Issues in pediatric research: safeguarding the children.

PURPOSE

To address the ethical question: "How can one safeguard children who participate in research?"

PATIENT POPULATION

Infants through adolescents.

CONCLUSIONS

Federal guidelines that delineate when research is allowable with children may not be enough to ensure children's safety from harm.

PRACTICE IMPLICATIONS

Risk evaluation conducted by those who understand child development because such understanding allows one to better anticipate children's potential exposure to harm. Safeguarding children requires a conscientious effort to envision children's understanding of events, their potential reactions, and the possible immediate and long-term consequences. This understanding provides the foundation for implementing sound research procedures to safeguard the children.