CORONA New rule may allow Covid shot given w/o patient knowledge / approval

[Countrymouse]

This is another post made on the long Covid thread, but a NEW one that I think most members would like to know about:


ht tps: // ww w. federal register. gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
(fair use applies) DELIBERATELY BROKEN LINK

EXCERPT (I only posted the summary - the entire piece is at the link)


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.


Publication Date:

12/21/2023


AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.

DATES:

This rule is effective January 22, 2024.

(original post link: CORONA - Main Coronavirus thread)

 

[Blacknarwhal]

Huh.

Well, then, I guess the original theories floating around about the corona shot damning you to hell forever by changing your DNA and making you no longer technically human can't apply, then.

 

[psychgirl]

Huh.

Well, then, I guess the original theories floating around about the corona shot damning you to hell forever by changing your DNA and making you no longer technically human can't apply, then.

They’re covering their tracks as fast as they can.

 

[Countrymouse]

Well, it makes sense. They have declared it "safe and effective"; therefore it "poses no more than minimal risk to the human subject" and thus they don't have to ask permission or notify the patient they're giving it.

I'm thinking of this applying to someone who's entering the hospital for some other purpose--not sick with covid but maybe for some surgery or other. Patient and relatives sitting with them see nurses / orderlies / other hospital staff go in/out all day long doing this/that/the other to their IV bags and tubes---they would have no idea what is being put into them unless they ask. I think of them even coming in when the patient is asleep, or already put under for a procedure, and administering this to them. And if Heliobas Disciple (and others who've read his post) are reading this right--this waives their having to inform them that they are doing so.

 

[Sacajawea]

So what constitutes an FDA-regulated minimal risk clinical investigation?

A physical exam??
A trauma initiated ER visit?
WHAT?

 

[Southside]

Well, it makes sense. They have declared it "safe and effective"; therefore it "poses no more than minimal risk to the human subject" and thus they don't have to ask permission or notify the patient they're giving it.

I'm thinking of this applying to someone who's entering the hospital for some other purpose--not sick with covid but maybe for some surgery or other. Patient and relatives sitting with them see nurses / orderlies / other hospital staff go in/out all day long doing this/that/the other to their IV bags and tubes---they would have no idea what is being put into them unless they ask. I think of them even coming in when the patient is asleep, or already put under for a procedure, and administering this to them. And if Heliobas Disciple (and others who've read his post) are reading this right--this waives their having to inform them that they are doing so.

Any time my DW or I go into the hospital, we write DIRECTLY ON THE ADMISSION PAPERS that they are expressly forbidden to give the Covid 19 vax, or ANY OTHER vaccine without written permission.

We have each gone into the hospital once since 2020

 

[bbbuddy]

Any time my DW or I go into the hospital, we write DIRECTLY ON THE ADMISSION PAPERS that they are expressly forbidden to give the Covid 19 vax, or ANY OTHER vaccine without written permission.

We have each gone into the hospital once since 2020

This is a great idea but you might want to amend it to include all shots that may contain mrna because they have been talking adding it to "other than vaccines"....

 

[bassgirl]

Well, it makes sense. They have declared it "safe and effective"; therefore it "poses no more than minimal risk to the human subject" and thus they don't have to ask permission or notify the patient they're giving it.

I'm thinking of this applying to someone who's entering the hospital for some other purpose--not sick with covid but maybe for some surgery or other. Patient and relatives sitting with them see nurses / orderlies / other hospital staff go in/out all day long doing this/that/the other to their IV bags and tubes---they would have no idea what is being put into them unless they ask. I think of them even coming in when the patient is asleep, or already put under for a procedure, and administering this to them. And if Heliobas Disciple (and others who've read his post) are reading this right--this waives their having to inform them that they are doing so.

Anything a Hospital does to you has to use informed consent. I find it interesting that this one thing they are allowed to get by with. This is getting beyond crazy.

The only thing I am aware of that does not require informed consent is an emergency (surgery or blood products) that are required to save your life. And they assume you are ok with it because you arrived by ambulance, or brought in by someone else who assumed you needed care. In other words, you showed up so that means you wanted the treatment.

In fact if you are a DNR or Hospice pt and you call the ambulance it negates your DNR and Hospice wishes. Why? Because you called- therefore you want help. At least that is the rational behind it.

 

[dstraito]

Attempted MURDER is what it is

 

[aznurse]

As an RN I will not administer any medication without consent. It is considered battery to administer without consent.

 

[desertvet2]

And ...the battery WILL be returned to those responsible... one way or another.

 

[Kris Gandillon]

Who or what is conflating an “investigation” with an “injection?”

I believe that is quite a stretch.

