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Human cloning and genetic engineering: the case for proceeding cautiously.

The irony inherent in the debate on "whole human" reproductive cloning is the amount that has been written and the emotions that have been stirred regarding a scientific advance that has not yet occurred (1) and that, at present, is only a potential threat to family and social structures. (2) This article is in no way intended to minimize the fears raised in the ongoing discussion regarding the potential for superhuman or subhuman replicants, (3) or the potential adverse impact upon the family from the need to nurture genetic duplicates of one or two parents. (4) This paper is merely presented as one alternative to the entertainment industry's popular depiction of the horrors of cloning (5)--a depiction that has the effect of detracting from a debate that is, potentially, highly productive. Arguably, a more realistic focus upon the beneficial, as well as on the destructive, potentials of human cloning would permit the evolution of a reasoned set of legal controls designed to protect the interests of individuals, the family, and society.

A debate motivated by fear is more likely to result in extreme solutions or absolute prohibitions; these are unlikely to withstand the test of time. Enforcement of absolute limitations in the face of continuing scientific curiosity and societal needs will ultimately fail. (6) Laws that attempt to ban what people want to have (7) or to find out about (8) are, generally, honored only in their breach. To presume that the enactment of laws prohibiting the application of scientific advances will end the debate on human cloning, is, in this author's belief, the height of folly. Our curiosity regarding the essential elements of our physical being have led us to the strands of DNA and, even deeper, to the basic protein structures of which those strands are composed. (9) Human cloning is merely a predictable tangent to the study of the human genome. (10)

The purpose of this article is to suggest that an absolute prohibition against human cloning is unworkable and ill-conceived; and, further, that there is sufficient time to engage in a reasoned debate to develop the type of restrictions upon cloning practices that will protect the interests of individuals, families, and the human species, while permitting an exploration of the potential benefits of cloning technologies. The first part below briefly discusses the scientific history of cloning and how this has led to present efforts to clone higher animals. The second part identifies the risks that have been identified in the current debate, and also considers some of the potential benefits implicated by both therapeutic and reproductive cloning. The third part presents a constitutional framework for either supporting or denying an individual right to engage in human cloning. The fourth part considers the present national legislative response to the prospect of both therapeutic and human reproductive cloning. Finally, this paper presents suggestions for the continuing debate and argues for the imposition of a more logical framework in order to achieve a reasoned result in light of the inevitable advances being made in the science of human cloning.

I. BACKGROUND

Scientific advances allowing the cloning of plant and lower animal structures are longstanding. (11) The replication of organisms for agricultural purposes has been commonplace for many years. (12) Similarly, cloning of certain animals, particularly for food production, has become commonplace, if not universally accepted. (13)

The progress heretofore made with respect to plants and lower animals was dramatically enhanced with the public disclosure that researchers in England had successfully cloned a female sheep by transplanting the nucleus of a cell--removed from an adult sheep's udder--into an enucleated egg cell from an adult female sheep. (14) After 277 attempts, scientists at Roslin Institute utilizing the process of somatic nuclear transfer succeeded in producing the genetic twin of the sheep whose nucleus was transplanted into the donee egg cell. (15) Out of twenty-nine live embryos, only one successful offspring was achieved. (16) Nonetheless, Dolly, as the first viable mammal cloned from the nucleus of an adult cell, became the internationally recognized symbol for the future potential of cloning and the spark for the debate on the efficacy of cloning humans.

Predictably, successful mammalian cloning culminating in the birth of Dolly has also heightened both the temptation of scientists and the consternation of ethicists regarding the application of similar procedures in humans. (17) It is not simply the success of Dolly, however, that has incited the curiosity of researchers. Rather a confluence of circumstances and discoveries has occurred during the last half-decade of the millennium--causing the prospect of human cloning to have value apart from, or perhaps in the face of, ethical concerns. These concerns include (1) advances and discoveries with respect to stem cells, (2) the mapping of the human genome, and (3) the integration of these achievements into the science of human cloning.

A. Stem Cells

Potential applications for human cloning have been enhanced by discoveries and advances in stem cell technology. In fact, as noted below, the avowed purpose of those who have announced the first cloned human embryo is to utilize this technology for the production of human stem cells.

Two types of stem cells--totipotent and pluripotent--originate from the embryo. (18) After fertilization, division of the egg begins and the initial cleaving produces two totipotent stem cells. Each totipotent stem cell possesses the capability to develop into a full human being. An example of the totipotent nature of these cells exists in the incident of identical twins. Identical twins form as a result of a separation of these two cells after the first cleavage. At approximately four days after fertilization, the dividing cells form a hollow sphere called an early blastocyst. (19)

As the blastocyst develops, two layers become evident: an outer layer of cells, called the outer cell mass (OCM); and an inner layer of cells, called the inner cell mass (ICM). At this point in time, the OCM becomes destined to develop into the placenta and other sustaining tissues. These cells will not differentiate into the embryo proper, but only into tissues that support fetal development in utero. The ICM consists of the cells that will eventually develop into the tissues of the human body, i.e., the embryo proper. (20) By this time in development, the cells of the ICM have lost their totipotent capabilities and have become what are known as pluripotent stem cells. Although the embryo will be formed from these cells, if isolated from the OCM and implanted into the uterus they would never develop into a fetus. (21) These stem cells nevertheless hold the capability to develop into numerous types of cells if properly induced.

1. Characteristics

In addition to the key characteristic of potentiality, the ability to differentiate into various cells, embryonic stem cells boast other characteristics that distinguish them from the other cells of the body. First, these stem cells have a higher resistance to senescence, or cell aging and death. (22) This is advantageous because stem cells can be maintained longer in culture for use in experiments and research. Next, stem cells have the ability to continually reproduce with little mutation occurring between generations. (23) The combination of these two traits would enable researchers to keep a library of stem cells. (24)

After the completion of the initial collection of stem cells, their replication through many generations would create a large supply of viable, usable stem cells. Successfully maintaining such a cell line could reduce or potentially eliminate the need to collect stem cells from embryos or fetuses. In addition, the storage of stem cells would decrease the time between problem identification and treatment via donation. (25)

Lastly, stem cells obtained from embryos and/or fetuses may be less immunogenic in nature. Due to their immaturity, scientists believe that stem cells may cause less of an immune response in donees than mature, specialized cells taken from an adult or child. (26) These three unique characteristics viewed in totem demonstrate that stem cells hold significant value as potentially important medical technologies.

2. Proposed Uses

Scientists hypothesize numerous clinical and research uses for embryonic pluripotent stem cells. One such use involves tissue transplantation. Traditionally, whole organs and tissues have been harvested to replace diseased or damaged tissues. In order to decrease rejection by the patient, the closest possible matching of types, including histocompatibility, was paramount. (27) Yet finding a perfect organ match is an arduous task, and the wait for a match is often very long. (28) The implementation of stem cell storage would lead to both a decrease in the amount of time for a patient to wait before a transplant, and an increase in the chance for donee acceptance. (29) Thus, stem ceils have the potential for being especially useful in treating diseases in which there is a shortage of suitable tissue for transplant, such as Type I diabetes in children. (30)

Another possible stem cell use being tested involves the implantation of fetal stem cells into the brain of Parkinson's disease patients. (31) Though still in the early stages of experimentation, evidence shows some effective replacement of lost nerve ceils in these patients. Further, researchers are optimistic about translating these methods to patients suffering from Alzheimer's disease and other degenerative nervous system diseases. (32) The National Institutes of Health (NIH) suggests that embryonic stem cells could have possible utility in drug development. (33) New drugs could be tested on tissues generated from stem cells, rather than on actual humans; henceforth, a new drug would be tested on humans only after it initially had been proven safe. (34)

Studies in human reproduction and development lie on the more research-oriented side of stem cell use. Instead of using embryos or fetuses, researchers could use these precursor cells to investigate how cell lineages are determined and what are the signals of induction. (35) These are but a few areas in which stem cells, with continuing research, would prove invaluable.

