Staff Working Paper

Preface

This document is in two parts, the first written to provide background and support for the second; the second will be the primary text for discussion at the meeting. Part I offers a synoptic account of human procreation, emphasizing its biological and anthropological significance. Its purpose is (1) to highlight those aspects of human procreation that have ethical meaning and worth and (2) to show how certain possible interventions and actions, possible because nascent human life can now exist outside the body, may pose threats to the dignity of human procreation. Part II offers a discussion of possible legislative measures that could defend the dignity of human procreation against some of the more extreme of those threats. Part II should be seen as a revision of Part III of the Council Recommendations discussed at the September meeting. Part I, suitably revised, will find its way into the beginning of the diagnostic part of the document, in its discussion of the human goods we seek to defend. Members should note that these two sections will not follow one another in the final report, but will be separated by a great deal of intervening text. The section on recommendations, decidedly practical, will not be encumbered with the more philosophical materials of Part I.

I. The Significance and Dignity of Human Procreation

Human procreation is an activity of deep biological and anthropological significance. Biologically speaking, as with other animals, human procreation represents life's answer to mortality, perpetuating the human species despite the perishability of every one of its members. And through the genetic recombination produced by the lottery of sexual reproduction, genetic novelty is assured, providing raw material for the gradual evolutionary emergence of new biological capacities and possibilities. Humanly speaking, procreation establishes ties of belonging, rooted in begetting, richly significant for parents, children, and the larger society. These last implications deserve further specification.

Through procreation, each parent(mother and father) acquires a share in a life that transcends his or her own, and thereby also a role in perpetuating the human species. Both parents together acquire an equal share in the fruit of their union; and, supported by social customs and expectations built on this biological foundation, they also acquire a shared responsibility to nurture, humanize, and civilize the children they generate, by caring for and rearing them well. Each child enters life as a unique, unbidden, and an as-yet-mysterious stranger; each child is endowed with both the universal human potential and his or her own unique and unprecedented version of it. The former potential anticipates the common human stage upon which the child now enters; the latter potential foreshadows the individuated, never-before-enacted life that he or she will henceforth live. As the parents' union issues in their child, who is the fruit of their separate flesh made one, so the child correlatively stands in immediate and dependent relation to its two progenitors, who are the child's dual and complementary sources. Viewed more broadly and looking backward, the child also stands as a singular intersection of long, venerable, and now converging chains of descent; viewed more broadly and looking forward, the child stands as a new sprout on the ever-branching and ever-widening family tree-and human-family tree. For any human society, procreation means the renewal of human possibility and the promise of ever-returning youth and freshness. It provides new members who can look upon the community and the world anew, who will be responsible for preserving and transmitting the best of what is past, and who will have the energy and the hope to try to improve upon it for the future.

Human procreation, when viewed most fully, is thus a panorama of wide import and overlapping human meanings. Yet when viewed concretely and on the smallest scale, the immediate focus is on the leading figures, individual parents and their children. At the very center of the picture of human procreation is the newborn child emerging from his or her mother's womb. Even as the child arrives, it is a still developing new life, first begun in the fertilization of egg by sperm, seeds contributed by the two adults who were and are the child's mother and (biological) father and whose child the newborn baby now becomes. Newly visible to the world after nine months of hidden growth, the child arrives not as "anyone" but as a "someone," with a defined and distinctive (beginning) identity-human, familial, individual, male or female. Part of any child's identity as this child lies in its special relationship to two particular human "someones" from whom the child descends. All of the child's being and identity it owes to a continuous developmental process that began with union of egg and sperm and that continued through an unbroken sequence of embryonic and fetal stages enacted within the womb of the mother. Though father and mother are equal contributors of seed, the mother alone brings the child to birth: its developing life absolutely depends on the protection and silent nurturing of her body, its emerging life depends absolutely on her labor.

In this brief synopsis of natural human procreation, several elements stand out as matters of human worth that are deserving of our respect: the humanity of the procreative process and the special human attachments it both manifests and generates; the special procreative power of woman and human pregnancy; the singular relationships of parents to child and of child to parents, central to the identity of each; and the (at least) special respect owed to nascent human lifeⁱ-and even, if to a somewhat lesser degree, to egg and sperm, in view of their standing as the potential seeds of a new child and of a new human generation.

Until the first extra-corporeal fertilization of human egg by human sperm in 1969, the processes of human procreation took place entirely inside a woman's body, not only immune to human intervention but also unknown to human beholders. Since that time, the beginning of many a human life has been brought outside the body and placed partially in human hands and under human control. Undertaken to make procreation possible for infertile couples, in vitro fertilization has been responsible for over a million births worldwide, to the great joy of the their parents. Yet by bringing the beginnings of human life outside a woman's body, it has already had several unintended yet foreseeable other consequences, and still others not yet here are today equally foreseeable possibilities. The presence of nascent human life in human hands exposed it for the first time to possibilities of manipulation and alteration prior to the initiation of a pregnancy, as well as to utterly novel uses altogether unrelated to procreation-in both cases raising unprecedented and vexing ethical issues.

