FDA Quietly Removes the Need for Informed Consent in Some Clinical Investigations

But only if there's minimal risk...so that's ok then

In 2023, the Food and Drug Administration (FDA), together with the Department of Health and Human Services (HHS) began the process of amending a provision of the 21st Century Cures Act (Cures Act). This involved taking and assessing comments which was done last year. The rule was then published on 21 December 2023 before becoming effective on 22 January 2024. Did you hear about it in the news? I didn’t think so.

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”.

What this means is that for some research, where there is “minimal risk” to participants, the detailed and important process of explaining the study and getting each participant’s consent can be skipped. This can be done if the Institutional Review Board (IRB) waives or alters the informed consent elements.

Whether this was done with the best intentions or not, if you give them an inch they will take a mile. Suddenly a clinical investigation doesn’t need to be conducted in a clinic. Suddenly minimal risk means as long as fewer than 50% of participants don’t die.

I’m exaggerating, I hope, but you get the drift, this is subject to abuse and will likely be done in a non-transparent manner. Do you really trust a review board to act in your best interests? And maybe if you do in normal times, you certainly shouldn’t in times of panic, such as a pandemic scare. All it would take would be a small emergency and informed consent would be removed “in your best interest”.

What about the Nuremberg Code you might be thinking. So were a number of comments that opposed the proposed rule. Two opposed it because they “assert that waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki and the International Covenant on Civil and Political Rights (ICCPR). Two other comments suggest that the FDA withdraw the proposal because the underlying law and revised Common Rule are defective and “against the spirit” of human subject projection.”

The FDA disagreed. Nothing to see here. Move along. They believe that there are “some situations in which important research cannot practicably be conducted if informed consent is required”.

What? A bit like rolling out an untested, novel mRNA product on the world whilst telling them it is safe, effective and fully tested?

In which case, they had better hope that this new rule is retrospective/retroactive, i.e. it can change the legal consequences of actions that have been committed before the rule was enacted. Because they already failed to obtain informed consent from half of the world before this rule went into effect.