3. Sources

In November 1998, almost simultaneously came the announcements that two groups of researchers had isolated the elusive embryonic pluripotent stem cells. (36) Dr. James Thomson's group, at the University of Wisconsin, isolated stem cells directly from the embryo at the blastocyst stage the same methodology utilized by researchers at Advanced Cell Technology (ACT) in producing the first human cloned embryo. (37) Thompson's research used extra embryos from in vitro fertilization clinics. "[T]hese embryos were in excess of the clinical need for infertility treatment ... [and] were made for purposes of reproduction, not research." (38) Informed consent of the gamete (sperm and egg) donors was, however, obtained to permit harvesting of the embryos for research. (39) Dr. John Gearhart's group, at Johns Hopkins University, isolated the stem cells from fetal tissues obtained from terminated pregnancies, with the informed consent of the donor. (40)

Another way to locate and ultimately extract stem cells is proposed through somatic cell nuclear transfer (SCNT)--a method that avoids the harvesting of embryos completely. (41) A somatic cell is any cell in the body other than the reproductive sperm and egg cells. This proposed methodology contemplates the transfer of a somatic cell nucleus from a cell obtained from the ultimate patient/recipient into an enucleated egg. This transfer basically would be a way of "resetting the cell's deoxyribonucleic acid (DNA)." (42) Hypothetically, when the egg fuses with its new nucleus, it creates a new totipotent combination cell. Once this new combination cell reaches the blastocyst stage, collection of pluripotent stem cells and their reimplantation into the patient can take place. These cells hold the potential to be more easily accepted by the patient, as the cells' DNA will have arisen from the patient's own somatic cell. (43)

B. Mapping the Human Genome

At the same time that research was proceeding toward the ultimately successful cloning of Dolly and toward a deeper understanding into stem cells, worldwide efforts were underway to map the human genome--to chart and place the believed-to-be greater than 100,000 genes in the human body along the DNA structures of which they are a part. (44) The efforts of the federally funded Human Genome Project (HGP) achieved its goal of mapping and sequencing the human genome as the new millennium commenced. (45) But the task of mapping, daunting as it may have seemed less than a decade ago, is only the beginning of the research programs that will be spawned by the HGP. Next comes the task of sequencing the identified genes and analyzing the traits expressed thereby which define our humanness--from eye color to intelligence, from the length of toes to gender orientation--fully recognizing that as the genetic interactions become more complex, even multi-genic interactions are countered by environmental conditions and learned behavior. (46) Along with the identification of traits ascribed to specific genes at specific locations, it is the hope that somatic and germ line therapies will be discovered that will establish genetic links to disease and afford medicine the means, by adjusting and altering genetic protein structures, to ease the suffering inflicted by diseases like Cystic Fibrosis, Parkinson's, and cancer. (47) Those cures could take place somatically in the suffering patient or, in the distant future, conceivably in the family line--the germ line--so that all future generations in a particular family bloodline would be free from now-incurable maladies such as Huntington's disease or breast cancer. (48)

Evolving the means to undertake genetic manipulation is, unfortunately, fraught with the same concerns that are associated with the topic of human cloning: (1) what, if any, trait modifications are appropriate; e.g., intelligence, strength, stature, or athletic ability; (2) who shall have access, and who shall have the right to choose; i.e., individuals, parents, the courts, and/or government; and (3) who shall bear the cost. The argument has been made that, once perfected, genetic alterations should be subsidized and available to all economic levels of society. (49)

Both human cloning and genetic manipulation raise fears of the creation of a master and/or subjugated population. Arguably, permitting germ line alteration of traits (50) may undermine human dignity, and may even violate the United States Constitution. (51) The Supreme Court in 1882 held that, as well as abolishing slavery, the Thirteenth Amendment empowers Congress to prohibit any form of infringement on an individual's free will or civil liberties that could be considered a form of enslavement or involuntary servitude. (52) Human cloning and genetic manipulation thus may run afoul of the Thirteenth Amendment because the results of either could be considered a form of genetic bondage, i.e., creating humans with a predetermined genetic makeup, laden with expectation, thereby limiting a cloned individual's freedom. Courts may choose not to support a procedure that implicates a genetic form of slavery, undermines free will, and infringes upon the civil liberties guaranteed under the Constitution.

In fact, one may well argue that the unfettered ability to alter genetic traits has the potential to cause greater societal horror and dislocation than human cloning. As will be discussed more fully below, unfettered application of genetic therapies to alter human traits may undermine the evolutionary progress of the species. While it remains unclear whether the human species will suffer over the long term from the manipulation of genetic structures in the germ line, there are substantial unknowns attendant to the long-range impact of genetic modification accompanied by cloning. Increased susceptibility to disease, increased occurrence of developmental abnormalities, and adverse effect upon longevity are but a few matters of current concern. (53)

C. The Impact of Advances in Stem Cell Research and the Mapping of the Human Genome upon the Future of Human Cloning

On the same biomedical stage where the mapping of the human genome and the exploration of stem cells are playing their roles, first enters Dolly and then the human cloned embryos of Advanced Cell Technology (ACT). (54) As suggested above, it is the confluence of these discoveries, rather than the individual occurrence of each, that raises the most challenging ethical and legal issues; and these will not be resolved simply by banning the progress of science.

The first human cloned embryos were developed by the scientists at ACT on October 13, 2001, utilizing nuclear replacement technology similar to that employed in the cloning of Dolly. (55) Keenly aware of the potentially adverse public and political reaction to their achievements, the principal scientists and researchers at ACT have gone to great lengths to describe their efforts and accomplishments as "therapeutic cloning"--cloning not designed to achieve reproductive results. (56)

The distinction, ff one actually exists, does not arise from any differences in the scientific processes. Nor does it arise from the fact that in the case of reproductive cloning an embryo is produced that is capable of being implanted into a woman's uterus for the purpose of producing human offspring, while in the case of therapeutic cloning one is not. Rather, the only difference seems to be the point in the growth cycle of the embryo at which the scientists involved in overseeing the cloning procedures halt its development, thereby preventing the embryo from developing to the point of being usable for reproductive purposes. (57) In other words, therapeutic cloning utilizes the same technology as reproductive cloning, but terminates the embryonic development at the blastocyst stage, at which point the early embryo has evolved into approximately one hundred cells, including an inner cell mass (ICM) containing stem cells. At this juncture, the ACT scientists break open the blastocyst, retrieve cells from the ICM, and transfer them to a culture medium for the purpose of creating stem cell lines. Allowed to progress in a proper environment, however, the so-called therapeutic cloned embryo could evolve into a mature embryo for reproductive purposes. (58) Only self-imposed restraint and/or legislative prohibition distinguishes the "therapeutic" human clone from its reproductive twin.

II. PHYSICAL AND PSYCHOLOGICAL CONSEQUENCES AND ADVANTAGES

Separate and apart from the definitional distinctions which plague the current debate, two fundamental areas of conflict have yet to be resolved: first, the physical and psychological (including psychosocial) consequences of both whole-human reproductive and therapeutic cloning; and second, the ongoing conflict regarding reproductive rights and the definition of human life. (59)

A. Adverse Physical and Psychological Consequences

At least as important as the unknown physical consequences of genetically altered clones, are the adverse psychosocial impacts and inequalities that could result from selective alteration of traits. Absent the process of genetic manipulation, cloning replicates from the existing gene pool. The "replicants," whether cellular or whole human, are merely genetic mimics, and not altered genetic beings. (60) From an evolutionary perspective, some might argue that the offspring are regressive because they are not the result of a combined gene pool of a male and female from a prior generation. Nevertheless, the greater danger occurs when human cloning is combined with the penultimate ability of science to manipulate the genetic structure of the germ line--the hereditary path of the species. We should worry less about replicating an existing being than about engineering a human nucleus to contain all of the social enhancements that we seem to hold so dear: strength, stature, intelligence, good looks, and/or engaging personality. In the latter scenario, the combination of genetic manipulation and cloning should sound a societal alarm. We must not treat the issue of human cloning separately from the concerns raised during the HGP regarding the development of genetic therapies and somatic cell and germ line manipulation.

Before considering legal and ethical rights and remedies, it is useful to catalogue the concerns that have been expressed regarding the potential risks to the individual, the family, and society attendant to the combined effects of both genetic manipulation and human cloning.

1. Adverse Physical Consequences

The application of adult somatic cell alteration, germ line manipulation, and/or human cloning--either alone or in combination--could result in adverse physical consequences to the offspring. Human cloning requires the deactivation and subsequent reactivation of the differentiated DNA of the nucleus of the adult cell, creating the possibility of revealing new mutations or damaging the DNA. (61) This may be why it took 277 attempts to clone Dolly the sheep. (62) Additionally, there is concern that a human, cloned from an adult somatic cell, might inherit the cellular age of the nucleus donor, thus subjecting the clone to a shorter lifespan or debilitating diseases. (63) Further, since an adult somatic cell is used in the cloning procedure, any mutations already present in that cell due to age or genetic inheritance could manifest themselves in all of the clones' cells. (64) Also of grave consequence is the fact that once altered in the germ line, the "adjusted" traits are carried from generation to generation, affecting without choice (unless subsequently altered again) the future bloodline of the genetically altered individual. Currently, we have no basis for knowing whether diseases and/or physical deficiencies could become more prominent in later generations as a result of cloning. (65) We must conclude that our lack of knowledge creates a risk to future generations concerning the combined effects of germ line genetic manipulation and human cloning.

