(FDA) Informed consent not required for ‘minimal risk’ studies

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.

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7 thoughts on “(FDA) Informed consent not required for ‘minimal risk’ studies”

  1. I’m so frustrated that we are to believe the “minimal risk” theory therefore no informed consent required! Look what happened with the COVID vaccine, we were all told “safe and effective”. If they are too scared to inform their human lab rats of possible risk, is the experiments worth it? There is something seriously wrong and dangerous with this way of thinking. It’s just mind blowing to think they can get away with this. 3rd world stuff and even they may not allow this barbaric practice.

  2. We just keep on taking steps backwards. Informed consent rules were put in place for a reason. Why are they taking them away? The only reason I can see is that the powers that be are tired of being forced to respect the rights of the average Joe that they want to experiment on. When will this stop?!?

  3. Test Congress and the FDA and get back to me.
    I would volunteer the White House, but since Joe received the reason he won’t be prosecuted for his records mishandling. I think that is best left alone.

  4. The FDA lacks the credibility to decide for people what is or isn’t “minimal risk.” The FDA did this to themselves. Nobody destroyed the FDA’s credibility but the FDA.

  5. If it’s such a minimal risk, what are they afraid of by giving informed consent? This needs to be repealed. I mean, what’s next, more forced compliance in the future?

  6. Thomas Joseph Hussman

    The FDA does not have the authority to decide what level of risk is appropriate for anyone. That decision is for the human test subject to make. If the human test subject is incapable of making decisions for herself, then a representative must be appointed by the court. If the court has a history of making unfavorable appointments, or has made prejudicial decisions in the past, then the matter must be appealed to the next court. As described clearly in the Markingson case, a judge cannot insist that a human test subject make decisions about healthcare, if the same human test subject had previously been ruled incapable of making responsible decisions for herself. LSD and ElectroShock testing methods posed minimal risks of death, but millions of innocent lives were ruined. What do FDA lawyers propose for those who break the rules? Prison? Death Penalty?

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