OHRP Caves Under SUPPORT Pressure Re: oxygen experiment tiny premature babies
Wednesday, 05 June 2013
Proposal by powerful medical research stakeholders who "argue for completely eliminating the need for any consent in similar studies."
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 (sic) 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 (sic) 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." (emphasis mine)
"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 here
via the American Medical Association
Opinion 8.08 - Informed Consent
The patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice. The patient should make his or her own determination about treatment. The physician's obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice. The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. Informed consent is a basic policy in both ethics and law that physicians must honor, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent. In special circumstances, it may be appropriate to postpone disclosure of information, (see Opinion E-8.122, "Withholding Information from Patients").
Physicians should sensitively and respectfully disclose all relevant medical information to patients. The quantity and specificity of this information should be tailored to meet the preferences and needs of individual patients. Physicians need not communicate all information at one time, but should assess the amount of information that patients are capable of receiving at a given time and present the remainder when appropriate. (I, II, V, VIII)
Opinion 8.082 - Withholding Information from Patients
Withholding pertinent medical information from patients under the belief that disclosure is medically contraindicated, a practice known as “therapeutic privilege,” creates a conflict between the physician’s obligations to promote patients’ welfare and respect for their autonomy by communicating truthfully. Therapeutic privilege does not encompass withholding medical information in emergency situations, or reporting medical errors (see E-8.08, “Informed Consent,” and E-8.121, “Ethical Responsibility to Study and Prevent Error and Harm”).
Withholding medical information from patients without their knowledge or consent is ethically
unacceptable. Physicians should encourage patients to specify their preferences regarding
communication of their medical information, preferably before the information becomes available. Moreover, physicians should honor patient requests not to be informed of certain medical information or to convey the information to a designated proxy, provided these requests appear to genuinely represent the patient’s own wishes.
All information need not be communicated to the patient immediately or all at once; physicians
should assess the amount of information a patient is capable of receiving at a given time, delaying the remainder to a later, more suitable time, and should tailor disclosure to meet patients' needs and expectations in light of their preferences.
Physicians may consider delaying disclosure only if early communication is clearly contraindicated. Physicians should continue to monitor the patient carefully and offer complete disclosure when the patient is able to decide whether or not to receive this information. This should be done according to a definite plan, so that disclosure is not permanently delayed.
Consultation with patients’ families, colleagues or an ethics committee may help in assessing
the balance of benefits and harms associated with delayed disclosure. In all circumstances,
physicians should communicate with patients sensitively and respectfully.
More on the SUPPORT study Public Citizen: The SUPPORT Study was Even Worse than We Thought by
Public Citizen Report to the Secretary of HHS: New Information About Baby Trial Shows It Was Even More Unethical Than Originally Thought via Public Citzen
photo credit: Wikimedia Commons