2. Adverse Psychological Impacts

While potential adverse physical consequences of genetic-trait manipulation and human cloning arise from a lack of quantifiable scientific information, adverse psychological consequences provide for easy speculation, but are even more difficult to assess. Nevertheless, it is not unreasonable to assume that genetic manipulation combined with human cloning may have one or more of the following adverse psychosocial impacts.

a. Effect upon Parent-Child and/or Family Relationships

The fact that the offspring is a replicant of one parent raises questions concerning the future relationship between the parent(s) and the cloned child(ren). Will traditional authority structures be threatened by the acknowledgement of the fact that the child is the biological twin of the parent? Further, will the genetically altered "twin" suffer regarding issues of self-image and identity, such that establishing traditional family relationships will become difficult if not impossible? (66) In ways we cannot yet comprehend, the clone's relationship status with respect to siblings and blood relatives may be adversely affected by the psychological realization that the genetically altered and biologically enhanced replicant is generationally distinct and, in fact, is not a member of the generation of his brothers, sisters, cousins, and other contemporaries. (67)

b. Adverse Impact upon Self-Determination

A human clone's sense of self-determination, of free will, may suffer in several ways, particularly ff the individual has been genetically altered. For one, the replicant will in all probability become aware of the life history of his or her "original"; their successes and failures, admirable and deficient qualities, as well as any specific enhancements which have occurred. Each revelation will raise questions in the mind of the clone regarding his or her own capabilities and qualities, and whether they will be limited in the manner and fashion of the clone's genetic predecessor-twin or stand to benefit from the genetic manipulation. (68) While there may be no valid basis for accepting such determinism, the psychological effect of the knowledge that one is in a sense a duplicate of another may well have the effect of encouraging behavior that is perceived to be limited and/or determined by the genetic forebear. The replicant could be psychically relegated to the life patterns existing in or created by the pre-existing genetic donor. Opportunities, achievements, and capabilities in effect become limited by that which came before, as the clone perceives that it is trapped by biological realities created by or upon the conduct and patterns of the behavior of the nuclear donor. (69)

Such a limitation upon self-determination and free will would be especially apparent in a situation in which the clone was created to "replace" a deceased family member. Parents fostering grief and replacement expectations would perhaps subconsciously discourage a replacement child's manifestation of individuality and attempt to limit his or her actions and interests to those manifested by the previous child. (70)

If, instead of merely replicating, the donor-parent actually engineers changes in genetic structures of the nucleus, the clone would then face issues that go far beyond simply being a genetic twin. The donor may have manipulated some traits to be superior (or inferior) to its own, such as intelligence or strength. The remaining unaltered qualities would be presumed by the clone to be either: (1) incapable of change because of scientific limitations; (2) resulting from a lack of the financial ability of the donor to alter some of the existing traits; or (3) deliberately selected to remain unaltered. Knowledge that the parent or parents may have altered some traits and allowed others to remain unchanged would psychologically burden and isolate the clone, could impose perceived limitations upon his own capabilities, and may be used to rationalize deficient or aberrant conduct. Deficient conduct is thereby explained and perhaps even excused, based upon the fact that such conduct--intellectual, emotional, or physical--was genetically predetermined. (71)

c. Adverse Social Impacts Resulting from a Combination of Genetic Engineering and Human Cloning

Just as family structures may suffer from a combination of genetic engineering and cloning, so too may social structures be sensitive and vulnerable to the impact of engineered replicants. Precepts in our own society regarding equality of opportunity, behavioral responsibility, and social worth will need to be reconsidered where the engineered clone has been relegated to a particular level of intelligence, strength, or aggressiveness. For example, the law may evolve new theories of self-defense where it is agreed that the overt conduct of the defendant (e.g., assault or psychical abuse) may be reasonably anticipated because of engineered traits. (72)

On a much broader societal scale cloning, if widely implemented, may compromise genetic variation, which is our species' greatest defense. Cloning promotes genetic uniformity, thereby decreasing the genetic variation that helps our species resist disease. (73) Consent issues may also arise if people are cloned involuntarily without their consent or knowledge--which is all too possible since the procedure simply requires one somatic cell, which can be obtained from hair or saliva. (74)

B. Positive Physical and Psychological Benefits

While the emphasis hereinabove has focused upon the potential adverse physical and psychological consequences of human cloning, it would be wrong not to include suggestions of potential benefits. In general, human cloning offers couples and individuals for whom other reproductive alternatives have been foreclosed an alternative with several distinct advantages.

In the first instance, cloning offers a male who is incapable of reproducing gametically, or who is unlikely to do so because of a low sperm count, the ability to produce by transplanting nuclei from other body tissue. (75) The resulting offspring is the genetic twin of the donor male. (76) No genetic input from a donor female is necessary, and--to the extent that the decision to reproduce by cloning is made by a male-female couple, a single male, or a male-male couple--the genetic characteristics of the nucleic donor have been preserved without the introduction of a third-party surrogate. (77) The same analysis applies with respect to the choice to reproduce by female couples and single females. (78)

Human cloning eliminates the need for genetic parenting by a third party who would otherwise be a stranger to the traditional or single-parent family unit. The biological assistance provided by the donor female is limited to enucleated egg donation and gestation. Removing the third party from the reproductive process: (1) preserves the genetic relationship to one parent in each instance (each parent could alternate nucleic donation so that the family would have genetic links to both); (79) and (2) reduces the degree to which the third party or surrogate has a basis for claiming a continuing relationship with the offspring. (80)

Although a third-party female may be involved in either or both egg-donation and gestation, family linkage to the third party will largely be eliminated and, thus, the marriage or family structure--to whatever extent one exists attendant to the reproductive effort--will not be undermined by the introduction of a third party. (81) In comparison to other means of assisted reproduction, cloning actually preserves traditional family structures and, on this point, is preferable to artificial insemination which utilizes third-party sperm or egg donors. (82) Only successful in vitro fertilization (IVF) without a surrogate has less impact upon traditional family structures. (83) That process requires a male partner with viable sperm and the extraction and fertilization of eggs capable of gestation from the female partner. (84) Traditional IVF is, to date, lengthy, expensive, and often painful. (85) Human cloning may offer a solution to some of the complexities inherent to IVF.

Similarly, it would be wrong to deny that germ line alterations also offer potential benefits. Nuclear gene therapy performed on a somatic cell which is subsequently cloned has the potential to eliminate hereditarily transmitted diseases. (86) Increasingly sophisticated techniques will lead to the ability to manipulate genetic and protein structures to affect more complex human diseases. In this process, cloning serves as an efficient means to transmit the therapeutically altered DNA and proteins. Only once the ease of genetic manipulation has become so great that the alteration of complex physical traits (intelligence, personality, and strength, for example) has become commonplace need we fear any threat to social stability from the combination of such techniques with the science of human cloning.

III. CONSTITUTIONAL ANALYSIS

The researchers at ACT engaged in, by their own definition, therapeutic cloning to produce stem cell lines. They claim that their undertaking is not procreation and therefore is outside the scrutiny of the courts with respect to an individual right to reproduce. (87) The fact that the cloned human embryo created for therapeutic purposes is disaggregated at the blastocyst stage arms those who distinguish therapeutic cloning from reproductive cloning with the argument that Constitutional comparisons to human reproduction are inappropriate.
 It is a new type of biological entity never before seen in nature. Although
 it possesses some potential for developing into a full human being, this
 capacity is very limited. At the blastocyst stage, when the organism is
 typically disaggregated to create an embryonic stem cell line, it is a ball
 of cells no bigger than the period at the end of this sentence.... It has
 no organs, it cannot possibly think or feel, and it has none of the
 attributes thought of as human. (88)


As the prospect of human cloning becomes a legitimate topic of discussion, proponents and opponents alike must confront the proposition that cloning for reproductive purposes is a Constitutionally protected right. Although human cloning in both its therapeutic and reproductive forms is viewed as a procreative act, the Constitutional basis for claiming such a right is less than clear. Even those who argue that the Supreme Court supports the right to procreate as a right of privacy inherent in the Fifth and Fourteenth Amendments, (89) cannot simply assume that such protections also extend to human cloning.

