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This staff working paper was discussed at the Council's January 2002 meeting. It was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.

Staff Working Paper

Human Cloning: Policy Considerations

This working paper, prepared for the third of our three sessions on human cloning, is devoted to public policy questions, and, in particular, the legislative alternatives now under active consideration. The working paper, like the discussion it seeks to prepare, is divided into two parts. The first part addresses the following matters: What are the major legislative or public policy alternatives with regard to human cloning? What are the arguments for each and the advantages and disadvantages of each? The second part explores in greater detail one of the critical issues in the public policy debate, the alleged promise of "research" (or "therapeutic") cloning and its significance for finding and choosing the wisest public policy.

I. Human Cloning and Public Policy: The Major Legislative Alternatives

At the end of its deliberations on human cloning, the Council may well be expected to provide specific recommendations regarding national public policy. It is therefore vital for the Council to begin to consider the major policy alternatives, even as it considers the meaning of cloning human beings and the moral and ethical arguments for and against doing it. While there may certainly be many possible combinations and arrangements of policies and regulations regarding human cloning, the public debate and discussion has focused on a legislative ban. Here there are three options: no legislative ban; a ban on "reproductive" cloning only, which would prohibit implanting cloned embryos into a woman's uterus to begin a pregnancy; or a ban on all human cloning, beginning with the first step, the creation of cloned human embryos. These seem to be the most likely options, and policy makers will probably be faced with a choice among them.

A. No Legislative Ban
The first option would be to enact no new federal legal restraints or prohibitions on human cloning. This option would continue the legal status quo: a continued moratorium on federal funding of any sort of human cloning ("research" or "reproductive") but no legal barrier to such work carried out with private funds (except in those six states that have enacted state statutes forbidding human cloning).1

Advocates of this approach make the following arguments, among others:

1. A ban on human cloning is unnecessary. The technical ability to clone humans successfully is far off in the future. Banning activities in the absence of clear and present danger sets a bad precedent and is, in general, bad public policy. There is, at least for now, no need for the government to act.

2. A ban on human cloning violates private rights. Cloning is a matter of private choice and reproductive freedom, and therefore not properly a matter for governmental action. (A temporary -- and perhaps only voluntary -- moratorium on human cloning may be acceptable until the technology is sufficiently safe for use, but thereafter the law should be silent.)

3. A ban on human cloning interferes with important public goods -- not only as a means for medical research and scientific progress, but also as a new mode of human reproduction with potentially good outcomes for society.

4. A ban on human cloning is unconstitutional. Congress lacks the constitutional authority to prohibit a scientific, medical, or technological activity, especially on moral grounds.

5. A ban on human cloning, while constitutional, is undesirable. Criminalization of scientific research would set a dangerous precedent and would tend to stifle scientific progress in the United States. Leading scientists would leave the country to work in more permissive places. The American economy would suffer in competition with other less restrictive nations.

6. A ban on human cloning will not succeed. The ban will be violated, if not here, then in other countries. It will also be unenforceable: It is impossible to police laboratories or clinics to prevent it; and there can be no acceptable and enforceable remedy should cloning occur, especially once a pregnancy has begun.

For one or more of these reasons, some have argued that the government should refrain from banning human cloning in any form. This option, however, seems to lack public and congressional support, as evidenced in the recent vote on human cloning in the House of Representatives, where nearly every member voted for at least some sort of federal ban on human cloning. Most Americans and most legislators seem to believe that some legislative action is required with regard to human cloning (for some of the reasons laid out in the previous working papers), but they are divided on which of the next two alternatives is the better legislative course.

B. Ban on Clonal Reproduction Only: Prohibit Attempts to Initiate Pregnancy with Embryonic Clones
One proposed legislative option seeks to ban only "reproductive" cloning. It would ban attempts to start a pregnancy by banning the transfer to a woman's uterus of a cloned human embryo. This option would allow, and even sanction or encourage, the creation of cloned human embryos for research purposes, provided that none of these embryos were used in efforts to produce a baby.

Advocates of this approach make the following arguments, among others:

1. This is an effective way to ban the cloning of human beings. If the goal is (only) to stop "reproductive" cloning (the cloning of live-born human babies), banning the implantation of cloned embryos will be just as effective as banning the creation of cloned embryos.

