Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

[Hugh Johnson]

Abstract​

Aims of the study: Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.

Methods used to conduct the study: Published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID-19 vaccines were reviewed to determine if risks were properly disclosed.

Results of the study: COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease - PubMed

The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical...

pubmed.ncbi.nlm.nih.gov

 

[Rick K]

Abstract​

Aims of the study: Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.

Methods used to conduct the study: Published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID-19 vaccines were reviewed to determine if risks were properly disclosed.

Results of the study: COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease - PubMed

The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical...

pubmed.ncbi.nlm.nih.gov

Amen, Hugh. I've heard so many people tell me that their doctor said "the vax is perfectly safe" and that was all the information they received and they didn't ask anything more. I've seen blank information sheets come out of the vax boxes. How can any doctor go through with this in good conscience?

 

[Peatness]

Abstract​

Aims of the study: Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.

Methods used to conduct the study: Published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID-19 vaccines were reviewed to determine if risks were properly disclosed.

Results of the study: COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease - PubMed

The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical...

pubmed.ncbi.nlm.nih.gov

I am really pleased to read this paper but sad that despite it governments are mandating experimental gene therapies as ‘vaccines’

Amen, Hugh. I've heard so many people tell me that their doctor said "the vax is perfectly safe" and that was all the information they received and they didn't ask anything more. I've seen blank information sheets come out of the vax boxes. How can any doctor go through with this in good conscience?

Something is seriously wrong. Why are doctors ignoring these warnings?

 

[Hugh Johnson]

I am really pleased to read this paper but sad that despite it governments are mandating experimental gene therapies as ‘vaccines’

Something is seriously wrong. Why are doctors ignoring these warnings?

It's not their job to think, just to follow orders.

 

[Peatness]

It's not their job to think, just to follow orders.

"Just following orders," history repeating itself. I don’t think it is far-fetched to evoke Nuremberg in this instance.

 

[Peatness]

How can the uninformed, legally inform consent?​

View: https://www.bitchute.com/video/I1jdBd1bG1pA/

 

[Rick K]

How can the uninformed, legally inform consent?​

View: https://www.bitchute.com/video/I1jdBd1bG1pA/

I don't think anyone in their "right mind" would ever choose these things if they really knew all the adverse affects. Kinda scary that they were calling people on the radio when she refused to take it.

 

[Ben.]

I don't think anyone in their "right mind" would ever choose these things if they really knew all the adverse affects. Kinda scary that they were calling people on the radio when she refused to take it.

Dont forget if they knew about the criminal, shady companys producing them, the interest conflict from all the people in politics and medical industry.

And lets not forget:

The publicly available data showing something else than what is communicated in media and from the medical "professionals".

 

[Peatness]

I don't think anyone in their "right mind" would ever choose these things if they really knew all the adverse affects. Kinda scary that they were calling people on the radio when she refused to take it.

That ‘vaccine’ centre is menacing, I was nervous for her.

 

[Apple]

That ‘vaccine’ centre is menacing, I was nervous for her.

How did you imagine ‘vaccine’ centre ? a walk in the Disneyland Park? :))

 

[Peatness]

How did you imagine ‘vaccine’ centre ? a walk in the Disneyland Park? :))

No, but I didn’t expect the atmosphere of a slaughter house

 

[Peatness]

I wanted to repost the article that starts this thread. As we move into the autumn/winter season the media might forget that they were warned about this but we should not forget it

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease - PubMed

The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical...

pubmed.ncbi.nlm.nih.gov

 

[Peatness]

21st Century Cures Act - Wikipedia

en.wikipedia.org

Informed consent​

In section 3024, the 21st Century Cures Act allows researchers to waive the requirement for "informed consent" in cases where clinical testing of drugs or devices "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."[12]

One example is a high-tech bandage that monitors blood flow. Standard procedure requires researchers to obtain the patient's permission before testing any new device on them. However in this example, researchers might want to test the bandage on unconscious patients. In such circumstances, researchers may waive an informed consent requirement since the patient is still getting the standard, medically accepted care of blood pressure and heart rate monitoring. Researchers would still need to obey standard research protocols including institutional review boards to approve their research design and ethics.[8]

 

[Peatness]

Covid-19 injections are experimental therapies being deployed under emergency use authorisation (EUA). They are not fully approved by any regulatory body and have not undergone the complete review process required for full approval. All individuals have certain inalienable rights: informed consent and bodily autonomy being two of them.

Informed Consent

by Abir Ballan | Informed consent is one of your basic human rights to freely accept (or not accept) a medical intervention, based on knowing the full risks, benefits, risks of not having it, and knowing your alternatives.

www.pandata.org

 

[Peatness]

View: https://twitter.com/RastaRedpill/status/1474291409113042955