by Joseph DeMaio, ©2021

https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf

(Dec. 16, 2021) — On occasion, interested individuals will offer comments on your humble servant’s P&E postings.  Normally, a response to such comments would appear in the comments section following the post.  In other situations, a more thorough response will take the form of a longer, follow-up formal post. 

Such is the case with regard to the 12:48 PM, 12/15/21 comment of one Garret Hobart – presumably no relation to former Vice-President Garret Hobart in the administration of President William McKinley – received and posted here.

Hobart asserts in his comment: “Neither the Nuremberg Code nor the Belmont Report is the law, so any perceived or imagined violation of them has no legal consequence.”  That assertion merits closer examination.

Both the Nuremberg Code of 1947 and the Belmont Report, while mentioned in the “Pandemic of the Mendacious” post, are discussed in more detail here.  

Both documents, in turn, constitute the conceptual underpinnings of Title 45, Part 46 of the Code of Federal Regulations.  Mr. Hobart’s asserted fact that the Nuremberg Code and the Belmont Report have not been “codified” in the United States does not mean that their principles and ethical protocols, as incorporated and articulated in the Code of Federal Regulations (“CFR”), import “no legal consequence” for their violation.  Indeed, just the opposite is true.

The provisions of 45 CFR Part 46 governing the “Federal Policy for the Protection of Human Subjects” were published, following public comment, in the Federal Register on Jan. 19, 2017, 82 FR 7149, and effective Jan. 19, 2018.  

Once an agency rule has been opened to public comment and published as a “final rule” in the Federal Register, under Supreme Court precedent it is accorded the “force and effect of law.”  See Perez v. Mortgage Banker’s Association, 575 U.S. 92, 96 (2015), citing Chrysler Corp. v. Brown, 441 U.S. 281, 302-303 (1979).  In fact, as noted by Justice Sotomayor in Perez, such properly noticed and finalized rules are frequently referred to as “legislative rules” and “have the force and effect of law.”  Perez, 575 U.S. at 96.

Because the rules comprising the regulations articulating the federal policy for the protection of human subjects were opened up to public comment – originally in 2011 and again in 2015, it is clear that the final rules are legislative rules rather than merely “interpretive rules” which are not normally accorded the same “force and effect of law” stature of the former.  See Perez at 96.  

That the rules in question were opened to public comment cannot be disputed, since the Executive Summary of the “final rule” confirms: “Public comments on both the ANPRM [i.e., Advance Notice of Proposed Rulemaking] and the NPRM [i.e., Notice of Proposed Rulemaking] have informed the final rule that is now being promulgated.”  See 82 FR at 7150.

Accordingly, turning to the principles underpinning the final rules here at issue regarding Mr. Hobart’s comment, the Belmont Report categorically states: “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).  The Goofball’s edict to OSHA to threaten employers of more than 100 employees to “get jabbed” or “get fired” seems suspect.

In this regard, 45 CFR, Part 46, § 46.101(a) mandates its application 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.” (Emphasis added)  Moreover, 45 CFR, Part 46, § 46.101(c) 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).  Again, the Goofball’s OSHA edict is now intubated.

Finally, 45 CFR, Part 46, § 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.”

Collectively, these restrictive CFR mandates – having the “force and effect of law” as “legislative rules” under controlling U.S. Supreme Court decisions – are violated by concealment of applicability or any coerced requirement that an unwilling human subject submit to being vaccinated with an experimental fluid or risk punitive sanctions, whether in the form of loss of vested benefits, loss of employment or consequential quarantine.  That is the plain language and plain import of the regulations.  Arguments to the contrary are fatuous…, and misinformed.

Against this backdrop, Mr. Hobart – or anyone else of a similar mindset, including the Goofball at 1600 or his marionette-masters – is invited to explain why “any perceived or imagined violation of … [the CFR rules] has no legal consequence.” 

Your humble servant will wait.

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  1. It is undisputed that violating the CFR rules could have legal consequences, notwithstanding this belated acknowledgement that the Belmont Report is not the actual law.

    And it is undisputed the concepts articulated in the Belmont Report (and Nuremberg Code) informed the language actually codified in the CFR. Even if this article continues not to cite the CFR rules applicable to the FDA.

    But the extensive passive voice continues to obfuscate exactly which investigator (as that term defined by the applicable CFR rules) is conducting exactly which experiment (as that term defined by the applicable CFR rules) on exactly which subject (as that term is defined by the applicable CFR rules).

    1. Nuremberg judges’ question to Nuremberg military prisoner: “What have you got to say for yourself before we pass judgment of hanging on you”?

      Nuremberg military prisoner response to Nuremberg judges: “There were no posted laws prohibiting what I did against humanity; besides, I was just following orders.

        1. Do we celebrate the written word or do celebrate the “spirit of the law?”
          I contend that we live by the latter.