2. A more restrictive ban is too costly. Proscribing the creation of cloned embryos, usable for research purposes, would shut down unique and promising new avenues of stem-cell research (such as "therapeutic" cloning), which seek to derive embryonic stem cells that are genetically virtually identical to (and therefore presumably immunologically compatible with) the person in need of stem cell therapy. Even if the promise of this research is uncertain, its value cannot be judged in any definitive way without allowing it to go forward. [This issue of "therapeutic" cloning figures prominently in the public and legislative debates. We shall return to it in the second part of this working paper.]

3. A more restrictive ban is unjustified and arbitrary. A ban on the creation of cloned embryos for research is inconsistent with present law and policy regarding embryo research. Research on cloned embryos is no different from other forms of embryo research that we allow in the private sector -- specifically, research on IVF embryos left over in assisted reproduction clinics and on IVF embryos created solely for research and destruction -- despite the fact that many people believe this research is unethical. A ban only on implantation would thus maintain the precedent set by President Bush with his decision on federal funding of embryonic stem cell research: Not every morally debated form of research justifies a criminal ban, but not every medically desirable form of research deserves public funding and endorsement.

4. A more restrictive ban will hurt science. The criminalization of research on cloned embryos would create a "chilling effect" in the scientific community that would hurt other avenues of scientific research, and set a dangerous precedent that scientific inquiry is no longer free. Scientists may take their work out of the United States, and thus harm America's standing as a world leader in scientific and medical research.

5. A more restrictive ban will hurt reproductive and genetic medicine. The criminalization of research on cloned embryos will create a "spill-over" effect, threatening the legality of other medical procedures and research -- such as IVF, gene therapy, and research with embryonic stem cells.
For one or more of these reasons, some of those involved in the public debate about cloning argue that a total ban on all human cloning (including research on cloned embryos) is not advisable and not necessary for the prevention of clonal baby-making. They suggest that banning the implantation of cloned embryos would be enough to stop "reproductive" cloning while allowing scientific research to continue.

C. Ban on All Human Cloning (Including the Creation of Embryonic Human Clones)
This option seeks to ban all human cloning from its very start, beginning with the creation of cloned human embryos. The proponents of this option hold that a ban on the transfer to the uterus of a woman is insufficient, and that cloning must be comprehensively stopped before it starts.

Advocates of this approach make the following arguments, among others:

1. Only a total ban will work. The only effective way to stop reproductive cloning is to stop the creation of cloned embryos. The reasons for this include the following:

a. The commercial production of embryos for research is protected by industrial secrecy. This means that those charged with monitoring and enforcing the ban on reproductive cloning will not know who is doing what with cloned embryos.

b. The transfer of cloned embryos to begin a pregnancy would be virtually undetectable and protected by doctor-patient confidentiality.

c. The IVF and assisted-reproduction industry is largely unregulated: The federal government has no track record in regulating or keeping track of the number and fate of embryos produced in IVF clinics. There is little or no reason to be confident that the necessary institutions exist or could exist to monitor the use of cloned embryos.

d. A ban only on implantation would be unenforceable: Once pregnancy has begun, there is no real remedy except forced abortion, something neither reproductive rights advocates nor pro-life advocates would accept.

2. The promise and especially the necessity of "research" cloning are exaggerated. "Therapeutic" cloning is a highly speculative form of research with no imminent medical benefits. It may not be needed to solve the "rejection problem"; it may not succeed in doing so; even if it succeeds, it will not be practicable on a large scale. [We will offer an expanded discussion of these matters in the second part of this working paper.]

3. The total ban would not have "spill-over" effects. A ban on the creation of cloned embryos would not affect other accepted forms of assisted reproduction -- including IVF, artificial insemination, etc. The proposed legislative total ban on human cloning has been carefully and narrowly drawn.

4. A ban only on the implantation of cloned embryos is morally and politically highly problematic. The less-total ban (option B, above), which explicitly allows the creation of cloned embryos for research and destruction, would permit and even endorse the creation of a new class of human embryos that cannot be brought to term but must be destroyed (or else left frozen indefinitely). Failure to destroy (or leave frozen) these embryos would be a federal crime. A ban on only the implantation of cloned embryos would put the federal government in the morally dubious position of sanctioning the creation of a class of embryos solely for research purposes and then mandating their eventual destruction.

