An examination of ethical issues raised in the pretreatment of normal volunteer granulocyte donors with granulocyte colony-stimulating factor

Objective.-To explore some of the ethical issues surrounding the administra tion of granulocyte colony-stimulating factor (G-CSF) to healthy individual s for the purpose of retrieval of granulocytes. Design.-Review of the historical precedent of drug administration to normal blood donors and review of the literature concerning the side effects of C -CSF administration to healthy individuals, particularly as related to gran ulocyte collection. We identify and discuss some of the ethical questions r egarding this issue. Results.-Although the short-term side effects of C-CSF use in normal donors are generally felt to be benign, little is known about the long-term side effects. Ethical questions regarding the administration of this drug to nor mal donors for the purpose of collecting large numbers of granulocytes incl ude the following: Does the potential benefit to a patient/recipient justif y the unknown risks to the medicated granulocyte donor? Who should act as a n advocate for donors so that their best interests are protected? What is t he role and quality of informed consent for donors undergoing G-CSF adminis tration? Is monetary compensation appropriate for donors administered C-CSF as part of a research protocol? Conclusions.-We recommend the establishment of a donor registry to collect the needed data on the side effects of C-CSF on normal donors. Until adequa te data are collected, the use of C-CSF and similar agents in normal donors should be regarded as experimental and subject to review by institutional review boards.