The FDA simplifies experimentation on children without parental consent

This FDA rule on informed consent (i.e. removing it) went into effect back in January:

By Sasha Latypova

Who determines if the risk is “minimal”? The institutional review boards are just as captured and brainwashed as all other academia, government and healthcare. This is a very troubling development.

I have published my criticism and questions for Siri Gilmstad legal complaint v. FDA demanding that already approved vaccines are studied “properly” in long-term studies on children.

Many of you agreed that this showed a very troubling lapse of ethics on the part of the petitioners. Some, however, threw accusations at me, saying that I do not understand the brilliant 5D chess moves of this litigation.

In light of anaphylaxis to common proteins from food and environment caused by vaccines to an unpredictable % of the population, no ethical clinical trials in vaccines are possible. You can’t design a safety testing strategy where you are exposing a healthy child to a life-altering poisoning. See this post with references:

On vaccination as intentional induction of chronic and acute anaphylaxis.

In addition to plainly being morally wrong, the experimentation on children with known poisons, especially on underprivileged, poor, disabled and otherwise disadvantaged kids is rapidly becoming an overt strategy of the government (and has been going on for a long time covertly, remember Fauci’s AIDS orphans?)

The FDA has removed parental informed consent, making it easier to experiment on children without informing the parents.

According to the new FDA final rule “Under 45 CFR 46.116(c), an IRB [Institutional Review Board] may waive the requirement for obtaining informed consent or parental permission or approve a consent or parental permission procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that the following two criteria are satisfied:

1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

• public benefit or service programs;

• procedures for obtaining benefits or services under those programs;

• possible changes in or alternatives to those programs or procedures; or

• possible changes in methods or levels of payment for benefits or services under those programs; 45 CFR 46.116(c)(1).

Note that this criterion means that only public benefit or service program research activities that are under state or local authority meet this criterion; similar research conducted under federal authority would not qualify here and is treated elsewhere in the regulations. Research conducted by or subject to the approval of only a private entity also would not qualify.

What this means is that if your child is receiving some sort of public benefit or is part of some state/local assistance program, they are fair game for the government to experiment on them without informing you. Let’s say your child receives a free lunch in school, or your child has a disability and has a special learning program or transportation assistance. Well, now they are in a pool of the experimental subjects, and you don’t need to know!

Even after the children are no longer part of any government assistance program, their data is deemed fair game:

2. The research could not practicably be carried out without the waiver or alteration (45 CFR 46.116(c)(2)).

   This criterion means that the practical circumstances of the research are such that the research is not feasible if the informed consent of the subjects must be obtained. For example, a study of identifiable private information about program benefit recipients using 20-year-old records might meet this criterion, if current contact information for those recipients is not available.”

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