October 26

Maryland Lead Paint Appeal Denied


Maryland Court of Appeals Denies Motion to Reconsider Lead Paint Ruling

October 10, 2001

FYI

Maryland’s highest court denied the motion for reconsideration or partial modification of its Opinion–as requested by Kennedy Krieger Institute and their powerful allies in the research community (who filed Amicus briefs in support of defendants’ request to reconsider ).

The Alliance for Human Research Protection (AHRP) submitted the only Amicus Brief in support of the Court’s landmark decision, against the motion to reconsider. 
(Click here to read AHRP Amicus brief.)

The Court stood firm in its original Opinion: (http://www.law.uh.edu/healthlaw/law/StateMaterials/Marylandcases/grimesvkennedykreiger.pdf)

In denying Kennedy Krieger’s motion for reconsideration, once again, in a 6 to 1 ruling, the Court said:

"Much of the argument in support of and in opposition to the motion for reconsideration centered on the question of what limitations should govern a parent’s authority to provide informed consent for the participation of his or her minor child in a medical study.  In the Opinion, we said at one point that a parent ‘cannot consent to the participation of a child…in non-therapeutic research or studies in which there is any risk of injury or damage to the health of the subject.

Contrary to a report in the Baltimore Sun (Oct 12, 2001) , the Maryland Court of Appeals did not modify its August 16th opinion; it reaffirmed its holding that parental authority does NOT extend to giving informed consent for the participation of their children in non-therapeutic research that might put them at risk without any personal benefit.

Referring particularly to Section VI of its original Opinion, the Court offered the following explanation: "by ‘any risk,’ we meant any calculable risk beyond the minimal kind of risk that is inherent in any endeavor. The context of the statement was a non-therapeutic study that promises no medical benefit to the child whatever, so that any balance between risks and benefit is necessarily negative."

Thus, the Court makes clear that subjecting children to risks beyond those they might encounter in everyday activities is unacceptable (specifically, to risks in research that offers them no direct benefit). This clarification was needed because those who oppose the Court’s decision tried to make it seem that "any risk," e.g., school athletics (and presumably even being involved in a car accident on the way to the clinic or the possibility of a child tripping on the hospital steps), would preclude the possibility of any research on children. That interpretation is ludicrous and they know it!

Section VI of the original Opinion, "Parental Consent for Children to Be Subjects of Potentially Hazardous Non-therapeutic Research" states:

"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?"

"The issue of the parents’ right to consent on behalf of the children has not been fully presented in either of these cases, but should be of concern not only to lawyers and judges, but to moralists, ethicists, and others. The consenting parents in the contested cases at bar were not the subjects of the experiment; the children were. Additionally, this practice presents the potential problems of children initiating actions in their own names upon reaching majority, if indeed, they have been damaged as a result of being used as guinea pigs in non-therapeutic scientific research. Children, it should be noted, are not in our society the equivalent of rats, hamsters, monkeys, and the like…Most of the relatively few cases in the area of the ethics of protocols of various research projects involving children have merely assumed that a parent can give informed consent for the participation of their children in non-therapeutic research."

"It is not in the best interest of a specific child, in a non-therapeutic 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 non-therapeutic 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 too often in the past, here and elsewhere, have resulted in practices we, or any community, should be ever unwilling to accept."

(The Court’s DENIAL to reconsider is at the end of the original Aug decision at: http://www.law.uh.edu/healthlaw/law/StateMaterials/Marylandcases/grimesvkennedykreiger.pdf


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