This month, Pediatric Research contains two letters that touch on some of the ethical issues surrounding the subject of research involving children. The first letter criticizes a published study (Pediatr Res 44:600–606, 1998) that involved normal children receiving an i.v. infusion of a drug. The author of the letter, while recognizing that no harm came to these children, points out that there was also no potential benefit offered to the subjects by the invasive measure. Accordingly, the author of the letter considers that such research was not ethical despite the view of the institution, which granted its approval for the study.

In their letter of response, the authors of the study indicate that the children who received the drug infusion and their parents gave informed consent for participation and that no subjects were subsequently harmed by the measures taken. They emphasize the importance of having obtained normal values for this study and the broader responsibility of the research community at large to involve normal children in research so that tests in children with disease can be related to normal values in healthy children.

Balancing the need to establish normal values for research against the responsibility of not causing harm to children was considered in the Guidelines prepared by the Council of International Organizations of Medical Sciences in collaboration with the World Health Organization. The Guidelines state:

“The risk of interventions that are not intended to be of direct benefit to the child-subject must be justified in relation to anticipated benefits to society (generalizable knowledge). In general, the risk from such interventions should be minimal—that is, no more likely and not greater than the risk attached to routine medical or psychological examination of such children. When an ethical review committee is persuaded that the object of the research is sufficiently important, slight increases above minimal risk may be permitted.” (1)

If it is agreed that there is a need for research studies of normal children, it follows that there is also a need to determine acceptable levels of minimal risk. There may be no clear line defining what is a permissible level of risk and what is not permissible. Accordingly much responsibility rests with Institutional Review Boards to determine the boundaries of acceptable research in healthy children. However, it is also vital that the international medical community continues to engage in open dialogue on the subject to enrich our understanding of this critical issue, so vital to our work.

Pediatric Research is striving to offer a forum for such dialogue. We welcome the input of our readers concerning their views on and experience with this and related subjects.