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A landmark
decision by Maryland's highest court, the Court of Appeals of Maryland,
is a victory for the human rights of children.
The decision affirms the responsibility of parents, the government, researchers
and institutional review boards (IRB) to protect children from non-therapeutic
experiments that may put their health at risk.
"We hold 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 non-therapeutic research or
other studies in which there is any risk of injury or damage to the
health of the subject. "
"We
hold that informed consent agreements in non-therapeutic research projects,
under certain circumstances can constitute contracts; and that, under
certain circumstances, such research relationships can, as a matter
of law, constitute "special relationships" giving rise to
duties, out of the breach of which negligence actions may arise."
Two cases involved a lead exposure experiment conducted by researchers at
the Kennedy-Krieger Institute of Johns Hopkins University. Little
children were deliberately exposed to lead dust poisoning for two years
so that researchers could measure their blood for comparison of lead
levels with children not exposed. Their blood was measured at 2 months,
6 months, 12 months, and 18 month intervals. The experiment was sponsored
jointly by the the federal government--Environmental Protection Agency--and
the Maryland Department of Housing and Community Development.
The 98 page decision issued by the 7 judge panel severely criticized
the researchers, "the research community as a whole," the
Johns Hopkins University IRB, and the University Joint Committee on
Clinical Investigation--all of whom, the Court ruled, "abdicated
their responsibility to protect the safety and health hazard impact
on the human subjects," in this case infants and little children." The
purpose of the study was manifestly not to reduce the level of lead
in the blood of the children that were the subjects of the study, but
to create a controlled research environment focusing on abatement of
lead dust."
The Court noted that "The researchers and their Institutional
Review Board apparently saw nothing wrong with the [re]search protocols
that anticipated the possible accumulation of lead in the blood of otherwise
healthy children as a result of the experiment...It can be argued that
the researchers intended that the children be the canaries in the mines..."
The Court found the Johns Hopkins IRB to be directly implicated in circumventing
federal regulations by "suggesting to the researchers a way to
miscast the characteristics of the study in order to avoid the responsibility
inherent in nontherapeutic research involving children."
The cases: Grimes v Kennedy-Krieger Institute; Higgins v Kennedy-Krieger
Institute:
http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf
This decision is particularly timely because the Department of
Health and Human Services had begun a process of redefining the language
of federal regulatory restrictions in order to facilitate expanded recruitment
of healthy "risk bearing children" for drug testing. The
Alliance for Human Research Protection (AHRP)is on record for its vigorous
opposition to the weakening of regulatory protections for children and
to the recruitment of children for nontherapeutic medical experiments--even
with parental permission.
The Maryland
court, noting "the relatively few cases in the area of ethics of
protocols of various research projects involving children" provide
strong support for AHRP's position:
The Court's decision states: "It is not in the best interest of
a specific child, in a nontherapeutic research project, to be placed
in a research environment, which might possibly be, or which proves
to be, hazardous to the health of the child. We have long stressed
that the 'best interests of the child' is the overriding concern of
this Court in matters relating to children. Whatever the interests of
a parent, and whatever the interests of the general public in fostering
research that might, according to a researcher's hypothesis, be for
the good of all children, this Court's concern for the particular child
and particular case, over-arches all other interests. It is, simply,
and we hope, succinctly put, not in the best interest of any healthy
child to be intentionally put in a nontherapeutic situation where his
or her health may be impaired, in order to test methods that may ultimately
benefit all children."
"To think otherwise, to turn over human and legal ethical concerns
solely to the scientific community, is to risk embarking on slippery
slopes, that all to often in the past, here and elsewhere, have resulted
in practices we, or any community, should be ever unwilling to accept."
The Maryland Court decision underscores the legal vulnerability of research
subjects - particularly America's children. The Court noted with
concern that "consent to research has been virtually unanalyzed
by courts and legislatures." It also noted that the well-defined
principles for medical research that are articulated in both the Nuremberg
Code and the Declaration of Helsinki have also been ignored in the legal
arena.
To ensure that medical ethics standards are no longer ignored--and to
prevent bureaucratic manipulation of the current vague and inadequate
regulations--clear and forceful legislation is long overdue.
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