5. The total ban on all human cloning, including cloning embryos for stem-cell research, is not, as some have alleged, arbitrary or inconsistent. Exploiting unused IVF embryos may have its own moral difficulties, but the deliberate creation of embryos exclusively for the purpose of their use and destruction is, in moral and social terms, a different and far more serious matter entirely. Besides, the point of this comprehensive ban is to stop all human cloning before it starts: It is a cloning ban, not an embryo research ban.

6. A ban on all human cloning, including the creation of embryonic human clones, would not affect other forms of scientific research -- such as embryonic stem cells, gene therapy, cell or molecular cloning, animal cloning, etc. Federally funded research on existing embryonic stem cell lines and private-sector research on new embryonic stem cells derived from IVF embryos will proceed. The feasibility of stem cell therapies will become clearer, without the need for research on cloned embryos. Moreover, if scientists can one day clearly demonstrate the "need" for cloned embryos for research, the ban can be revisited.

7. A total ban on cloning will not hurt the United States in the international arena. A comprehensive ban in the United States would be an important step in moving toward a worldwide ban of human cloning, now being explored at the United Nations. By enacting a total ban on human cloning, the United States would clearly stake out a position of leadership in this global effort.

For one or more of these reasons, many opponents of clonal baby-making believe that the only way to effectively and ethically prevent human "reproductive" cloning is to prohibit human cloning entirely, beginning with the creation of cloned human embryos. They argue that the potential scientific promise is not sufficient to offset the very serious moral, ethical and prudential arguments against human cloning. They argue, in addition, that scientists must, in rare cases, accept moral limits on what they may do. Scientists want complete freedom to experiment without restrictions -- believing both that science itself is a self-justifying enterprise, and that scientists have professional institutions in place to govern themselves. For the most part, society gladly grants them this freedom; we support, celebrate, and benefit from their work. Occasionally, however, scientists must accept the need for limits, when their research and the technologies it creates threaten core human, moral, and social goods. While conceding that some future benefits may be delayed or lost by banning the creation and use of cloned human embryos, proponents of a total ban argue that the increased risk of opening the door to cloned children and the moral problem of creating human embryos solely for research, exploitation, and federally required destruction justify a total restriction in this case.

II. "Research" (or "Therapeutic") Cloning -- Some
Scientific, Moral, and Policy Questions

Central to the current debate over whether or how to ban human cloning are questions about the promise and morality of "research" (or "therapeutic") cloning. As indicated above, opponents of a total ban on human cloning believe that the potential medical benefits of "research" cloning are sufficient to justify allowing the creation of cloned human embryos to continue. In recent months, some scientists and biotechnology advocates have been strongly making the case for the prospects and benefits of this research. In November 2001, Advanced Cell Technology (ACT) published the first results of its program in "research" (or "therapeutic") cloning, the creation of a zygote by somatic cell nuclear transfer and its subsequent cleavage to form a six-celled embryo (see Working Paper: Scientific Aspects of Human and Animal Cloning).

In testimony before Congress and in various media appearances, the ACT scientists touted the therapeutic promise of "rejection-proof" stem cells that their research on cloned human embryos would, they claimed, soon make possible. Because of the importance of this matter to the current policy debates, and also because of the importance of this issue both in itself and as a test case for thinking about how to judge competing claims about scientific promise and moral hazard, we shall look into the subject of "research" cloning. We will focus in particular on the issue of "therapeutic" cloning, which is the most widely discussed and defended (at least in public debate and discussion) form of research on cloned human embryos. We shall first present an account of what "therapeutic" cloning is and what it hopes to accomplish. We shall then pose a series of questions about the necessity, efficacy, feasibility, practicality, and morality of this research. Our purpose here is to indicate and open up some of the questions that are relevant to evaluating the significance of "therapeutic" cloning for the public policy options now before us.

A. "Therapeutic" Cloning: What It Is and What It Hopes to Achieve
Q: What is the idea behind "therapeutic" cloning? How do advocates for this research claim that it will work?

