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Reproduction and Responsibility:

The Regulation of New Biotechnologies


Table of Contents

The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov




Chapter One

Introduction

It is by now a commonplace that advances in biomedical science and technology are raising challenging and profound ethical issues—for individuals and families, for scientists and health care professionals, and for the broader society. Many important human goods are implicated, among them health and the relief of suffering, scientific progress, respect for life and the human person, human freedom, and human dignity. The flourishing field of modern bioethics, not yet forty years old, arose to explore these issues, and various bodies, including local research review boards, academic bioethics institutes, and several national commissions, have been wrestling with them. Yet amid all this activity, it is far from clear whose responsibility it is to monitor, oversee, and offer guidance where guidance is needed, in order to safeguard the diverse and often competing human goods at stake. Which institutions, public or private, are now responsible for which sorts of oversight or regulatory activity, and in the name of what? We can readily name some—the Food and Drug Administration, for example—that are responsible for the efficacy and safety of new drugs or devices. But which permanent bodies, if any, are vested with effective authority to protect some of the other goods we care about? And how well are they doing their job?

I. Background

At its very first meeting, the President’s Council on Bioethics signaled an interest in exploring how, if at all, the existing regulatory mechanisms in the United States address the various ethical and social issues that arise from advances in biomedical science and technology. Some members of the Council suggested that new regulatory institutions might need to be devised. Others were skeptical, especially before we knew how well the current arrangements worked or which principles should guide any such new institutions. In the Council’s report, Human Cloning and Human Dignity, published in July 2002, a suggestion emerged to pursue this interest regarding regulation in a specific domain. Members observed that, for the activities at the intersection of assisted reproduction, human genetic testing, and human embryo research,
we lack comprehensive knowledge about what is being done, with what success, at what risk, under what ethical guidelines, respecting which moral boundaries, subject to what oversight and regulation, and with what sanctions for misconduct or abuse. If we are to have wise public policy regarding these scientifically and medically promising but morally challenging activities, we need careful study and sustained public moral discourse on this general subject, and not only on specific narrowly defined pieces of the field.1

Three months following the release of that report, the Council decided to undertake a thoroughgoing inquiry into the current regulation of those biotechnologies that touch human reproduction. This report is the fruit of that inquiry. Its principal aim is to describe and critically assess the various oversight and regulatory measures that now govern the biotechnologies and practices at the intersection of assisted reproduction, human genetics, and human embryo research.

II. The Domain of Inquiry

The reason for and focus of this inquiry is the growing capacity to influence and control the beginnings of human life, especially as exercised ex vivo (outside the body), in the clinic and the laboratory. These capacities emerge from a confluence of work in reproductive biology, developmental biology, and human genetics. The well-established practices of assisted reproduction are today being augmented by techniques of genetic screening and selection of embryos; some day, gametes or embryos may be modifiable by directed genetic manipulation. Our focus here is not assisted reproduction as such, nor is it the fate of human embryos or the evolving understanding of human genetics and the novel capacities for genetic diagnosis and manipulation. Rather, we are concerned with the unique interactions among these elements and the new possibilities these interactions create for controlling and perhaps someday altering the character of human procreation and human life.

Our point of departure will be the practice of assisted reproduction. We are well aware that assisted reproduction is not new—indeed, it has over the past quarter-century become firmly established within the practice of medicine, and it is thus subject to the usual formal and informal mechanisms that regulate medical practice. With great success, assisted reproductive technologies (ART) have enabled over one million otherwise infertile couples and individuals to have biologically related children and to participate in the joys of family life. Our purpose here is not to second-guess how this novel and profoundly important practice grew and came to be regulated in the way it has. Neither are we interested in interfering with that practice. However, three reasons, taken together, recommend assisted reproduction as our point of departure. First, all the other activities of interest—preimplantation genetic diagnosis, sex selection, germ-line genetic modification, human embryo research, and a range of potential new modes of human conception—presuppose the creation and existence of human embryos in vitro. The ability to screen and select genetic traits in vitro depends on the prior ability to initiate and sustain embryonic life in the laboratory. Thus, in vitro fertilization and related techniques are the starting point for all the others, both in practice and, hence, in our inquiry. Second, as a consequence, any oversight or regulation of the use of genetic technologies in the context of human procreation will necessarily depend on the systems that oversee and regulate assisted reproduction itself: what they are and how well they work. Third, the addition of genetic technologies to existing techniques of assisted reproduction has made it clear—if it had not been clear before—that we are dealing here with a most unusual branch of medicine. In no other area of medicine does the treatment of an ailment—in this case, infertility—call for the creation of another human being. Here, the therapeutic intervention, addressing the needs and desires of the procreating adults, aims at and consists in the production of a new human child, who may be at risk of harm from the very procedures used to conceive or produce him. It is our concern for the safety and well-being of children that suggests to us the need for special attention—especially now that genetic screening and selection are being added to the practices of assisted reproduction.

