How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.

The concept of minimal risk is defined in the regulations as follows:

The first reported case of postmortem sperm retrieval occurred in 1978, involving a man who became brain dead after a motor vehicle accident and whose wife requested removal of his sperm so that she could be artificially inseminated. Physicians performed the retrieval by surgically excising the ducts that transport sperm from the testes (the epididymis and vas deferens) and removing sperm from them. Since that time, several other methods for retrieving sperm from such patients have been reported, and at least 141 cases have been documented in which requests were made for removal of sperm from men who were dead or irreversibly unconscious. Moreover, there have been several reports of pregnancies and births resulting from assisted reproduction using sperm retrieved in such cases.

Assisted reproductive technology has enabled thousands of infertile couples to experience the joys of parenthood. At various times, however, significant problems have come to light concerning the providing of infertility treatment in the United States. An early problem was misleading advertising by some infertility programs, particularly in regard to pregnancy success rates. This unacceptable activity suggested the need for more oversight of assisted reproductive technology and prompted the passage of a federal law requiring the reporting of success rates in a standardized format. Another problem, one that was especially disturbing, was the transfer of preembryos to infertile women at the University of California, Irvine, without the consent of the progenitor couples. Disclosure of these events added fuel to the debate over whether assisted reproductive technology should be subject to greater governmental regulation.

Jean E. Chambers and Timothy F. Murphy responded to my article “Cloning and Infertility” and extended the debate over human cloning in interesting ways. I had argued that none of the objections to cloning by somatic cell nuclear transfer are successful in the context of infertile couples who use cloning to have genetically related children, assuming the issue of safety is overcome by scientific advances.

Several methods have been reported for extracting sperm from a man after he dies or enters a persistent vegetative state (PVS). Although such sperm retrieval could be performed for nonprocreative purposes, such as research, in this paper I focus on cases involving procreative intent. Since 1980, more than ninety cases have occurred in which family members requested sperm retrieval from patients who died or were irreversibly unconscious, with the intent that a wife, girlfriend, or other woman would be inseminated. Recently, the first report of pregnancy and birth following postmortem sperm retrieval appeared in the media.

In these cases, death or PVS typically is caused by anoxic injuries, trauma, or rapidly progressing infections.

In this case, one should expect that providing hydration sufficient to maintain fluid balance would tend to prolong the dying process. In a well-known case at Johns Hopkins University, fluids (and feedings) were withheld from a newborn with anomalies, and the infant died after 15 days, compared to three weeks in the present case, in which fluids were given. In the famous Baby Doe case, fluids and nutrition were withheld and the infant lived only six days. In the case at hand, prolonging the dying process risks causing suffering for the infant from various complications that can arise, and it adds to the emotional burden on the family. We learned from the Johns Hopkins case that prolonged dying is also emotionally difficult for the nurses and other health professionals caring for the infant.

Although there are important moral arguments against cloning human beings, it has been suggested that there might be exceptional cases in which cloning humans would be ethically permissible. One type of supposed exceptional case involves infertile couples who want to have children by cloning. This paper explores whether cloning would be ethically permissible in infertility cases and the separate question of whether we should have a policy allowing cloning in such cases. One caveat should be stated at the beginning, however. After the cloning of a sheep in Scotland, scientists pointed out that using the same technique to clone humans would, at present, involve substantial risks of producing children with birth defects. This concern over safety gives compelling support to the view that it would be wrong to attempt human cloning now. Thus, we do not reach the debate about exceptional cases unless the issue of safety can be set aside. I ask the reader to consider the possibility that in the future humans could be cloned without a significantly elevated risk of birth defects from the cloning process itself. The remainder of this paper assumes, for sake of argument, that cloning technology has advanced to that point. Given this assumption, would cloning in the infertility cases be ethically permissible, and should it be legally permitted?