the Cures Act, which was signed into law on Dec. 13, 2016.
The Cures Act made statutory changes to the Federal Food, Drug, and Cosmetic Act, including amending key sections — 505(i)(4) and 520(g)(3) — so that informed consent was no longer required in clinical testing that “poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings.”
The FDA’s latest ruling is just “codifying that further and clarifying,” Lyons-Weiler told The Defender, “because I suspect that institutional review boards and research scientists looking to do other kinds of research started claiming that they didn’t have to have the oversight … if the risk to the patients was minimal, and that the FDA was swamped with requests for clarification. So this is a clarification, if you will … a bureaucratic dictate that ‘yes, that’s correct.’”
Code of Federal Regulations still requires informed consent
Meanwhile, the FDA ruling and Cares Act both violate existing parts of the Code of Federal Regulations (CFR) that secures people’s right to informed consent — and the CFR is stronger, legally speaking, according to Lyons-Weiler. He said:
“46 CFR 45 … and other parts of the Code of Federal Regulations absolutely prohibit coercion of any kind into clinical research studies and protect people’s right to informed consent.
“That comes first. That takes precedence over [any] stated policy of any HHS [U.S. Department of Health and Human Services] director. They have to answer to the code of federal regulations because that comes from the Senate and is signed into law by the President. …
“The 21st Century Cures Act and the statement by the FDA do not undo the code of federal regulations requiring informed consent.”
Who decides what ‘minimal risk’ means?
A key issue regarding removing informed consent for “minimal risk” studies is who determines what constitutes “minimal risk.”
According to the HHS:
“Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected.”
HHS lists these examples of “Minimal Risk” studies:
- Study poses no more risk than expected in daily life (e.g., blood draw, physical exam, routine psychological testing).
- Non-interventional studies (e.g., observational studies of behavior or nutrition).
- Survey/Questionnaire studies of a non-sensitive nature.
- Electrophysiological studies in healthy subjects or clinical populations (surface recordings such as EEG, ERP, MEG).
- Genomic studies.
- Non-invasive imaging (e.g., MRI and fMRI) in healthy subjects or clinical populations to investigate basic mechanisms of brain function.
- Research involving the collection or meta-analysis of existing data, documents, records, pathological specimens, or diagnostic specimens to understand basic bio-behavioral processes.
IRB members are the ones who decide whether a planned study poses minimal risk or more than minimal risk.
What about kids?
The FDA ruling will likely impact kids, said Lyons-Weiler, because pharmaceutical companies will likely use it to deny the parents’ informed permission.
But such a move falls on faulty legal grounds, he said, because neither the Cures Act nor the FDA ruling includes the language of “permission.”
“So a legal argument could be made that this doesn’t apply to cases of informed permission,” he said.
Who should make decisions — doctor or patient?
On his Substack, Lyons-Weiler wrote that Dr. Anthony Fauci and Christine Grady, Ph.D. — chief of the bioethics department for the National Institutes of Health — in 1986 argued that having an ethical physician in charge of decision-making was more important than informed consent:
“Their position is that the world can trust people in white coats conducting medicine and human experimentation to be ‘virtuous’ while, at the same time, writing their own rules and setting their own standards for ‘virtue’ — and that physicians’ say over the disposition of patients in medical research is more important than the patients’ say because the physicians understand more.”
Fauci and Grady’s view runs contrary to foundational medical ethics documents, such as the Nuremberg Code, Lyons-Weiler said.
This kind of thinking — which the FDA’s ruling supports by stripping away informed consent — is dangerous, Lyons-Weiler said:
“In my view, the right to informed consent is sacred and it comes above every other policy. Because if we don’t demand that, then we’re on a slippery slope where they could say, ‘Oh, you’re on a blood pressure medication. I have to update your script.’ ‘Why doctor?’ ‘Oh, no reason. I just want to update your script.’
“And then what he’s really doing is telling the pharmacist, ‘Stop giving the person drug A, we’re going to put them on experimental drug B. I think the risk is minimal. The research team thinks the risk is minimal.’”
“In a historically normal regulatory and bioethical environment, this breach of international bioethical norms concerning informed consent would rise to the level of a clear-cut crime against humanity.
“But in the ‘through the looking glass’ world of COVID post late 2019, established legal, moral and ethical norms concerning patient and citizen rights to proper informed consent have all been turned upside down.”
Big Pharma will abuse this, critics say
Critics like Lyons-Weiler say the FDA’s ruling will likely be abused by Big Pharma.
“If you set this culture within one context of population-wide clinical research that informed consent is not required,” Lyons-Weiler said, “of course every drug manufacturer with a popular drug — or everyone that would like to have a wide drug that’s in widespread use — would love to be able to do this.”
Such a culture is a ripe environment for abuse by pharmaceutical companies chasing profits, he said. Big Pharma will learn and they will attempt to argue that studying their product poses only “minimal risk,” and they’ll use “the same excuses” the vaccine makers used. “That doesn’t make me a pessimist, it just makes me a realist.”
Dr. Steven Kritz, an IRB chair and retired physician, agreed. He pointed out that the FDA received only about 50 comments before it finalized its ruling. “Not one of the comments mentioned exceptions to informed consent in the context of research involving a pharmaceutical product,” he said.
Regardless of the FDA’s ruling, all IRBs should insist that any research project involving a pharmaceutical product include informed consent, Kritz said.
The Defender asked the FDA Office of Clinical Policy what the agency would like to tell members of the public who are concerned that this unethically strips people of their right to informed consent. The office did not respond by our publication deadline.