Pediatric Research OK in Maryland

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Science  19 Oct 2001:
Vol. 294, Issue 5542, pp. 493
DOI: 10.1126/science.294.5542.493c

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Summary

The Maryland Court of Appeals last week reassured worried researchers that a controversial recent decision was not intended to bar most studies in that state involving children.Universities and biomedical groups feared that language in the 16 August decision--involving a home lead paint cleanup study by the Kennedy Krieger Institute (KKI) associated with Johns Hopkins University--would outlaw studies involving "any risk" to children (Science, 28 September 2001, p. 2367). KKI filed a motion asking the court to reconsider. On 11 October the court denied the motion but stated that "by 'any risk' we meant any articulable risk beyond the minimal kind of risk that is inherent in any endeavor." Several groups that filed an amicus brief, including Hopkins and the Association of American Universities, say the clarification puts Maryland law back in accord with federal regulations allowing pediatric studies involving "minimal risk."

The court was not asked to reconsider its overall ruling, which found that the lead study was unethical. The case will now go to a trial court.