Court ruling is slowing research that could help sick children

September 23, 2001|By Robin Weiss, Timothy F. Doran and Susan Leviton

A RECENT ruling by Maryland's Court of Appeals meant to protect children who participate in medical research may in fact do immeasurable harm to all children if it stands unchallenged.

The court's new rule that was announced in August was contained in a ruling on a civil case about the Kennedy-Krieger lead-poisoning study. In it, the court holds that parents cannot consent to the participation of a child in "nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject."

This opinion threatens to paralyze the conduct of research on children in Maryland. Many research protocols that may result in new therapies for children are being put on hold because scientists are confused about what is now permissible in the state.

The decision appears to be at odds with extensive federal regulation, developed over years with the participation of ethicists, medical researchers and consumers. Prevailing standards, promulgated by various governmental and private entities both here and abroad, allow children to participate in nontherapeutic medical research (with parents' consent) when that research would benefit other children and entails minimal risk.

The court, in moving from the federal standard of allowing minimal risk, to allowing no risk, would render illegal a wide range of medical research crucial to improving the health of children. The development of improved diagnostic tests and our understanding of normal and abnormal physiologic functioning in health and disease frequently involve some minimal risk to those children participating in investigational studies.

Most experts agree that participation in a research study is never risk-free; even answering questions on a questionnaire, for example, might be upsetting. What constitutes minimal risk for children has been carefully defined, and usually includes such procedures as a small amount of blood testing, urinalysis, other less invasive standard testing or minor changes in diet or daily routine.

To further complicate matters, the court has not clearly defined what it means by nontherapeutic. Some research protocols involve new therapies for very ill children in which the drug under study may directly benefit the research subject -- that is, be therapeutic.

But what about research on vaccines, in which the subjects may be healthy children and the treatment under study is not directly therapeutic? Meningitis and other life-threatening infections from a type of influenza -- HIB -- decreased by more than 95 percent after the introduction of an effective vaccine in 1985. There were 20,000 severe cases of HIB and more than 1,000 deaths a year before its introduction.

The development of this vaccine for children was only possible with their participation. Vaccine trials always entail risk, even though the vaccines are extensively tested in animals first.

If the court's ruling had been the law in 1985, thousands of children would not be alive today. The ruling is so broad that even studies entailing minuscule but potential risk might be prohibited. Advanced imaging techniques (MRIs and PET scans) on children with autism are yielding important clues about the brains of children with this devastating disease. Would the theoretical risk of future consequences from these nontherapeutic studies halt their conduct?

In fact, the crisis in the last few decades, emphasized by myriad national reports, has been the paucity of research on treatments for children. Medical research must involve children in order to advance our understanding of diseases that uniquely affect them. To deprive children of participation in these studies will, ultimately, also deprive them of effective diagnostic methods and possibly cures for many terrible diseases.

The Maryland Court of Appeals must affirm that state law is not in conflict with federal regulations so that Maryland's children can continue to contribute to and benefit from important pediatric research advances.

Robin Weiss, M.D., is president of the Maryland Psychiatric Society. Timothy F. Doran, M.D., is chairman of the Department of Pediatrics at Greater Baltimore Medical Center. Susan Leviton is director of the Children's Law Clinic at the University of Maryland Law School.

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