The rights of individual autonomy and personal choice in marriage and family life are firmly established by the Supreme Court as fundamental liberty interests. (90) Such elements are included in the "zones of privacy" protected by the United States Constitution. (91) The consequence is that legislative limitations and government intrusion into family relationships (92) and procreative decisions are highly suspect. (93)

The Court has never expressly stated, however, that even the right to reproduce "naturally" is protected by the right of privacy inherent in the Due Process Clauses of the Fifth and Fourteenth Amendments, let alone the right to reproduce through human cloning. Perhaps most significant is the argument that cloning for the production of stem cells is not reproduction at all within the Constitutional definition of procreation. (94) Although reproductive to the extent that stem cells are replicated from a human embryo, cloning for the purpose of the production of stem cells is not a family or procreative decision, but one undertaken for research or therapeutic purposes. While the Court has addressed the need to assure due process in protecting every person's substantive rights to "life, liberty and property," this due process protection has yet to be extended fully to reproduction, and certainly has not been extended to replication. But the cases which implement a right of privacy as the premise for reproductive rights concern the right to prevent reproduction through contraception and abortion, not the right to bring about procreation through natural or assisted reproduction. (95)

It remains unclear whether any of the Constitutional protections offered to autonomous reproductive choice will extend to assisted reproduction generally, or to therapeutic and/or procreative human cloning specifically. (96) Although the Supreme Court has yet to expressly recognize a positive right to procreate, an Illinois federal district court has interpreted the protective umbrella of reproductive rights broadly, and in so doing has arguably recognized a positive right to procreate. In Lifchez v. Hartigan, (97) the court stated:
 It takes no great leap of logic to see that within the cluster of
 constitutionally protected choices that includes the right to have access
 to contraceptives, there must be included within that cluster the right to
 submit to a medical procedure that may bring about, rather than prevent,
 pregnancy." (98)


The legal argument that the constitutional right of privacy encompasses methods used to prevent and bring about pregnancy is a line of reasoning that could be implemented if a reproductive human cloning issue ever were to be brought before the Supreme Court.

Although these recent trends in the law arguably suggest that new reproductive technologies will be afforded constitutional protection, not all "intimate and personal decisions" are embraced by the Due Process Clause. (99) Over-generalized applications of due process protection historically have been frowned upon by the Court, (100) and it would be foolhardy to assume that human cloning falls within the zone of autonomy protected by the Constitution. The Court has limited the constitutionally protected right of privacy, for example, to include only those liberties that are "`deeply rooted in this Nation's history and tradition'" (101)--which human cloning certainly is not.

Furthermore, the imposition of limits upon the constitutional right of privacy is justified only when there is a "compelling state interest" (102) and the limitations imposed to further that compelling interest are narrowly drawn. (103) In regard to reproductive rights, for example, while states cannot interfere with a woman's decision to terminate her pregnancy, Roe v. Wade (104) and its progeny established that states can constitutionally limit reproductive acts by denying a woman's right to obtain an abortion in her third trimester. (105) States have a legitimate interest in safeguarding health, maintaining medical standards, and protecting potential life. (106) Similarly, choices regarding reproduction are among the most sacrosanct one can make, and, therefore, are protected by the mantle of due process. (107) Nonetheless, parental and family decisions that may cause harm to family members are not necessarily within the zone of privacy, and thus may be limited. (108)

These issues have clear implications for any future scrutinization by the Court of human cloning. Whether defined as therapeutic or reproductive, if cloning were to be afforded constitutional protection by the Court, it would, in this author's belief, be subject to severe definitional limitations and regulatory restrictions, with each state citing numerous legitimate compelling interests warranting such restrictions. This is both good and bad news for those who advocate the cause of research in this area. In order for cloning to receive due process protections, the possible individual and social harms concomitant to cloning must be offset. Toward this end, human cloning will have to be strictly defined and carefully and continuously scrutinized in order to ensure conformance with certain reproductive limitations. This view is consistent with the position taken by the Court--that it will not hesitate to refine due process protections where other individual rights are at stake. (109)

At this point in the emergence of the science of cloning and human genetic engineering, we face a number of definitional variables which prevent us from arriving at a comprehensive legal and regulatory framework for distinguishing between human cloning for therapeutic and for reproductive purposes. Given these uncertainties, we are unequipped to determine whether either or both of these technologies--or, for similar reasons, whether human cloning combined with genetic engineering--should be permitted generally, permitted only under the strictest regulatory conditions, or prohibited altogether. Legal scrutiny is complicated by the fact that the science itself is at such an early stage of development. There remain huge risks to individual safety and to the safety of the species in advancing without extreme caution toward unrestricted genetic manipulation and human cloning.

Partly because the range of possible applications and therapies is presently unknown or, at best, imperfectly understood, there can be only the most superficial and inadequate debate regarding issues of the social impact of human cloning. We can pursue our science fiction and anticipate the horrors attendant to the unfettered creation of an offspring who is a genetic twin of the parent, or we can be more patient and allow science to proceed to test and experiment as long as the research and therapeutic protocols for such actions are consistent with the highest standards we currently expect for all human research. (110) The best response in the face of such a high degree of uncertainty on so many levels is to defer Constitutional analysis and undertake only a measured legislative response.

Being somewhat less anxious about the science will permit us to deal with what arguably are the real issues inherent in the emergence of human genetic manipulation and human cloning, namely: (1) who will choose--the individual, the family, or the state; and (2) who will pay--the individual, the private sector, or government entities. The question of who chooses is really the question of who benefits from genetic engineering and reproductive human cloning and, ultimately, from the genetic engineering that will be incorporated into the cloning process. Even more than the impact of the science, the decision of who will pay for the benefits--therapeutic or reproductive--may be the most challenging and most threatening to societal harmony. Many, if not most, parents would seek to provide the best level of genetic improvement to their offspring. Unequal or socially stratified levels of access to the latest medical advances may sow the seeds of popular revolutions undreamed of in past centuries.

Finally, if genetic engineering and human cloning technologies advance because of our natural human curiosity and desire to attain them, then governmental efforts to restrict such research, both in this country and abroad, will be largely futile. Science will advance, privately funded if necessary, and without the protective mantle offered by government regulation. By way of example, Advanced Cell Technology has successfully cloned human embryos entirely with private funding. (111) Faced with limitations on the ability of government to stem the tide of science, the goal with respect to research leading both to genetic therapy and to human cloning should be reasonable regulation undertaken carefully and enforced strictly, as opposed to outright prohibition. In an environment of government oversight, with assistance and funding provided by governmental agencies, there is sufficient leverage to require disclosure of the nature of research being undertaken as well as ample opportunity to regulate both the manner in which research is conducted and the application of the technologies being developed thereby. (112)

IV. LEGISLATIVE RESPONSE

Proposed federal legislation to regulate human cloning has been primarily reactionary, and the law continues to lag behind the science. ACT's announcement that it had successfully cloned human embryos in November 2001, for example, influenced the proposed Human Cloning Prevention Act of 2001 that purported to prohibit federal agencies from making grants to, contracting with, or paying "any individual, business, institution, or organization that within the past one year has engaged in human cloning." (113) Legislative debates have proven controversial, emotional, and lengthy, as legislative representatives have simultaneously struggled to make decisions, to understand complicated science, and to balance the purported remarkable benefits of human cloning against the dreadful risks associated with it.

Since March of 2001, various legislative amendments have been proposed in response to the prospect of human cloning research, primarily aimed at prohibiting all forms of human cloning. In March 2001, the Ban on Human Cloning Act was the first of several pieces of legislation that proposed the criminalization of human cloning, by subjecting violators to fines and imprisonment of not more than five years. (114) Subsequent resolutions have become increasingly detailed and prohibitory, imposing greater fines and criminal punishments and explaining banned procedures in greater detail. (115) Congress also attempted to stifle the funds needed for research by proposing the Human Cloning Research Prohibition Act, which purported to eliminate the expenditure of federal funds to conduct or support research on the cloning of human beings. (116)

April 2001 marked the beginning of a series of nine varied items of legislation proposed to amend the United States Code to include chapters or sections prohibiting human cloning. (117) All prohibit human cloning for reproductive purposes and impose severe civil and criminal penalties for violators. Only a few of the proposed statutes adopt the premise advanced in this writing that a measured rather than a prohibitory approach should be adopted with regard to cloning. (118) Even amongst these resolutions, however, the single proposal that permits the cloning of human embryonic cells for research purposes (119) may be distinguished from the several that do not. (120)

