Frontline ethical issues in pediatric clinical research: ethical and regulatory aspects of seven current bottlenecks in pediatric clinical research.

In the course of the past decades, considerable effort has been expended on the ethical guidance and legal regulation of pediatric clinical trials in Europe. Nonetheless, the conduct of clinical research in the population of minors continues to generate myriad ethical and regulatory issues. This paper explores seven bottlenecks in the ethical guidance and legal regulation that currently govern pediatric clinical research: (1) the integration of research in therapy, (2) the education of clinicians, (3) the empowerment of families, (4) the harmonization of protocol review, (5) the assessment non-clinical research objectives, (6) the control of placebo use, and (7) the provision of fair incentives for pediatric research conduct. For all of these issues, a clear view on the way forward is largely lacking, either because these issues have not been discussed in depth to date or because the existing debates have failed to generate a generally supported consensus.