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 Alleged Parental Consent Forms

 

for the 2005 to 2010 oxygen-withholding SUPPORT trial
of asphyxiating premature babies to protect their eyes

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

(a) An Institution, or when appropriate an IRB, shall prepare and maintain appropriate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.

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":

"Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied."

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:

"... please let me know your procedures for verifying whether the documents provided to you, if any, are genuine. The case at hand is about parental consent for a medical baby-asphyxiating experiment with knowingly increased risks of death versus an unknown chance of maybe preventing some eye damage to the child. No parent informed about these relative risks will volunteer their child’s life for such a comparatively minor hoped-for benefit, or has a legal right to do so since such a skewed trade-off is not in the interest of the child. The experimenters are therefore likely to either have lied about these risks or else to have omitted to inform the parents at all that they were experimenting on their baby. I am therefore concerned that if any of the 16 participating hospitals submit to you any consent forms allegedly used for this experiment that these forms are likely to be post hoc fabrications that were never shown to or signed by any of the parents involved. I plan to inform my readers about the search for these so far unfound consent forms, and knowing your verification procedures will allow them to judge the confidence they can have in their authenticity in case these phantom forms suddenly do turn up.

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
posted on the Capital News of Kenya website by CATHERINE KARONGO on July 14, 2011:

"The Ethics Committee Chair acknowledges that one of the weakest areas of research in the country is monitoring and evaluation of research after approval.

“After you approve a research, nothing stops a dishonest researcher from designing a different consent form and administering to participants. We usually do random checks on researchers to curb this,” he says.

He anticipates that based on the complaints they get, at least 10 percent of researchers could be sidestepping some of the procedures. “When we get such researchers, we close the study completely,” he informs."

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 8-17-2011 letter from Bill Hall, Director, News Division, Office of the Assistant Secretary For the Public Affairs at U.S. Department of Health and Human Services, admitting that DHHS cannot find the mandated copies of the "informed consent" forms for the SUPPORT trial published in the May 16, 2010 online edition of the New England Journal of Medicine:


Page 2:

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,
sent to info@bioethics.gov
University of Pennsylvania President and
Christopher H. Browne Distinguished Professor of Political Science &
Chair of the Presidential Commission for the Study of Bioethical Issues

from Peter Aleff, 2097 Cottonwood Drive, Vineland, NJ 08361,
prevent@retinopathyofprematurity.org
February 22, 2011

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,
Presidential Commission for the Study of Bioethical Issues

This is an addendum, posted also as a comment at http://blog.bioethics.gov/2011/03/01/international-panel-named-to-review-scientific-trials/, to my letter of February 22 to Professor Gutmann about “Two US clinical studies more unethical and lethal than the syphilis studies in Guatemala and Tuskegee”, as posted at retinopathyofprematurity.org/BioethicsSUPPORT.htm and retinopathyofprematurity,org/Bioethics1955Oxygen.htm.

On February 23 I received a letter from the Freedom of Information Coordinator at the NICHD Neonatal Research Network Pregnancy and Perinatology Branch at the US National Institutes of Health. He wrote that this Branch had searched its files and did not locate any records regarding Informed Consent Forms for the oxygen-withholding SUPPORT study. That imprudent study ran from 2005 to 2010, and it preventably killed 23 premature babies.

It appears therefore that this unethical and patient-harming trial was conducted behind the backs of those babies’ parents. This was probably easier to do than openly asking them to agree with significantly increasing the risk of killing or maiming their child. No sane parents would willingly agree with such a knowingly unsafe research protocol, or would be legally allowed to do so since they are obliged to protect the interest of the child.

I plan to appeal this determination that no records exist because these consent forms are mandated by law. However, I am concerned that when pressed for the blank forms which I requested the researchers will simply make up some fake ones and pretend that they used these with the parents. I suggest therefore that you audit the existence and completeness of the forms allegedly signed by the parents or guardians of the enrolled children if you want to know whether the SUPPORT researchers actually complied with this basic mandate for any research on human subjects, and whether they fully informed the parents about the risks to which the researchers wanted to expose their babies.

The previous poster of comments on the web page of my original post had stated, “There is no agency to investigate unethical research conduct.” Indeed, the so-called Office of Research Integrity does not do that job, as I explained in part 1 of my above letter. It is therefore up to your Commission to thoroughly investigate the compliance of those SUPPORT researchers so that you can accurately inform President Obama whether the current domestic rules for research participants protect people from harm or unethical treatment.