 

[Barry Natchitoches]

As an RN I will not administer any medication without consent. It is considered battery to administer without consent.

I just had both knees replaced a few months ago. I spent four days in the hospital and another two weeks in a rehab unit.

I feel very sure that they did NOT administer the clot shot to me during that visit.

However, they administered all kinds of other drugs into me during that time. Especially in the four days I was inpatient in the hospital itself.

I guess I gave a blanket consent, because my IV bag stayed full of who knows what drugs. Theoretically, they could have slipped just about anything into that bag, or into my arm. How would I have known?

This proposed legislation concerns me, because they could assume “implied consent” in the future, and inject that “harmless” poison into my body without me even knowing.

Worse yet, my wife gets chemo for her cancer. It was a constant fight with the folks at the cancer clinic last time to keep them from shooting that poison into her arm. Major pressure and even guilt trips were applied on both of us. The only thing that protected her was that law that allows a patient to refuse a specific treatment.

This legislation, if it passes, removes the last protection that my wife had, to keep the clot shot outbof her body.

 

[Housecarl]

So much for the Helsinki Declaration and the Nuremberg Codes.....

 

[night driver]

If it is an IRB making the determination, you are discussing a RESEARCH INVESTIGATION.

Has basically f*ck-all to do with general administration of any meds, even mRNA based meds.

 

[Tristan]

Any time my DW or I go into the hospital, we write DIRECTLY ON THE ADMISSION PAPERS that they are expressly forbidden to give the Covid 19 vax, or ANY OTHER vaccine without written permission.

We have each gone into the hospital once since 2020

This is a new rule, and apparently is to allow for the administration of such all neat-and-legal.

As I have posted, way back when, they're determined to get that shit in you, somehow.

I guess I gave a blanket consent, because my IV bag stayed full of who knows what drugs. Theoretically, they could have slipped just about anything into that bag, or into my arm. How would I have known?

How, indeed?

This proposed legislation concerns me, because they could assume “implied consent” in the future, and inject that “harmless” poison into my body without me even knowing.

Worse yet, my wife gets chemo for her cancer. It was a constant fight with the folks at the cancer clinic last time to keep them from shooting that poison into her arm. Major pressure and even guilt trips were applied on both of us. The only thing that protected her was that law that allows a patient to refuse a specific treatment.

This legislation, if it passes, removes the last protection that my wife had, to keep the clot shot outbof her body.

Not legislation, a 'Rule'. A Rule amending current Regulations.

 

[Reasonable Rascal]

Anything a Hospital does to you has to use informed consent. I find it interesting that this one thing they are allowed to get by with. This is getting beyond crazy.

The only thing I am aware of that does not require informed consent is an emergency (surgery or blood products) that are required to save your life. And they assume you are ok with it because you arrived by ambulance, or brought in by someone else who assumed you needed care. In other words, you showed up so that means you wanted the treatment.

In fact if you are a DNR or Hospice pt and you call the ambulance it negates your DNR and Hospice wishes. Why? Because you called- therefore you want help. At least that is the rational behind it.

It negates things as far as EMS in concerned because they are not there to watch you die or to provide hospice care. Calling EMS instead of the medical examiner is generally considered permission for treatment. Of course if you are truly deceased the Triple Zero protocol comes into play. Once you reach the hospital other rules come in to effect. But a verbal directive by someone other than the patient themself is not enforceable. Nor is a written directive sitting in your PC's office 100 miles away. Have had that one tried several times. It is akin to telling the nice officer you have valid car insurance without any proof.

The best one was the guy who presented to the ER, loudly proclaimed to the receptionist that he was DNR, and collapsed. Yeah, he was trying to suicide. Didn't work. Ended up with an intraosseous IV and saved. Being in CA though he was just directed to seek OP mental health counseling after discharge.

RR

 

[Southside]

This is a new rule, and apparently is to allow for the administration of such all neat-and-legal.

As I have posted, way back when, they're determined to get that shit in you, somehow.

Better never happen to me or my loved ones. Someone will pay, and I do not think their families will be comfortable with the price.

 

[FireDance]

As an RN I will not administer any medication without consent. It is considered battery to administer without consent.

Correct. So, the mind asks “how do they get around this little rule?”

I’m not going to speculate, because it’s probably not productive. But you do have to wonder. ???

 

[SSTemplar]

Bullshit. THEY can kiss my ass.

 

[Tristan]

Better never happen to me or my loved ones. Someone will pay, and I do not think their families will be comfortable with the price.

Honestly, not trying to goad you; but how would you know?

 

[Heliobas Disciple]

This is another post made by HD on the long Covid thread, but a NEW one that I think most members would like to know about:


ht tps: // ww w. federal register. gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
(fair use applies) DELIBERATELY BROKEN LINK

EXCERPT (I only posted the summary - the entire piece is at the link)

BOLDING MINE (HD's)


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.


