Cloning: US and global perspectives.

It has been said that the cloning of Dolly the sheep in 1996 bifurcates the history of the world. It announces to humankind that we are in line to become not only the creators of our own selves, but, in sad tandem, also its creatures, the products of our own inventive selves, Homo sapiens in the hands of Homo faber. (a) Thus do we cross the Rubicon.

Cloning stands first in a succession of waves of technological development that, one after another and in combinations we cannot predict, are set to break upon the moral structures of our culture. It is intertwined with the patenting of genetic material and engineered embryos that has suddenly made this field hugely attractive to investors and crippled the motivation of research for the public good. At the root of this moral dilemma lies the prospect of "germline" gene interventions--modifications of the germ cells that are inheritable by succeeding generations, as we become able to "design" our babies and their progeny forever. In addition, future developments in cybernetics and nanotechnology that take us beyond biology to the control and replication of intelligence and enhancement devices, and the integration of the human and the mechanical, will force us to examine our moral structure. While there are serious debates about whether artificial intelligence will be able to replicate and supersede the life of the mind, there is no question that each of these waves of technological advance and corporate opportunity will pose afresh the question at the heart of our culture: what does it mean to be human, and what value do we place on human nature?

The Background: History of Policy on Embryo Research

Four flash point policy debates have characterized the formation of United States biopolicy during the opening years of the 21st century. While they have a common focus in the question of the human embryo and its use, each is of a different character. The US engagement in the discussion of policy in respect of research on the human embryo has a long history. Years before the biologic technical terms jumped into the headlines and became household words, a series of federal documents had offered policy proposals to guide the emerging field of human embryo experimentation that had been opened up by the development of in vitro technology which, for the first time, made available the early embryo ex utero as a potential object, and subject, of experimentation. The significance of these documents has been largely eclipsed in recent debate, and it is worth briefly revisiting their positions for two reasons.

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First, the National Bioethics Advisory Commission (NBAC) and other advisory panels were constituted as broadly representative bodies--but were, in fact, representative of the "bioethics community" which tends to be politically and culturally liberal in its general disposition (a fact dramatically illustrated in its cloning report), and tends also to be secular in its assumptions. Although culturally conservative and religious participants are not absent in the discussion of bioethics, the group tends to accept the secular ground rules of the field. Certainly, they were not much in evidence at NBAC and its cognates in the 1980s. The contrast with the President's Council on Bioethics (PCOB), appointed by President George W. Bush in 2001, has been overdrawn in much press commentary. But there is no doubt that the PCOB, chaired by cultural conservative Leon Kass, has been widely perceived as taking a very different approach to the question of reflection on the significance of developments in biotechnology. One key difference lies in the composition of the Council, which, while it includes members (such as Francis Fukuyama (1) and Kass (2) himself) who have distinguished themselves through distinctive contributions to the discussion of questions in bioethics, has no member who would be primarily regarded as a professional "bioethicist." To that extent, the PCOB takes the bioethics discussion back to a stage where it was more genuinely interdisciplinary, and there was no bioethics "profession." Criticism of the Council for its supposed monochrome approach to the questions on its agenda has been common but misinformed. There would seem, for example, to be a much wider spread of opinion among Council members on some key questions than there was on NBAC. Certainly, there is (more) representation of culturally and ethically conservative opinion, but the wrong-headedness of much of the criticism attracted by the Council on this ground was evident in its early failure to endorse the position of the Bush administration on cloning. (3)

Second, the positions taken by NBAC on embryo research issues were reached before a combination of discovery and speculation fueled a massive inflation of expectation in respect to the "therapeutic" potential of embryonic stem cell research. While these issues have always been controversial, never before has it been suggested--as was being said before 9/11--that the embryonic stem cell issue was of such significance that it might be seen as the defining issue of a presidency. In the run-up to the 2004 presidential election, it reemerged as a dominant political-cultural question.

The central thrust of these early biopolicy documents was to seek middle ground by approving embryonic research under strict conditions, yet to do so with candid recognition of the unique character of the human embryo. (4(b)) While not ruling out deleterious experimentation on the early embryo, the positions adopted were surrounded by ethical caveats, and centered in the clearly articulated conviction that the human embryo deserves "profound respect," even if not "the full legal and moral rights attributed to persons." So in 1994, the NIH Embryo Research Panel agreed that "the preimplantation human embryo warrants serious moral consideration as a developing form of human life" even though "it does not have the same moral status as infants and children." (5) Moreover, what the panel refers to as "the respect due to the preimplantation embryo" is listed as one of the reasons why certain research proposals should not be funded, "even if claims were made for their scientific or therapeutic value." Five years later, the National Bioethics Advisory Commission (NBAC), appointed by President William J. Clinton, commented that there was wide agreement that "human embryos deserve respect as a form of human life." (6-8(c)) These positions reflect a general approach that was perhaps most influentially articulated in the United Kingdom's Warnock Report (1984), to the effect that the research use of human embryos might be approved but only in a situation of great moral seriousness since the human embryo is unlike any other laboratory material. (9) This language stands in marked contrast both to the mass-production techniques envisaged for "therapeutic cloning" and the decisive triumph of ends over means that has, in most public debate, used the prospect of "cures" to quash even the simulacrum of serious ethical reflection.

