Protect children more in research, panel says

September 20, 2005|By Julie Bell | Julie Bell,Sun reporter

A federal advisory panel released a report yesterday recommending extra protections for children in research experiments, saying its findings were prompted by a Baltimore lead-paint study blasted four years ago in a court ruling.

The report, drafted by an expert panel named by the National Research Council and the Institute of Medicine, specifically declined to criticize Kennedy Krieger Institute researchers who measured lead levels in the homes of low-income Baltimoreans - in some cases allegedly without warning of dangerously high levels. Though the report is aimed at children and housing research, a government scientist told panel members yesterday at a Washington briefing that it might have broad application.

"We think that the findings aren't just applicable to housing-related research but to other research involving disadvantaged populations," said Peter J. Ashley, who works for the U.S. Housing and Urban Development Department's Office of Healthy Homes and Lead Hazard Control.

Recommendations include:

All federal agencies should adopt regulations aimed at giving additional protections to children in research, something only some agencies have done.

Community representatives should be involved in designing or consulting on such research.

Ethics oversight panels and researchers should ensure parents thoroughly understand the experiments proposed for their children before consenting.

Researchers consider designing studies that provide benefits to all children, rather than having some be in a "control" group.

The report was prompted by a 2001 Maryland Court of Appeals ruling that found fault with an early 1990s study designed to identify affordable lead-abatement techniques. The ruling said the study "presents similar problems" to the Tuskegee experiment of untreated syphilis, in which researchers withheld drugs from African-American men while monitoring progression of their disease.

The lawsuits involved in the Maryland Court of Appeals ruling were settled for undisclosed terms. Plaintiffs attorney Suzanne C. Shapiro said neither she nor her clients could comment.

Protection of children in research experiments is again in the limelight.

The Environmental Protection Agency, under pressure from Congress and environmental groups, has suspended some pesticide research. One study called for households to be sprayed so the effects on children could be measured. The EPA is reviewing how to handle experiments on children. Neither it nor HUD has specifically adopted regulations that protect children involved in research, the report noted.

Even agencies that have done so, such as the Department of Health and Human Services, are faced with confusing language that the government should clarify, the panel said.

For example, the regulations say it is acceptable to approve experiments on children that involve only "minimal risk." But they don't define the term.

Reaction to the recommendations was mixed. Kennedy Krieger spokesman Bryan Stark called them "sensible and reasonable."

Ruth Ann Norton, head of the Coalition to End Childhood Lead Poisoning, welcomed them.

"We have to break the link between lousy housing and poisoned children," she said, "but if research has to be done it cannot be done without the community having a place at the table."

But Adil Shamoo, co-founder of Citizens for Responsible Care and Research, said the suggestions fell short. What the country needs is a single law that covers all research on humans and that mandates researcher training, he said.

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