Among these additional possibilities are the following (those that have already been accomplished or that are today possible are underlined): (1) The early human embryo can be frozen and stored for later use. (2) The (4- to 8-cell) human embryo can be disaggregated into its separate blastomeres (= embryonic cells), which can then be recombined with blastomeres from other human embryos (including those of opposite sex) to produce a hybrid human embryo (of four or more biological parents). (3) Human blastomeres could potentially be combined with blastomeres from another species (including primates) to produce a cross-species hybrid embryo (an embryonic chimera). (4) Any ex vivo human embryo, altered or not, can be introduced into a large variety of carriers, including women other than the donor of the egg. (5) Any ex vivo human embryo could also, in principle, be introduced into the uterus (or other body cavity) of a non-human animal, where it might be grown to later stages for purposes of research or (in due course) for the production of human tissues and organs. (6) An ex vivo embryo can be grown outside the body for a brief period for purposes of research on early human development or (at the blastocyst stage: 5-6 days, 100-200 cells) used as a source of embryonic stem cells, themselves usable in research and the pursuit of novel therapies. (7) An ex vivo embryo can be genetically screened prior to transfer, and, in principle, genetically or otherwise altered by the addition of cytoplasm (ooplasm), genes, or other materials. (8) Egg and sperm (or their precursors) may be extractable from fetuses or derivable from embryonic stem cells (achieved in mice), making it possible that a child might have a fetus or a five-day old embryo as its biological mother or father. (9) With the aid of synthetic devices (now being pursued) that might serve as an artificial placenta, an embryo could in principle be grown to later stages outside of any living body, for purposes of research or needed tissue or organs. (10) An ex vivo embryo (and externalized human eggs, as well as sperm) can be treated as an article of commerce. (11) If suitably and usefully modified, a human embryo may be treated as a novel "invention" or "product" suitable for patenting.

These novel technical possibilities, all of them connected with the existence of early human life outside the human body, are for many people a source of disquiet. Indeed, whatever one's opinion regarding the propriety or morality of any of these additional uses and practices, one must readily agree that they raise ethical questions bearing on the dignity of human procreation broadly conceived, well beyond anything involved in in vitro fertilization for procreative purposes to help an infertile couple have a child of its own. The ongoing public debate about the ethics of embryonic stem cell research, centering on the morality of destroying embryos to obtain stem cells, touches on only one of the pertinent issues. Other possibilities touch on the respect owed to women and human pregnancy, the respect owed to children born with the aid of assisted reproductive technologies, and the respect owed to the humanity of human procreation, as well as other aspects of the respect owed to the seeds and origins of new human life.

The enumerated non-procreative operations, present and projected, that may be performed on or with ex vivo human embryos not only raise direct ethical questions. They may also have indirect but important implications for our thoughts about and attitudes toward human procreation itself. On the one hand, by gaining new knowledge and understanding of human development through research on nascent human life, we can acquire an increased appreciation of how nature works in this truly wondrous domain, as well as expanded abilities to help infertile couples to have a child of their own. On the other hand, and at the same time, should we adopt a merely technical attitude toward the beginnings of human life, we risk a diminution of wonder and awe. The existence of the early embryo in the artificial setting of the laboratory invites an analytic, reductive, and partially disembodied view of the procreative process. It risks isolating and reifying the early stages of human development-"the embryo," "the blastocyst"-thus making it easy to forget their natural place in a continuous, goal-directed, and humanly significant process of natural human procreation (for example, the natural link between an early embryo and its mother). And the very fact that the early stages of human life are now partly subject to human manipulation and control invites, at least in some people, a diminished regard for the "naturalness" and awe-inspiring power of the procreative process. Treating as "normal" all the novel things we are learning to do with nascent human life ex vivo might also desensitize us to still greater departures from the natural and human way of procreating, putting us at risk of weakening, in thought as well as in deed, our regard for the meaning and dignity of human procreation. This risk, hard to measure, is not itself subject to any preventive measures. Yet it does provide an additional argument for erecting certain barriers against certain extremely dehumanizing interventions, placing a burden of justification on those who would casually break these barriers in the absence of public debate about the wisdom and propriety of doing so. Erecting such barriers would also require the public to consciously confront the novel possibilities as they occur, rather than complacently acquiescing in the necessity of every fait accompli.

