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


The Cures Act was passed in the tail end of 2016. Today I focus on Section 3023, 2024 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? Yesterday 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 Quorum Review

From Science Blogs:

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.

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

  1. Anthony Tornambe Says:

    Cool job

    Liked by 1 person

  2. The Weekly Headlines – My Daily Musing Says:

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

    Like

  3. Steve Dennis Says:

    This is the first I have heard of this and it is pretty scary stuff! There is a bill in one state, I believe it is Connecticut, that would give the state the right to harvest a resident’s organs after death without the person being an organ donor. What are we coming to?!

    Liked by 1 person

    • bunkerville Says:

      Wow,,,, little respect for life from those that should know better, Its not like we haven’t been down this road and know where it goes. I don’t think anyone reads these bills anymore. This thing grew to be a monstrosity. Add the agencies adding their “rules’ and interpretration and we have what we have.

      Like

  4. petermac3 Says:

    Two points:
    First: Of course no one signing onto this bill read one word of it- follow the money.
    Second: we were onto this Sesame Street autism agenda from day one. My soon to be three year old grandson, when he watches any Sesame Street they are old pre-autism episodes. My son teaches autistic and special needs students and is aware of main streaming, which years back attempted to have the abnormal integrated into the normal classroom but just as we’ve come full circle from global cooling to global warming so now are “they” aiming to mainstream the normal into the abnormal populaation.,(I’m using normal and abnormal for convenience sake only). Next will be burqa clad Sesame Street characters replete with honor killings when a female character happens on to Sesame Street with an ankle exposed.

    Liked by 1 person

    • bunkerville Says:

      All part of the conditioning for the new era of whites becoming the minority. Islam as the majority religion.

      Liked by 1 person

  5. the unit Says:

    Got to find out what makes the deplorables so deplorable and not be swayed by propaganda that the elite knows what’s best. And then find a cure to bring these irreconcilables into harmony through necessary and proper adjustment.

    Liked by 2 people

    • bunkerville Says:

      There you go…. no doubt a few electrodes placed on brain with some volts of electricity should do the job.

      Liked by 1 person

  6. Just Simply Linda Says:

    sigh…another overreach…never ending, is it?

    Liked by 2 people

    • bunkerville Says:

      Nope..We are on our own….

      Liked by 2 people


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