III. The Human Goods at Stake

All regulatory institutions and practices operate, either explicitly or tacitly, in order to promote or protect one or more important human goods. Identifying those goods and the things that challenge them is indispensable for any analysis and evaluation of how—and how well—regulatory activities are conducted. It is therefore useful, at the start of this document, to identify the major goods, values, and ethical concerns that the Council finds pertinent to the subject area, and hence to our assessment. First among these, as already indicated, is the health and well-being of the human subjects directly affected by the biotechnologies, not only the individuals or couples seeking their use but also and especially the children who may be born with their aid. Concern for the bodily health, safety, and well-being of those children is of prime importance, especially in an age in which more and more features of their genetic make-up could be shaped by technical intervention and deliberate human decision.

Other human goods of crucial relevance to this discussion include:i (1) Relief of the suffering and sorrow of those afflicted with infertility, for whom assisted reproductive technologies are an avenue of hope and possibility and offer the chance to enjoy the blessings of rearing (biologically related) children. (2) Compassion for children with serious genetic diseases, and relief of the sorrows and burdens that they and those who love and care for them must bear. (3) The intrinsic value of new knowledge of human development and genetic function in addition to the inestimable practical value of new treatments for diseases and disabilities—the main goals of some of the associated genetic and reproductive technologies under consideration and of research using embryonic stem cells. (4) Privacy of genetic information and reproductive practice. (5) The foundational value of human life and the respect owed to it in its various stages. (6) Several expressions and avenues of human freedom, including the freedom of parents to make their own reproductive decisions or to use or refuse genetic screening, and the freedom of scientists to conduct research. As important, as well, is the necessity to protect the freedom of children from improper attempts to manipulate their lives through control of their genetic make-up or from unreasonable expectations that could accompany such manipulations. (7) The promotion of justice and equality, including equitable access to the use and benefits of new technologies, equal respect and opportunity in a world that places great emphasis on genetic distinctions, and the prevention of discrimination and contempt for genetic “defectiveness” or “inferiority.” (8) The protection of human dignity, including the dignity of the human body and its parts, the dignity of important human relationships (parent and child, one generation and the next), and the humanity of human procreation.

IV. Some Specific Issues

Some of the aforementioned human goods—for example, relieving the sorrows of the infertile or preventing and treating heritable diseases—are, of course, among the primary goals of the practice of ART or the study of human genetics and development. Although many have reaped the benefits of these technologies, many others who seek these benefits still wait in sadness and hope. Other goods—for example, protecting the freedom and privacy of reproductive choice or preventing genetic discrimination—have been the focus of professional self-regulation and legislative enactments. Nevertheless, other relevant human goods appear not to be receiving comparable attention. And, while ethical issues connected with these various goods are identifiable, there appears to be no existing oversight body or significant regulatory activity directly concerned with those issues. Accordingly, throughout our analysis we shall be especially mindful of how various existing regulatory practices address these ethical issues. Some issues are raised by the practice of ART as such, others by the practices of genetic screening and selection, and still others by potential new techniques of human conception. In addition, there are concerns raised by the commercialization of human reproductive services and the advent of commerce in eggs, sperm, and embryos.

Beyond the obvious and important issues of health and safety, there are a number of broader ethical and social concerns that have been called to our attention—some already here, others perhaps on the way. These concerns include the following: (1) The daunting complexity of options confronting would-be ART patients, and the need for full and candid reporting of the successes and failures of different ART treatments and techniques. (2) The adequacy or inadequacy of procedures for informed decision-making by patients. (3) The potential aggravation of existing social inequalities, should such technologies become available only to the wealthy or the privileged. (4) The possible emergence of new grounds for inequality and discrimination based on genetic characteristics. (5) The prospect of making entrance into human life contingent on passing certain genetic tests. (6) The concern that the state, insurance providers, or others may attempt to impose prenatal or preconception testing on prospective parents. (7) The use, cryopreservation, and destruction of embryonic human life. (8) Questions about the boundary between disease-prevention and so-called “enhancement” uses of these technologies—how to define that boundary and what to do about it. (9) The effects of commercialization of aspects of human procreation (such as the sale or patenting of gametes and embryos). (10) The consequences of moving procreation more and more into the laboratory and possibly turning it in the direction of manufacture. (11) The changing expectations of parents regarding children born using—or not using—genetic screening and selection. (12) The concern that children born through certain assisted reproductive technologies (for example, cloning) will be denied a share in our common human heritage (such as a biological connection to two adult parents and two clear lineages). (13) A blurring of the line between the human and the animal in certain laboratory research techniques. (14) The fear that a growing emphasis on genetic determinants of human life will exaggerate the primacy of genetic causation over environment, free will, agency, and choice.

