Embryonic stem cell research (ESCR) is a hot topic in public debate once again. Within the past few years, some states, most notably California, have allocated public funds for this research. The U.S. Congress and Senate recently passed S. 5, the "Stem Cell Research Enhancement Act" of 2007. This act would open up federal funding for research that destroys human embryos, but I argue in this article that federal regulations logically provide protection of the human embryo against destructive research.
A brief background to the regulatory scheme is warranted prior to analyzing it. Part 46 of Title 45 of the Code of Federal Regulations (45 CFR 46) was the culmination of work that began with the National Research Act of 1974.1 That act was instituted primarily in response to major research ethics violations in the United States and abroad. The victims of these violations were often vulnerable people, for example, uneducated African Americans and mentally retarded children. The subparts of part 46 are meant to codify protection for specific vulnerable groups, including pregnant women, fetuses, children, and prisoners. Since the regulations were promulgated by the federal government, they applied only research activities receiving federal money were required to follow them. Most major institutions today, however, have what are called federal-wide assurances. These assurances promise that all research done at the institution (regardless of funding) will comply with the regulations. I should clarify as well that the 1995 Dickey Amendment aimed only to prohibit federal funding for embryonic stem cell research.2 It did not intend to extend the existing regulations (part 46) to cover such research. In consequence, ESCR could be performed at institutions with federal-wide assurances so long as private funds supported it.
Subpart B of 45 CFR 46 defines a fetus as "the product of conception from implantation until delivery" (46.202c). Further on, the regulations describe conditions for which research on pregnant women is permissible. They list several conditions, all of which must be satisfied. One of those conditions reads,
The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means. (46.204b)3
The point here is that for research purposes, the fetus is subject to (at least) the above protection. The definition of a fetus, however, entails that such protection does not start until implantation occurs. Prior to implantation, the regulations do not apply, and since an embryo is a product of conception prior to implantation, it is not afforded regulatory protection.
But what is the morally relevant difference between a product of conception pre- versus post-implantation? What is it about the pre-implantation conceptus that affords it no research protection, while the post-implantation conceptus is afforded copious protections? The proponents of ESCR cannot advert to a difference in organizational structure or complexity, since the difference here is very slight. Furthermore, the proponents would have to not only point out a difference but argue that the difference is morally relevant. Differences in the complexity and organizational structure of the pre- versus post-implantation conceptus are clearly trivial.
Suppose the proponents of ESCR refer to the very property the regulations specify, namely, implantation. Does possessing the property of implantation amount to a morally relevant difference? Here we need to understand what kind of property implantation is. Metaphysicians would refer to implantation as a relational property - a property something has in relation to other objects or things. Examples of relational properties are "x is to the left of y," "x connects to y," and "x is the father of y." Non-relational properties are about the subject x alone. Contrast relational properties with non-relational ones, such as "x is a human being," "x has blond hair," and "x is snub-nosed."
Consider the property "x implants on y." Clearly, implantation is a relational property. In addition, pointing out that x implants on y does not tell us anything about what x or y is, or about the moral standing of either one. Suppose we were not told what the variables x and y stood for. Clearly, we would not then know what x or y is, and we would not know its moral standing. Thus, implantation does not tell us what kind of thing the conceptus is - it could be a mouse embryo or a chicken embryo. What is relevant concerning research protection is that we know what the subject is.
Suppose the critic replies with the claim that implantation is an internal relation, that is, a relation essential to what a thing is. Thus, for instance, the relational property of being the son of David and Bathsheba is a property essential to Solomon. Only Solomon, we are told, enjoys such genetic origins. Take away the relation and you have a different person. Implantation, the critic contends, may be the kind of relational property that is essential to what an embryo is. Thus, prior to implantation, the embryo is not a human being or is not a human being worthy of research protection.
The critic presents us with an opportunity to make a distinction. The relational properties of the sort mentioned are essential to the identity of this individual. That is, the property being the progeny of David and Bathsheba designates one and only one individual in our world. These kinds of relational properties are called individuating relations. But what we are concerned about here is whether the relational property can tell us what kind of being Solomon is. Suppose I named my two pet snakes David and Bathsheba and their progeny Solomon. It is true that being the progeny of David and Bathsheba distinguishes an individual snake (assuming that the snake litter comprises only one snake). Solomon, then, is the only one who possesses the relational property, but Solomon is not human. So even internal relations do not tell us what kind of being the entity is, but serve only an individuating function. And since what is relevant for generating research protection is not that x is this particular being, but that x is this kind of being (i.e., human), implantation will not tell us what we need to know.
One immediate consequence of the previous points is that if the fetus is a human being, then it was a human being before implantation - since implantation does not tell us what the being is. So if the fetus is a human being, then so is the embryo. Does the embryo enjoy the same moral status as the fetus? I think so. We are in a position, however, to make an even stronger argument, one that does not rest on a claim about a beingÕs moral status. The regulations are "turned on" any time research is done on human subjects (and either the research is funded by DHHS or the institution has a federal-wide assurance). Now, the fetus is considered a human subject in the regulations. If there is no intrinsic difference between the embryo and the fetus (as defined by the regulations), and if implantation is irrelevant to discerning what a being is, then the embryo is a human subject as well. Therefore, if the embryo is a human subject, then he or she should be the subject of regulatory protection.
Of course, the proponents of ESCR will disagree. They will point out that if the regulations were meant to cover embryos they would simply say so; since they do not, the authors did not intend to afford embryos any protection. My argument has been only to show that they should have; I am well aware that they do not. My point is that, for the sake of consistency, the regulations should cover embryos. The reader should also notice that the argument here is driven by a logical point about the property implantation and about a commonly understood purpose of the regulations, i.e., to protect (all) human subjects from research abuses.
The strength of my argument is that it does not rest on contentious moral intuitions or purely subjective ascriptions of moral standings to things. There are solid logical reasons for extending research protection to embryos consistent with the regulatory scheme as it already stands.
1 Title 45, part 46 of the Code of Federal Regulations is available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. [Back]
2 In the 1995 session, the U.S. Congress attached language to the 1996 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (the budget bill that funds DHHS and the National Institutes of Health) prohibiting the use of any federal funds for research that destroys or seriously endangers human embryos. Jay Dickey of Arkansas proposed the addition, and it subsequently became known as the Dickey Amendment. The amendment prohibits the use of federal funds to support any research that destroys human embryos or subjects them to serious risk of harm, but does not prohibit such research from being undertaken with private funding. [Back]
3 Pregnancy is defined as there existing a product of conception from implantation to delivery. Pregnancy, according to the regulations, does not start at the point of conception. [Back]