The House of Representatives adopted an absolutist version of the Human Cloning Prohibition Act of 2001 by voting in favor of the Weldon-Stupak bill, on July 31, 2001. (121) Specifically, the Act prohibits the shipment of embryos produced by human cloning and criminalizes the effort of any person or entity engaged in, performing, or participating in any attempt to perform human cloning. (122) Further, the knowing importation of an embryo produced by human cloning is expressly prohibited. (123) Both civil and criminal penalties are provided for in the Act, including imprisonment for up to ten years and a minimum one million dollar fine. (124)

The House also considered a liberal variation of the Human Cloning Prohibition Act of 2001, that would inferentially have permitted human cloning research. This variation, the biotech-industry-favored Greenwood-Deutsch bill, proposed a compromise--banning reproductive cloning, yet permitting human cloning for research. (125) While the Greenwood-Deutsch bill expressly prohibited human reproductive cloning, the language of the bill did not apply to "[t]he use of somatic cell nuclear transfer technology to clone molecules, DNA, cells, or tissues." (126) Since this language permits the cloning of cells, it would inherently have permitted the cloning of human embryos for research purposes. The Greenwood-Deutsch bill was the only proposed legislation seriously considered that attempted to preserve the potential benefits of human cloning research while still prohibiting the unsafe reproductive aspect of human cloning. (127)

The House's decision to adopt the Weldon-Stupak bill, while certainly constituting a major victory for those seeking an absolute ban on all forms of human cloning, will have no legal effect until the Senate also votes in favor of the Act. Pending Senate approval, human cloning remains largely unregulated at the federal level. Companies such as ACT will continue to forge ahead and to negate most, if not all, of Congress' well-intended efforts to impede their progress. The question to be considered in light of the tenor of such reactive and reactionary legislation is not the clarity of prohibitory language or the attempts by Congress to ban all forms of human cloning, but rather whether absolutist legislation such as the Weldon-Stupak bill will effectively serve to protect the public while anticipating future societal needs. At a minimum, if federal support of research regarding human cloning is to be banned for the present, such legislation should include sunset provisions to allow for orderly reconsideration by Congress as advances occur which resolve issues of safety and efficacy.

History proves the futility of prohibition laws. (128) As Albert Einstein noted, "nothing is more destructive of respect for the government and the law of the land than passing laws which cannot be enforced." (129) The Weldon-Stupak bill, endorsed by the Bush administration, (130) has been referred to the Democrat-controlled Senate, and only time will tell if the Senate will also embrace the House's broad ban, and halt the progression of human cloning research in this country.

V. CONCLUSION

While fascinating both in its concept and for the purpose of intellectual debate, the cloning of whole humans remains a "distant prospect." (131) Of more immediate significance is the cloning of human tissue for therapeutic purposes: the manipulation of the DNA of those tissues with genetic structures in order to alleviate the suffering caused by diseases such as Alzheimer's, diabetes, Parkinson's, cardiovascular disease, and various genetically linked cancers. Therapeutic cloning of tissue might well assist in providing the cellular medium to achieve goals such as the replacement of bone, tissue, skin, and cartilage and the regeneration of spinal cord tissues. Therapeutic cloning of tissue, however, would not be intended to produce a whole human being.

Because there are potential benefits that may emerge from current research in genetic therapies which may be applied to therapeutic tissue cloning, we should not reject the concept of replication. Prohibitory legislation which is all encompassing undermines the advances that are being achieved through the exploration of the human genome.

On the other hand, extreme caution is needed in undertaking even early research to support the distant possibility of whole human cloning. Whereas manipulation of the genome through somatic cell therapies integrated into cloning procedures offers therapeutic advantages to society, combining genetic engineering and manipulation with somatic nuclear implantation for the purpose of creating a human clones raises immense questions regarding the impact upon individual well-being and social stability, the transmission of disease, and the potential undermining of the health and longevity of the offspring and the germ line.

The view expressed above, however, is that outright prohibition will not stifle the inclination of scientists to advance both therapeutic and reproductive cloning or to seek the ability to replicate whole human clones. If we take the view that the science often advances notwithstanding our immediate ethical, moral, and social concerns, we will need to consider whether it would be better to establish a supportive but firm regulatory environment for overseeing and controlling that research, and in return to require complete disclosure of the empirical and clinical processes; rather than simply and naively to prohibit through legislation or short-term judicial solutions. (132)

An enlightened governmental approach which encourages science to inform society of its methods and discoveries is to be much preferred over the alternative: research in genetic engineering and human cloning that takes place in dark corners--hidden from the light of public scrutiny.

(1) As of this writing, Jose B. Cibelli, Robert P. Lanza, and Michael D. West, of the privately held biotechnology company Advanced Cell Technology (ACT), have announced the first human cloned embryo and the first human embryos generated only from eggs (i.e., parthenogenesis). Jose B. Cibelli et al., The First Human Cloned Embryo, 286 SCI. AM. 44, 45-46 (2002). The impact of their achievement and announcement will be discussed infra, at footnotes 54-58 and accompanying text.

(2) See, e.g., Lori B. Andrews, Is There a Right to Clone? Constitutional Challenges to Bans on Human Cloning, 11 HARV. J.L. & TECH. 643, 656-57 (1998); George J. Annas, Commentary, Human Cloning: A Choice or an Echo?, 23 DAYTON L. REV. 247, 249-50 (1998); Note, Human Cloning and Substantive Due Process, 111 HARV. L. REV. 2348, 2348, 2350-51 (1998) [hereinafter Human Cloning]; David Orentlicher, Cloning and the Preservation of Family Integrity, 59 LA. L. REV. 1019, 1022-25 (1999). These writings--representative of the dozens written on this as yet unattainable scientific possibility--all reflect upon the legal, ethical, and moral grounds for permitting or prohibiting human cloning.

(3) Dan Brock's extraordinary article is extremely insightful on these points. See generally Dan Brock, The Human Genome Project and Human Identity, 29 HOUS. L. REV. 7 (1992). See also infra Part II (identifying and discussing physical and psychological advantages and consequences to individuals and families).

(4) See Orentlicher, supra note 2, at 1027-31.

(5) See GATTACA (Columbia Studios 1997); MULTIPLICITY (Columbia/Tristar Studios 1996); JURASSIC PARK (Universal Studios 1993); BLADE RUNNER (Warner Bros. Studios 1982); THE BOYS FROM BRAZIL (Fox 1978); SLEEPER (MGM/UA Studios 1973); see also Annas, supra note 2, at Part III (discussing how cloning has been depicted in science fiction movies and novels).

(6) Although laws prohibiting the production and consumption of alcohol are obvious examples, other laws, such as the draft, are inconsistent with the public will and are useful examples. See Philip E. Ross, The Futile Crackdown, FORBES, Oct. 18. 1999, at 70. Prohibition laws are self-defeating. Smoking laws, for example, seem to have increased the number of teenager smokers--perhaps because banned items are more attractive and alluring to teenagers. See id. at 71, 76.

(7) Prohibition is an oft-cited example. Laws that are too strict, like the outright prohibition on alcohol in the 1930s, can have negative public policy impacts, such as fueling organized crime. See id. at 76.
 The prestige of government has undoubtedly been lowered considerably by the
 Prohibition law. For nothing is more destructive of respect for the
 government and the law of the land than passing laws which cannot be
 enforced. It is an open secret that the dangerous increase of crime in this
 country is closely connected with this.


ALBERT EINSTEIN, My First Impressions of the U.S.A., in IDEAS AND OPINIONS 6 (Sonja Bargmann trans., Modern Library ed. 1994).

(8) The current debate regarding the legalization of marijuana, the banning of cigarette smoking in public spaces, and the conduct of research involving human embryos are relevant examples. For state and federal marijuana penalties, see State Guide to Marijuana Penalties, at http://www.norml.org/states/index.shtml (last visited Feb. 19, 2002). See also Prohibitions Against Smoking on Scheduled Flights, 49 U.S.C.A. [section] 41706 (West Supp. 2001); LA. REV. STAT. ANN. [subsections] 9:121-133 (West 2000) (establishing limitations and guidelines for in vitro fertilization); ME. REV. STAT. ANN. tit. 22, [section] 1593 (1964) (criminalizing experimentation on human fetuses or on "any product of conception considered live born"); MASS. ANN. LAWS ch. 112, [section] 12J (Law. Co-op. 1991) (prohibiting experimentation on live human fetuses).

(9) See infra notes 44-45 and accompanying text (discussing the make-up of the human genome).

(10) See infra notes 46-48 and accompanying text (discussing how the mapping of the human genome will in turn lead to further advances in cloning technology).

(11) See DAVID M. GLOVER, GENE CLONING: THE MECHANICS OF DNA MANIPULATION 158, 179 (1984) (citing a 1984 study on the transformation of yeast, stating that "[t]he ability to transfer DNA into mammalian cells ... has been known for over two decades").