In several significant human diseases (for example, Parkinson's disease), cells that produce a needed substance die selectively, and disease results from the lack of that substance. In theory, such diseases could be treated by isolating cells that produce the needed substance (dopamine in the case of Parkinson's) in appropriate amounts, and then transplanting such cells into the patient. This is the hypothesis and goal of embryonic stem cell research: the capacity to regenerate, repair, or replace the diseased or damaged cells that cause many human diseases or disabilities, including Parkinson's disease, juvenile-onset diabetes, leukemia, stroke, burns, and spinal cord injury, among others.

However, if stem cell therapies are to work, the transplanted cells must not be recognized as "foreign" by the immune system of the patient. If this happens, the transplanted cells will be attacked and the transplantation therapy may not produce a lasting improvement. Researchers disagree about how best to try to solve this problem, and about which avenues of research or possible research are currently the most promising.

One proposed method for solving the rejection problem is to produce "individualized" stem cells that are genetically virtually identical to the patient who needs them. It is this avenue of research that is now commonly referred to as "therapeutic" cloning. These presumably immunocompatible stem cells would be obtained by taking cells from the living patient, inserting the DNA from those cells into an enucleated human egg using "somatic cell nuclear transfer," developing the resulting (genetically virtually identical) zygote to the blastocyst stage in the laboratory, and then deriving stem cells from the embryo clone (which is destroyed in the process). The hypothesis is that by deriving these stem cells from an embryonic clone of the patient, the cells would not be rejected, since the patient's body would treat them as if they were his or her own cells.

As an example, in the case of a patient with Parkinson's, the following steps could be envisioned:

1. Obtain human egg cells from informed and consenting donors.

2. Remove the nucleus from these eggs and insert a nucleus from an informed and consenting donor-patient with Parkinson's. The zygote and the resulting embryo would be a clone of the patient.

3. Grow the reconstructed egg in vitro until the embryo reaches the stage where an inner cell mass containing stem cells has been formed.

4. Take the embryo apart and isolate "individualized" stem cells that are genetically virtually identical to the patient.

5. Induce the "individualized" stem cells to differentiate in vitro into dopamine-producing, neuron-like cells.

6. Transplant these dopamine-producing cells into the appropriate brain location of the donor-patient.

As only experiments resembling steps 1 and 2 have been reported to date, and no "individualized" stem cells have been isolated, it may take years or decades to develop such therapies. It should also be noted that a legislative ban on all human cloning (Option C, in Part I above) would make continuing such research a criminal offense. Evaluating the promise of such therapies is therefore an essential factor in weighing the alternative cloning policy options (though certainly not by itself determinative of which option should be chosen).

B. Scientific and Practical Questions about "Therapeutic" Cloning
The idea and rationale of "therapeutic" cloning are clear enough. But the idea is not yet a reality. Even before reaching possible moral and political difficulties, there are a series of scientific and practical questions that need to be considered, including its likelihood of success and the availability of alternative approaches to the same goal. Among these questions are the following:

1. Will "therapeutic" cloning work? Will it solve the rejection problem?
In addition to the many unanswered questions surrounding embryonic stem cell research in general, many scientists dispute whether "therapeutic" cloning would actually solve the problem of immune rejection of transplanted stem cells. Some questions include: Is there evidence from animal studies that "individualized" stem cells can be developed through cloning? If such "individualized" stem cells are transplanted into the donor animal, are they rejected by the immune system of the recipient? In animal systems, when stem cells that have been differentiated in vitro to produce neuron-like cells are transplanted into the brain of the donor animal, are they attacked and killed (for example, by microglial cells)? Do the mitochondrial proteins derived from the egg (and which render the clone not 100 percent identical to the donor-patient of the somatic cell nucleus) cause the "individualized" stem cells to be recognized as foreign by the recipient and attacked by the immune system? Do the animal cell proteins in the media used to grow the reconstructed egg and "individualized" stem cells cause the cells to be recognized as foreign by the recipient?