Not all of these ethical issues are equally susceptible to regulatory activity, and few of them are likely to be the subject of anything so far-reaching as restrictive legislation. Not all of these concerns are shared or shared equally by every member of this Council. But most, if not all, of these issues are sufficiently serious as to suggest the desirability of monitoring what is going on, with a view at the very least to informing patients and policymakers how well we are handling any possible untoward consequences.

Also animating the following inquiry are concerns about the chilling effect that overbroad or excessive regulation might have on the development and practice of promising and worthwhile technologies. Just as the absence of fitting and effective regulation is ethically problematic, so too is overly burdensome or unjustifiable regulation of practices that alleviate human suffering and bring great joy. The possible costs and drawbacks of potential regulation must themselves be counted among the concerns that drive our interest in this field. However, while this report will touch on a wide range of subjects, our main focus is on the well-being of children who might be conceived and born with the aid of new reproductive and genetic technologies, and on the possible implications of these biotechnologies for human reproduction considered more broadly.

V. The American Legal Landscape

Before moving to the substantive analysis of the present regulatory landscape, it is worth noticing briefly some unique aspects of American law that create the backdrop against which the current regulatory mechanisms exist.

First, because practices touching reproduction and developing human life raise questions related to the central themes of the abortion debate, any efforts at regulation are likely to be fraught with political difficulty. Proposed efforts to regulate or monitor assisted reproduction are viewed by many people through the prism of Roe v. Wade and the legal-political context it has created, arousing suspicion and concern among individuals on both sides of the abortion conflict. Defenders of reproductive freedom want no infringement of the right to make personal reproductive decisions, and they fear that the regulation of ART might undermine the right to privacy. Pro-life opponents of embryo destruction fear that the federal regulation of assisted reproduction or embryo research might give tacit or explicit public approval to practices that they find morally objectionable. This situation creates a powerful disincentive for any regulation of the uses of reproductive technologies. More generally, there is deep disagreement in our society about the degree of respect owed to in vitro embryonic human life and the weight that respect should carry in relation to other moral considerations, such as helping infertile couples to have children, helping couples to have healthy children, and advancing biomedical knowledge that could well lead to cures for dread diseases. This disagreement is one of the main reasons for the current relatively laissez-faire approach to regulation. While some observers urge that the standoff over the moral status of embryonic human life should not be permitted to hold up appropriate and useful regulation of ART and related practices, others respond that resolution of this dispute is the sine qua non of any responsible approach to regulation.

Second, the practice of medicine (now embracing ART) occupies a special place in the American legislative and legal system. The practice of medicine is principally regulated through state licensure and certification of physicians rather than by reference to specific legislative proscriptions or prescriptions of conduct. Legislatures defer to the profession not only because medicine is highly esteemed, but also because of the special expertise of physicians in their various specialties and the relative lack of medical expertise on the part of legislatures or other governmental authorities. Medicine is a profession where crucial judgments must be made on a case-by-case basis by a practitioner familiar with the details and circumstances involved. The law tends to give physicians ample latitude to make such judgments.

Third, the U. S. Constitution has several distinctive features that bear on the present discussion. The American system of federalism has tended to vest principal authority for safeguarding the health, safety, and general welfare of citizens in their respective states. This broad mandate of the states leads to a lack of uniformity across local jurisdictions, but also permits states to serve as “laboratories” for regulatory experimentation. In addition, the enumeration of federal powers in the Constitution sets limits on what the national government may legislate. Only conduct that meets a specific jurisdictional threshold (for example, activities that involve interstate commerce) is reachable by federal mechanisms of regulation. (The authority of the FDA, for example, a key player in the regulation of human biotechnology, is grounded partly in the constitutional power of the federal government to regulate interstate commerce.) On the other hand, the Constitution recognizes certain individual rights inhering in all citizens (or, depending on the right, in all persons), as well as liberties that may be vindicated against both state and federal governments. The assertion of such rights can be controversial, especially in cases in which the rights in question are not explicitly enumerated in the Constitution itself. One such controversial right is, of course, the right to privacy in intimate matters relating to procreation. The relevance of the right to privacy to the regulation of assisted reproduction is easily recognized, while its likely application in actual cases is difficult to predict.