Publication Date:

12/21/2023


AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.

DATES:

This rule is effective January 22, 2024.

(original post link: CORONA - Main Coronavirus thread)

ETA: thank you to the mod who changed the title.

This was my response on the covid thread to this discussion there:

No, it does not meant they can give you the covid shot without telling you they are giving it.

It doesn't say that anywhere.

This is for CLINICAL INVESTIGATIONS.

It's a horrible horrible rule. Informed consent should ALWAYS be given. No matter what. Informed consent should never be allowed, under any circumstance whatsoever, to be waived. It sets a horrible precedent and leaves open taking it away in the future for other reasons. That was what the alarm was about.

BUT THIS HAS NOTHING TO DO WITH GIVING SOMEONE A COVID SHOT WITHOUT THEIR PERMISSION.

HD

ETA: see follow up post below. The original vaxx was already given without informed consent! But actual consent had to be given; ie: they couldn't stick anything in your arm without your allowing it, (so far) no forced vaccines are allowed. This rule doesn't change anything having to do with the covid vaxx, that already happened. The alarm is that they will now do this going forward - skip informed consent if it follows their new rule change.

 

[Publius]

No my body my rules.
Law or no law they have given you a death sentence you may act in your own defense! Long ago when AIDs was reported ramped and in New York city one gay guy had unprotected sex with another gay guy and told the other afterwards that he had aids, the other guy went off on the other for having infected him like that and killed him, it went to trial and he got off as the jury seen it as an act of self defense.

 

[JMG91]

Any time my DW or I go into the hospital, we write DIRECTLY ON THE ADMISSION PAPERS that they are expressly forbidden to give the Covid 19 vax, or ANY OTHER vaccine without written permission.

We have each gone into the hospital once since 2020

That’s a good idea. I’ll keep that in mind.

 

[Countrymouse]

CM,

Please change the title of this thread. I never said that this rule applies to the covid vaccine. You falsely attributed to me something I never said or meant to say and then made a thread out of it. ?????? If you interpret this rule to be applicable to the covid vaccine, that's fine, and I don't mind you starting a thread about whatever you believe, but I never said that, I don't believe that, so I don't want my name attached implying I said it or believe it.

The questioned about what the rule meant was posed on the long Covid thread and I didn't get a chance to answer it, as I wasn't on TB when it was asked, which I will answer on that thread, where I posted it and meant for it to be discussed.

ADMIN: I'd like the subject name of this thread changed so my name is not associated with it (as I never said this and I believe it is incorrect to boot).

Thank you,
HD

ETA: thank you to the mod who changed the title.

This was my response on the covid thread to this discussion there:

No, it does not meant they can give you the covid shot without telling you they are giving it.

It doesn't say that anywhere.

This is for CLINICAL INVESTIGATIONS ONLY. testing. etc.

It's a horrible horrible rule. Informed consent should ALWAYS be given. No matter what. Informed consent should never be allowed, under any circumstance whatsoever, to be waived. It sets a horrible precedent and leaves open taking it away in the future for other reasons. That was what the alarm was about.

BUT THIS HAS NOTHING TO DO WITH GIVING SOMEONE A COVID SHOT WITHOUT THEIR PERMISSION.

HD

I'll just ask a mod to close the thread. Thanks for the clarification, HD.

 

[Coulter]

Huh.

Well, then, I guess the original theories floating around about the corona shot damning you to hell forever by changing your DNA and making you no longer technically human can't apply, then.

Are you suggesting that this shot will turn them in to a Nephilim?

I'd like to hear what LA Marzulli has to say about this.

Nephilim's were the cause of Noah's flood.

 

[Blacknarwhal]

Are you suggesting that this shot will turn them in to a Nephilim?

I'd like to hear what LA Marzulli has to say about this.

Nephilim's were the cause of Noah's flood.

The idea, at the time, was it makes you non-human. It changes your DNA, apparently, to where you no longer classify as human and therefore out of God's plan of salvation. It's shaky logic at best and certainly can't be proven true. Actually, I would think that, if that were the case, you would be classified the same as an animal and obliterated upon death, which would be a mercy compared to hell.

 

[Countrymouse]

I've messaged the mod on duty--Kathy in FL--

Hopefully she'll see it soon and can close the thread.

Thanks all.

 

[Heliobas Disciple]

I've messaged the mod on duty--Kathy in FL--

Hopefully she'll see it soon and can close the thread.

Thanks all.

It doesn't have to be closed, it's an interesting discussion. The subject line was changed, that is good enough for me!

