ACBSCT recommends to the Secretary that the following informed consent principles and standards be implemented for public cord blood banking.
Informed consent for clinical care, research, donation of tissue and organs is based on the ethical principle of personal autonomy – a person has the right to make decisions about what shall be done to and with his or her body. Although informed consent for public cord blood banking is akin to donation of organs, it is complicated by the fact that the birth mother, the biological mother, the newborn child and the intended parents can all be affected by the choice. Cognizant of these relationships, the ACBSCT sets forth the following recommendations. ACBSCT intends these recommendations to allow individual banks the flexibility to adopt their own procedures consistent with the recommendations. These recommendations should be interpreted in light of State and Federal laws and regulations, as well as Institutional Review Board requirements.
ACBSCT recommends one basic principle to guide the decision about who should consent for cord blood banking: the birth mother and, if applicable, one legal parent or guardian of the child should consent for donation.
Rationale: The birth mother should consent because she needs to undergo testing prior to donation. The legal guardian needs to consent because he or she is responsible for providing the bank with information about the child and will be responsible for the child. For example, when the birth mother is not the intended parent, whether she is the biological mother or not, then both the birth mother, who will have to be tested for infectious disease, and one intended parent, who will be responsible for providing the bank with information about the child and who will be responsible for the child, should consent.
Information should be provided to the person for whom it is likely to have medical impact.
Rationale: Information obtained from the testing of the birth mother should be provided to the birth mother if it is likely to impact her health and medical care and to the child’s intended parent if it is likely to impact the child’s health and medical management.
- Ideally, the first discussion of cord blood banking should occur at a regular office visit well before labor and delivery. However, if the woman has not pre-registered, the information about cord blood banking can be given on presentation to the hospital for delivery. Each bank should have a policy about how consent is offered, which addresses the following issues: the stage of labor and stress of the mother, the amount of pre-counseling that has taken place and the amount of time available for an adequate discussion of the consent. The banks should also consider offering a “pre-consent” for collection only, with the consent for banking completed after delivery.
- ACBSCT encourages banks to develop procedures so that all eligible mothers are consistently approached with particular attention to approaching mothers from underrepresented demographic categories. (ACBSCT does not recommend that hospital staff be required to offer banking to all birth mothers.)
- Because public banking is based on altruism, ACBSCT suggests that donors not be allowed to direct the unit’s use, so that it may be used most optimally for either clinical use or laboratory research.
- The consent should inform the donors that:
- There is no guarantee that the donated unit of cord blood will be available or suitable if their child or a sibling needs cord blood in the future, but that the normal process of searching the public registry will be available to them. If, however, a child from a donating family needs a unit, the ACBSCT encourages banks to offer the unit to him/her, if available. The bank does request that the parent notify it if the donating child develops a serious illness, because this information may impact the usefulness of the cord blood.
- The unit may not be used at all, but if it is, it may be used either for clinical use or laboratory research.
- Any human subjects research using the cord blood will be reviewed by an ethics board, called an Institutional Review Board, so that only ethical research is conducted.
- The donors can discuss with the banking team what kind of cord blood research is presently being done.
- The donors will not have any rights to any commercial product produced by the cord blood.
- Alternatives to public banking, namely, private banking, research or discard should be included in the informed consent document.
- The cord blood bank should have procedures that will allow the donating parents to provide relevant health information about the donor-child in the event of the onset of serious diseases, such as childhood leukemia or an inherited disorder, which could adversely affect the well-being of a recipient of that cord blood. Procedures also should be in place for relevant health information to be offered to the donor-child’s guardian if the recipient develops a serious disease that may have been transmitted by the cord blood.