October 26

Lead Paint Study – Background of Maryland Appeals Decision

Highest Court in Maryland Validates AHRP’s Position in Decision to Affirm Federal Prohibition on Non-Therapeutic Experimentation on Children

To read the full text (98 pages) of the Maryland Court of Appeals decision, go to the following URL for a pdf version: http://www.law.uh.edu/healthlaw/law/StateMaterials/Marylandcases/grimesvkennedykreiger.pdf
(Depending on the speed of your connection, it could take a few minutes to download.)

August 16, 2001

Background Summary of the Maryland Court Decision

Children who are incapable of legally making an informed choice, are being increasingly subjected to non-therapeutic experiments that put them in harm’s way, often without their parents ability to anticipate those risks.

On August 16, 2001, the Maryland Court of Appeals issued a strongly-worded, 98 page, precedent-setting decision [Higgins vs. Kennedy Krieger Institute, Inc.] The case involved an experiment in which healthy babies and young children were exposed to lead paint poison: it was conducted by an affiliate of Johns Hopkins University. The case was brought to the Maryland Court of Appeals because a lower court ruled against plaintiffs whose children had been exposed. An appeal was then made to have the Court of Appeals reverse the lower court decision.

The Maryland Court of Appeals remanded the case to the trial court and rendered a far-reaching opinion that unequivocally affirmed federal regulations prohibiting the use of children in non-therapeutic experiments involving risks of harm. The Court cited the Nuremberg Code and the Declaration of Helsinki, affirming the primacy of individual human rights. The Court validated AHRP’s position on children as experimental subjects: the Court unequivocally ruled that children may not be used in non-therapeutic experiments that put them at any risk of harm:

" 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 non-therapeutic situation where his or her health may be impaired, in order to test methods that may ultimately benefit all children." [p.82]

We believe the Court has clearly and unambiguously ruled on matters that have long needed judicial attention: * Parental authority does NOT extend to giving informed consent for the participation of their children in nontherapeutic research that might put them at risk without any personal benefit. The Court stated:

* " What right does a parent have to knowingly expose a child not in need of therapy to health risks or otherwise knowingly place a child in danger, even if it can be argued it is for the greater good?" (p 79)

* "It is not in the 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." (p. 80)

á The Court further held, and AHRP agrees, "Science cannot be permitted to be the sole judge of the appropriateness of such research cases, the research study protocols, especially in respect to children. We hold that in these contested cases, the research study protocols.were not appropriate." [p.84]

The defendants, Kennedy Krieger Institute (KKI) of Johns Hopkins University, filed a motion to reconsider. Amicus Curiae (friend of the court) briefs in support of KKI were filed by powerful members of the research establishment with vested interests in research, namely, the Association of American Medical Colleges, the Association of American Universities, Johns Hopkins University, and the University of Maryland.

AHRP filed the only Amicus Curiae brief in Maryland’s Appellate Court urging the court to uphold its decision affirming the federal prohibition against the use of children in non-therapeutic experiments involving risks of harm. AHRP provided the court with additional evidence of harmful children’s experiments to support the decision.

Despite pressure brought to bear by the research establishment, the Maryland court refused to reconsider its decision, letting stand its strongly worded criticism of the research community that approved the experiment, and ban on non-therapeutic experiments that put children in harm’s way. The Court’ ruled in favor of AHRP’s motion, thereby validating AHRP’s position on unacceptable experimentation on children.

Click here to read the text of the Amicus brief.

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