In late December 2023, a rule was issued by the FDA allowing certain clinical trials to operate without obtaining informed consent from participants. The rule officially went into effect on January 22, 2024. According to Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, the rule was passed to encourage the discovery of more treatment and diagnostic options in the medical field by reducing administrative burdens. “We anticipate this new rule will enable minimal risk research that would not be practical to conduct otherwise,” Califf said. “This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.”
But what qualifies as “minimal risk?” The FDA defines something as exceeding minimal risk if there is a likelihood the research subject will experience harm or discomfort greater than they would from an ‘everyday task.’ Not only does this put the power to determine what is constituted as minimal risk in the hands of a third party, but if they do decide that the potential risks do not cross their artificial threshold, a research subject will never be informed of those risks.
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Informed consent is widely regarded as one of the most important advancements in modern clinical trial research. As documented in an article in 2013 in the Journal of Advanced Pharmaceutical Technology, it states, “Informed consent is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects.” But informed consent has not always been a priority among the research community, and like many positive advancements, the idea was formed in response to negative outcomes.
Never forget the Tuskegee syphilis study done to purposely torture Black men in America
The most infamous example of a lack of informed consent in a clinical trial is the Tuskegee Syphilis study of the early to mid-1900s. For decades the United States Public Health Service (USPHS) purposefully misled and withheld treatment from African American men with syphilis so that they could study the effects of the disease if left untreated. This study and others like it are the reason that strict rules exist for Institutional Review Boards (IRBs) to require clear and informed consent.
Today, with the new rule change, it seems the FDA has taken two steps backward to take one step forward. The vague terminology of “minimal risk” is not only open to misinterpretation but can also be abused by third parties. Not to mention that allowing IRBs to compromise on their stringent standards opens the door for further reducing the rights of human subjects in medical research.
It is perplexing that the federal government would make a move to decrease the rights of human research subjects while at the same time claiming to try and make up for the lack of clear and truthful information dissemination during COVID.
Modern medicine couldn't really care less about "informed consent," when the true mission seems to be genocide, and genocide of minorities at that. Remember when the CDC head blew the whistle on the MMR vaccine causing autism in African American boys under age 3? Well, that's just the tip of the iceberg, folks.
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