Does the FDA now allow medical research on people without their knowledge or informed consent?!
Take a look at the viral claim by US Presidential candidate Robert F. Kennedy Jr., and find out what the facts really are!
Claim : FDA Now Allows Medical Research Without Consent!
People are sharing a series of posts (here, here, here, and here) on X (formerly Twitter) by Robert F. Kennedy Jr., who claimed or suggested that the FDA just issued a new ruling allowing clinical trials to be conducted on people without their knowledge or informed consent!
Truth : FDA Has Long Allowed Some Medical Research Without Consent!
This is yet another example of MISINFORMATION created / spread by Robert F. Kennedy Jr., and here are the reasons why…
Fact #1 : Medical Research Without Consent Was Permitted Since 1991
Let me just start by pointing out that the the FDA has permitted “minimal risk” medical research without informed consent since 18 June 1991, when the Common Rule was issued (Federal Register archive PDF).
At that time, the Common Rule had four criteria for the waiver or alteration of informed consent for minimal risk research. It was then revised on 19 January 2017, to add a fifth criteria – “[i]f the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format”.
So the claim by Robert F. Kennedy Jr. that it was a recent 21 December 2023 FDA ruling (PDF) called “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” that exempts “minimal risk” clinical trials from informed consent is false.
This was specifically mentioned in Section III A. of the FDA ruling, so it is odd that Robert F. Kennedy Jr. would make such a claim.
Fact #2 : Final FDA Rule Has Strict Limits
The new FDA rule basically allows Institutional Review Boards (IRBs) to decide on the waiver or alteration of informed consent for “certain minimal risk clinical investigations”.
To be clear – the FDA is not simply waiving the need for informed consent where researchers can simply “claim that what they are testing is safe“. Such medical research have to be approved by an Institutional Review Board (IRB).
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Fact #3 : Informed Consent Waiver Only Permitted For Minimal Risk
In addition, I should point out that IRBs are only allowed to grant or alter informed consent waivers for research that meet FDA’s definition of “minimal risk”:
In short – the new FDA rule strictly limits the waiver or alteration of informed consent only to “minimal risk” research in which the subjects are not exposed to harm or discomfort that they would not normally experience in their daily life, or routine examinations.
It would therefore not be possible to get IRB approval for the “testing of new medicines via the water supply or aerolized spraying” as Robert F. Kennedy Jr. suggested.
Fact #4 : FDA Amended Its Rules To Comply With Law
The FDA isn’t simply creating this new rule for fun. It was more or less compelled to do so by the 21st Century Cures Act (Cures Act), which was was signed into law by President Barack Obama on 16 December 2016.
Amongst its provisions were Section 3024, which specifically amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to “provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject”.
In addition, Section 3023 of the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,” to the extent practicable and consistent with other statutory provisions.
In short – the US FDA was only issuing its final ruling based on the Cures Act, which was enacted by Congress and signed into law by President Obama.
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Fact #5 : FDA Amendment Was Open For Public Comment
It is odd that concerned citizens like Robert F. Kennedy Jr. are only now complaining about the FDA rule amendment, when it was open for public comment years ago!
The FDA issued the proposed rule changes in the Federal Register of 15 November 2018, and asked the public to submit any electronic or written comments to the proposed rule changes by 15 January 2019.
In the end, the FDA received fewer than 50 comment letters from the academia, Institutional Review Boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, individuals, and other organizations.
Where were these concerned citizens when the FDA asked for their comments, before making its decision on the final rule?
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