Sly FDA Ruling Allows IRBs to Let Researchers Enroll Patients WITHOUT Informed Consent - and Gives Vague Definition of "Minimal Risk" that Could Allow the COVID Shot to Be Jabbed Without Permission
What is an IRB? See the Five Criteria that Must Be Met for this New Ruling to be Effective.
Quick on the heels of the FDA being hand-slapped for giving online medical advice not to take ivermectin, many are recently finding that the FDA quietly finalized a ruling that allows some clinical experiments to get a green light to enroll patients WITHOUT giving them ANY INFORMED CONSENT.
Scott Schara had previously covered this topic, and this is exactly what they did to his daughter Grace: they drugged her, overdosed her, and then made her a DNR. No informed consent was given for a “Do Not Resuscitate” order - yet the nurse in the room refused to resuscitate her while Scott and Cindy were on FaceTime, watching her die and screaming that she's NOT a DNR! (And the hospital got paid for it.) Scott has gleaned much knowledge about how all the hospital murderers occur, including who is involved, and more, in his 7-part series mentioned in this article. It explains the real issue: the spiritual battle for souls.
This “no informed consent needed for research” discussion is still making headlines in lots of groups, and I will clarify exactly what the FDA says can and cannot be done by a researcher who writes a protocol that goes before an Institutional Review Board (IRB). A research protocol goes through a process in this order:
Researcher > Submit Protocol to the IRB > IRB Review > IRB Approval > Research Starts
I hope this deep dive provides good context, uncovers more truth, and empowers you to keep being in charge of your health care. I also hope you are left without fear, knowing that all your treasures are being stored in heaven and no one can take them away from you - unless you deny Christ is the Son of God. Because at some point, we will all have to bow down to either God Himself, or the anti-Christ. And the only way to God is through His Son.
First we describe the role of an IRB,
What is an IRB?
During over twenty years of clinical experience, I have sat on two IRBs: one at the University of Pennsylvania and the other at UCLA’s West Los Angeles Veteran’s Administration Medical Center. Our IRBs either approved, disapproved, or sent back many research protocols for modification.
The IRB is a bunch of people sitting around a conferenct room table. Participants include doctors, nurses, and research assistants. There is an Agenda and Minutes are taken, following Robert’s Rules of Order. Votes are taken for or against a “move” that one party makes, e.g., to approve or disapprove a research project.
While usually the meeting is quite civilized and academic, some discussions can get heated, especially if one research project is full of holes yet just one person wants it to be approved. A majority vote is required for a reseach project to be approved.
Two Types of IRBs: Hospital and Private
A hospital IRB is “public” because it operates out of a public hospital. Each hospital has its own. Any on-staff doctor practicing in a hospital or clinic can submit a research protocol to the hospital IRB, to do any research they want. It can be approved, disapproved, or kicked back for revision.
A “private” IRB can be used by any doctor or practitioner in a clinic. It can operate from across the country (via phone or Zoom meetings). The researcher simply pays a fee for them to review and approve their research protocol. Any doctor or practitioner in any private clinic can use a private IRB and submit any research project they want for consideration and approval. They don’t visit the clinic or do any on-site inspections.
FDA Ruling was Effective on January 22, 2024
It was on December 21, 2023 when the FDA issued their final rule that allows an exception AWAY from the normal informed consents that a patient has to sign before enrolling in a clinical study. It was effective on January 22.
Here is the popular Telegram video by America’s Frontline Doctors (AFLDS) that is currently circulating:
For paid subscribers, here is the transcript and a discussion, followed by the entire ruling. If your budget won’t allow $7 a month, just email me at therebelpatient@substack.com and I will happily gift you a subscription, no questions asked. And join us on the App for more comments and discussion.
I am sharing My Final Thoughts on this rule here and at the end of the article, so that all readers have access.
I recommend you add to your Medical Directives:
I refuse to participate in ANY IRB-approved research, including that which does not require an informed consent, and is considered to be “minimal risk”.
The Transcript
Emphases and paragraph breaks are mine.
Dr. Peterson Pierre, MD (AFLDS Doctor): Hey freedom lovers, this is Dr. Peterson Pierre with America’s Front Line Doctors, bringing you Today’s Daily Dose.
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