In the course of our review, discussion, and findings, we have encountered and highlighted several particular practices and techniques (some present, some likely forthcoming) touching the beginnings of human life that raise new and distinctive challenges to the special character and dignity of human procreation. Given the importance of the matter, we believe these require special attention, not only from professional societies but also from the people's representatives. Especially because technological innovations are coming quickly and because there are today no other public institutions charged with setting appropriate limits, we believe the Congress should consider some limited targeted measures that might give expression to and provide protection for the dignity of human procreation, by restricting or limiting the practice of a number of carefully defined activities. These measures, perhaps collected in a "Dignity of Human Procreation Act," would remain operative at least until policy makers and the public can discuss the possible impact and human significance of these new possibilities and deliberate about how they should be governed or regulated.

The benefits of such Congressional legislation, as we see it, are multiple:

(a) It could affirm and teach about some of the goods that we hold dear (respect for the humanity of human procreation, respect for women who use ARTs and children conceived with their aid, respect for nascent human life).

(b) It would institute a temporary moratorium on certain practices, setting a few carefully defined boundaries on what may be done and preventing any individual from acts that would radically alter what is acceptable in human procreation without prior public discussion and debate.

(c) If carefully drafted, it would not interfere with important scientific research. On the contrary, it could serve to protect the reputation of honorable scientists and practitioners of assisted reproduction against the mischief of "rogues," whose misconduct might invite harsh and crippling legislative responses.

(d) Practically, it would place the burden of persuasion on those innovators who would transgress these important boundaries without adequate prior public discussion or due regard for social or moral norms.

(e) It would demonstrate a way forward for public governance in these areas, and would demonstrate that scientists and humanists, physicians and laymen, "pro-lifers" and "pro-choicers" can find aspects of our common humanity that they are willing to defend collectively and by deliberate agreement.

Legislative concern for the integrity and dignity of human procreation might give rise to a fairly wide range of specific provisions, and the Congress should consider these in their full array. But the concerns we have taken up in this report, and which emerge from our findings, suggest to us a few that are especially crucial, and also especially likely to command fairly broad assent. They may be usefully grouped around four principles or desiderata, each pointing to one, two, or three particular provisions we believe to be in order and that we now recommendⁱⁱ

1. Respect for the humanity of human procreation, preserving a reasonable boundary between the human and the non-human (or, between the human and the animal) in the beginnings of a human life. The question of the human-animal boundary in general can, in some respects, be quite complex and subtle, and the "mixing" of human and animal tissues and materials is not by itself objectionable. In the context of therapy and preventive medicine, we accept the transplantation of animal organs or their parts to replace defective human ones; we welcome the use of vaccines and drugs produced from animals. Looking to the future, we do not see any overriding objection to the insertion of animal-derived genes or cells into a human body-or even into human embryos and fetuses, where the aim would be to prevent a dread disease in the developing child. And in the context of biomedical research, we see little objectionable in inserting human stem cells into animal bodies or even into animal embryos-though we admit that these are both scientifically and morally complicated matters. But in the context of procreation-of actually mixing human and non-human gametes or blastomeres at the very earliest stages of biological development-we believe that the ethical concerns surrounding that boundary are at their most acute, and at the same time that the prospect of drawing reasonable lines is greatest and most crucial. One bright line should be at the creation of animal-human hybrid embryos, produced ex vivo either by fertilization of human egg by animal (e.g., chimpanzee) sperm (or the reverse) or by fusion of blastomeres obtained from early animal and human embryos: we do not wish to have to judge the humanity or moral worth of such an ambiguous hybrid entity (e.g., a "humanzee," the analog of the mule); we do not want a possibly human life to have other than human ancestors. A second bright line would be the insertion of ex vivo human embryos into the bodies of animals: an ex vivo human embryo entering a womb belongs only in a human womb. If these lines should be crossed, it should only be after clear public deliberation and assent, not by the private decision of some adventurous or renegade researchers. We therefore recommend that, in an effort to guard the humanity of human procreation, the Congress should:

• Proscribe the transfer, for any purpose, of any human embryo into the body of any member of a non-human species;
  
• Prohibit the production of a hybrid human-animal embryo by fertilization of human egg by animal sperm or of animal egg by human sperm; and
  
• Prohibit the combination of blastomeres from human and non-human embryos to produce a hybrid human-animal embryo.

Note to Members: There are potential pitfalls regarding the second and third items. For example, in testing for male-factor infertility, practitioners of assisted reproduction now use hamster eggs to test the capacity of human sperm to penetrate an egg; yet there is no intent to produce a human-animal hybrid embryo. Also, blastomere-mixing to create a hybrid very-early embryo needs to be distinguished from stem cell insertion at a much later stage; and it will not be easy to say, at that later stage, what fraction of the total cell population the animal contribution needs to be before one regards it as an illicit amount of "mixing." Still, the point is clear enough, and we should explore the matter thoroughly to see whether we can agree about it.

