Beyond proforma consent for childhood cancer research.

A critical negotiation is that of obtaining informed consent from those responsible for the child with cancer who is to be involved in clinical research. It requires that the researcher weigh the merits to society of the proposed research trial and the interests of the patient and family. The clinical setting in which agreement to participate is requested and the regulations of the DHHS for such investigations also place special demands on all of those involved. This article is an ethical and psychosocial analysis of informed consent. It is intended to provide pediatric physician-investigators with a better understanding of this complex process to improve their fiduciary relationship with decision makers.