To The Editor:

I read with growing disbelief the paper by De Wolf et al. (1). The infusion of dobutamine in healthy children for nontherapeutic research is clearly outside of published relevant guidelines and is not consistent with ethical practice. The consent of the children or their parents is irrelevant in such a circumstance. It is not surprising that parents of a child who had been treated for a life threatening condition might consent to a procedure on another child out of a sense of gratitude and obligation to the physicians. This dilemma is addressed by the Helsinki Declaration:

“When obtaining informed consent for the research project the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship”.

It seems to me that parents do not have the right to consent to nontherapeutic research on their children if there is even a modicum of risk involved. The performance of noninvasive echocardiography would probably be within the limitations of ethical research on healthy children. Insertion of an i.v. catheter and administration of potent cardiac medications are clearly not.

Pediatric Research states in the Instructions to Authors that Institutional Review Board approval should be “noted in the text.” I can find no notation in the text of this article that such approval was obtained.

Pediatric Research also states in the Instructions to Authors that all human investigations must be conducted according to the principles expressed in the “Declaration of Helsinki.” This document includes the following statement: “physicians should cease an investigation if the hazards are found to outweigh the potential benefits.” This study had no potential benefits to the healthy control group; therefore, even the smallest possibility of potential harm would outweigh this. I am surprised and disturbed that Pediatric Research chose to publish this unethical study, and I suggest in the future that the Journal should state clearly in the Instructions to Authors that nontherapeutic research conducted in children, which poses even a modicum of risk, will not be acceptable for publication.

Keith J. Barrington MB