by Joseph DeMaio, ©2021 

(Dec. 8, 2021) — In a 9-part “docu-series” entitled “COVID REVEALED,” producer Patrick Gentempo assembles some extraordinary interviews with a variety of doctors, researchers, virologists, epidemiologists and victims of “adverse reactions” to the several types of C-19 “vaccines” now being used.

The term “vaccines” is considered by some of the interviewees to be a gross misnomer – some might call it “disinformation” – as they are in reality still experimental fluids being used under a continuation of the Food and Drug Administration’s “emergency use authorization” rather than the fluids having achieved final, official FDA “approval” which would normally occur only after the completion of at least two years of controlled clinical trials. 

Thus, many of the docu-series interviewees contend that until the final formal FDA approval occurs – if ever – the fluids now being injected into the arms of Americans (but not the arms of illegal aliens who have been invited and permitted to flood over the border since the inception of the Goofball Regime) constitute experimental research activities being “allowed” – but not “approved” – under a purported “emergency” declaration by the FDA. 

In effect, the ongoing coerced “jabbing” of the public is viewed by the interviewees to be merely an ersatz “clinical trial” where the “vaxxed” populace constitutes the body of “research subjects.”  Several of the episodes have been addressed and profiled at The P&E, including here, here and here

These episodes were to be viewed free of charge online for a 24-hour period before they were voluntarily de-posted by the producer.  Suffice it to say that all of the episodes relate to challenging the propaganda narratives that the “vaccines” are the only way to address and fight the C-19 pandemic; that vaccination mandates are a proper and exclusive way to impose the goals of the narrative on the populace; that the fluids are “safe;” and that anyone who challenges the narratives must be censored, silenced and, in many cases, punished.

In true capitalistic form, Gentempo is offering the complete series in a variety of “sets,” including transcripts of the interviews, additional “non-streamed” episodes and jabbed patient “adverse reaction” stories for a variety of price ranges.  As the intrepid P&E Editor has noted, The P&E is not associated with the production of the series and neither encourages nor dissuades readers from making a purchase. 

One reason why your humble servant will be making a purchase is to make sure a “hard copy” of the information contained in the interviews is secured, lest digital chicanery or cancel culture attacks become involved at some point in the future.  Fight Memory-Holing!  But I digress.

One of the persons interviewed is Dr. James Lyons-Weiler.  In one portion of his interview by Gentempo, Lyons-Weiler references a provision of the Code of Federal Regulations (“CFR”) which he claims provides a defense to any employee who is being coerced or forced by his/her employer (yes, Virginia, your humble servant subscribes to the theory that there are but two human species genders…) to “get the jab” or be fired.

That provision is found at CFR Part 45, § 46.101.  That and following sections provide for the “protection of human subjects in research at 45 CFR 46 [and] include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects.” Unbeknownst to most people, there actually exists within the federal Department of Health and Human Services an “Office of Human Research Protections” (“OHRP”). 

That office is charged, supposedly, with enforcing the typically convoluted, complex and intertwined provisions of the statutes and regulations in order to, as the title suggests, effectuate “the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.” (Emphasis added)

One of the provisions to be enforced is the “Common Rule,” summarized here.  The full text of the Common Rule is found here.  In the OHRP summary of the Common Rule, it is stated that “[t]he current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.” (Emphasis added)

The Belmont Report, in turn, lays out in three main sections, the principles and ethical protocols which should underpin all decisions and activities involved in conducting human medical and bio-medical research and experimental treatments.  The Report specifically references not only the physician’s Hippocratic Oath, but also the Nuremberg Code of 1947, enacted in the wake of the ghoulish medical experiments undertaken by Adolph Hitler’s “physicians” such as Josef Mengele, the “Angel of Death.”

Interested readers should peruse the entire 10-page Belmont Report document in order to more fully understand what is now taking place in the nation regarding the maniacal insistence by the Goofball at 1600 that every living American over age 5 “get jabbed” to conquer C-19…,  illegal aliens excepted, of course. 

The Belmont Report states with respect to “informed consent,” for example, that “Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.” (Emphasis added)  Informed consent is then categorized under the headings of “information,” “comprehension” and, most importantly, “voluntariness.”

The Report then states categorically: “An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.” (Emphasis added).

Returning to the requirements of 45 CFR § 46.101(a), it is there stated that it applies to “all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research”  Paragraph (c) of the regulation states: “Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.” (Emphasis added).

Finally, 45 CFR § 46.116 (a)(1) mandates that “[b]efore involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.” (Emphasis added) Subparagraph (a)(2) of the regulation then requires that “[a]n investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.” (Emphasis added)  The term “investigator” is not separately defined in the rules, but instead is loosely characterized as a person conducting the “research on human subjects.”

Against this backdrop, faithful P&E reader, ask yourself these questions: are the current C-19 policies of (a) the Goofball at 1600; (b) Dr. Anthony Fauci; (c) the Centers for Disease “Control” [sic]; (d) the FDA; (e) the bulk of the mainstream media; and (f) Democrats in general consistent with the protocols of the Belmont Report?  Or with 45 CFR Part 46?  Or with the provisions of the Nuremberg Code of 1947?  Or with the Hippocratic Oath?  Think hard…, I’ll wait.

If you answered “no” to any one of the above questions – let alone several of them – and you are threatened with employment termination by a cowardly automaton “go-along-to-get-along” employer lacking the fortitude to resist the oppressive C-19 edicts spewing from the Beltway, you may want to engage a competent employment attorney and ask that professional whether the case for resistance based on the federal regulations and the Belmont Report might be relevant.

