Advancing Honest and Ethical Medical Research
www.ahrp.org
FYI
Newly obtained documents from the oxygen experiment (SUPPORT) reveal far more extensive medical ethics violations than those specified in the March 7, 2013 letter by the Office of Human Research Protection to the University of Alabama. http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf
On May 8, 2013, Public Citizen submitted a follow-up letter to Secretary of Health and Human Services and detailed analysis (31 pages) of the SUPPORT research protocol and consent forms approved by each of the 23 IRBs at the participating medical centers at which the experiment—Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) had been conducted on more than 1,300 extremely premature babies.
See letter: http://www.citizen.org/documents/2124.pdf
See, consent documents: http://www.citizen.org/documents/support-study-consent-form.pdf
The review of 22 IRB-approved consent forms for the SUPPORT trial reveals that NONE complied with mandatory Federal disclosure requirements:
· NONE of the 22 consent forms explained that death was a risk—especially for babies randomized to low oxygen levels;
· Only two of 22 consent forms disclosed that babies randomized to high oxygen levels were at increased risk of retinopathy or blindness.
· NONE of the 22 consent forms disclosed that the pulse oximeter readings—that neonatologists rely on to determine an infants’ need for supplementary oxygen—were intentionally altered to provide the treating medical teams with either false high or false low oxygen saturation values (SOP2).
SUPPORT experiment was not designed to support or improve the babies’ survival rate or to decrease the risk of retinopathy; indeed, multiple elements of the protocol sacrificed rather than supported the babies’ survival needs.
The consents were obtained from mostly young single mothers who were in labor.
They trusted the doctors at the medical centers--but they were deceived.
They did not suspect that the experiment for which they entrusted their babies was designed and conducted as if their vulnerable tiny premature babies were lab rats.
Read how dubious deception in the trial design sacrificed the babies' welfare, impacted on vital clinical decisions, resulting in some babies undergoing protocol-driven, clinically unnecessary invasive interventions--thereby increasing risks, trauma and discomfort for the vulnerable babies.
Read WHO poses a very serious threat to legitimate medical research, the enemies of honest research would pervert the values of our society if they are not repudiated.
See, http://www.ahrp.org/cms/content/view/921/9/
Vera Sharav
www.ahrp.org
FYI
Newly obtained documents from the oxygen experiment (SUPPORT) reveal far more extensive medical ethics violations than those specified in the March 7, 2013 letter by the Office of Human Research Protection to the University of Alabama. http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf
On May 8, 2013, Public Citizen submitted a follow-up letter to Secretary of Health and Human Services and detailed analysis (31 pages) of the SUPPORT research protocol and consent forms approved by each of the 23 IRBs at the participating medical centers at which the experiment—Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) had been conducted on more than 1,300 extremely premature babies.
See letter: http://www.citizen.org/documents/2124.pdf
See, consent documents: http://www.citizen.org/documents/support-study-consent-form.pdf
The review of 22 IRB-approved consent forms for the SUPPORT trial reveals that NONE complied with mandatory Federal disclosure requirements:
· NONE of the 22 consent forms explained that death was a risk—especially for babies randomized to low oxygen levels;
· Only two of 22 consent forms disclosed that babies randomized to high oxygen levels were at increased risk of retinopathy or blindness.
· NONE of the 22 consent forms disclosed that the pulse oximeter readings—that neonatologists rely on to determine an infants’ need for supplementary oxygen—were intentionally altered to provide the treating medical teams with either false high or false low oxygen saturation values (SOP2).
SUPPORT experiment was not designed to support or improve the babies’ survival rate or to decrease the risk of retinopathy; indeed, multiple elements of the protocol sacrificed rather than supported the babies’ survival needs.
The consents were obtained from mostly young single mothers who were in labor.
They trusted the doctors at the medical centers--but they were deceived.
They did not suspect that the experiment for which they entrusted their babies was designed and conducted as if their vulnerable tiny premature babies were lab rats.
Read how dubious deception in the trial design sacrificed the babies' welfare, impacted on vital clinical decisions, resulting in some babies undergoing protocol-driven, clinically unnecessary invasive interventions--thereby increasing risks, trauma and discomfort for the vulnerable babies.
Read WHO poses a very serious threat to legitimate medical research, the enemies of honest research would pervert the values of our society if they are not repudiated.
See, http://www.ahrp.org/cms/content/view/921/9/
Vera Sharav
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