Conducting research with children: legal and ethical issues.

Research with children and mentally disabled individuals raises difficult legal and ethical issues. It is the obligation of researchers and those who review research to protect both the rights and welfare of research subjects. Ethicists, legal scholars, and national commissions have examined the circumstances under which it is acceptable to use incompetent people as research subjects, since they are unable to provide consent for participation. Furthermore, there is an extensive set of federal rules that govern the use of children as research subjects. Children may be used as research subjects after a careful weighing of risks and benefits, and as long as they participate in the decision to the extent they are able to do so. However, research projects that will not provide children with direct benefit, such as some placebo-controlled trials, raise particularly difficult issues concerning the protection of these subjects. While biomedical research is an important and socially desirable undertaking, it must proceed only when the rights and welfare of the subjects are scrupulously protected.