Bioethics and innovation in pediatric nutrition research.

Advances in technology and understanding of fundamental human biology allow for an increasingly innovative research agenda in pediatric nutrition. All human research is governed by the norms of bioethics, which are in turn based on four primary principles: free will in participation, freedom from harm, opportunity to benefit, and non-discrimination in access. Legally, if not essentially, juveniles do not have free will to affirm their participation as research subjects. They have an absolute right, in nontherapeutic research, however, to decline. Pivotal in the discussion in nontherapeutic research in healthy children is the tolerance for risky procedures. Complicated situations include: multi-national protocols, choice of developing country sites, the inclusion of placebo treatment arms, analysis of genetic biomarkers, and research for commercial enterprises. The overly stringent interpretation of bioethical principles, as adapted to children, would stifle innovation in research. A relaxed bioethical attitude in pursuit of advancing science, by contrast, could violate essential human rights and expose a population worthy of special protection to undue risk and harm. By following the course of utility, seeking the steepest benefit-to-risk ratios, weighted toward safety and child welfare, the divergent nature of the considerations should be brought into convergence for the sake of continuing innovation.