A fourth principal concept in American law, directly relevant to the present inquiry, is that the public and private realms of conduct are legally and ethically distinct. The reach of law is in many ways driven by this distinction: public action may properly be regulated by the government, especially to protect public health, safety, and welfare, and to vindicate individual rights; by contrast, the realm of private conduct (that is, actions undertaken in private, affecting only the particular individuals involved) is the zone of maximum individual liberty. To be sure, this distinction, while simple in theory, proves complicated in practice. The new biotechnologies and practices treated in this report involve human life in its most intimate and private aspects: procreation, child rearing, human suffering, and individual conscience. In such matters, there is a strong legal and cultural presumption in favor of personal liberty. This presumption is only overcome by an equally compelling governmental and societal interest, typically the protection of life and limb. The tension between these concepts—public and private, liberty and the public good—should be borne in mind when considering these technologies and practices.

A fifth concept, related but different, is the distinction often drawn between publicly funded and privately funded activities. Some activities the law chooses silently to tolerate while withholding its official sanction or endorsement through public support; other activities are actively promoted and funded by the government; and still others are regulated or prohibited entirely. This distinction between prohibition, silence, and active endorsement is especially significant in some arenas touched on in this discussion.ii

A sixth crucial principle is the special role of parents in American law. They are considered the principal protectors of the well-being of their children, including their as-yet-unborn children. As such, they are granted wide latitude by the law to make decisions that directly affect their children’s well-being, and this is especially true in the context of assisted reproduction. At the same time, however, the law recognizes certain circumstances in which the state may intervene to protect the welfare of children.

A seventh feature of American law relevant to the present inquiry is the presumption in favor of commerce and free enterprise. The values of freedom to contract, to participate in the free market, and to profit from the fruits of one’s labors are embodied in the Constitution, statutes, and decisional authorities that constitute U.S. law. Any governmental efforts to regulate biotechnology and related activities would take place against this legal backdrop. Similarly, unlike many other nations, our health care system is not run by the government, and physicians enjoy a large measure of autonomy in their own economic activity. The largely private funding of medical care also places additional obstacles in the way of attempts at government regulation.

An eighth element that informs the present inquiry is the absence of human dignity as an explicit concept in American law. Much of the legal discourse in this country employs operative terms such as liberty, equality, justice, and rights. Unlike some of our European counterparts, “human dignity” is not in our legal lexicon. Thus, legislators and courts lack the language (and therefore the explicit authority) to fashion responses and remedies to conduct solely on the grounds that it threatens the dignity of the human person.

Ninth, it is necessary to bear in mind the range and variety of activities that may be properly deemed “regulation” for purposes of this inquiry. Regulation comes in myriad forms, from various sources, with widely differing results. Regulation can include a variety of mechanisms, ranging from legal prohibition and statutory obligations to mere monitoring and data collection. Methods of enforcement range from criminal prosecution to mere hortatory suggestion. Even information-gathering can serve as a kind of cautionary regulatory function. It signals to practitioners in the field that society is paying attention and has a stake in the underlying activity. In addition, the source of regulation can be governmental (with the coercive power of the state as the principal mechanism for implementation) or nongovernmental (where market forces and peer evaluation are the chief means of implementation).

Finally, another distinctive aspect of regulation in the United States is the nation’s deeply ingrained commitment to pluralism. The potential need to regulate assisted reproduction runs up against American individualism and an aversion to “legislating morals.” Americans expect their governments to give compelling reasons before restricting individual liberty. Many people also harbor suspicions that governmental regulations and the bureaucracies needed to manage them are harmful, ineffective, and threatening to salutary personal freedoms and economic progress.

