|
|
Office of External Affairs • 515 West Lombard Street • Baltimore, Maryland • 21201-1691 • 410/706-0780
Contact: Ed Fishel
Phone: 410/706-3810 Pager: 410/471-1735
efishel@oeamail.umaryland.edu
September 17, 2001
The University of Maryland Baltimore (UMB), a leading center for pediatric health care research, has asked the Maryland Court of Appeals to clarify one aspect of its opinion in a suit filed against the Kennedy Krieger Institute, Inc. The suit was filed by the parents of two children who participated in a study funded by the National Institutes of Health.
The motion for reconsideration filed by UMB asks the court to clarify the meaning and scope of a single sentence near the end of the opinion, and hold that Maryland law is consistent with federal regulations defining acceptable pediatric research. The sentence is:
“We hold that in Maryland a parent, appropriate relative, or other applicable surrogate, cannot consent to the participation of a child…in nontherapeutic research of studies in which there is any risk of injury or damage to the health of the subject.”
“We need clear guidance for parents and medical investigators. A far reaching interpretation of that holding could end a wide range of pediatric research, including trials of unproven new drugs and vaccines,” says David J. Ramsay, DM, DPhil, president of the University of Maryland Baltimore. In a literal interpretation, “nontherapeutic research” might be construed to mean any research in which the child does not receive treatment with a proven therapeutic benefit. The point of much pediatric research is, in fact, to determine whether a treatment has therapeutic benefit in children. “The welfare of children is at stake,” says Dr. Ramsay.
Approximately 190 pediatric studies are currently underway at UMB in the Schools of Medicine, Nursing, Dentistry, Social Work and Pharmacy. Several studies focus on healthy children at risk for diseases such as HIV. Other studies include vaccine trials to prevent healthy children from contracting serious diseases and tests of experimental cancer treatments for desperately ill children.
“No research is entirely risk-free,” says Howard Dickler, MD, associate dean for research at the University of Maryland School of Medicine. “Even a simple questionnaire carries the risk of upsetting a child.” All human subject research on the UMB campus, including studies involving children, must be approved and monitored by the Institutional Review Board under generally accepted ethical principals and regulations established by the federal government.
###
http://www.oea.umaryland.edu/Media/NewsSum/News.htm
The Baltimore campus of the University of Maryland is home to the dental school, graduate school, and schools of law, medicine, nursing, pharmacy, and social work. It is the founding institution of the University System of Maryland.
(court clarification)