This story was originally published by the WND News Center.
A little-known rule of the Food and Drug Administration allows the government, pharmaceutical companies and universities to bypass "informed consent" requirements when involving individuals in certain clinical research or trials for new drug approval.
WorldNetDaily spoke to Brian Ward, the creator of CovidPenalty.com, a consultant and expert in regulations governing the $600 billion biomedical research industry. Ward reached out to WND to express concern that universities, for example, have been authorized to conduct trials using investigational compounds without the explicit consent of participants.
As Ward explained, in February 2024 Democrats finalized a new rule that fundamentally amended how clinical trials can be conducted in the United States. "Before the new rule was enacted," he told WND, "if a person's identifiable private information was known, the clinical trial's sponsor was lawfully bound to obtain the individual's legally effective informed consent before involving them."
Identifiable private information, or IPI, refers to data that can be used to trace an individual's identity or, when combined with other data, can identify the individual.
For example, suppose an individual undergoes surgery. After the patient is removed, college students arrive to study the efficacy of a new antibacterial cleaning agent. The students do not look at medical charts or obtain data relating to the surgery. In that case, the students do not need to obtain the individual's consent to research because no data is involved that can be traced back to the individual.
However, if the students were to examine the patient's medical chart or obtain the date, time and patient's code, they are legally required to obtain that individual's legally effective informed consent, because that data directly identifies the individual or can be used to trace his or her identity.
The IPI requirement has always served as a buffer between the researcher and the individual, ensuring the individual participates only after having granted legally effective informed consent.
Legally effective informed consent means the sponsor must ensure that the individual is not pressured to participate in the research activity when the opportunity to participate arises.
Research is broadly defined as any activity for which a person's IPI is known, and data obtained from their interaction with the activity adds to the generalizable knowledge of the product. For example, hospitals routinely administer investigational drugs to patients undergoing cancer treatment. In every instance, the hospital must obtain the individual's legally effective informed consent because the individual's IPI is known, and how he or she responds to the drug's treatment is added to the drug's generalizable knowledge.
"However," Ward pointed out, "the new rule allows governments and private entities to involve Americans in clinical trials even if their identifiable private information is known, which means the researcher is not required to ask for permission or inform the individual before involuntarily subjecting them to the research activity."
The FDA, says Ward, has not allowed sponsors of research to involve individuals in clinical trials without their informed consent since Congress enacted the National Research Act. "The trigger mechanism for obtaining consent always occurred when an individual's identifiable private information was known for the protection of human subjects," he added.
"Under this new rule, a college student, medical patient, school child or employee can be subjected to biomedical research, including invasive research, daily without their knowledge," Ward emphasized.
"The FDA was warned that the rule violates an individual's constitutional protections," he said, adding, "the constitutional protections against unwanted investigational medical treatments are well-settled" under Union Pacific Railway Co. v. Botsford (1891), Cruzan v. Director, Missouri Department of Health (1990), Washington v. Glucksberg (1997) and Albright v. Oliver (1994).
"The Supreme Court could not be clearer," Ward argues. "In Cruzan, it held that it is considered 'assault' to involve humans with unwanted medical treatments," he explained.
"Suppose the clinical trial injures an individual but [he or she] is not informed that their injury results from the trial," Ward questioned. "How can one effectively exercise their fundamental due process rights to seek judicial remedy from the injury?"