Scientific opinion is not clear on these questions, even if many leading scientists believe ACT's claims for "therapeutic" cloning are premature and overly optimistic. But defenders of continuing research on cloned human embryos, whatever their judgment of ACT's work in particular, argue that it is different to say that something will not imminently work versus something will never work, which is different in turn from saying that nothing useful will be learned by doing such research. What works and what doesn't is often unpredictable, and often the pursuit of a hypothesis that turns out to be wrong opens up avenues of inquiry that might not otherwise have been possible or likely.

2. Is "therapeutic" cloning necessary? Or are there other, simpler, more promising, and less controversial ways of solving the rejection problem?
Is "therapeutic" cloning necessary for solving the problem of immune rejection in proposed stem-cell therapies? Critics of the research argue that the development of stem-cell based cures is going to take a long time, and therefore that immunogenics may very well solve the stem-cell rejection problem well before the treatments are ready; or that adult stem cells taken from the patient's own body (and which would be in principle immunocompatible) could be used to treat the disease; or that standardized embryonic stem cell lines can be used rather than having to create customized cell lines for each patient; or that recent studies with cross-species stem-cell transfer may offer more promise; or that stem cells, once available, could be turned into bone marrow cells, injected into the patient's bone marrow where the cells of the immune system are generated, and thus could create a mixed immune system that would not treat transplanted cells as "foreign."

Defenders of "therapeutic" cloning counter that we cannot know for sure which avenue of research will eventually work; and that it would be a shame if major advances in stem cell therapy were held back by rejection problems that could have been fruitfully explored by studying cloned embryos.

3. Is "therapeutic" cloning an accurate term?
The term "therapeutic" cloning is a heavily disputed one. It was created to describe the above hypothesized procedure, named both for the intention of the researchers and for what it might make possible in the future. It was also created in an effort to separate the creation of embryonic clones for research from the identical procedure of creating embryonic clones for reproduction.

However, both many advocates and many opponents of this research believe the term is misguided. Some research advocates believe that the use of the term "cloning" is inaccurate because the researchers have no intention of creating a cloned live-born human being. They say that what they are really doing is one (or all) of the following: "somatic cell nuclear transfer" (the procedure used to create embryonic clones); "nuclear transplantation" (which presumably describes both the transplantation of DNA used to create embryonic clones and the hoped-for transplantation of stem cells to future patients); or "cell replacement by nuclear transfer" (again, putting the emphasis on the procedure that creates embryonic clones and the future hoped-for medical benefits).

At the same time, some opponents of this research believe that the term is inaccurate for very different reasons. They argue that "therapeutic" cloning is cloning, because the nature of the act does not turn on the intention: The product of the procedure (namely, cloned embryos) does not differ from the cloned embryos created for the purpose of initiating a pregnancy. The intended uses may be different, but the cloned embryos are not. The opponents have difficulty especially with the label "therapeutic." They argue that to refer to the procedure as "therapeutic" cloning suggests that the procedure itself is therapeutic -- that is, that the act of "therapeutic" cloning serves or heals an existing patient. But there is no patient as yet, only future and hoped-for patients. In reality, they argue, "therapeutic" cloning is simply a euphemistic way of describing experimental research on cloned human embryos, thereby obscuring the fact that the embryos would be destroyed in the process of deriving stem cells from them. A more accurate term, they argue, would be "experimental" cloning or "research" cloning.

4. Are there additional reasons, besides "therapeutic" cloning, that might make research on cloned human embryos useful or desirable?
In addition to "therapeutic" cloning, there may be other potentially beneficial scientific or medical reasons to conduct research on cloned human embryos. Some scientists would like to use cloned embryos to study the mechanism by which somatic cell nuclei undergo reprogramming, hoping thereby to learn ways to convert any adult somatic cell into a pluripotent stem cell, available for regenerative medicine without the need for embryonic cells at all. In addition, there may be benefits of having genetically virtually identical embryos to study how the introduction of specific genes affects early human development.

C. Moral, Social, and Prudential Considerations
In addition to these scientific and practical questions, the issue of "therapeutic" cloning raises a series of moral, social, and prudential questions. These questions include the following: Would the creation of cloned embryos for research increase the risk or likelihood of reproductive cloning, and if so, to what extent? Does the risk of future dangers (live human clones) outweigh the hope of future benefits (new medical therapies and cures for diseases)? Even if "therapeutic" cloning became possible, would it be practicable for large-scale use? Would its benefits be equitably or widely available or only available to select groups (such as the very wealthy and those able to secure a large supply of human eggs)? Does the possibility of saving future lives justify the present exploitation and destruction of embryos, especially embryos created solely for research use? Does the need to treat certain diseases or forms of suffering justify using what may be morally hazardous forms of research?

