Tuesday, October 7, 2014

Justina Pelletier and the other Children Chosen for Nontherapeutic Research

No Entity may Utilize Children in Nontherapeutic Research—Maryland Court of Appeals

Medical researchers are generally required to obtain consent before selecting subjects for experimental studies but there are two vulnerable populations not covered by the The Federal Policy for the Protection of Human Subjects (Common Rule). The first consent-waiver group is foster children , the other, trauma patients . Wards of state have been clinical trial test vessels since 1989.

The most recent example of a foster child being used in ambiguous behavioral research is Justina Pelletier. She and other minors while patients at Boston Children's Hospital were placed under state custody on the premise that the parents were medically abusing their children. Once under state jurisdiction, these children were held by the hospital and treated for their newly-diagnosed psychosomatic disorders. These novel measures, instituted by Dr. Alice Newton , were expected to demonstrate that parental influence was the cause of the children's physical complaints. The circumstances of Justina's sixteen-month confinement as reported by The Boston Globe has precipitated a law to protect children from similar mistreatment. Titled, Justina's Law, H.R. 4989 would:
prohibit the use of federal funds to conduct or support treatment or research involving a ward of the state in which the individual's health is subjected to greater than minimal risk with no or minimal prospect of direct benefit.
An example of the use of children, with parental consent, in nontherapeutic research is the Kennedy Krieger Institute/Johns Hopkins lead abatement clinical study conducted in the early nineties. In 2001 the Maryland Court of Appeals determined , along with other issues, that:
in Maryland a parent, appropriate relative, or other applicable surrogate, cannot consent to the participation of a child or other person under legal disability in nontherapeutic research or other studies in which there is any risk of injury or damage to the health of the subject.
The lead measurement blood study 1993-1999, deliberately exposed hundreds of children to a known toxic property on the basis of the principle of the greater good. Involved parties, outside the complaint, included the EPA and the Johns Hopkins Institutional Review Board.

Concerns expressed by the court:

The researchers and their Institutional Review Board apparently saw nothing wrong with the search protocols that anticipated the possible accumulation of lead in the blood of otherwise healthy children as a result of the experiment, or they believed that the consents of the parents of the children made the research appropriate.

Annotation: Of the more than three thousand Institutional Review Boards directing research, many have been censured for their conduct. Members of Congress and the General Accounting Office have found IRB standards lacking, but nevertheless these entities control the clinical trial environment. Janet Woodcock, director of CDER at the FDA, has reported that " the agency inspects at most 1 percent of all clinical trials ." An AMA survey conducted in 2002 found that IRB chairpersons could not agree on risk parameters for routine procedures performed on a healthy eleven-year-old child. For instance there was no consensus on whether pharmacokinetic testing was a minimal risk, minor increase over minimal risk or more than a minor increase over minimal risk procedure.

Otherwise healthy children, in our view, should not be enticed into living in, or remaining in, potentially lead-tainted housing and intentionally subjected to a research program, which contemplates the probability, or even the possibility, of lead poisoning or even the accumulation of lower levels of lead in blood, in order for the extent of the contamination of the children's blood to be used by scientific researchers to assess the success of lead paint or lead dust abatement measures. Moreover, in our view, parents, whether improperly enticed by trinkets, food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous nontherapeutic research surroundings, than do researchers. In such cases, parental consent, no matter how informed, is insufficient.
Here, the IRB, whose primary function was to insure safety and compliance with applicable regulations, encouraged the researchers to misrepresent the purpose of the research in order to bring the study under the label of "therapeutic" and thus under a lower safety standard of regulation. The IRB's purpose was ethically wrong, and its understanding of the experiment's benefit incorrect.
Children, it should be noted, are not in our society the equivalent of rats, hamsters, monkeys, and the like.

The Nuremberg Code , cited often by the Appeals Court, was written to guard the public from scientific abuses with the "essential" informed consent rule. In the court's opinion citizens are empowered with the freedom to choose their medical course of treatment both by the Nuremberg Code and the due process Amendments.

Those who disagree with the Appeals Court Nuremberg Code ruling argue that:
the failure to conduct such research causes greater harm because it deprives disadvantaged populations of the benefits of imminent improvement in their health conditions.
The question is, whose opinion is trustworthy?

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