          Professor ‘Trash the masks’ Zorkophsky

    2. Unfortunately, the Biden-Harris Administration is not a figment of an insane person’s imagination: it is real, and only real by the refusal of the Joint Chiefs of Staff that allowed an insurrection to occur because they are just as corrupt as the DOJ, FBI, and the Fake News in pushing the Deep State’s agenda, which is to turn the USA into a Third World Puppet Nation with China as the Master, although the Islamic faction may have something to say about the final outcome.
      Suffice to say that the USA is up for grabs, and as long as Biden, Pelosi, Schumer, and all the other idiots that are in The Swamp, we’ll get naysayers who will willingly allow the child molester to walk out of the courtroom because Joeseph didn’t precisely place the dot above the ‘I’.
      Face it, the Nurenberg conclusions have stood the test of time and no amount of careless nitpicking will change the facts at any time on any level.

      OPOVV

    3. From the author:
      ———————-
      Hobart misapprehends the role of the Nuremberg Code and the Belmont Report. It has never been argued that either document was codified as a statute by the U.S. Congress, so the suggestion that there has been a “belated acknowledgment that the Belmont Report is not the actual law” is something of a straw-man non sequitur.

      Moreover, the assertion that there is no citation to “the CFR rules applicable to the FDA” is similarly flawed. Title 45 CFR, Part 46, § 46.101(a) mandates its application 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.” (Emphasis added)

      The Hobart comment disregards the plain English words “all” and “any” in the CFR regulation. If there is a specific different CFR “legislative rule” which excludes the FDA from the application of Title 45 CFR, Part 46, § 46.101(a), your humble servant awaits its citation.

      Finally, the use of the term “obfuscate” in the final paragraph of the comment is amusingly ironic, given the balance of the sentence.

      Still waiting.

      1. Repeated articles have made vague accusations of violating the Nuremberg Code. Which is legally impossible because that code was never codified into law. A serious inquiry would focus on the actual law, and not rely on ill-informed allusions to the Holocaust.

        The Department of Health and Human Services has said the FDA isn’t a common rule agency and therefore not subject to the common rule’s regulations:
        https://www.hhs.gov/ohrp/regulations-and-policy/regulations/fda/index.html

        The department also has specified where the FDA’s regulations are located:
        https://www.hhs.gov/ohrp/regulations-and-policy/regulations/fda/index.html

        Surely the department has a better understanding of the regulations than a dilettante.

        Regardless, there’s no indication that anyone with oversight over the vaccines believes there has been any violation of any regulation.

        Still waiting for some specification as exactly which investigator is running exactly which experiment on exactly which subject.

        1. Response from Joseph DeMaio:
          ———————-
          One could posit – hypothetically, of course – that individuals who offer up incomplete sentences in an effort to articulate complete, rational thoughts are either grammatically challenged or may be “grammatical dilettantes”…, if one were so inclined.

          That issue aside, while the FDA may be “considered” a non-Common Rule agency, its parent department – the Department of Health and Human Services – is a Common Rule signatory. Moreover, as discussed in the comments here (Vax Mandates, the “Common Rule,” the Belmont Report and Brandon – The Post & Email (thepostemail.com)), the FDA is nonetheless “required to harmonize with the Common Rule whenever permitted by law.” (Federal Policy for the Protection of Human Subjects (‘Common Rule’) | HHS.gov).

          Apart from the “informed consent” required of all “non-excepted” human clinical trial experimental subjects prior to the Aug. 23, 2021 FDA letter approving the “license application” for the Pfizer fluid “Comirnaty” (August 23, 2021 Approval Letter – Comirnaty (fda.gov)), if the clinical trials regarding the fluid are still underway – a matter confirmed in the FDA letter – by what authority does the FDA, consistent with its obligation to “harmonize” its actions with the Common Rule – in turn, a product of the Belmont Report (Read the Belmont Report | HHS.gov) – sanction and ratify the mass vaccination of persons who remain, in effect, “human subjects” of the continuing clinical trials scheduled to end years in the future when viewed against the backdrop of the FDA’s acknowledgment of the fluid’s “known serious risks of myocarditis and pericarditis?” (Emphasis added). See FDA Aug. 23, 2021 “BLA” (Biologics License Application) letter at 6.

          While 21 CFR § 50.24 allows for “exceptions from informed consent requirements” for emergency research (eCFR :: 21 CFR 50.24 — Exception from informed consent requirements for emergency research.), none would seem to apply to individuals who “voluntarily” agree to submit to a vaccination mandate under the coercive threat of the loss of their employment.

          These and similar questions may be answered in the litigation now pending here (FDA Rep a No-Show at Court Hearing, Citing COVID Concerns; FDA Releases Additional Docs; and FDA Triples Down On 75-Year Production (substack.com)) and discussed here (The FDA’s 2096 FOIA Gambit – The Post & Email (thepostemail.com)). In the meantime, the continuing P&E comment exchanges – if not a source of outright giddy amusement – remain interesting.