Medical Malpractice for a Failure to Obtain Informed Consent
A failure to obtain informed consent can create substantial liability for a physician or practice, including a lawsuit which alleges that the provider failed to obtain legally sufficient informed consent – a form of medical malpractice in many jurisdictions.
In the realm of healthcare laws, a patient’s right to be informed of the risks of treatment might be compared to a criminal defendant’s Miranda rights (“you have the right to remain silent…”). A practice that forgoes this necessary pre-treatment discussion will almost certainly find itself embroiled in civil action. A proper informed consent discussion might include these elements:
An explanation of the patient’s diagnosis and prognosis;
The nature of each of the available treatment options;
The anticipated risks and benefits of each available treatment option;
Any potential alternative treatment options;
The potential risks and benefits of alternative treatment options;
The risks and benefits of refusing treatment.
§ 46.116 General requirements for informed consent.
(a)(1) Before 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.
Anyone thinking that efficacy studies have completed, aren't paying attention. We are in the human trial phase, with 2% of the US population.
(a)(5)(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(a)(5)(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
National Vaccine Injury Compensation Program
Here are the Vaccines that are listed on the G'ments website:
mRNA Rona vaccines not listed... anyone able to find a source that says the VICP covers the untested Rona vaccine?
Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19
Lot to read. I did a quick search for 'consent', not present.
The summary article I read to find this indicated that the manufacturers were protected. Will read this in more detail... but protecting the manufacturers is not the same as protecting Hospitals from informed consent.
This is the law governing the immunity from prosecution
Public Readiness and Emergency Preparedness Act
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:
I don't see where it's saying that informed consent is not required.
COVID PREP Declaration
still no exceptions for informed consent...
I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.
Not a recommendation to skip informed consent...
The PREP Act has an exception for immunity from lawsuits as "willful misconduct". So, what is that?
Examples of willful misconduct may include a deliberate violation of safe medical procedures, making conscious medical choices that would veer from standard care and purposefully causing harm to a patient without regard for the outcome.
So... you mean like not obtaining informed consent of a human vaccine trial, while ignoring alternatives that are available?
Declaration to 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. Under the PREP Act, a Declaration may be amended as circumstances warrant.
Note the exception
OK, so maybe clinical trials are completed...?
No large trials of any mRNA vaccine have been completed yet.
The only evidence on safety of mRNA vaccines comes from small phase I and phase II trials of SARS-CoV-2 vaccines, with follow-up typically less than two months.
Severe systemic adverse events were reported by 5 to 10 percent of trial subjects.
Larger trials of SARS-CoV-2 vaccines are in progress, with results expected in mid-2021
This Vaccine stuff it's all just Big Pharma's fault right?
One local RN said she was recruited to do COVID-19 vaccinations at a rate of $70 an hour for a 40-hour week plus a stipend of $2,200 for a total of $5,000 a week. But she said she met other nurses at an orientation session and some said they would be pulling down $11,000 a week.
... That's a Registered Nurse ...
How's lockdown treating you?
Not a single COVID-19 Vaccine is finished with Phase 3 trials.
The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)
"must occur" ... is it occurring?
Conover said it looks like the pharmaceutical giant will charge the government around $39 for a two-dose treatment based on Pfizer’s contract with the U.S., and it will cost around $15 to manufacture. However, he noted that the company still has to factor in distribution, marketing and admin costs.
so prior to distribution, marketing and admin costs that is a 62% gross margin.
Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease
"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."
Here is Dr. Vladimir Zelenko's website where he has published his #COVID19 protocols. HCQ and/or Ivermectin along with Zinc, Vitamin C, Vitamin D3.
English version other language versions available from first link.
Just another coincidence. Move along slaves.
In a spectacular plot-in-the-real-world coincidence, this episode derives its plot from an airborne virus distributed by contact with an airline hostess from a Chinese flight. Virus compared by medical officials to a "coronavirus" and SARS-like. This plot of 2002 predates the global pandemic of 2020, with a theory of chloroquine as a treatment.
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