Thursday, June 27, 2013


Subject: Another View_Academics FOR INFORMED CONSENT
Date: Thu, 27 Jun 2013 06:36:47 -0400
From: AHRP <>

Advancing Honest and Ethical Medical Research


"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.

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.
To register to attend and speak, you need to send an email to, 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
 Also include your name, address, telephone number, email address, and fax number.
 Registration to attend the public meeting will be accepted on a first-come, first-served basis. If seating capacity has been reached, you will be notified that the meeting has reached capacity.
Request to speak may be: I am writing to register for the August 28 public meeting regarding certain provisions of the HHS requirements related to the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context. I request XX minutes of time to present at the 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.”

Read Part I

Vera Sharav

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