(12) See id. at 175; see also John Charles Kunich, Mother Frankenstein, Doctor Nature, and the Environmental Law of Genetic Engineering, 74 S. CAL. L. REV. 807, 808-13 (2001) (describing early techniques used for replication and recent genetic developments responsible for successful agriculture production).

(13) See Kunich, supra note 12, at 810-13 (explaining the historical development of genetic engineering of crops, plants and livestock); Stacy J. Ratner, Note, Baa, Baa Cloned Sheep, Have You Any Law? Legislative Responses to Animal Cloning in the European Union and the United States, 22 B.C. INT'L & COMP. L. REV. 141, 144 (1999) (providing some potential benefits of genetic cloning to the agricultural industry).

(14) See I. Wilmut et al., Viable Offspring Derived from Fetal and Adult Mammalian Cells, 385 NATURE 810, 810-11 (1997) (describing the procedure used to produce live lambs); Gina Kolata, Scientist Reports First Cloning Ever of Adult Mammal, N.Y. TIMES, Feb. 23, 1997, at A1.

(15) See Janet Rossant, Ph.D., The Science of Animal Cloning, in 2 CLONING HUMAN BEINGS: REPORT AND RECOMMENDATIONS OF THE NATIONAL BIOETHICS ADVISORY COMMISSION (NBAC) B-1, B-10 (1997), available at http:/bioethics.georgetown.edu/NBAC/PUBS.HTML.

(16) Id. Almost two years later, the successful cloning of a cow was reported. See Gina Kolata, Japanese Scientists Clone a Cow, Making Eight Copies, N.Y. TIMES, Dec. 9, 1998, at A8 (noting that "[c]ows are the third adult mammal to be cloned").

(17) See Katheryn D. Katz, The Clonal Child: Procreative Liberty and Asexual Reproduction, 8 ALB. L.J. SCI. & TECH. 1, 3-5.

(18) National Institutes of Health, Stem Cells: A Primer, at http://www.nih.gov/news /stemcell/primer.htm (May 2000) [hereinafter Stem Cells Primer] (explaining the role of both totipotent and pluripotent stem cells in fetal development and emphasizing the potential for virtually unlimited yield in this area of research).

(19) Id.

(20) T.W. SADLER, PH.D., LANGMAN'S MEDICAL EMBRYOLOGY 30-31 (John N. Gardner ed., 6th ed. 1990).

(21) See Stem Cells Primer, supra note 18 (noting that "[a]lthough the inner cell mass cells can form virtually every type of cell found in the human body, they cannot form an organism because they are unable to give rise to the placenta and supporting tissues necessary for development in the human uterus").

(22) AUDREY R. CHAPMAN, PH.D. ET AL., AM. ASS'N FOR THE ADVANCEMENT OF SCI. & INST. FOR CIVIL SOC'Y, STEM CELL RESEARCH AND APPLICATIONS 2 (1999).

(23) Id. Mutations between generations create problems for research, as cells become unintentionally altered from previous cell generations. Thus, experiments performed on normally mutating cells may not be compared to control experiments or to results from experiments on non-mutated cells.

(24) See id. (stating that "[t]he isolation and subsequent growth of ES cells in culture allow scientists to obtain millions of these cells in a single tissue culture flask, making something once rare and precious now readily available to researchers").

(25) See generally Ania M. Frankowska, Note, Fetal Tissue Transplants: A Proposal to Amend the Uniform Anatomical Gift Act, 1989 U. ILL. L. REV. 1095, 1095-97 (discussing some of the technical difficulties involved with the transplantation of fetal tissue, including how rapid degradation of tissue obtained from aborted fetuses necessitates almost immediate transplantation--a problem that would be solved with the storage of a supply of stem cells).

(26) See Chapman, supra note 22, at 7 (emphasizing that the use of pluripotent stems cells in the transplantation arena could "create an unlimited supply of cells, tissues, or even organs that could be used to restore function without the requirement for toxic immunosuppression and without regard to tissue matching compatibility"); Frankowska, supra note 25, at 1097 (noting that "[f]etal cells are immunologically reactive; this means the host body is less likely to reject the transplanted fetal tissue"). Further, fetal "tissue's lack of maturity also reduces the incidence of graft-versus-host reaction, which occurs when the transplant tissue attacks the host tissue in the recipient's body." Id.

(27) See Darryl R.J. Macer, Ethical and Social Issues in Xenotransplantation, in BIOETHICS IN INDIA: PROCEEDINGS OF THE INTERNATIONAL BIOETHICS WORKSHOP IN MADRAS (Jayapaul Azariah et al. eds., 1997), at http://www.biol.tsukuba.ac.jp/~macer/india/bii31.html (last visited Mar. 1, 2002).

(28) For up-to-date statistics demonstrating the increasing shortage of donated organs available for transplantation, see United Network for Organ Sharing (UNOS) Online, Newsroom, Critical Data, at http://www.unos.org (2002).

(29) See Stem Cells Primer, supra note 18.

(30) Chapman, supra note 22, at 5.

(31) Id.

(32) Id.

(33) Stem Cells Primer, supra note 18.

(34) Id.

(35) Chapman, supra note 22, at 6-7 (noting that "[h]uman ES cells may allow scientists to investigate how early human cells become committed to the major lineages of the body").

(36) See Chapman, supra note 22, at 2 & n. 1.

(37) See Ronald Kotulak, For First Time, Body's Building Blocks Captured, CHI. TRIB., Nov. 6, 1998, at C1 (defining blastocyst as "a mass of about 150 cells grown in a cell culture from a fertilized human egg"), available at 1998 WL 2913735; Miranda Biven, Administrative Developments: NIH Backs Federal Funding For Stem Cell Research, 27 J.L. MED. & ETHICS 95, 95-96 (1999).

(38) Stem Cells Primer, supra note 18 (emphasis added).

(39) Id.

(40) Biven, supra note 37, at 96. The consent was obtained after--and independently of--the decision to terminate the pregnancy. Stem Cells Primer, supra note 18.

(41) See Biven, supra note 37, at 96 (reporting that this process, which is better known as "cloning," has primarily been performed using animal cells, not human cells).

(42) Lewis D. Solomon, Reflections on Human Cloning, 27 HOFSTRA L. REV. 659, 660 (1999).

(43) See id. (discussing the benefits of using these cells to repair damaged tissue, e.g., how using cloned cells would prevent tissue mismatch, thereby lessening the potential for tissue rejection).

(44) Funded at a cost of three billion dollars and jointly operated by the National Institutes of Health and the Department of Energy, the Human Genome Project "is the largest coordinated effort in biology ever directed at a single goal." COMM. ON GOV'T OPERATIONS, DESIGNING GENETIC INFORMATION POLICY: THE NEED FOR AN INDEPENDENT POLICY REVIEW OF THE ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS OF THE HUMAN GENOME PROJECT, H.R. Rep. No. 102-478, at 1 (1992), 1992 WL 74179.

(45) Mapping of the human genome was completed in 1994. See Maxwell J. Mehlman, The Law of Above Averages: Leveling the New Genetic Enhancement Playing Field, 85 IOWA L. REV. 517, 519-20 & n. 11 (2000). Sequencing of the human genome, at least the initial phase of this endeavor, has been completed as of 2001. See News Release, Appelera Corporation, Celera Genomics Completes Sequencing of the Genome from One Human Being (announcing the completed sequencing phase of a human individual's genome) (Apr. 6, 2000), at http://www.pecorporation.com/press/prccorp040600.html; see also Stephen Handelman, Wading Into the Gene Pool: A Genetic Bank in Quebec Could Be a Canadian Breakthrough in Biotech, TIME CAN., July 2, 2001, at 45; Celera Reports Advance in its Genome Quest, MED. INDUS. TODAY, Apr. 7, 2000.

(46) See RUTH HUBBARD & ELIJAH WALD, EXPLODING THE GENE MYTH 8-10 (1993) (advancing the view that heredity and environment play key roles in shaping human character).

(47) See Robertson Parkman, Gene Therapy in the 1990s, 65 S. CAL. L. REV. 411, 420 (1991) (describing the quest to find ways to use gene therapy to cure these and other diseases as "the holy grail of gene therapy").