Do not rely on the fevered ruminations of your humble servant, who – surprise – thinks the Goofball, aka “Brandon,” needs to go.  Now.

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        1. Reply from the author:
          ———————–

          Hobart states: “The FDA approved Comirnaty in August.”

          An examination of the August 23, 2021 FDA letter (August 23, 2021 Approval Letter – Comirnaty (fda.gov)) reveals that it is an “approval” not of the “vaccines,” but instead of the BioNTech Manufacturing GmbH/Pfizer Inc. “Biologics License Application” or “BLA.” Indeed, the first page of the letter discloses just above the date that it is the “BLA APPROVAL” (emphasis in original).

          The letter also notes that the “review of this product [i.e., “Comirnaty”] was associated with the following National Clinical Trial (NCT) numbers: NCT04368728 (Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals – Full Text View – ClinicalTrials.gov) and NCT04380701 (A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults – Full Text View – ClinicalTrials.gov).”

          An examination of those two NCT numbers reveals that as to a “[a] group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial’s protocol” — characterized in the study as an “Arm” — there are numerous references to the actions taken as being “Experimental” and “Biological.”

          As to NCT04368728, the number of participants in that study is: 43,998. The “Actual Study Start Date” is listed as April 29, 2020; the “Estimated Primary Completion Date” is listed as May 2, 2023; and the “Estimated Study Completion Date” is listed as May 2, 2023.

          As to NCT04380701, the number of participants in that study is: 476. The “Actual Study Start Date” is listed as April 23, 2020; the “Estimated Primary Completion Date” is listed as “April, 2023;” and the “Estimated Study Completion Date” is listed as “April, 2023.”

          Accordingly, as to both NCT studies, simple arithmetic and a perpetual calendar will demonstrate that the “experimental” and “biological” studies are still in progress and are not “estimated” to be completed for, at minimum, at least another sixteen to seventeen months. Indeed, with regard to required reports of “potential long-term sequelae of myocarditis after vaccination (in collaboration with [the] Pediatric Heart Network),” the licensee must submit its “final report” by May 31, 2027, more than five years from now.

          Finally, the “BLA Approval” letter advises that “[w]e did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited [sic] from an advisory committee discussion.” Seriously?

          Against this backdrop, the skepticism of the interviewees in the “COVID REVEALED” series seems to remain far less than unfounded and suggests that the Belmont Report and 45 CFR Part 46 may still have relevance.

    1. Response from the author:
      —————————
      Hobart states: “The FDA said it ‘approved’ a COVID-19 ‘vaccine,’” (Emphasis added), citing an FDA August 23, 2021 press release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. The FDA has “said” a lot of things.

      The August 23, 2021 press release date coincides with the date of the FDA letter granting the “Biologics License Application” previously discussed. While that letter may “imply” approval of the “vaccine,” it does not directly grant approval. And if full approval has been granted, why does the press release also state that although the application was granted “Priority Review,” such a grant “does not affect the length of the clinical trial period?” (Emphasis added)

      Indeed, if a “vaccine” has been “approved,” why is there any remaining “clinical trial period” at all? And if the “clinical trial period” is to continue into 2023, has a purportedly “final approval” been prematurely issued?

      The FDA press release also states that “FDA scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine.” (Emphasis added) How that claim can be rationally squared with the August 23, 2021 “BLA Approval” admission that “[w]e did not refer your application to the Vaccines and Related Biological Products Advisory Committee” (“VRBPAC”) remains obscure.

      The VRBPAC “reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases….” (Vaccines and Related Biological Products Advisory Committee | FDA). The phrase “incredibly thorough” is difficult to reconcile with the admission that the BLA application was not submitted to the specific office within the FDA charged with reviewing and evaluating data concerning the safety, effectiveness and appropriate use of vaccines, i.e., the VRBPAC.

      Against this collective factual backdrop, one might be tempted to surmise that the BLA license application was not submitted to the VRBPAC – the very committee organized and charged with evaluating the “safety, effectiveness and appropriate use of vaccines” – for other, undisclosed reasons.

      Hobart also states that: “[t]he FDA is not a ‘Common Rule’ agency,” linking to: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.

      While true that the FDA “is not considered [to be] a Common Rule agency because its regulations differ from the Common Rule…,” (Emphasis added), it is clear that the FDA “is required to harmonize with the Common Rule whenever permitted by law (see section 1002 of the 21st Century Cures Act, Public Law 114-255).” (Emphasis added). Section 1002 of Pub. L. 114-255 relates to the funding of “FDA Innovation Projects.” What those have to do with C-19 issues also remains obscure, but that opacity aside, whenever “permitted by law,” the FDA “is required to harmonize with the Common Rule.” (Emphasis added)

      Accordingly, the skepticism of the “COVID Revealed” docu-series interviewees seems, again, to be something less than altogether unwarranted.

      1. The FDA said it “approved” a COVID-19 “vaccine.” Pfizer said the FDA “approved” its COVID-19 “vaccine.” It is curious to suggest both the donor and the receiver of this approval are wrong about this basic fact.

        Especially when relying on incorrect bases such as the Nuremberg Code (not the law), the Belmont Report (not the law), or the Common Agency rule (not a law applicable to FDA).

        Doubly so when failing to specify exactly who is conducting a human experiment.

        1. The FDA is legally obligated to comply with FOIA, and that includes exceptions to disclosure written into FOIA.

          If you are unhappy that FOIA mandates exceptions to disclosure, then lobby to have FOIA’s exceptions eliminated.

          Complaints that the FDA is complying with FOIA’s requirements aren’t serious.