The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

The COVID vaccine arrival as well as Biden’s choice for his nomination of California Attorney General Xavier Becerra to lead the Health and Human Services Department makes it imperative that we give the Cures Act a review. There have been administrative tweaks to the bill but section 3023 remains.

Jan 31, 2020 — The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. (Link) 21st Century Cures Act

The Cures Act was passed in the tail end of 2016. Today I focus on Section 3023, 3024 regarding Informed Consent and why you should care. No longer is the Gold Standard of “Informed Consent” required if there are “no more of minimal risks to participants.” And who decides this?

Earlier I posted Trump hogties the EPA, will he stop their illegal human medical experiments? This is why you should care. But let me not get ahead of myself. I include a video.

A year and a half after the original bill left the House of Representatives, the much-discussed and highly anticipated 21st Century Cures Act became law on December 13, 2016. The legislation went through more than a few changes in those seventeen months; it expanded from four sections to twenty-five and from 362 pages to 966. Informed Consent Waiver or Alteration for Clinical Investigations

The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.

The law sets two requirements for waiving or altering informed consent:

  1. The research must pose no more than minimal risk to participants; and
  2. Other measures to protect study volunteers must be in place.

The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make.

From Science Blogs:

Title:The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry. (Well worth the full  read.)

Worse, the bill undermines informed consent, as I discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject.

Add to that now that it would be acceptable to forego informed consent 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.”

As Merrill Goozner put it and I agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk.

Well worth a good look. Our lives may depend on it. An excellent review of the bill and the ramifications.

This is a B-ville repost done in March of 2017:

The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

I am not sure I for one want the Biden administration in charge of:

Human research subject protections

The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order “to reduce regulatory duplication and unnecessary delays” and “modernize such provisions in the context of multisite and cooperative research projects.” – Wikipedia,

Unfortunately the Quorum links are no longer available.

Other than this all is well in the swamp.

14 Responses to “The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments”

  1. New York introduces bill mandating COVID vaccination – if you die or injured reimbursed | BUNKERVILLE | God, Guns and Guts Comrades! Says:

    […] The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments […]


  2. Adrienne Says:

    Excellent, Bunk. You’re always on top of stuff. I’m not even on top of my dust bunnies (which have evolved into giant rats.)

    Liked by 1 person

  3. Mustang Says:

    Members of the US Congress are nothing — nothing at all — if not clever. They learn by doing, and I suspect they learned a lot about dealing with the electorate in the wake of Obama Care. So, they now pass bills that contain no more than four or five pages, which are always vague and therefore easy to get passed into law, and then later amend them with 994 or so pages. The amendment process is usually a ‘voice vote,’ and no big deal. Meanwhile, since the USA no longer has what used to be called ‘investigative journalism,’ no one in Happyville Idaho is the wiser … until they are suddenly ‘under the knife.’ No one knows what ‘minimal risk’ means, as you say, but I suppose it means ‘minimal risk to legislators.’ Sort of like making the decision to release Covid-19 patients into elderly care facilities, where there was minimal risk to governors and state medical officers who are always protected from lawsuits.

    But even if we suppose that 99.9% of the American people do not approve of Congress, it doesn’t matter. Members of Congress (and local or state officials) no longer work for us. In truth, they never did. It’s one of those better lies told to us years ago and passed down through the ages. You know, like unicorns, Tinker Belle, and “I did not have sex with that woman.”

    Elections have consequences … but thank goodness for social media, or else the American people might pay attention to the Shenanigans inside the beltway. But even if they did “pay attention,” again, as you’ve pointed out, what are they going to do about it? My guess is that there is not a single soul in the Congress that gives a damn what you or I think, and in the absence of powerful lobbies … they never will.

    I groan …

    Liked by 4 people

    • bunkerville Says:

      Agree Mustang… as I commented I needed to expound more on how this will impact the vaccine forth coming mandate.. As shown in the video.. vaccines can be lumped into this concept of “minimal risk” quite easily.
      I can recall that to get a bill “out of committee” might take months..if it did it was most likely to pass as compromises had occurred and nonsense was eliminated for the most part. Now as you say, a voice vote for amendments and even worse turning it over to an agency to make a “rule” regarding the issue..That is how federal agencies became so powerful.. One only need to read the Federal Register to learn about the proposed change-rule…. 60 -90 days to make comment and then it becomes law.
      Regarding the vaccines — there are always known risks to any vaccine. A number of kids get polio from the polio vaccine for example. Bells Palsy is a well known risk with the flu vaccine.
      There will be more….and then watch the nonsense begin.

      Liked by 1 person

  4. markone1blog Says:

    Add to this the fact that the HHS “nominee” (even though Mr. Dementia called the position “Health and Education”) Xavier Becerra was the one who took up the prosecution of David Deleiden for the videos that exposed Planned Parenthood. Of course, Mr. Becerra has no medical experience.

    One other thing that can be noted of Mr. Becerra is his vehement opposition to Catholics. We can expect the Little Sisters of the Poor to be persecuted for a third time.

    Liked by 4 people

    • bunkerville Says:

      Indeed… and wait for them to implement in forcing the COVID vaccine on everyone… I failed to make the point clear unfortunately..

      Liked by 1 person

    • markone1blog Says:

      Have I mentioned my decision to be called “President-Elect” Mark? I have as many electoral college votes as Mr. Biden; therefore, I feel that I deserve to set up a shadow government, communicate with foreign governments, and receive special funds from the U.S. government.

      Liked by 3 people

    • peter3nj Says:

      Mark also makes a good point. Once they get a foot in the door any excuse will do to search for and confiscate firearms along with laptops,etc. With law enforcement neutered you can’t even call the cops; they would know better than to rspond anyhow. For the umpteenth time,ad nauseam I know, I will again mention that on my trip to Cuba in 1999 los viejos Cubanos me dijeron que the first thing Fidel did was confiscate the guns. May we mention putting a BLM sign on the front lawn might help?

      Liked by 2 people

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