Trial Participation for Newborns Raises Questions

August 8, 2008

Although newborns deserve medical treatments based on clinical research, recruiting infants to more than one study carries important scientific and ethical implications, according to a commentary in the Aug. 9 issue of The Lancet.

FRIDAY, Aug. 8 (HealthDay News) -- Although newborns deserve medical treatments based on clinical research, recruiting infants to more than one study carries important scientific and ethical implications, according to a commentary in the Aug. 9 issue of The Lancet.

Kathryn Beardsall, of the University of Cambridge in Cambridge, United Kingdom, and colleagues write that a preterm infant in a typical U.K. subspecialty neonatal unit might be eligible for six research studies. Opinions on the limit for participation vary according to regulatory bodies.

Recruiting infants into more than one trial may reduce the power of each trial, and interactions between drugs in different trials may be beneficial or harmful, the authors note. Even observational trials may require additional blood samples, and multiple blood draws could lead to the need for transfusion, the article points out. In addition, obtaining consent from parents for studies, particularly within a short time frame, can add to their anxiety, the authors write.

"Any new intervention should be thoroughly investigated as part of a sound research protocol rather than being adopted into clinical practice without a good evidence base. We advocate that infants should be eligible for recruitment to multiple studies unless there is evidence that this would undermine the biological and scientific validity of that research or compromise the care, safety or legal rights of an individual. The current situation in which individual ethics committees, perhaps without any perinatal expertise, can give opinions on exclusion from other unknown studies is not helpful," Beardsall and colleagues write.

All the authors have been involved in organizing efforts to bring infants into multiple studies.

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