retinopathy of prematurity.org
Alleged Parental Consent Forms
for the 2005 to 2010 oxygen-withholding
posted by H. Peter Aleff, 2011
See below the answers I received from the Office of FOIA Services at the US National Institutes of Health to my request for copies of the informed consent forms allegedly used in the baby-asphyxiating medical SUPPORT experiment described at retinopathyofprematurity.org/BioethicsSUPPORT.htm. Their continued inability to locate the "informed consent" forms for a Federally funded medical experiment on human babies raises strong suspicions that no such consent was ever obtained, and that the doctors involved ran that lethal asphyxiating experiment behind the back of those babies' parents.
The Code of Federal Regulations for guidance in experiments on human subjects states in its §46.115 on "IRB records" states that
The next several paragraphs deal with the mandated requirements for informed consent and its documentation, and conclude with §46.122 on "Use of Federal funds":
In other words, the department or agency at the National Institutes of Health that funded this medical experiment on human babies could not legally have disbursed any funds to the researchers unless that agency had examined the documentation of the proposal and determined that the all-important "informed-consent" form met all the requirements. It is hard to imagine how anyone could have approved such a form without having seen it, and without having kept a copy to document that it met those requirements. The absence of these essential forms is a strong indication that they may have never existed, and that the nursery doctors in that experiment never told the parents to what risks they were exposing their children, or why the lives of 23 "extra" babies in the asphyxiation group had to be sacrificed to .
The next letter posted here, sent 9 days before the above one, indicates that the US National Institutes of Health do not appear to have a policy of checking whether the documents submitted to it for a clinical trial are truly the ones used in that trial. I had asked the following question in my letter of August 2:
Their response posted below only offers the service of certifying that the documents provided are genuine, apparently meaning true copies of the papers submitted to the NIH, as stated in their fee schedule, Section 5.43, Title 45 in the Code of Federal Regulations. That response fails to mention any procedures for verifying whether the consent forms given to the NIH are the ones actually submitted to and signed by the parents.
Compare this, for
instance, with this excerpt from the article: "Kenya’s ‘guinea pigs’
short-changed" about the protection of human
research subjects in that country, as
The US National Institutes of Health, by contrast, appear to work entirely on the honor system in trusting blindly that the researchers applying for its grants will follow its procedures for the protection of human subjects, without any policy of checking whether they do, and apparently without even receiving a copy of this most vital document in any research on humans. To judge from the lack of understanding my question how genuine the consent forms are, it does not even seem to cross their mind that some researchers could be cheating against procedures which many of them complain about as an unnecessary burden.
Copy of the 8-8-2011 letter from Amy McNulty, Senior FOIA Specialist, Division of FOIA Services, U.S. Department of Health and Human Services, admitting that the National Institutes of Health do not appear to have a procedure for verifying that the consent forms, if any, submitted by the researchers receiving Federal grants are the ones actually used in the trial.
Updates to my initial letter to Professor Amy Gutmann
about the knowingly baby-asphyxiating SUPPORT experiment
and the impossibility of obtaining truly informed
parental consent to this high risk for their children,
from Peter Aleff, 2097 Cottonwood Drive,
Vineland, NJ 08361,
from Peter Aleff, 2097 Cottonwood Drive,
Vineland, NJ 08361,
Misinformed Parental Consent
I requested on January 10 from the National Eye Institute at the National Institutes of Health under the Freedom of Information Act copies of the “Informed Consent” Forms for the SUPPORT study used by each of the participating hospitals and some other related documents. After some email and phone discussions with a FOIA Analyst at the Eunice Kennedy Shriver National Institute of Child Health and Development/NIH about the scope of my inquiry, we reduced the number of documents involved, and I emailed my agreement to the so reduced request on January 18.
The FOIA law obliges the government agency in charge of the requested records to release these to me within twenty working days. As of February 22, I have not received any of the requested material but when I do receive it I will post a representative sampling here at retinopathyofprematurity.org/BioethicsConsent.htm .
Addendum to my email of 2/22 about unethical studies on premature babies, as sent on 3/2/2011
To the attention of Valerie H.
