Subject: | Another View_Academics FOR INFORMED CONSENT |
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Date: | Thu, 27 Jun 2013 06:36:47 -0400 |
From: | AHRP <ahrp@ahrp.org> |
To: | Infomail1@ahrp.org |
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Advancing Honest and Ethical Medical Research
www.ahrp.org
FYI
"The OHRP and SUPPORT--Another View" by a group of 45 physicians, ethicists, and scholars in allied fields who have stepped up to the plate to express their support for OHRP's determination that the informed-consent documents that were used in the SUPPORT experiment in which were seriously inadequate.
See, http://www.nejm.org/doi/full/10.1056/NEJMc1308015
The issues are far more insidious than this commentary in the NEJM suggests. It follows a series of editorials and commentaries by influential "key opinion leaders" (as they're referred to within the biomedical industry) which condoned that unethical medical experiment conducted on tiny premature babies whose parents were deceived about the purpose of the experiment, the alternative standard of care, and concealed from them the risk of death.
The thrust of those editorials was to assert the entitlement of the medical research enterprise to decide if and when medical experiments require obtaining informed consent. These KOLs included the directors of the National Institute of Health and the National Institute of Child and Human Development who challenged the authority of the Office of Human Research Protections to enforce Federal Informed Consent regulations.
It appears that some medical researchers are having trouble getting volunteers for their experiments. So, they are attempting to redefine "research" and "risk" and would leave to their own discretion if and when to comply with legal informed consent requirements.
Powerful forces are clamoring to dispense with Informed Consent requirements--for experiments that test variations of currently used interventions, "comparative effectiveness research" which may test -different strengths of medicines, different doses, different combinations, different durations...etc.
Such trials constitute research by any standard, and they pose foreseeable risks--as does any randomized medical experiment.
If successful, their effort would be a GIANT step toward dismantling Federal research protections from experiments for which they cannot get volunteers.
~~~~~~~~
A public meeting is to be held in Washington Aug 28, from 9 a.m. to 5 p.m in DC.
Written comments are also solicited.
https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-15160.pdf
To
register to attend and speak, you need to send an email to OHRP@hhs.gov,
indicating you want to register to attend AND speak at the
meeting.
Include the following in the subjects heading of your email: “Registration for HHS Public Meeting”
Include the following in the subjects heading of your email: “Registration for HHS Public Meeting”
~~~~~~~~~
We have posted the first of 4 Parts of an in-depth documented overview of the high stakes and key players involved in this serious effort to eviscerate current Federal regulations.
"Trust in Medical Research is Undermined by Researchers, Bioethicists, and NIH Officials Who Condone an Unethical Experiment in Violation of Informed Consent"
Soon after publication of the SUPPORT trial report in The New England Journal of Medicine, (2010) SUPPORT researchers have been publishing articles in the journal Pediatrics in which they stated: “obtaining informed consent requires time and effort; the number of patients enrolled seemed to be much smaller than the number screened…” They acknowledged SUPPORT had encountered resistance from mothers whose consent to enroll their vulnerable babies in the study was difficult to obtain:
“Of the 2228 mothers who were approached, 1219 (54.7%) gave consent… The frequency of approaches [to obtain informed consent] ranged from 1 time to 11 times... It took between 1735 and 2790 hours to obtain consent decisions from the 2228 mothers who were approached, to enroll 611 infants. Our results revealed that 5 families needed to be identified and screened for every 1 infant enrolled successfully.“ 13
They blame the enrollment bias of their study on informed
consent requirements—rather than taking responsibility for their
failure to design an ethically and scientifically
acceptable research protocol:
“use of prenatal consent may not represent adequately
the populations that trials are intended to study…the consent
process is very inefficient, costly and biased the trial enrollment, such that the mothers and their infants differed in important ways from the available eligible population of very preterm infants.”13
Read Part I http://www.ahrp.org/cms/content/view/925/9/
Vera Sharav
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