Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor : Issues, Guidelines & Limits

Preimplantation genetic diagnosis (PGD) has been used to biopsy and analyze embryos created through in vitro fertilization (IVF) to avoid transferring to the woman’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. It prevents gestation of an affected embryo and reduces the chance that the parent or parents will be faced with a difficult decision of whether to terminate the pregnancy. However, PGD to create a donor child (sometimes called a "savior sibling") who is immunologically matched with an ill, preexisting sibling in need of a stem cell transplant is highly controversial. This article offers a unique analysis of this combination of genetic testing and assisted reproductive technology (ART). The analysis is schooled by direct knowledge of the first clinical case. The authors argue that PGD to create a donor is not one technology, but three: IVF, PGD for immunological matching (sometimes combined with PGD to rule out the mutation causing illness in the sibling), and stem cell transplant. Yet there are no real data demonstrating the efficacy of the combination of technologies for saving or prolonging the sibling’s life, nor are there data on the medical and psychosocial risks for the donor or recipient child. Consequently, the authors recommend that these three technologies be combined only in the context of a research protocol, with the attendant safeguards, including heightened consent requirements and IRB review. This is the first known article suggesting that an intervention combining clinically accepted technologies raises new questions that require the systematic data collection and safeguards of a research protocol. This article analyzes the ethical, policy, and legal issues raised by this combination of technologies, and ultimately recommends more protections and limits than other commentators. The authors do so not only because of the risks and uncertainties generated by combining these technologies, but also because this use of PGD creates an immunologically matched child who remains a potential stem cell and organ donor for the ill sibling as long as they both remain alive. This counsels limits and procedural safeguards protecting the donor child from exploitation before he or she becomes capable of making a mature and autonomous decision about whether to donate. The article recommends safeguards to attend not only the IVF, PGD, and birth process, but all subsequent testing and harvesting of the donor until the donor can decide for him- or herself