tion (FDA). This well-established mechanism allows for the use of experimental drugs or biological products in studies with humans via a registration process.

This chapter focuses on: (1) issues surrounding the procedures used to obtain informed consent from potential cord blood donors; (2) concerns about disclosure to donors of significant clinical information discovered during the donor screening process; (3) and points to consider in the research use of cord blood, including protection of donor confidentiality. In addition, brief mention is given to the potential impact of patent litigation on cord blood banking practices.

INFORMED CONSENT OF DONORS

Until recently, cord blood was considered one of the many biological waste materials discarded after the birth of a baby (Fernandez, 1998; Gluckman, 2000). The possibility of using cord blood as a source of stem cells for transplantation altered this view and introduced different rules and regulations for appropriate decision making, handling, and use of this biological material. It is ethically important to obtain informed consent for the donation of any cord blood unit, regardless of the timing of collection or the potential use of the unit (see Table 5-1 for descriptions of consent practices among several agencies). Informed consent procedures for the donation of cord blood should follow a consistent set of protocols that educate the donor about the various options for cord blood use. The requirements should be modeled on already established criteria for transfusion of whole blood and other unfrozen blood products (Fernandez, 1998).

Who Provides Consent?

The need for consent from the mother, father, or both varies according to the individual circumstances of the potential donors. If the cord blood is removed while the placenta is still in the uterus, generally the mother’s consent is sufficient because it is an extension of her body. If the cord blood is removed after the placenta has been taken from the mother’s uterus, however, an argument could be made that the father’s wishes are also relevant—just as both the mother and the father would be decision makers about their child’s care. Few cord blood banks or collection centers obtain consent from both parents (Institute of Medicine bank survey; see Table 5-1 and Appendix C). Because the father may not be available at the moment of delivery, it would be difficult for a cord blood bank to obtain the both paternal and maternal consent within the time frame needed to begin processing. The majority of women polled in a recent study (86 percent) believed that cord blood was a valuable resource and should be collected,



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