August 20

AHRP Comments on Landmark Decision by the Court of Appeals of Maryland

“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:

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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