Ethical and practical issues regarding research in children: the European perspective.

Children, like all humans, are exposed to compounds in the environment and sometimes to drugs. The effect of this exposure cannot simply be deducted from studies in adults or animals. Effects might be different and even more dramatic than in adults due to the stage of growth and development of the infant. Around 80% of drugs used in young individuals are not licensed for use in this age group. Almost three new chemical compounds enter the environment each day. Toxicological studies in infants and children therefore are needed and ethically acceptable. However, appropriate safeguards must be taken into account. According to the Good Clinical Practice Directive of the European Parliament (2001/20) not only therapeutic, but also non-therapeutic research in infants and children is allowed, provided the study can only be conducted in children, and the results of the study in children will be of benefit to the group represented and no more than minimal harm and risk is inflicted to the children. Many more toxicological studies are needed in children and infants. Not conducting these studies is detrimental for this age group.