All these considerations make thinking about regulating new reproductive biotechnologies extremely complicated, in ways largely peculiar to the United States. Although the Council has heard presentations on regulatory schemes used in other countries, this document does not deal with them. We are eager, first of all, to disclose and assess what is going on in our own country. And, given the noted peculiarities of American law and political culture, there is good reason to doubt whether foreign practices can serve directly as models for what we can and should do here. In any event, there is no consensus among those nations that have chosen to regulate in this domain.iii

VI. The Character and Significances of Human Procreation

While following our inquiry into the regulation of new reproductive biotechnologies, it will be important to keep in mind the character and significance of the area of human life we are discussing—namely, human procreation. Thus, before considering the new technologies and how they are regulated, we would do well to reflect (however briefly) on the character of human reproduction itself—especially on the significance of procreation in shaping fundamental human relationships, both familial and social.

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. In addition, through the genetic recombination produced by the lottery of sexual reproduction, genetic novelty is assured, allowing for the gradual evolutionary emergence of new biological capacities and possibilities. Humanly speaking, because these deep biological facts are lifted up into human self-consciousness, procreation commonly establishes ties of belonging, rooted in begetting, richly significant for parents, children, and the larger society. These last implications deserve further specification.iv

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 wittingly acquire an equal share in their offspring; 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 as-yet-mysterious stranger; each child is endowed with both the universal potential for human activity 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, 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—and can later also understand that he stands—as a singular intersection of long, venerable, and now converging chains of descent; viewed more broadly and looking forward, the child stands—and can later also understand that he stands—as a new sprout on the ever-branching and ever-widening family tree—a 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, derived from the union of “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 human procreation, several elements stand out as matters of human worth that are deserving of our respect: the special human attachments that human reproduction both manifests and generates; the special procreative power of women and the special nature of 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 embryonic human lifev—and perhaps even some regard for 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 unobserved by 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 parents. Yet by bringing the beginnings of human life outside a woman’s body, in vitro fertilization has already had several other consequences, unintended yet foreseeable, and still other possibilities not yet here that are today equally foreseeable. The presence of developing human life in vitro 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 italicized): (1) The early human embryo can be frozen and stored for later use. (2) The early human embryo (at around the eight-cell stage) 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) An ex vivo human embryo, altered or not, can be introduced into women other than the donor of the egg. (5) An 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: five to six 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.

These novel technical possibilities, all of them connected with the existence of early human embryos 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 new ethical questions bearing on the character of human reproduction, well beyond anything involved in in vitro fertilization for procreative purposes to help an infertile couple have a child of their own. The ongoing public debate about the ethics of embryonic stem cell research, centering on the morality of destroying embryos to obtain stem cells, concerns 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 boundary between human and animal life in the context of reproduction.

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 human embryos, we can acquire an enhanced appreciation of how nature works in this truly wondrous domain, as well as expanded abilities to help infertile couples to have a child—and a healthy 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 human procreation (for example, the natural in vivo 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 embryonic human life ex vivo might also desensitize us to still greater departures from the human way of procreating, putting us at risk of weakening, in thought as well as in deed, our regard for the meaning and worth 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.vi

VII. Brief Outline of the Report

The rest of the report is in two major parts: a diagnostic survey of existing regulatory practices (Chapters 2 through 8) and a discussion of policy options and recommendations (Chapters 9 and 10).

Chapters 2 through 7 explore precisely which institutions currently provide oversight and guidance in this context, pursuant to what authority, according to what principles and values, and with what ultimate practical effect. Those chapters are strictly diagnostic and expository in nature. They seek to describe the current state of affairs, and they are neutral regarding what changes, if any, might be necessary, desirable, or feasible if one should wish to improve upon the present arrangements.

Chapter 8 is a distilled account of the specific findings growing out of the preceding diagnosis.

Chapter 9 is a discussion of the universe of possible public policy options that might be considered in light of the findings and diagnosis.

Chapter 10 sets forth a list of recommendations that the Council agrees should be adopted immediately. These recommendations are not for structural or institutional changes; we do not propose the wholesale creation of new regulatory institutions or the reform of existing ones. Rather, these recommendations are offered as interim measures with two goals or aims in mind: first, to strengthen existing legislation and existing regulatory mechanisms in order to gather more complete and crucial information, information that patients, policymakers, and the general public do not now have and that is essential to decision-making in the future; and second, to erect certain legislative safeguards against a small number of boundary-crossing practices, at least until there can be further deliberation and debate about both the human goods at stake and the best way to protect them.