2. Respect for women and human pregnancy, protecting women against certain exploitative and degrading practices. Respect for women with regard to assisted reproduction encompasses many things, including respect for their health, autonomy, and privacy; these are by and large properly attended to in current assisted-reproduction practices. But in the face of some new technological possibilities, we recognize that respect for women also involves respecting their bodily integrity and the dignity of human pregnancy. A number of animal experiments using assisted reproductive technologies have shown the value of initiating pregnancies purely for the purpose of research on embryonic and fetal development or for the purpose of securing tissues or organs for transplant. We generally do not object to such practices in other animals, but we do not believe they should, under any circumstances, be pursued in humans, or that human pregnancy should be initiated using artificial reproductive technologies for any purpose other than to seek the birth of a child. A woman and her womb should not be regarded or used as a piece of laboratory equipment, as an "incubator" for growing research materials, or as a "field" for growing body parts. We therefore recommend that, in an effort to protect and to express our society's profound regard for the dignity of human pregnancy and of pregnant women, Congress should:

• Prohibit the initiation of a human pregnancy (using embryos produced ex vivo) for any purpose other than to attempt to produce a live-born child.

Respect for children born with assisted reproductive technologies, securing for them the same rights and human attachments naturally available to children conceived in vivo. We believe that children conceived with the aid of assisted reproductive technologies deserve to be treated like all other children, and to be afforded the same opportunities, benefits, and attachments available to children conceived by natural means. If some care is taken, this can surely be accomplished, as it has been for twenty-five years with in vitro fertilization as ordinarily practiced. But as we have seen, certain applications of embryo manipulation and assisted reproductive techniques could deny to children born with their aid their full and equal share in our common human origins, for instance by denying them the natural connection to two human biological parents or by giving them a fetal or embryonic progenitor. We believe that such departures and inequities in human origins should not be inflicted on any child. We therefore recommend that, in an effort to secure for children born through assisted reproductive technologies the same rights and human attachments naturally available to children conceived in vivo, Congress should:

• Prohibit attempts to conceive a child by any means other than the union of egg and sperm obtained directly from no more and no less than two adult human parentsⁱⁱⁱ; and
  
• Prohibit attempts to conceive a child by fusing blastomeres from two or more other embryos, or by fertilization using gametes obtained from a human fetus or derived from human embryonic stem cells.          

4. Respect for early stages of nascent human life and for the seeds of human life, setting some agreed upon boundaries on how embryos (and gametes: eggs and sperm) may be used and treated. What degree of respect is required will, of course, continue to arouse great controversy. But we all agree that the human embryo deserves, as we have said, "(at least) special respect." Accordingly, we believe some measures may be agreeable to all parties to the significant ongoing dispute over the moral status of the human embryo, whether as modest steps toward the protection of nascent life, or as demonstrations of a limited but nonetheless genuine respect for the precursor(s) of a human child. Along these lines, we believe that Congress should:

• Prohibit the use, or the preservation, solely for the purpose of conducting research, of any human embryo past the 14^th day after first cell division, not counting any time in a frozen state; and
  
• Prohibit the buying and selling of human embryos, eggs, and sperm.

Moreover, these concerns, combined with a certain ambiguity in the patent laws described in the preceding pages, also suggest to us the need for a provision instructing the United States Patent and Trademark Office not to issue patents on claims directed to or encompassing human gametes or human embryos or fetuses at any stage of development; and amending Title 35, United States Code, section 271(g) (which extends patent protections to products resulting from a patented process) to exclude these items from patentability. The language of any such statute would in our view need to take some care not to exclude from patentability the processes that result in these items, but only the products themselves.

Note to Members: Money now changes hands for the "donation" of sperm and oocytes, under the claim that it is compensation for time and inconvenience. Because the compensated giving of sperm is long-established practice, and because payment to egg "donors" is now also fairly common, the part of the last provision dealing with gametes may prove controversial and untenable in actual legislation. Nevertheless, because we are concerned with placing the beginnings of human life into commerce, we should explore a moratorium on buying and selling gametes as well as on buying and selling embryos.

These recommendations indicate the kinds of specific measures that could give concrete expression to widely shared goals and that might serve as safe interim boundaries, as public deliberation tries to catch up with rapidly changing technologies. We do not presume, here, to make very particular suggestions regarding specific legislative language or the assignment of penalties, as the Congress, should it choose to take up these recommendations, would most appropriately determine these in accordance with its usual procedures. Also, of course, these are by no means the only possible legislative measures Congress might take up to limit practices that put at risk the dignity of human procreation. But we offer these recommendations for what in our view are reasonable and moderate measures, which could do genuine good and might command relatively broad assent across the usual spectrum of opinion on these subjects.

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Footnotes