Here we try to consider some of these questions in greater detail:

1. Would "therapeutic" cloning be practicable for large-scale use?

Given the low success rate of attempts to bring a cloned zygote to the blastocyst stage, it appears that a very large number of eggs would be required to make "therapeutic" cloning a reality. Will this large supply of eggs be available? Who will provide them? What will be required to obtain them? How much will it cost? Will entrepreneurs be willing to invest in such a high-risk venture, especially if there are cheaper and simpler avenues to pursue to solve the "rejection problem"? Will regulators be able to verify the safety of each cell line? Is the creation of "individualized" stem cells practicable on a large scale?

2. Would its medical benefits be equitably available?
Given the above concerns, would access to "therapeutic" cloning be equitably distributed and widely available, or would it be available only to those who could bear high financial costs or those who have access to large supplies of human eggs? How should these considerations bear on the public policy debate regarding what to do about human cloning?

3. Is "research" (or "therapeutic") cloning morally acceptable?
It is at this point that the subject of the ethics of human cloning intersects with the otherwise separate subject of the ethics of human embryo research, crucial to the debate about embryonic stem cell research. Our current study of human cloning cannot take up the ethics of embryo research in general (this is a topic for another occasion, as when the Council examines the federally funded work now being done with stem cells). Nevertheless, we must acknowledge that the moral acceptability of "therapeutic" cloning research is tied to the moral acceptability of all embryo research, especially where the embryos are specially created for research purposes. And we must also acknowledge that for some who favor a total ban on all human cloning, it is their objections to the use and abuse of human embryos that centers their opposition. Accordingly, we indicate here a few of the relevant moral questions regarding the ethics of embryo research in general, before looking at moral questions peculiar to research with cloned human embryos.

a. When, if ever, is it ethical to use nascent human life for research purposes? In answering this question, what if any is the moral significance of the following distinctions?

i. Between different stages of nascent human life: fertilized egg or zygote, embryo (including the blastocyst stage), fetus.

ii. Between the manner in which and for which nascent human life is created: IVF embryos created for reproductive purposes and left over in clinics; IVF embryos created solely for research purposes and eventual destruction; cloned embryos created solely for research purposes and eventual destruction.

iii. Between different experimental uses of nascent human life: stem cell research, fertility research, embryological or genetic research.

iv. Between forms of research that should be publicly funded and endorsed, allowed in the private sector but not publicly funded or endorsed, or regulated or banned.

b. Does the use of embryo clones for research or experimental purposes create new moral problems or questions distinct from the moral problems and questions raised by research on IVF embryos? Conversely, how significant are the unique scientific or medical benefits of conducting research on cloned embryos? Three considerations seem most important:

i. Would the use of embryo clones increase the risk of human "reproductive" cloning?

ii. What is the moral significance of the fact that legislation may create a new class of human embryos that must be destroyed? Of the fact that it would be illegal not to destroy them?

iii. How do we balance these moral concerns with the potentially unique scientific or medical benefits of research on cloned embryos?

c. Besides the moral questions regarding the use and fate of human embryos, there are questions about the moral implications for the human researchers and the society that encourages and supports them: What happens to the attitudes, sensitivities, and outlooks of people who are willing to regard nacsent human life as a resource to be exploited?

4. How do we judge among present versus speculative hazards and benefits? What does prudence require? What are the different human goods that are at stake?
The ethical and prudential considerations regarding "therapeutic" cloning raise more general questions about how we judge present versus future hazards and benefits -- especially when the hazards are mostly moral and the benefits are mostly medical. In the matter of human cloning, we must judge among (and perhaps between) the following:

a. The possible future medical benefits of research on cloned human embryos, and whether those benefits can or cannot be achieved in other, less morally problematic ways.

b. The likelihood that the creation of embryo clones for research will increase the probability that cloned children will be produced and that a ban only on reproductive cloning will be violated.

c. The ethics of creating cloned human embryos for research, exploitation, and destruction.

d. The use or non-use of government power to stop certain scientific research from proceeding, and whether this will have other unintended and undesirable effects.

e. The precedent that judgment on these matters establishes for future public decisions about advances in the science of human cloning, assisted reproduction, and genetic engineering.