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FootnoteS

i. Each item on the list that follows is considered important by most, though not necessarily all, Members of the Council. And, of course, we often differ among ourselves as to which goods, values, and concerns are more important than others.

ii. Scientific research involving the destruction of human embryos, for instance, is not legally prohibited at the federal level, though federal government funding of nearly all such activity is prohibited. This distinction has played an important role in the political controversies surrounding embryo research, and it is held by many people on all sides of the question to be of great significance. For example, there are some who argue that the proscription of federal funding for such embryo research deters scientists from undertaking valuable studies of the safety and efficacy of various techniques of assisted reproduction. Moreover, it is argued that this limitation on funding deprives the federal government of a useful opportunity to provide meaningful oversight in this domain. Others, not persuaded by these observations, respond that research involving the destruction of human embryos can proceed in the private sector without any governmental restriction. They argue further that federal funding is not a prerequisite for governmental oversight in this area; indeed, the federal government regulates a number of activities that it does not fund. For a more extensive discussion, see the Council’s report, Monitoring Stem Cell Research, published in January of 2004, especially Chapter 2, pp. 37-41. See also the commissioned paper by Peter Berkowitz, contained in Appendix F of that report.

iii. Approaches vary widely. In the United Kingdom, for example, assisted reproduction and embryo research are regulated through a system of licensure; there are limits on the number of embryos that can be transferred during each cycle, and sex selection for non-medical purposes is forbidden. In Germany, there is an “Embryo Protection Law” that effectively forbids destructive embryo research. In February 2004, the Italian Parliament enacted legislation that prohibits donation of sperm or eggs from third parties, limits in vitro fertilization techniques to cohabiting heterosexual couples, prohibits destructive experimentation on embryos, forbids the creation of more than three embryos at one time, and requires all embryos created to be transferred to the patient’s uterus. In March 2004, the Canadian Parliament enacted the “Assisted Human Reproduction Act,” a comprehensive piece of legislation that covers the whole field of assisted reproduction. The bill imposes a system of licensure for the creation, alteration, or manipulation of in vitro embryos and provides for the creation of an “Assisted Human Reproduction Agency of Canada” that will administer all the newly enacted regulations. These regulations include, among others, prohibitions of: all human cloning (both to produce children and for biomedical research); sex selection for non-medical purposes; the creation of chimeras (for any reason) and hybrids (for reproductive purposes); the creation of in vitro embryos for any purpose other than reproduction or “improving or providing instruction in assisted reproduction procedures”; the maintenance of an in vitro embryo past 14 days of development; heritable genetic modification; commercial surrogacy contracts; and the buying and selling of gametes. (For further information about international models of regulation, see the transcripts of presentations to the Council by Patricia Baird [Canada], Lori Knowles [United Kingdom, Germany, and France], Spiro Simitis [Germany], Suzi Leather [United Kingdom], and Baroness Helena Kennedy [United Kingdom], all available on the Council’s website at www.bioethics.gov.)

iv. The present discussion focuses on the human significance of the biological relationship between parents and children, and on the ways in which that relationship takes shape in the context of human procreation. In no way is this meant to suggest that biological ties are the most important (or the only) ties that bind, nor is it meant to devalue the central importance of child-rearing, including the bond that exists between parents and children who are not biologically related. Neither does this discussion mean to cast a negative light on the laudable practice of adoption or on those who, for whatever reason, must give up their biological children to be raised by others. The present discussion does suggest, however, that biological ties often do matter, in ways that may significantly affect the subsequent nurture of children by their biological parents. It is, indeed, the desire of infertile couples to have “their own (biological) children” that is the major driving force for the use of ART.

v. In using the term “special respect,” we do not mean to beg the question, much debated, whether human embryos, from the time of fertilization, are entitled to “full moral status,” or whether they are entitled to less than that. (The Council, like the larger American public, is divided on this question.) The term “special respect” is frequently used in these debates by those who deny early human embryos full moral standing, and who hold instead that embryonic human life has some “intermediate worth,” between “person” and “thing.” Yet whether or not one believes that a human embryo is a person straightaway from fertilization, it is a very special entity precisely because of what it is and where it is directed in its integrated, self-unfolding, and self-directed growth. People of all sorts of opinions about “moral status” see the difference between a growing embryo and any other group of cells multiplying outside of the human body (or in it). It is this agreement that lies behind our formulation here: “(at least) special respect.”

vi. The Council will offer specific suggestions for regulation regarding such barriers in Chapter 10, Recommendations.

 

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Endnotes

1. The President’s Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry, Washington, D.C.: Government Printing Office, 2002, p. 211.

 

 

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