Tag Archives: informed consent issues


THEY LIED TO US about the death rates saying they were 15%. Even by their grossly inflated numbers, they’re less than 0.1%
THEY LIED TO US about the need for hospital space. Most makeshift hospitals and the hospital ships saw little to ZERO patients. Most regular hospitals had more available beds than ever.
THEY LIED TO US about the spread of asymptomatic people. Asymptomatic people don’t spread it.
THEY LIED TO US about the severity. 80% of the people who have it don’t even know they were infected.
The deaths that do occur, just like the flu, – are limited to elderly people with serious adverse conditions to begin with. YOUNGER PEOPLE ALMOST NEVER DIE EVEN IF THEY HAVE CHRONIC DISABILITIES!!!
But yet the MANUFACTURED, Mass Hysteria Madness, – with poisonous/long lasting/hormone-disrupting/easily transferred sanitizers, oxygen depleting/immune system impairing/asthma triggering masks, uselessly inaccurate testing and tracking leading to medical kidnap IS RAMPING UP!
Why? Who benefits from steering everybody to the international globalist corporate stores, destroying the well-to-do middle-class and their employees? The Hidden Hand of The Illuminati that have been PLANNING THIS FOR YEARS, to force their products and HORRIFIC OTHER AGENDAS on you. Do you know that this plandemic ‘EVENT 201’ was put on by Bill Gates in October of 2019?!? Guess who else attended?!?
What’s the real cost to you, an absolutely essential worker to your family for the food on the table and paying the bills, regardless of what the government mischaracterizes you as?!? What’s the devastating cost to our way of life, with these insanities designed to manipulate us down?!?
The flu vaccine every year has one of the highest reported rates of LIFELONG CRIPPLING INJURIES AND FATALITIES!!! It also, often doesn’t work!!! Now they want to MANDATORILY INJECT EVERYONE WITH A SCANTILY RESEARCHED VxAxCxCxIxNxE THAT WILL CHANGE YOUR DNA!!! WHAT COULD POSSIBLY GO WRONG?!?
RESEARCH: Operation Paperclip, Operation Mockingbird, Rockefeller Lockstep, Agenda 21, Agenda 2030, Georgia Guidestones, DEAGEL DEPOPULATION FORECAST!!!
Behind the scenes, these are in full swing and progressing rapidly!!!
IS AMERICA FACING A COVID COLLAPSE? With America caught up in the politics of Masks Mandates and Life on Lockdown, Political Economist Toby Rogers, PhD, details a coming tsunami which could be a greater threat to America than Covid ever was. Is a Covid Collapse on the table for America?#CovidCollapse #Covid19 #Health #America #Covexit
A friend of mine got pneumonia. Her doctor would not give her a covid test saying the tests were inaccurate. Had she shown signs of covid he would have quarantined her and given her antibiotics, so why bother with a test. At the lab she had her blood drawn and they too would not give her a covid test saying the tests were inaccurate. COVID-19 TESTS ARE INACCURATE.
Planned Economic Collapse , The Great Reset Klaus Schwab , To bring in the Digital Dollar Social credit score card point system society Grass in your Neighbours to start with for Extra Digital Buck’s at the end of the Week.
Read Dr Marcia Angell’s “What the Drug Companies Don’t Want You to Know.” She was the head editor for the JAMA, for God’s sake, and wrote the best indictment of this medical-industrial complex ever in that book.
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The “Greatest Depression” has

The Worst is Yet to Come
Since the lockdowns began and millions lost their jobs, continually, Gerald Celente forecast there would be escalating crime and violence, warning,

“When people lose everything and have nothing left to lose, they lose it.”

Problem – Reaction – Solution = ” Hegelian Dialectic ”

The MSM fake jew propaganda machine is provoking fear and panic, leading to a Solution.

The Solution is more fake laws restricting our freedoms, rights and liberties, forced vaccinations, and the transition to a cashless system.



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Fake Fake Fake !

The famous motto of the Fake jew is : ” IF IT ISN’T THERE – WE WILL MAKE IT UP ” !!!!

One thing is for sure, there will be a second wave (phase 2 human experiment by the CDC, the WHO and Bill Gates Organizations) of fake coronavirus fear and hysteria. Are you mentally and physically prepared? Turn off the TV and ignore their demands or join Slavelandia.


Gerald Celente – https://trendsresearch.com/subscribe/

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Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

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BIMO Inspections – GCP Dilema

BIMO stands for Bioresearch Monitoring. The FDA releases each year, a list of findings for FDA-regulated product that may be in violation of the agency’s requirements. These inspections’ findings are listed on an FDA Form 483 by the inspector.

Last year, there were over 600 findings from different FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, and good laboratory practices).

For example, Findings related to Clinical investigators were:

  • Protocol deviations
  • Inadequate recordkeeping
  • failure to report AEs and informed consent issues
  • Among others…

Common IRB deficiencies were:

  • Inadequate SOPs
  • Subpart D issues
  • Inadequate communication with Clinical Investigator/institution
  • Among others…

The question we would ask ourselves… what have caused these type of findings? Not enough GCP training? Good clinical practice is mandatory for everyone involved in the conduct of clinical research.

The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). (2.8, E6 Guideline for Good Clinical Practice)

Form 483 Inspection findings

Observations Frequency of findings
Safety reports (adverse events reporting) 14
Informed consent – Failure to obtain informed consent in accordance with 21 CFR Part 50 from each subject prior to drug administration 23
Consent form not approved/signed/dated 13
protocol compliance 164

Additional information about findings and metrics can be found on the FDA website.

Need an ICH GCP refresher? Contact us and we can recommend a few e-learning training.

Source: Wikipedia Form 483 & BIMO

anayansi gamboa - GCP