D. Conclusion: The Need for Prudence
We have tried to outline some of the major questions about "therapeutic" cloning, and in particular how these questions (scientific, moral, prudential) bear on the legislative options regarding human cloning. In this policy context, it is not enough to set forth a vision of possible future benefits. Much work remains to be done evaluating the science of "therapeutic" cloning and the scientific alternatives, but more importantly seeing the science in the clearest possible ethical, social, and prudential terms. In making judgments about "therapeutic" cloning (as with any other future scientific prospect), we need to take into account the best scientific opinion about where the research will lead and how successful it might be in achieving the human benefits it promises. But, at least in matters such as the present one of cloning human beings, the judgment about policy cannot and should not be made on the basis of the scientific judgment alone (or by scientists acting alone). It must be made on the basis of prudent (and moral) judgment about what the community believes is the wisest course.

In the end, a practical decision will have to be made about how and whether the public should act, and about which policy option, if any, it should pursue. When that judgment is finally made, it should be made soberly -- with the knowledge that some human goods may be foregone for the sake of protecting or preserving others. (Or conversely, that some human goods may be risked in the pursuit of other, more important ones.) But it is also true that any such judgment, when finally made, is not necessarily final. Even a permanent ban, in a democracy like ours, can be revoked if scientific, ethical, and prudential considerations justify doing so.

As we seek to clarify what prudence demands in the matter of human cloning, a final point deserves emphasis. A ban on human cloning would shift the burden of proof to those who seek to revoke it (those who seek to clone), and away from those who seek to stop cloning. This would represent a significant departure from previous practice in the area of scientific research and technology. Some people believe strongly that, given the high human stakes involved, such a shift in the burden of proof is necessary, if only with regard to those few areas of science and technology that may pose significant threats to the meaning of our humanity. Others regard such a shift as perilous, a threat to scientific and technological progress and to individual freedom. The decision about human cloning should have this issue clearly in mind. The prudent choice of who bears the burden of proof must be informed by the kind of analysis the Council is undertaking: an investigation of the state of science and scientific opinion on the potential benefits of research on cloned human embryos; a deeper consideration of the human meaning of cloning human beings and an assessment of the ethical implications involved; and an ethical and prudent deliberation about the policy options available, keeping in view the competing human goods at stake.

Appendix A: Typology of the Moral Status of the Embryo

The following staff-prepared typology of views about the moral status of the human embryo is for members' discussion purposes only and does not purport to be definitive or exhaustive.

a. Embryos are cells, no different from other cells in the body. All types of embryos should be available for use in biomedical research.

b. Embryos are not nothing, but they are certainly not the moral equivalent of the later stage fetus or of post-birth human beings: Therefore, possible medical benefits for the living do justify the use of all types of embryos for research -- both those created via IVF and those created via cloning.

c. Embryos are not nothing, but they are not the moral equivalent of the later stage fetus or of post-birth human beings: Given this, possible medical benefits for the living do justify the use of embryos for reproductive purposes through IVF but left unused, but do not justify the creation of cloned or IVF embryos solely for research and destruction or the added danger of opening the door to human reproductive cloning.

d. Embryos are not nothing, but they are not the moral equivalent of the later stage fetus or of post-birth human beings: Nevertheless, possible medical benefits for the living do not justify the use of any embryos for research and destruction or the added danger of opening the door to human reproductive cloning. Embryos created through IVF that are left over in clinics should be left to "die naturally" or be adopted.

e. Embryos are the moral equivalent of both the later stage fetus and all living human beings. They are what human beings should look like -- what human beings are -- at that stage of development. They should not be used for research in any way, and couples that use IVF should not create embryos that they do not intend to implant with the goal of pregnancy.

1. The states that have enacted legislation banning human cloning are California, Louisiana, Michigan, Missouri, Rhode Island, and Virginia.

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