FDA Waives Informed Consent?
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FDA Waives Informed Consent?
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Certain medical trials with “minimal risk” no longer require informed consent from patients. But what is minimal risk, and who will determine it?
From The Epoch Times. In an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the U.S. Food and Drug Administration (FDA) has finalized a rule allowing certain clinical trials to operate without obtaining informed consent from participants.
Talk about issues like these on The Community.
The hitch? The study cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.
The rule was issued in late December 2023 and went into effect on Jan. 22, 2024. …
A Road Toward Eroded Trust?
Much of the pushback against the new rule suggested the changes would allow IRBs to compromise on standards more and more, adding that the term “minimal risk” is too vague and could be misinterpreted or abused. The result would be decreased public trust in research and health care providers. …
Minimal risk, as defined by the FDA, means the likelihood of experiencing harm or discomfort is not greater for a subject during a study than for them during everyday tasks. In other words, there’s minimal risk in nearly every activity, from walking to putting away the dishes to picking the kids up from school; the study’s risk cannot exceed the risk one experiences daily. …
What do you think? Share this article to raise awareness of this new rule.
(Excerpt from The Epoch Times. Photo Credit: fotostorm/Getty Images Signature via Canva Pro)
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Comments
I feel this is a very bad ruling. All participants should be aware of possible risks. Just one more reason that public trust is eroding.
You do not need to be afraid but ask Holy Spirit to protect you and have your fellow Christians pray for you while you are in the medical facility,
As for the medical facility that you are in, a polite but firm statement upon admission to the facility should work. Something such as “I am a Christian and would like to pray with other Christians in your facility, however, I also know that Reiki is practiced in some hospitals and I do not want that practiced on me.
There should be no issue with this type of statement and your wishes can be noted in your Electronic Health Record (chart).
Just like JAB
Father, protect us from this harm. May we be aware and fight the good fight of faith, depending on you to protect us.
As a retired nurse, I know the importance of informed consent in the medical field! Although many MDs and RNs “gloss over” instead of explaining informed consent, any patient facing a medical intervention or any person agreeing to participate in research, MUST know the potential issues associated with each. It is foolish to ignore informed consent!
In addition, Reiki practitioners (usually nurses) practice channeling spirits CURRENTLY without informed consent on sedated patients, comatose patients, and others. Please know that if you are a patient anywhere in a medical facility, you have the right to insist on informed consent BEFORE anyone employs Reiki on you. It is NOT Godly and uses demonic powers. And if anyone says that they are channeling the Holy Spirit, it is a lie. Holy Spirit cannot be channeled.
Wow! That’s horrible. Is that a common practice? I know Reiki is completely evil. A few years ago I worked with this guy who his girlfriend’s mother worked and did energy healing (Reiki) and I immediately starting feeling sick even hearing about it.
Any precautions I or anyone else should take before getting out under? What should be ask etc
Thank you.
Oh, LORD, may the eyes of ALL Your children be opened to see and know the truth of Your word that by opening a door even so much as a tiny crack gives place to becoming a slippery slope to destruction. By not providing or needing informed consent for ALL experiments, no complete decision may be made
One more erosion of our rights
Lord, forgive the lawmakers for this one, they really don’t know what they are doing. Informed consent is the only real, authentic consent. You have shown us we don’t know everything, only You do. Please help medical people be wise, kind and speak up truth so this bad law is receded.
Not done by lawmakers, but FDA–unelected bureaucrats who refused to acknowledge the adverse effects reported following COVID vaccines, many of them ANYTHING but “minimal”. So who thinks we should let them determine what “minimal” means when they ignored serious adverse effects, including death?