June 5

OHRP Caves Under SUPPORT Pressure Re: oxygen experiment tiny premature babies

BEWARE of the powerful influence of institutional medical research.

They have pushed hard to get the federal research oversight agency, OHRP, to backtrack from its oversight action after determining that there was an institutional failure of compliance with Federal regulatory requirements by medical centers that conducted the SUPPORT oxygen supplementation experiment  in premature babies.  http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

In a letter to the the University of Alabama (May 4, 2013), OHRP alerts the public that powerful forces are intent on lowering the bar for medical research ethics.   The June 4 letter in part  states:

“Ultimately the issues come down to fundamental difference between the obligations of clinicians and those of researchers. Doctors are required, even in the face of uncertainty, to do what they view as being best for their individual patients. Researchers do not have the same obligation: Our society relaxes that requirement because of the need to conduct research, the result of which are important to us all.  As a trade-off in allowing researchers such flexibility, society requires that researchers tell subjects how participating in the study might alter the risks to which they are exposed.”

OHRP does reamain steadfast in its finding that the SUPPORT consent forms failed to disclose the increased risks to parents–including risk of death:

“it would seem appropriate that the parents of the infants should have been informed of the real concerns withing the medical community regarding  those [high and low end of ] oxygen levels” to which babies may be randomly assigned in the study.

Lest anyone have any doubt about the ultimate goal of the powerful government-sponsored researchers who conduct high risk experiments, OHRP notes that:

“some of the researchers involved in the SUPPORT study and others have argued that there was no need for researchers to have obtained any consent from parents before placing their  children in this study. 

This discussion takes place in the midst of a much broader discussion regarding a proposal from a distinguished group of scholars that is receiving prominent attention, which argues for completely eliminating the need for any consent in similar studies.”

“These are crucially important issues, not just with regard to our ability to be able to conduct research with appropriate oversight, but also with regard to fundamental questions about the obligations owed by doctors to patients.”

“Most important, given the controversy engendered by our determination in the SUPPORT study, we will ensure that the process for producing guidance [on what the rules are with regard to disclosure of risks in randomized studies whose treatments fall within the range of standard of care] is as open as possible, to allow input from all interested parties.”

OHRP promises to conduct an open public meeting on this topic.

In the meantime, OHRP has “put on hold all compliance actions against UAB to the SUPPORT case, and plan to take no further action in studies involving similar designs until the process of producing appropriate guidance is completed.”

Take action to prevent a return to pre-Nuremberg medical research standards when medical atrocities were committed “for the greater good.”

We, the 99.9% are at increasingly high risk of becoming human guinea pigs without our consent.

Vera Sharav

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