Pharmacogenomics and children: meeting the ethical challenges.

Pharmacogenomic research promises to permit the development and delivery of safer and more effective drugs. If children are to receive these benefits, as justice would demand that they should, children must be included in trials that assess the impact of genetic variation, changing patterns of gene expression over time, and the effects of administering drugs. The ethical and legal challenges to conducting the necessary research include concerns about vulnerability and issues of consent, the scientific validity of the studies and the larger policy question of priority setting. Proposed strategies for ensuring the appropriate conduct of this research include analysis of the ethics based on risks and harms rather than presence or absence of a disorder, the development of model substrates to conduct physiological testing more safely, and the consideration of the disposition and impact of individual study results. With appropriate study, ultimately the use of pharmacogenomic testing can become available for children in the clinical setting.