from WND:
‘It is considered assault to involve humans with unwanted medical treatments’
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.
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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.
