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David E. Martin: Informed Consent: You'Re A Lab Rat

The document discusses informed consent requirements for human subjects research under U.S. federal regulations. It notes that during declared emergencies, the medical industry is exempted from liability for injuries caused by experimental medical countermeasures. It discusses a Supreme Court case, U.S. v. Stanley, regarding a soldier who was subjected to secret human experimentation without consent. The document urges readers that they can take action by filing a claim with the Department of Health and Human Services.

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122 views

David E. Martin: Informed Consent: You'Re A Lab Rat

The document discusses informed consent requirements for human subjects research under U.S. federal regulations. It notes that during declared emergencies, the medical industry is exempted from liability for injuries caused by experimental medical countermeasures. It discusses a Supreme Court case, U.S. v. Stanley, regarding a soldier who was subjected to secret human experimentation without consent. The document urges readers that they can take action by filing a claim with the Department of Health and Human Services.

Uploaded by

Alberto
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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David E.

Martin
Speaker, Author, Fully Human

Informed Consent:
YOU’RE A LAB
‘Butterfly’ of the Week: RAT…
www.davidmartin.world
Rules on Informed Consent

• 21 Code of Federal Regulations


• §50.20 – Except as provided in 50.23 and
50.24, no investigator may involve a human
being as a subject in research covered by these
regulations unless the investigator has
Relevant Laws: obtained the legally effective informed
consent of the subject or the subject's legally
authorized representative.
• §50.23 – waiver for DOD and in “emergency”
• §50.24 – suspended “with the concurrence of a
licensed physician who is a member of or
consultant to the IRB and who is not otherwise
participating in the clinical investigation”
Why This Matters
• During “declared emergencies”, the medical industry is exempted
from liability: “provide liability immunity to certain individuals and entities
(Covered Persons) against any claim of loss caused by, arising out of, relating to,
or resulting from the manufacture, distribution, administration, or use of medical
countermeasures (Covered Countermeasures), except for claims involving “willful
misconduct” as defined in the PREP Act.”
https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-
emergency-preparedness-act-for-medical-countermeasures

• A must read… When Human Experimentation is Criminal by L. Song


Richardson https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=7314&context=jclc
The Case… U.S. v. Stanley, 479 U.S. 1005 (1986)
• Justice Brennan - The Court confers absolute immunity from money damages on federal officials
(military and civilian alike) without consideration of longstanding case law establishing the
general rule that such officials are liable for damages caused by their intentional violations of
well-established constitutional rights.

• Justice O’Connor - No judicially crafted rule should insulate from liability the involuntary and
unknowing human experimentation alleged to have occurred in this case. Indeed, as JUSTICE
BRENNAN observes, the United States military played an instrumental role in the criminal
prosecution of Nazi officials who experimented with human subjects during the Second World War,
ante, at 687, and the standards that the Nuremberg Military Tribunals developed to judge the
behavior of the defendants stated that the "voluntary consent of the human subject is absolutely
essential . . . to satisfy moral, ethical and legal concepts." United States v. Brandt (The Medical
Case), 2 Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council
Law No. 10, p. 181 (1949). If this principle is violated the very least that society can do is to see
that the victims are compensated, as best they can be, by the perpetrators. I am prepared to say
that our Constitution's promise of due process of law guarantees this much. Accordingly, I would
permit James Stanley's Bivens action to go forward, and I therefore dissent.
https://biotech.law.lsu.edu/cases/research/stanley.htm
You can take action

US Department of Health and Human Services


Office of the General Counsel
200 Independence Ave. S.W.
Washington, D.C. 20201

https://www.aoc.gov/sites/default/files/pdf/TortFormSF95.pdf

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