Those who are reading the series on Sons of Liberty Media, “Informed Consent – An Unalienable Right”, are becoming familiar with the idea that informed consent involves more than just the medical industrial complex, is a process that is on-going, and relies on proactive means to ensure your rights are upheld.
In the introduction to the series, readers were introduced to the 21st Century Cures Act, which basically lowered the standard of informed consent in Section 3024. On January 22, 2024, The Epoch Times, reported the Food and Drug Administration (FDA) finalized a rule that would allow some clinical trials for discovery of more treatment and diagnostic options to “operate without obtaining informed consent.” Following along with Section 3024 of the 21st Century Cures Act, the “new rule” at the FDA allows these trials without informed consent IF the study poses no “more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.”
There is plenty wrong with this finalized rule. Negating informed consent, which is a natural right recognized, guaranteed, and protected under the Ninth Amendment of the Constitution for the united States of America, is denying rights. As we have seen with the CONvid-1984 debacle and injections, there were limited safeguards or no safeguards to protect the safety and welfare of those involved. Those injured by the CONvid-1984 injections were left to fend for themselves, scouring resources to find interventions that would ease or reverse their symptoms. Who gets to determine what is an appropriate safeguard or what a safeguard is?
According to FDA commissioner for food and drugs Dr. Robert M. Califf, “We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise. This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.”
Doesn’t this already happen when a doctor prescribes a certain product for treatment of a diagnosed illness and performs assessment and evaluation on his/her patient’s response? Is there really any need for a “clinical trial” where informed consent is basically removed? Determining which “approved product” or intervention is best for patients should be left to their physicians.
The FDA initially proposed the rule in November 2018, permitting an institutional review board to waive the requirement for informed consent under certain conditions. The agency received fewer than 50 comment letters on the proposed rule from academia, institutional review boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, and citizens.
Most of the comments favored the agency’s efforts, supporting the rule because it reduced administrative burdens on both IRBs and researchers while encouraging valuable research on important health issues affecting the public without putting trial participants at risk, according to the FDA.
Remember, informed consent also includes the right to refuse at any point in time for any intervention(s) recommended or prescribed. Part of a “safeguard” is the right to refuse at any point in any medical intervention. Sounds a bit like living in Auschwitz, doesn’t it?
It should surprise anyone where the positive comment letters originated – academia, institutional review boards, public advocacy groups, industry, trade organizations, and public health organizations. What does come as a surprise is comment letters from citizens who would support the eradication of informed consent.
Remember, informed consent cannot be assumed, presumed, supposed or implied and it follows a process that is ongoing. There is no majority, minority, or entity that can remove the right to informed consent.
Not all comments were supportive, with some warning that “a waiver of consent may be necessary and ethically justifiable for certain types of clinical investigations that are critical for medical advancement, patient care, and safety.” Two commenters believed the rule simply goes “against the spirit” of protecting humans in medicine.
However, many researchers noted in their support that certain minimal-risk trials are nearly impossible to conduct if consent is required. One example includes the analysis of a retrospective records review; before the new rule, such a study required informed consent from the patients whose data were being studied. By being able to dig into such information, these researchers and the FDA argue they may be able to make medical advancements without sacrificing patient safety or rights.
At least someone recognized this “rule” would go against the ethics of protecting human beings in medicine. Naturally, researchers would argue against informed consent, particularly when wanting to conduct “retrospective records reviews”. Another part of informed consent is giving consent for your medical records to be viewed by those who are not authorized to view them. It is part of privacy and protecting personal information under HIPAA laws. In retrieving medical records for a family member, it took an extraordinary amount of paperwork and time to get them, plus proof of identification and relationship was required. This FDA rule would bypass all of that.
Much of the pushback against the new rule suggested the changes would allow IRBs to compromise on standards more and more, adding that the term “minimal risk” is too vague and could be misinterpreted or abused. The result would be decreased public trust in research and health care providers.
“No third parties, including IRBs, should be allowed to make decisions for study subjects as to what constitutes ’minimal risk,’” one commenter stated.
Minimal risk, as defined by the FDA, means the likelihood of experiencing harm or discomfort is not greater for a subject during a study than for them during everyday tasks. In other words, there’s minimal risk in nearly every activity, from walking to putting away the dishes to picking the kids up from school; the study’s risk cannot exceed the risk one experiences daily.
The ruling comes at a time when the FDA can’t afford to lose any more public trust; the agency has been attempting to rebuild its reputation after the COVID pandemic, during which many believe it was heavily swayed by political influence. The agency has been called upon by industry leaders to tighten its prescription drug and medical device approval process—and to make it more transparent.
In his blog post, Dr. Califf says the new rule is a start.
“These efforts will promote additional robust clinical research to generate the evidence needed to inform clinical decision making and ultimately enhance treatment and diagnostic options for patients,” he wrote.
After the CONvid-1984 debacle and injections, public confidence in research and health care providers is more than likely at an all time low. If not, it should be. The proposed removal of informed consent for any type of “research”, even “minimal risk” that is ill-defined and broad, should bring that confidence to zero. To even use the word “trust” is a misnomer. No one should put their “trust” in man. Trust should only be placed in God and Jesus Christ. You can have confidence in something, even man, but at this point, that confidence has proven to be misplaced.
This is another way for government tools to get their hands on confidential, private information contained in medical records using eradication of informed consent, when one is talking about conducting a retrospective records review. Moreover, the FDA is a revolving door for pharmaceutical CEOs and researchers and vice versa, with the pharmaceutical companies paying one-third the cost of FDA employee salaries. This unethical link between private industry and the unconstitutional FDA should produce great pause in everyone.
In case you missed it, the claims by Dr. Califf – “these efforts will promote additional robust clinical research to generate the evidence needed to inform clinical decision making and ultimately enhance treatment and diagnostic options for patients” – did not include an answer to the ultimate question, “how does the removal of informed consent for these ‘clinical investigations (trials)’ do that?”
The process of informed consent applies here. While heads of government agencies are quick to tell you the “benefits”, the risks are never divulged. There is never an appropriate time for questions and comments, nor is there any mass communication to the people to engage in the process of informed consent. And, those “researchers” that would benefit from the removal of informed consent, a right of all individuals, are quick to board that train and whiz on down the track. Informed consent is an ethical, moral, and legal requirement. It is the States who are authorized to establish legislation regarding it, not the federal government or any federal entity.
In other words, you could be part of an “experiment” and never know it should this be allowed to stand. Trying to define “minimal risk” as “the likelihood of experiencing harm or discomfort is not greater for a subject during a study than for them during everyday tasks” is disingenuous. Everyday tasks and living are filled with “risks”. Ask anyone who has broken a foot stepping off a curb, been in a car accident when picking a child up from school, slipping in the bathtub, or falling off a step ladder when getting items from a high up cabinet. Being free is filled with risks. While these may be few and far between, the risk is still there and some would not classify those risks as minimal. There is not one guarantee that any clinical research, including conducting retrospective records reviews, would carry the same few and far between risk. Moreover, you have the option to avoid many of what the FDA terms “minimal risks”. But, with the removal of informed consent, the right to end participation or refuse to participate is negated.
Please read the entire series on Informed Consent – An Unalienable Right as it appears on Sons of Liberty Media to understand what is truly involved when informed consent is proposed to be negated for any reason. There are collateral damage/unintended consequences and sometimes intended consequences that occur when negating informed consent. If you would like a digital copy of Informed Consent – An Unalienable Right, keep your eye on the announcement of its availability at Sons of Liberty Media.