(48) See Roberta M. Berry, Genetic Enhancements in the Twenty-First Century: Three Problems in Legal Imagining, 34 WAKE FOREST L. REV. 715, 717, 720-22 (1999) (hypothesizing a "not-too-distant future" in which genetic enhancement technologies, having become commonplace, will pose novel legal questions and require innovative legal solutions); see also John C. Fletcher, Moral Problems and Ethical Issues in Prospective Human Gene Therapy, 69 VA. L. REV. 515, 528-33 (1983) (proposing several benefits gene therapy would bring to both medical treatment and prevention). Somatic gene therapy involves the introduction of a cloned gene into somatic (body) cells by viral vector to replace either genetically defective functions or alter pathological disease processes. Germ-line gene therapy involves the introduction of a cloned gene by viral vector into germ-line cells so that the resulting gene correction is passed to future generations. See Parkman, supra note 47, at 418-19 (providing a distinction between somatic and germ-line gene therapy and noting that advancements in the latter, which affect future offspring as well, should be pursued cautiously). These advancements, however, may not be available to all who desire it. See Mehlman, supra note 45, at 540-54 (discussing the availability of genetic therapy and its effect on increased social stratification).

(49) See Mehlman, supra note 45, at 554-55 (arguing that inadequate guarantees of equal access to genetic enhancement technology would result in social inequality).

(50) See supra notes 46-48 and accompanying text.

(51) The Thirteenth Amendment, in pertinent part, states that "[n]either slavery nor involuntary servitude, except as a punishment for crime ... shall exist within the United States." U.S. CONST. amend. XIII, [section] 1.

(52) See United States v. Harris, 106 U.S. 629, 640 (1882).

Barry Brown, Professor of Law and Director of the Health & Biomedical Law Concentration Program, Suffolk University Law School. The author expresses grateful thanks to Maureen McBrien, a second-year student at the Law School for her assistance in the research, preparation, and editing of this Article.

(53) See Andrews, supra note 2, at 649-52 (describing safety concerns associated with human cloning as analogous to the current problems associated with animal cloning); Orentlicher, supra note 2, at 1021 (citing developmental abnormalities, premature death, and rapid aging as among the potential risks of cloning).

(54) See Cibelli et al., supra note 1, at 45.

(55) The procedure utilized by ACT for substantiating human genetic material is apparently similar to that applied to reproduce Dolly. The process is a follows:
 (1) Eggs are coaxed to mature in a culture dish. Each has a remnant egg
 cell called the polar body and cumulus cells from the ovary clinging to it.
 (2) While an egg is held still with a pipette, a needle is used to drill
 through the zona pellucida, removing a plug. (3) After ejecting the zona
 plug, the needle is inserted back in the egg through the hole to withdraw
 and discard the polar body and the egg's genetic material. (4) A cumulus
 cell from another egg is taken up into the needle. Cells called fibroblasts
 (or their nuclei) can also be used in this step. (5) The cumulus cell is
 injected deep into the egg that has been stripped of its genetic material.
 (6) The injected egg is exposed to a mixture of chemicals and growth
 factors designed to activate it to divide. (7) After roughly 24 hours, the
 activated egg begins dividing. The cells contain genetic material only from
 the injected cumulus cell.


Id. at 46-47.

(56) See id. at 46 (describing the distinction between "therapeutic" cloning and "reproductive" cloning).

(57) Id. at 46-47.

(58) See Ronald M. Green, The Ethical Considerations, 286 SCI. AM. 48, 48 (2001) (admitting that there is potential for "a cloned organism" to develop "into a full human being").

(59) See infra Section III (providing a constitutional analysis of this issue).

(60) Clones are not perfect mimics of one another. Mitochondrial genetic material from the enucleated donor cell may contribute about five percent of the cloned individual's genes. It is not known presently whether this non-nucleic genetic material affects the gene structures of the cloned offspring. See Andrews, supra note 2, at 647 (noting that "[u]nlike naturally occurring twins ... the clone will not be one hundred percent genetically identical [to the donor]"); see also Mark D. Eibert, Human Cloning, Infertility, and Reproductive Freedom, at http://www.reason.com/opeds/eibert.shtml (last visited Feb. 20, 2002) (maintaining that cloning merely enables infertile couples to have what others "take[] for granted--the chance to have raise and love their own genetic children").

(61) See Andrews, supra note 2, at 650.

(62) Id.

(63) Scientists are not certain whether Dolly inherited the cellular age of the adult sheep from which she was cloned or whether she inherited a normal genetic clock. See id. at 650-51. Evidence suggests the former because the tips of her chromosomes--telomeres, "which tend to shrink as cells grow older--are shorter than normal for her age." See Ronald M. Green, I, Clone, SCI. AM. (Sept. 1999), available at http://www.sciam.com/1999/0999bionic /0999green.html. In fact, Dolly, at age five-and-a-half, "`has arthritis in her left hind leg at the hip and the knee.'" CNN.com, Cloned Dolly Has Arthritis, (Jan. 4, 2002) at http:/ /www.cnn.com/2002/TECH/science/01/04/cloning.dolly/index.html.

(64) See Orentlicher, supra note 2, at 1021.

(65) See Rossant, supra note 15, at 24.

(66) See Andrews, supra note 2, at 653-54.

(67) See Human Cloning, supra note 2, at 2351 (discussing the impact that cloning could have on family relationships); see also LEON KASS, M.D., TOWARD A MORE NATURAL SCIENCE: BIOLOGY AND HUMAN AFFAIRS 113 (1985) (declaring that "[c]larity about your origins is crucial for serf-identity, itself important for serf-respect").

(68) See Andrews, supra note 2, at 655 (presenting the possibility that "the original's life `would always haunt the later twin, standing as an undue influence on the latter's life, and shaping it in ways to which others lives are not vulnerable"'). (citation omitted).

(69) See id. See generally Mehlman, supra note 45; Berry, supra note 48.

(70) See Andrews, supra note 2, at 653 (adding that cloned children might very well become labeled as "disappointment[s]" if they failed to live up to their parents' expectations).

(71) See Brock, supra note 3, at 13-15 (considering legal and moral responsibility and how they reflect "our conception of ourselves as [moral] agents").

(72) See id. at 14 (noting that the effectiveness of criminal law in "command[ing] people to conform their behavior" depends on the clarity and depth of each individual's understanding of the bounds placed on their behavior).

(73) See Andrews, supra note 2, at 656 ("genetic adaptation has allowed the human species to survive; producing genetically identical humans may therefore be threatening to the species.").

(74) See Orentlicher, supra note 2, at 1025.

(75) See id. at 1027-28 (pointing out that the use of cloning allows infertile couples to "have children genetically related to either one of them rather than to only one of them, as would be the case if they had children only by artificial insemination or only by egg donation or surrogacy"); Lawrence Wu, Note, Family Planning Through Cloning: Is There a Fundamental Right?, 98 COLUM. L. REV. 1461, 1470 (1998).

(76) Wu, supra note 75, at 1464-65 (distinguishing cloning from sexual reproduction in that the former requires only a single genetic parent).

(77) John A. Robertson, Two Models of Human Cloning, 27 HOFSTRA L. REV. 609, 620-21 (1999) (explaining the sacrifice that a wife must endure when the child only has a genetic link to the father).

(78) Orentlicher, supra note 2, at 1028.

(79) Id.

(80) Id. at 1030 (noting that in cases where third party donors are utilized for reproduction, "[i]t is ... argued that relationships between parents and children are compromised by artificial methods of reproduction because genetic parenthood no longer coexists with social parenthood").

(81) See id. See also Margaret Talbot, A Desire to Duplicate, N.Y. TIMES, Feb. 4, 2001 (Magazine), at 67 (suggesting that "cloning would allow ... couple[s] to sidestep `a genetic third party who, years down the line, might want to gain access to the child'").

(82) Orentlicher, supra note 2, at 1030-31.

(83) Wu, supra note 75, at 1469-70 (describing two types of IVF which do not, in most cases, require a surrogate).

(84) JOHN A. ROBERTSON, CHILDREN OF CHOICE: FREEDOM AND THE NEW REPRODUCTIVE TECHNOLOGIES 98 (1994) (describing in vitro fertilization as a reproductive alternative for infertile couples).

(85) Id. at 114-17 (chronicling the potential negative effects of in vitro fertilization).

(86) See Berry, supra note 48, at 719-20 n.5 (explaining the scientific process of gene therapy); see also Mehlman, supra note 45, at 520-21 (describing the Human Genome Project and its aim to "devise gene therapies" for individuals with hereditary diseases).

(87) See, Cibelli et. al., supra note 1, at 46 (distinguishing therapeutic cloning from reproductive cloning and stating that ACT "support[s] a restriction on cloning for reproductive purposes until the safety and ethical issues surrounding it are resolved").

(88) Green, supra note 58, at 48.

