Ethical issues pediatric studies

The American Academy of Pediatrics formed a Committee on Drugs to examine ethical issues of pediatric studies for its members and for the guidance of IRBs dealing with pediatric studies. The Committee released its report in 1995. This report (Committee Drugs, American Academy of Pediatrics) is very comprehensive, but amongst its many recommendations the following areas are highlighted. 

As the pediatric subgroup represents a vulnerable population, studies in children are endowed with specific challenges such as additional ethical (e.g., informed consent be obtained from the legal guardian) or clinical-technical (e.g., minimize the amount of blood drawn and the number of venipunctures) issues. 

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