September 21, 2001

AAMC Files Amicus Brief in Kennedy-Kreiger Opinion

The AAMC and the Association of American Universities (AAU), announced Sept. 18 that they have joined with two individual institutions, the University of Maryland Medical System, and The Johns Hopkins University, to file an amicus brief supporting the appellant's motion for reconsideration of the opinion issued by the Maryland Court of Appeals in Grimes v. Kennedy Krieger Institute, Inc. The brief does not ask the court to reverse its decision that the two cases at issue should return to the circuit court for adjudication. Instead, it strongly urges that the Court review, reconsider, and rescind only that portion of its decision "that would have a devastating impact on health and human development research."

The August 16, 2001, opinion of the Maryland Court of Appeals made it illegal for parents or guardians to give consent for children or legally impaired adults to participate in non-therapeutic research that poses any level of risk. Since most critically important medical research is, strictly speaking, "non-therapeutic," and since virtually all research, by its nature, poses some level of risk, the Court's ruling would make most medical and public health research involving children or legally impaired adults impossible to conduct in Maryland.

Under existing federal rules, parents or guardians may consent to the participation of children and legally-impaired adults in medical research under carefully controlled circumstances. The signatories ask the Court to revise the portion of its opinion that would erect an unworkable standard for participation in research in Maryland, one that would be "vastly more restrictive than that of any other state or that of the federal government." The AAMC and the AAU believe that unless modified, the legal standard announced in the Court's opinion would greatly harm the progress of medical science. As noted in the amicus brief, "if the legal standard is that research must be therapeutic for each and every individual involved who faces any risk, a great deal of health research involving children and other persons under legal disability (e.g., persons with Alzheimer's disease), including research regarding the causes, progression, prevention, and treatment of conditions of high morbidity and mortality, could never be conducted."

Neither the brief nor the motion for reconsideration being filed by the Kennedy Krieger Institute asks the court to set aside its decision to permit a trial on the issues raised in the underlying litigation, which concerns the conduct of an EPA-supported study of lead abatement conducted by the Kennedy Krieger Institute.

Information: David Korn, M.D., AAMC Division of Biomedical and Health Sciences Research, 202-828-0509.