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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 23 "extra" babies in the asphyxiation group had to die
unnecessarily.
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
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