Curbs eased on childhood illness studies

State's high court modifies language of Krieger ruling

Lawsuits can continue

Children can be put in research having `minimal risk'

October 12, 2001|By Tom Pelton | Tom Pelton,SUN STAFF

Maryland's highest court modified yesterday the language of a recent court decision that put sweeping restrictions on research into childhood illness.

Officials at the Johns Hopkins University and Kennedy Krieger Institute praised the Maryland Court of Appeals' clarification, saying it will allow hundreds of important studies to continue.

The state's high court made the modification to an Aug. 16 ruling that allowed the families of two Baltimore children to sue the Kennedy Krieger Institute, a children's center affiliated with Hopkins, over claims that they became poisoned with lead paint during a study from 1993 to 1995.

Yesterday's decision allows Ericka Grimes and Myron Higgins to continue their lawsuits but alters language that prohibited parents across the state from enrolling their children in experiments that pose "any risk" or fail to directly benefit the children.

In a 7-0 decision, the judges said yesterday that parents should be allowed to enroll their children in experiments that pose "minimal risk." This means that researchers in Maryland will continue to follow federal regulations, ending the threat that millions of dollars in research grants -- such as for the development of vaccines for children -- would go instead to out-of-state institutions.

"We are pleased," Kennedy Krieger and Johns Hopkins officials said in a joint statement. "The clarification restores the ability of Maryland's institutions to continue their important research involving children."

The court's ruling wasn't entirely in Kennedy Krieger's favor. Although the judges clarified the language of their Aug. 16 decision, they denied the institution's request to throw out language that compared the lead-paint study to the infamous Tuskegee syphilis studies, in which researchers deliberately withheld treatment from poor black men with the illness.

Kennedy Krieger officials had argued that the studies were in no way comparable. Their 1993 to 1995 study examined the effectiveness of partial lead abatement techniques in about 100 older Baltimore rowhouses. All families in the study had the lead dust in their homes reduced by at least 80 percent, researchers said.

Saul Kerpelman, an attorney for one plaintiff, said that the judges' clarification yesterday had little meaning to his lawsuit and that Kennedy Krieger exaggerated the risk to childhood research.

Kerpelman said that no date has been set for trial, but that he has three more families -- for a total of five -- ready to sue Kennedy Krieger over the lead study.

Dr. Gary Goldstein, president of Kennedy Krieger, said he looks forward to having the facts of the study presented in court.

The clarification yesterday means that Kennedy Krieger and Hopkins may not need to continue with efforts to persuade state lawmakers to create legislation to negate the court decision, Goldstein said. Several top lawmakers had agreed to do this.

Legislative leaders said yesterday that they were uncertain if the court's clarification provided enough protection for medical studies to proceed.

If not, they said, the General Assembly would consider next year a law that would ease concerns of parents and scientists.

State Sen. Barbara Hoffman, a Baltimore Democrat and Hopkins employee who is chairwoman of the Budget and Taxation Committee, said the clarification's language is too murky. She said she might consider legislation that would spell out more specifically what kind of studies involving children researchers could perform.

Sun staff writer David Nitkin contributed to this article.

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