Informed consent: never enforced by FDA, now not required!

(found on Dr. Judy's transcripts: https://therealdrjudy.com/judy-mikovits-transcripts/)

Del Bigtree: They didn't know about this premature baby oxygen study.
Sharyl Attkinson: Public Citizen watchdog group that does great work in the health space had been following the controversy over a federally funded study being done at organizations like Duke, you know, very famous hospitals that, in retrospect, according to the government's own watchdog, was unethical. It put extremely fragile premature babies in a study that manipulated their oxygen levels, not for their own good, but for some kind of test purposes, without, according to the parents, telling the parents that they were doing this. So the parents didn't get, according to them, informed consent. The ethics watchdog said they didn't get informed consent. They were told, according to the parents and multiple ones have the same story, as they're being rushed in to have a premature baby, they're handed a piece of paper and said: this will help provide support for you. So it was their understanding
Del Bigtree: Get in the study, and you'll get extra support for your baby…
Sharyl Attkinson: They didn't use the word study. They just thought they were signing to have their baby's weight and height measured and get emotional support for how hard it was going to be.... One causes blindness, one causes death. They wanted to know where the sweet spot was. But here's the kicker. By keeping a baby in the oxygen level that they were assigned, normally, it’s adjusted, depending on how the baby's doing. The oxygen monitors were disabled to provide false readings on purpose.
Parents weren't told this. So that the medical personnel caring for the babies wouldn't be tempted to put them in the right range for them. This is how horrific that was. It's that greater good argument. "Well, we'll be helping babies in the future, but at the expense of the ones who were in the study" that the parents said they didn't know about... One of the defenders of the study at the time, is now head of FDA.
Del Bigtree: Is it Califf?
Sharyl Attkinson: Yes. And how ironic is this, they had a look back at what they'd done wrong, because there was sort of an uproar. There was a lot going on. I go to the meeting where they're having this look back, thinking they're going to say: "this is what needs to happen, Iinformed consent has to be stricter, this was horrible...." Instead, about half of the researchers argued: "Why do we have informed consent anyway? Because people aren't getting in studies because we're telling them all these scary things." And would you believe that, maybe you know this, in the past year, their dream came true. The FDA changed its rules where they no longer have to give informed consent to everybody in a study. So they can enroll you in a study, and if they determine that they think the risks are minimal, they don't have to tell you about it...
Del Bigtree: I think the most important interview is your interview of Bernadine Healy.

Transcript of interview by Sharyl Attkinson with Former NIH Director Bernadine Healy, on Vaccine and Autism Link: https://therealdrjudy.com/judy-mikovits-transcripts/f/former-nih-director-on-vaccine-and-autism-link?blogcategory=Autism

09/19/2024 - TheHighwire: Episode 390: Hot Off The Press: https://thehighwire.com/ark-videos/the-truth-finds-a-way-to-be-told-sharyl-attkisson/