Did FDA change law to allow medical research without consent?!

Did the US FDA just quietly amend the 21st Century Cures Act to allow medical research without consent?!

Take a look at the viral claim, and find out what the facts really are!

 

Claim : FDA Changed Law To Allow Medical Research Without Consent!

People are sharing an article (archive) by The People’s Voice (formerly NewsPunch), which claims that the US FDA just quietly amended the 21st Century Cures Act to allow medical research without consent!

Here is an excerpt from the article, which is (intentionally?) long and confusing. Feel free to skip to the next section for the facts!

FDA Just Quietly, Deceitfully Changed Law To Allow ‘Medical Research Without Consent’

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Truth : FDA Did Not Change Law To Allow Medical Research Without Consent!

This is yet another example of FAKE NEWS created / promoted by The People’s Voice, and here are the reasons why…

Fact #1 : FDA Did Not Change Any Law

The People’s Voice article claimed that the US FDA just amended the 21st Century Cures Act to allow “medical research without consent” in certain situations. That’s simply not true, and is easily proven false.

All you have to do is read the FDA’s final ruling on the “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations“.

As the summary at the top explained, the FDA was amending its own regulations (not any law), to implement a provision of the 21st Century Cures Act (Cures Act).

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act).

The People’s Voice article provided the same link, so it is certainly aware of what it actually said.

Fact #2 : Congress Enacts Laws, Not Agencies

For the benefit of people who are not aware of how laws are enacted or amended in the United States, I should point out that Congress is the legislative branch of the US government.

Established by Article 1 of the US Constitution, the Legislative Branch consists of the House of Representatives, and the Senate. Together, they are known as the United States Congress.

Only the US Congress that has the power to enact and/or amend laws in the United States of America. Not the executive branch, or the judicial branch. Certainly not government agencies like the FDA, which fall under the executive branch.

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Fact #3 : Cures Act Permitted FDA Amendment In 2016

The 21st Century Cures Act (Cures Act) was signed into law by then 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 the President.

Fact #4 : Medical Research Without Consent Was Permitted Since 1991

What The People’s Voice article does not point out is that minimal risk medical research without informed consent has been permitted 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 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”.

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Fact #5 : FDA Amendment Was Open For Public Comment

The People’s Voice article suggested that the FDA “quietly” made those amendments out of sight and public discourse. That’s simply not true.

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.

Fact #6 : Amendment Does Not Affect Informed Consent For Vaccinations

The People’s Voice article suggested that the removal of consent for minimal risk medical research may eventually spill over to allowing people to be injected without informed consent. That’s simply not true.

Not only was the FDA ruling an amendment of existing rules which have permitted minimal risk without informed consent since 1991, it has nothing to do with informed consent for medical treatments and/or vaccinations.

The FDA final ruling cannot be used to void the need for informed consent for any medical treatment and/or injections of drugs and vaccines. The People’s Voice article certainly offered no evidence to back up its claims or suggestions.

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Fact #7 : The People’s Voice Is Known For Publishing Fake News

The People’s Voice is the current name for NewsPunch, which possibly changed its name because its brand has been so thoroughly discredited after posting numerous shocking but fake stories.

Founded as Your News Wire in 2014, it was rebranded as NewsPunch in November 2018, before becoming The People’s Voice. A 2017 BuzzFeed report identified NewsPunch as the second-largest source of popular fake news on Facebook that year.

Its articles have been regularly debunked as fake news, so you should never share anything from NewsPunch / The People’s Voice.  Here are some of its fake stories that I fact checked earlier:

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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