An FDA rule that went into effect January 22 allows for individuals to be enrolled into medical experiments, referred to as clinical trials, as well as receive investigational drug treatments without first consenting to becoming a medical test subject. The process is now operational.
“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,” the Federal Register said.
Nine health care sites in the country are now automatically enrolling people in a clinical trial for fentanyl and ketamine, administered during transport in an ambulance while the patient is unconscious from a traumatic accident, such as a car wreck.
“Normally, researchers must ask a person for their consent before they can be in a study. Because severe traumatic injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses and having time to think about whether to join. A person with traumatic injury is often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of a traumatic injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception From Informed Consent (EFIC),” a press release from the medical provider network Guthrie said.
The specific clinical trial Guthrie is referring to is a Department of Defense (formerly Department of War) funded study ‘Prehospital Analgesia INtervention (PAIN) Trial‘ led by the University of Pittsburgh.
Importantly, once the prospective medical test subject who’s being transported via ambulance in an unconscious state is given either fentanyl or ketamine, they are enrolled in the experiment and as such are expected to participate with study protocols for up to six months.
“The study will enroll about 1000 random trauma patients (randomizing them to fentanyl or ketamine) from nine health care sites in the LITES Network in the United States. Patients are expected to participate in the study for up to six months,” the Guthrie press release said.
Of note, the serious side effects of the drugs are discussed, despite the FDA rule stating that risks to non-consenting medical test subjects must be minimal.
“Fentanyl is associated with addiction and low blood pressure. Ketamine may have some complications, including hallucinations, anxiety, and a feeling of disconnectedness, but may be more beneficial to some patients and lessen exposure and risks to opioids,” Dr. Sperry said in the Guthrie press release.
The doctor went on to discuss the military-funded program of medical experimentation on civilians.
“The goal is to help the military to provide the best care for injured personnel, help determine the best pain medicine and determine what are the best short and long-term outcomes when comparing these medications,” he said in the Guthrie press release.
If a person wishes to opt out of being experimented on with potentially lethal drugs, they must wear a bracelet attained via contacting the study administrators.
“You can opt-out of the study by calling 1-800-664-0557, emailing [email protected], or by filling out the form at the bottom of www.LITESnetwork.org/PAIN. The LITES Network can provide you with a hypoallergenic silicone bracelet to wear that indicates that you should not be enrolled into the study,” the information page said.
An informational notice was mailed out to the affected areas, which include the rural region of northern Pennsylvania and southern New York State.
Males age 18 and older and females age 50 and older are the target of the military-funded experimentation, according to the mailed documentation.
There is a video released by LITES explaining the clinical trial.
Infowars reporter Sean Miller reached out via phone to the toll free number listed on the press release but was only able to leave a voicemail. After which Miller called the local number listed on the press release at 8:56 am Eastern Tuesday. After informing the phone operator of questions regarding the study and intent to publish the article by 11:00 am Eastern, the operator said that a doctor who works with the study will call back.
At 10:30 am Eastern the operator called back informing Miller that their marketing department will call.
At 10:55 am Eastern, Manager of Corporate Communications at Guthrie, Kathy Cramer, called to inform Miller that all questions must first be emailed to her prior to them being answered.
Specifically, questions that weren’t answered in the study literature or video are of concern, such as:
-If enrolled into the study, when will the participant be able to find out which medication they received?
-What are participants’ obligations during the 6 month followup period? What tests and appointments should they expect?
-What happens if a medical test subject refuses to comply with the study process after enrollment?
-What happens if a person received the opt out bracelet, but isn’t wearing it at the time of being taken by EMS?
-What happens if the person was wearing the bracelet, but in the course of the accident it was lost or destroyed and EMS never saw it? Might they still be enrolled?
-Is it only residents of the catchment area who may be enrolled in the study, or does any person of the right demographics who is transported by EMS in the study area subject to enrollment?
-Are you aware of any other studies throughout the U.S. that are being conducted without the need for patient consent?
-Do you expect there to be future studies that are conducted without the need for patient consent?
-Is any law in place to prevent a future study from administering experimental vaccinations to patients?
BREAKING: Documents Show Government Knew COVID Shot Takes Over The Human Body