Bonham, Executive Director,
The following is a copy of my correspondence with the Office for Human Research Protections, beginning with the email I sent on 5/24/2011 to firstname.lastname@example.org
To the attention of Kristina Borror,
Director, Division of Compliance Oversight,
Office for Human Research Protections
U.S. Department of Health and Human Services
In a blog post at the bioethics.gov website under the title "Could another Guatemala case happen?", John Donelly cited one of the speakers at the 5/19 meeting of the Presidential Commission for the Study of Bioethical Issues as saying that such a patient-abusing study "could not happen again because of informed consent".
I want therefore to
alert you to a recent unethical study in the
Moreover, the authors of this grotesque baby-killing experiment appear to have conducted their trial without the informed consent of the parents. When I asked for details about the U.S.-based part of that international experiment, the Freedom of Information Coordinator at the NICHD/OSPAC-PICB wrote to me on 2/23/2011 that
I filed a FOIA Appeal and received an acknowledgment of receipt for my appeal with the Request Number PHS - 11-0303 - AA. That receipt was dated 3/23/2011, but I have not heard any further reaction to my appeal and must suspect that the longer it takes them to send me those legally mandated but apparently unavailable forms the more likely it is that these will be fabricated post facto to try and cover up the crime of intentional medical murder.
Indeed, those "Informed Consent" forms are unlikely to exist because no properly informed parent would ever have agreed to volunteer their child for this baby-suffocating experiment. And even if any parent could have been talked into signing a form that honestly described the known risks from that experiment, that parent could not have legally consented on behalf of their child for a potentially lethal experiment that was not in the best interest of the child and offered him or her no compensating benefit.
patient-abusing experiment is part of a wider trial with the
acronym SUPPORT that was conducted in the
The SUPPORT study is one of five parallel studies
around the world that are all based on the same knowingly
baby-killing and -harming protocol of oxygen withholding to try
and prevent retinopathy of prematurity (
You will find at http://retinopathyofprematurity.org/BioethicsSUPPORT.htm a detailed discussion of this knowingly patient-killing experiment in my letter of 2/22/2011 to the Presidential Commission for the Study of Bioethical Issues in which I tried to alert that Commission to this ongoing patient abuse. Because this study killed some of its subjects instead of "only" infecting them with a less lethal condition, the abuse in this recent experiment is even worse than in the much mentioned syphilis study in Guatemala from 65 years ago. That study in Guatemala led to President Obama's request for that Commission to reassure him about the current protections for participants in federally funded medical research projects. Unfortunately, his instructions to that Commission asked them to investigate only that Guatemala study but not the current protections for research subjects about which he asked them only to reassure him without specifically mentioning that obviously these reassurances should be based on an investigation.
It seems that this Commission took these instructions literally because it did not investigate the above alert about an obvious breach of those alleged protections although it had in its possession for more than three months a full documentation of the patient-killing SUPPORT medical experiment. Contrary to that documented evidence, its members still assert that the present rules on informed consent prevent a repetition of past abuses although the current abuses are even worse.
I hope therefore that you will be able to do a better job than this falsely reassuring Commission and actually investigate the reckless baby-killing in that consent-less suffocating experiment, as well as the even more lethal rigged trial of oxygen withholding from premature babies 55 years ago that misled intensive care nursery doctors ever since into falsely believing that suffocating preemies would protect them from going blind.
Please see the admission in the SUPPORT paper at the above link that the results of that earlier study killed about 16 infants for each case of blindness prevented, and led to an estimated 150,000 preemie deaths in the first 20 years after its never replicated bogus results became instantly a central part of the neonatologist doctrine.
You find that initial bogus study described at http://retinopathyofprematurity.org/Bioethics1955oxygen.htm, and another rigged as well as patient-abusing study of blinding premature babies in the mid-1990s at http://retinopathyofprematurity.org/BioethicsLIGHT-ROP.htm plus at the supporting pages mentioned in its links.
Thank you in advance for your urgent attention to these ongoing abuses of human research subjects in unethical medical experiments, and for protecting future preemies from their nursery doctors' misled and patient-harming beliefs about the cause of their continued blinding epidemic.
Dr. Borror replied first on 5/31/2011 to acknowledge receipt of my complaint, and then on 7/18/2011 to promise an investigation:
Borror, Kristina C (HHS/OASH)
Dear Mr. Aleff:
Thank you for your email. OHRP is reviewing it and will get back to you shortly.
Kristina C. Borror, Ph.D.
no further reply from Dr. Borror or her
Office, but that Office released on April 14, 2013, a
"letter of determination" it had written to Dr. Waldemar Carlo at the University of Alabama at Birmingham.
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