(89) See, e.g., Carey v. Population Servs. Int'l, 431 U.S. 678, 684-85 (1977) (holding that procreation is "among the [personal] decisions that ... individuals may make without unjustified government interference"); Eisenstadt v. Baird, 405 U.S. 438, 453 (1971) (stating that "[i]f the right of privacy means anything, it is the right of the individual married or single, to be free from unwarranted government intrusion into matters so fundamentally affecting a person as the decision to bear or beget a child"); Skinner v. Oklahoma, 316 U.S. 535, 541 (1942) (observing that "procreation [is] fundamental to the very existence and survival of the race").

(90) See, e.g., Zablocki v. Redhail, 434 U.S. 374, 386 (1978) (invalidating a Wisconsin statute requiring court permission to marry ff the applicant already had children and placing the decision to marry on the same level as decisions relating to procreation, childbirth, childrearing, and family relationships); Roe v. Wade, 410 U.S. 113, 152 (1973) (stating that the "right to privacy is broad enough to encompass a woman's decision whether or not to terminate her pregnancy"); Loving v. Virginia, 388 U.S. 1, 12 (1967) (finding a Virginia miscegenation statute unconstitutional, in that it violated a fundamental right to marriage).

(91) See Griswold v. Connecticut, 381 U.S. 479, 484 (1965). Justice Douglas opined that a right of privacy was inherent in the Bill of Rights, such as in the First Amendment's freedom of association, the Fourth Amendment's protection from unreasonable searches and seizures, the Fifth Amendment's self-incrimination protection, and the Ninth Amendment's retention of unenumerated rights by the people. Id. at 484.

(92) See Moore v. City of E. Cleveland, 431 U.S. 494, 503-04 (finding that "the Constitution protects the sanctity of the family precisely because the institution of the family is deeply rooted in this Nation's history and tradition").

(93) See, e.g., Roe, 410 U.S. at 155-56 (noting that once a fundamental right has been recognized, a "`compelling state interest'" is required for the statute to pass constitutional muster); Griswold, 381 U.S. at 485.

(94) If cloning is not reproduction at all, but is merely replication, then the constitutional protections relevant to reproduction would arguably not apply to cloning. For a brief--and rather conclusory--assertion of this position, see George J. Annas, Human Cloning: Should the United States Legislate Against It? Yes: Individual Dignity Demands Nothing Less, A.B.A.J., May 1997, at 80.

(95) See Human Cloning, supra note 2, at 2354-55 & n.65 (distinguishing between the protections provided by past Supreme Court jurisprudence and an absolute right to procreation via human cloning).

(96) See Human Cloning, supra note 2, at 2356-57 (stating that human cloning [does not] deserve[] constitutional protection merely because it can be scientifically characterized as an act of procreation").

(97) 735 F. Supp. 1361 (N.D. Ill. 1990).

(98) Id. at 1377. Section 6(7) of the Illinois Abortion Law was held unconstitutional, both because it was vague in failing to define the terms "experimentation" and "therapeutic" in the context of fertilization technologies, and because it infringed upon a woman's fundamental right to privacy. Id. at 1376-77.

(99) See Washington v. Glucksberg, 521 U.S. 702, 727-28 (1997).

(100) See, e.g., Minnesota v. Carter, 525 U.S. 83, 97-98 (Scalia, J., concurring) (1998) (commenting that the Constitution does not guarantee a "generalized `right of privacy'").

(101) Bowers v. Hardwick, 478 U.S. 186, 191-92 (1986). The Court refused to extend constitutional protection to consensual homosexual relations, reasoning that neither precedent, the express language of the Constitution, nor any of the formulations previously used to find rights by implication support recognition of a fundamental liberty interest. Id. at 190-93.

(102) See generally Kramer v. Union Free Sch. Dist., 395 U.S. 621, 627 (1969); Shapiro v. Thompson, 394 U.S. 618, 634 (1969); Sherbert v. Verner, 374 U.S. 398, 406 (1963).

(103) See generally Griswold v. Connecticut, 381 U.S. 479, 485 (1965); Aptheker v. Sec'y of State, 378 U.S. 500, 508 (1964).

(104) 410 U.S. 113 (1973).

(105) See, e.g., Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 853 (1992).

(106) See Casey, 505 U.S. at 853; Roe, 410 U.S. at 162.

(107) See Casey, 505 U.S. at 851.

(108) See, e.g., Glucksberg, 521 U.S. at 735 (upholding the State of Washington's ban on assisted suicides).

(109) See Casey, 505 U.S. at 851 (explaining that the Due Process Clause affords constitutional protection to various individual rights, including "marriage, procreation, contraception, family relationships, child rearing, and education").

(110) See, e.g., Protection of Human Subjects, 45 C.F.R. [section] 46 (2001) (defining the regulatory standards for the protection of human research subjects, as promulgated by the Department of Health and Human Services).

(111) See Cibelli et al., supra note 1, at 45.

(112) See BARRY R. FURROW ET AL., HEALTH LAW [section] 1-7 (2d ed. 2000) (discussing how the government's spending power is the ultimate source of all regulation in the health care field).

(113) Human Cloning Prevention Act of 2001, H.R. 3495, 107th Cong. [section] 2(a)(2) (2001).

(114) Ban on Human Cloning Act, H.R. 1260, 107th Cong. [section] 2(c) (2001).

(115) See, e.g., Human Cloning Prohibition Act of 2001, H.R. 1644, 107th Cong. [section] 3 (2001); Human Cloning Prohibition Act, S. 704, 107th Cong. [subsections] 3-4 (2001).

(116) Human Cloning Research Prohibition Act, H.R. 1372, 107th Cong. [section] 2(a) (2001).

(117) The following proposals all are variations of a proposed Human Cloning Prohibition Act of 2001. See H.R. 1608, 107th Cong. [section] 3 (2001); H.R. 1644 [section] 3; H.R. 2505, 107th Cong. [section] 2 (2001); H.R. 2608, 107th Cong. [section] 2 (2001); H.R. 2172, 107th Cong. [section] 2 (2001); S. 704 [section] 3; S. 790, 107th Cong. [section] 3 (2001); S. 1758, 107th Cong. [section] 4 (2001); S. 1899, 107th Cong. [section] 2 (2002). See also H.R. 3495 (proposing a "General Rule" prohibiting federal funding of human cloning).

(118) See, e.g., H.R. 1372 [subsections] 2, 4 (providing protections for "promising work" in cloning technologies that do not involve human embryo cells); Human Cloning Ban and Stem Cell Research Protection Act of 2002, S. 1893, 107th Cong. (2002) (protecting some areas of cloning research); see also H.R. 1644 [section] 3(a); H.R. 2505 [section] 2; S. 790; and S. 1899 (all three allowing research in the cloning of non-human cells and/or organisms).

(119) See S. 1893 [section] 2 ("Nothing in this section shall be construed to restrict areas of biomedical, agricultural, and scientific research ... including somatic cell nuclear transfer or other technologies to clone molecules, DNA, cells, and tissues.").

(120) See S. 790 [section] 3; H.R. 2505 [section] 2; H.R. 1372 [section] 4; H.R. 1644 [section] 3; S. 1899 [section] 2. All of these proposals specifically--and exclusively--protect research into the cloning of cells other than human embryos.

(121) The bill, H.R. 2505, was introduced by Republican Dave Weldon of Florida and Democrat Bart Stupak of Michigan. The bill passed by vote of 265 to 162, with six not voting. See Office of the Clerk, U.S. House of Representatives, Final Vote Results for Roll Call 304 (Human Cloning Prohibition Act) (July 31, 2001), available at http://clerkweb.house.gov. (122) Id. [section] 2(a).

(123) Id.

(124) Id.

(125) H.R. 2608.

(126) Id. [section] (2)(a). The same language appears in an earlier Greenwood sponsored bill. H.R. 2172 [section] 2(a).

(127) Compare H.R. 2608; and H.R. 2172; with H.R. 2505.

(128) See supra notes 6-8 and accompanying text.

(129) EINSTEIN, supra note 7, at 6.

(130) See Julie Rovner, WH Declines to Weigh in on Legislation Banning Cloning, CONG. DAILY, June 21, 2001, available at 2001 WL 20347564 (clarifying the White House position on human cloning generally and on competing pieces of legislation specifically).

(131) See Storm in a Test Tube, THE ECONOMIST, Dec. 1, 2001, at 76, 77 available at 2001 WL 7320940 (opining that "sensible regulations" could effectively allay fears of reproductive cloning and balance the potential benefits of therapeutic cloning).

(132) See, e.g., H.R. 2505 (banning any type or manner of human cloning).
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