 

[Heliobas Disciple]

Slight correction because it's important.

Keep in mind that INFORMED CONSENT is not the same thing as CONSENT. No one can give you a shot (right now) without your consent, although technically for the covid vaxx it didn't need to be 'informed'.

Because in fact, the EUA of the vaccines given in 2020 said they were not subject to informed consent requirements! I kind of remembered that so did some research to confirm it. So this rule doesn't change anything re: the vaxx, it was already given without 'technical' informed consent. (it was given with a fact sheet instead).

From: https://www.nejm.org/doi/full/10.1056/NEJMp2031373
EXCERPT

Use of an investigational vaccine under an EUA would not be subject to the usual informed consent requirements for clinical investigations; nevertheless, vaccine recipients will be provided a fact sheet that describes the investigational nature of the product, the known and potential benefits and risks, available alternatives, and the option to refuse vaccination. To minimize the risk that use of a vaccine under an EUA will interfere with long-term assessment of safety and efficacy in ongoing trials, it will be essential to continue to gather data about the vaccine even after it is made available under the EUA. Continued follow-up of clinical trial participants to further refine efficacy estimates, further evaluate the potential for enhanced disease and waning of immunity, and obtain additional active safety follow-up will be essential in order to ensure public confidence in a broadly administered vaccine. The quality of the data available to inform ongoing assessment of a vaccine’s benefits and risks will depend on the ability to continue evaluating the vaccine against a placebo comparator in clinical trials for as long as feasible. Moreover, evaluation of other potentially superior vaccines will depend on the ability to continue to maintain placebo controls in ongoing trials. Thus, issuance of an EUA should not, in and of itself, require unblinding of a Covid-19 vaccine trial and immediate vaccination of placebo recipients, since doing so may jeopardize approval of these products.​

​

​

and​

​

Emergency Use Authorization for Vaccines Explained

FDA explains the Emergency Use Authorization for Vaccines

www.fda.gov

EXCERPT​

​

How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?​

FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website.​

​

​

What this rule does is codify what was done with the vaxx for future uses and make it 'air tight'. But again, no one can force you to take a vaccine based on this rule. INFORMED consent is something completely different than actual consent. You can consent without being totally informed as to what you are consenting to.​

 

[Countrymouse]

Thanks, HB. If y'all are cool with it, I am!

 

[tnphil]

The idea, at the time, was it makes you non-human. It changes your DNA, apparently, to where you no longer classify as human and therefore out of God's plan of salvation. It's shaky logic at best and certainly can't be proven true. Actually, I would think that, if that were the case, you would be classified the same as an animal and obliterated upon death, which would be a mercy compared to hell.

If God made you a "human", and He is all-powerful, neither the works of man, demons or angels can ever change that. To say otherwise is to deny God.

 

[Blacknarwhal]

If God made you a "human", and He is all-powerful, neither the works of man, demons or angels can ever change that. To say otherwise is to deny God.

Well, that's about what I figured. That's why all I said was that was what other people were saying.

 

[tnphil]

Well, that's about what I figured. That's why all I said was that was what other people were saying.

Oh I get that. Just commenting. Some Christians apparently believe in an all-powerful God whose will can be usurped by lesser beings.
The clot-shot was (most likely) not the "mark". But it's a darn good prototype.

 

[Zardoz]

Apologies in advance. I did NOT read all the comments. But this thread brings up some serious concerns for those who want control over their lives. Talked at length with my wife about this possibility, because we are old. We rarely go into the Hospital, but from this point forward, we intend to be more proactive about what "they" can do to us. Yes, I am ready to make a scene at the hospital about our care. FAFO..

 

[lojoma]

Well it’s not a far cry from Covid jabs since due to the EUA, everyone was a test subject except for those who resisted and were the controls.

 

[Bad Hand]

Our own Government is our #1enemy.

 

[BUBBAHOTEPT]

Who or what is conflating an “investigation” with an “injection?”

I believe that is quite a stretch.

It’s 2024 not 2004. Think about it….

 

[DazedandConfused]

My return shot i give them will be less painful. They will not feel a thing.

 

[Heliobas Disciple]

There are many people who if the tv tells them to go get a shot or a booster, they will go get a shot or a booster. Especially if there is a future pandemic that they are told is even deadlier than covid. If that shot or booster falls under the same Emergency Use definition as the Covid shots fell under, thanks to this rule spelling it out, there will no longer be any question or discussion as to whether or not informed consent need to be given before the shot is administered. They will give the shots and not require that the consent of the injectee be informed. There have been many good doctors who have been arguing that informed consent was necessary for the covid shot and not requiring it was illegal and immoral. That will no longer be the case as for legality. It will still be immoral imho.

HD