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Clue about motive for poor data collection by public health authorities, on post-injection injuries and deaths.
Reading Jessica Rose posts from the last couple of days:
An interesting possibility has turned up in the US laws. Canada may have done similar things in their federal laws.
In 2017, HHS changed the 1981 definition of human subject in a clinical trial from a “recipient of a test article or control” to someone about whom data is obtained.
This suggests that VAERS, DMED other data collection failures may be deliberate (which we already know) and the reason why: no data collection means no human subjects. When combined with the acts themselves — injection with pharmaceutical products — being redefined as not clinical investigation once an Emergency Use Authorization is put in place by the FDA, no test subject has informed consent rights.
Still digging, need to confirm further. Will be starting a series of posts that are summaries and analysis of the key statutes and regulations adopted between 2000 and 2020, and two new, pending bills introduced in 2021: the Cures Act 2.0, which on first look sets up a framework to define all illnesses, injuries and deaths after Covid outbreaks as Long Covid, thus disappearing vaxx injuries, and the PASTEUR Act, which sets up a subscription model between US government and pharmaceutical companies for development and sales contracts for anti-microbial products.
Timeline of index card files:
1981/01/27 - Food and Drug Administration regulations on Institutional Review Boards - 21 CFR 56.101-56.124. Multiple revisions 1981-2016, Federal Register citations logged.
1981/01/27 - FDA regulations on Informed Consent of Human Subjects - 21 CFR 50.2 et seq. Human subject defined as recipient of test article or control. Multiple revisions through 1999, FR citations logged.
1982/12/31 - Termination date for President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 48 FR 34408.
1991 - Common Rule. Federal Policy for the Protection of Human Subjects. 45 CFR Part 46
1997/11/18 - 50 USC 1520a, restrictions on use of human subjects for testing of chemical or biological agents.
2004/07/21 - Project Bioshield Act, Emergency Use Authorization provisions. As soon as a product (vaxx, mask, test) has EUA status, by legal definition, it’s under 21 USC 360bbb-3(k), and the product cannot be considered part of any “clinical investigation.”
“(k) Relation to other provisions - If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].”
Project Bioshield Act provisions were adopted by Congress to help military leadership work around the protections for military personnel as human subjects implemented in wake of mandatory anthrax vaccinations and resulting Gulf War Syndrome. See Section II, Assessing COVID-19 Emergency Use Authorizations, Parasidis et al.
2013/10/13 - Army Regulation AR 40-562, in effect 11/07/2013. Enumerates exemptions for vaxxes.
2016/12/13 - 21st Century Cures Act. Amended informed consent sections of FDA FDC Act of 1938 - Section 520(g)(3) and 505(i)(4) and parts of Public Health Service Act of 1944.
2017/01/19 - HHS revised 45 CFR 46.104 relating to “basic HHS policy for protection of human research subjects.” 82 FR 7259 and 82 FR 7273 The regulatory changes were made under authority of 5 USC 301, 42 USC 289(a) and 42 USC 300v-1(b). Human subject defined as someone about whom data is obtained, not to whom treatment is given. 45 CFR 46.102:
1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
2017/01/19 - HHS changes to the 1991 Common Rule on waivers of informed consent and Institutional Review Boards. 82 FR 7149. Went into effect 1/19/18. Need to find and read FR entry.
2017/07/25 - HHS FDA IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects: Guidance for Sponsors, Investigators, and Institutional Review Boards (not published until 5/29/20?) HHS-0910-207-F-7422. Waiver of informed consent and IRB review for clinical investigation involving no more than minimal risk to human subject.
2018/06/19 - Another set of revisions to 45 CFR 46.101-124. Need to track down. 83 Federal Register 28518.
2018/07/19 - More HHS revisions to 45 CFR 46.116, regulations on informed consent under the Public Welfare laws. Need to find Federal Register citation.
2021/06/12 - Bridges v. Houston Methodist Hospital ruling, Judge Lynn Hughes, USDC Southern District Texas, concludes that nurses, doctors and other hospital staff can’t be considered “participants in a human trial” for legal purposes because they are “licensed doctors, nurses, medical technicians and staff members.”
“[Plaintiff, nurse Jennifer Bridges] also argues that injection requirement violates federal law governing the protection of "human subjects." She says that the injection requirement is forcing its employees to participate in a human trial because no currently-available vaccine has been fully approved by the Food and Drug Administration. Federal law requires participants give legal, effective, and informed consent before participating in a human trial; this consent cannot be obtained through coercion or undue influence. Bridges says the threat of termination violates the law.
Bridges has again misconstrued this provision, and she has now also misrepresented the facts. The hospital's employees are not participants in a human trial. They are licensed doctors, nurses, medical technicians, and staff members. The hospital has not applied to test the COVID-19 vaccines on its employees, it has not been approved by an institutional review board, and it has not been certified to proceed with clinical trials. Bridges's claim that the injection requirement violates 45 C.F.R. § 46.116 also fails.
She also says that the injection requirement is invalid because it violates the Nuremberg Code, and she likens the threat of termination in this case to forced medical experimentation during the Holocaust. The Nuremberg Code does not apply because Methodist is a private employer, not a government. Equating the injection requirement to medical experimentation in concentration camps is reprehensible. Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.
2021/07/06 Deputy AG Dawn Johnsen’s July 6, 2021 slip opinion about the lawfulness of public and private vaxx mandates, citing Bridges v. Houston Methodist Hospital and other legal authorities (statutes, regulations) on informed consent, human subjects, etc.
1983 Public Health Emergencies, Section 319, added to Public Health Service Act, 42 USC 247d
1988 Health Omnibus Programs Act
2000 Public Health Improvement Act
2001 USA PATRIOT Act
2002 Public Health Security and Bioterrorism Preparedness and Response Act
2002 Homeland Security Act
2004 Project Bioshield Act
2005 Public Readiness and Emergency Preparedness Act
2006 Pandemic and All-Hazards Preparedness Act
2007 John Warner Defense Authorization Act
2012 National Defense Authorization Act
2013 Pandemic and All-Hazards Preparedness Reauthorization Act
2016 21st Century Cures Act
2019 Pandemic and All-Hazards Preparedness and Advancing Innovation Act
2020 Coronavirus Aid, Relief, and Economic Security Act
2022 Cures Act 2.0 (pending, in committee)
2022 PASTEUR Act (pending, in committee)