Thank you in advance for your urgent attention to the misguided and originally eugenics-inspired oxygen withholding which led to this unethical SUPPORT study and which continues to harm many premature babies in this country and around the world every day.

Sincerely,
Peter Aleff
prevent@retinopathyofprematurity.org

 

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 kristina.borror@hhs.gov

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 US of blinding premature babies that severely reduced the usual oxygen breathing help for half of its subjects to try and reduce their blinding, despite the known increase in the babies' risk of death from this tight rationing of the life-saving gas. That study violated all the codes of medical ethics with its unsuccessful attempt to reduce the combined incidence of death and blinding among these preemies although blindness is a non-fatal condition and cannot justify the intentional increase in those babies’ risk of death. Predictably, this study killed 23 “extra” children with this attempt to protect their eyes from getting damaged, as if intact eyes were of any use to a dead child.

 

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

"the NICHD Neonatal Research Network Pregnancy and Perinatology Branch searched its files and no records regarding Informed Consent Forms (...) were located".

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. 

 

This patient-abusing experiment is part of a wider trial with the acronym SUPPORT that was conducted in the US by the Support Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.  The oxygen-withholding part of that SUPPORT study enrolled 1316 preemies from 2005 to 2009, and its preliminary results were published in the May 16, 2010, online issue of the New England Journal of Medicine under the title “Target Ranges of Oxygen Saturation in Extremely Preterm Infants” at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781.

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 (ROP). These studies were conceived in 2003 by “an eminent international group of over 30 trialists, bio-statisticians, neonatologists, ophthalmologists, and developmental pediatricians” with the goal to evaluate their results not only individually but also together in a pooled meta-analysis, called NeOProM, for greater statistical discerning power. The other four studies of this group are currently going on in Australia, New Zealand, England, and Canada. The Canadian study recruited subjects not only in its own country but also in the US, Argentina, Germany, Israel, and Finland. The NeOProM study is posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf [2].

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.

 

Sincerely,

Peter Aleff

Dr. Borror replied first on 5/31/2011 to acknowledge receipt of my complaint, and then on 7/18/2011 to promise an investigation:

From: Borror, Kristina C (HHS/OASH)
Sent: Tuesday, May 31, 2011 9:35 AM
To: 'Peter Aleff'
Subject: RE: Clinical trial killed 23 premature babies without parental consent

Dear Mr. Aleff:

Thank you for your email.  OHRP is reviewing it and will get back to you shortly.

Kristina C. Borror, Ph.D.
Director
Division of Compliance Oversight
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
The Tower Building
Rockville, MD 20852
email: kristina.borror@hhs.gov
Phone: (240) 453-8132
Fax: (240) 453-6909

From: "Borror, Kristina C (HHS/OASH)" <Kristina.Borror@hhs.gov>
To: "hpaleff@verizon.net" <hpaleff@verizon.net>
Date: Mon, 18 Jul 2011 11:27:23 -0400
Subject: RE: Clinical trial killed 23 premature babies without parental consent


 

Dear Mr. Aleff:

 

The Office for Human Research Protections (OHRP) has received your May 24, 2011 email concerning research supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. 

 

OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46 at http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).  In carrying out this responsibility, OHRP evaluates, at OHRP’s discretion, substantive allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations (see OHRP memorandum dated October 14, 2009 at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf for an explanation of OHRP’s jurisdiction).

 

OHRP will be evaluating the allegations related to informed consent/parental permission.  The first step in the evaluation process involves notifying the institution of the allegation and requesting that the institution provide OHRP with relevant information.  Upon completing its evaluation, OHRP may require corrective actions intended to remedy ongoing noncompliance and/or prevent reoccurrence of prior noncompliance.

 

OHRP appreciates your concern about the protection of human research subjects.  Please do not hesitate to contact me at any time should you have any questions or wish to provide additional information.

 

Sincerely,

Kristina C. Borror, Ph.D.
Director
Division of Compliance Oversight
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
The Tower Building
Rockville, MD 20852
email: kristina.borror@hhs.gov
Phone: (240) 453-8132
Fax: (240) 453-6909

As of April 14, 2013, I received no further reply from Dr. Borror or her Office, but that Office released a letter it had written to Dr.  at the University of Alabama at Birmingham

 
 

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