Policy discussion and development on general questions of embryo research, which of course predated the development of cloning technology (by somatic cell nuclear transfer), set the immediate context for responses to the announcement that Dolly had been cloned. Although federal law did not already prohibit cloning (as some other states, such as the Federal Republic of Germany, had done, in anticipation of such a technological development), it restricted the availability of federal funds for cloning-related research. Since 1996, Congress has included riders in appropriations measures for the Departments of Labor, Health and Human Services, and Education that prohibit the use of appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed (the so-called Dickey Amendment). In general, the riders define the human embryo as any organism "derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells." (See below for details.)

In fact, while federal advisory bodies reflective of the bioethics mainstream were offering cautious encouragement to limited research on human embryos, federal funding of any type of research involving human embryos, starting with in vitro fertilization (IVF), has been blocked by various policy decisions dating back 25 years. Following the birth in England of the first IVF baby, Louise Brown, in July 1978, the Ethics Advisory Board (EAB) of the Department of Health and Human Services (HHS) was tasked with considering the scientific, ethical, legal, and social issues surrounding human IVF. (d) The EAB released its report on May 4, 1979, finding that IVF research was acceptable from an ethical standpoint and could be supported with federal funds. The EAB's recommendations were never adopted by HHS, and the Board was dissolved in 1980; no other EAB has been chartered. Because federal regulations that govern human subject research (45 CFR 46) stipulated that, at the time, federally supported research involving human IVF must be reviewed by an EAB, a de facto moratorium on funding human IVF and other related embryo research resulted. The National Institutes of Health (NIH) Revitalization Act of 1993 (P.L. 103-43, Section 121 [c]) nullified the regulatory provision (45 CFR 46.204 [d]) requiring EAB review of IVF proposals, thereby lifting the de facto moratorium.

In response, the NIH established the Human Embryo Research Panel to assess the ethical issues raised by this research and develop recommendations for NIH review and conduct of human embryo research. The NIH panel released a report providing guidelines and recommendations on human embryo research in September 1994. It recommended that some areas of human embryo research be considered for federal funding, including somatic cell nuclear transfer (SCNT), stem cells and (under certain limited conditions) embryos created solely for the purpose of research. (5) The NIH panel also identified areas of human embryo research it considered to be unacceptable, or to warrant additional review. It determined that certain types of cloning without transfer to the uterus warranted additional review before the panel could recommend whether the research should be federally funded. However, the panel concluded that federal funding for cloning techniques followed by transfer to the uterus should be unacceptable into the foreseeable future. The panel's report was unanimously accepted by the NIH Advisory Committee to the Director (ACD) on December 2, 1994.

After the ACD meeting on December 2, 1994, President Clinton directed NIH not to allocate resources to "support the creation of human embryos for research purposes." (e) The President's directive did not apply to research involving so-called "spare" embryos resulting from clinical IVF procedures. Following the December 2, 1994 directive to NIH from President Clinton, the agency proceeded with plans to develop guidelines to support research using spare embryos.

Advances in medical science proceeded and in 1998, critical developments were recognized by scientists at the University of Wisconsin. These researchers were able to isolate human embryonic stem cells and coax them to grow into specialized cells. HHS General Counsel, Harriet Rabb, concluded that then-current law prohibiting the use of HHS-appropriated funds for human embryo research would not apply to research using embryonic stem cells "because such cells are not a human embryo within the statutory definition." (f) HHS concluded that NIH could fund research that used stem cells derived from the embryo by private funds. Because of the language in the rider, NIH could not fund research that, with federal funds, derived the stem cells from embryos.

Some members of Congress strongly opposed HHS' view and believed that the legislative ban covered and prohibited such research. In response, Secretary Donna E. Shalala stated in a letter that the definition of embryo used in the HHS legal opinion relied on the definition of embryo in the statute and that the ban applied only to research in which human embryos are discarded or destroyed--not to research preceding or "following on such projects." (g) The letter stated: "Moreover ... there is nothing in the legislative history to suggest that the provision was intended to prohibit funding for research in which embryos--organisms--are not involved." NIH indicated that it would fund research on pluripotent stem cells derived from human embryos and fetal tissue once guidelines were issued and an oversight committee was established. Draft guidelines were published in the Federal Register in December 1999 and final guidelines were issued in August 2000. (h) The guidelines provided that studies utilizing pluripotent stem cells derived from human embryos may be conducted using NIH funds only if the cells were derived, without federal funds, from human embryos that were created for the purposes of fertility treatment and were in excess of the clinical need of the individuals seeking such treatment. NIH initiated the applications process, which was running when the Bush administration took office at the start of 2001, and was left in place through the early months of 2001. It rapidly developed into the major issue in pre-9/11 American politics.

Human Cloning in Federal Policy

When the cloning of Dolly the sheep was announced in February of 1997, it elicited a speedy response from President Clinton, who issued a memorandum to the heads of the executive departments and agencies that addressed the funding of human cloning stating that federal funds would not be used for the cloning of human beings. In remarks to the press, President Clinton urged the private sector to take a similar stance. His vigorous response stands in sharp and somewhat curious contrast to the NBAC report that he commissioned which after high-profile and hurried meetings (it was asked to report within 90 d) published a lengthy document that included extensive discussion of religious and other views on the subject. NBAC reported its findings and recommendations on June 9, 1997. While concern was expressed about the impact of cloning on even a physically healthy child, in respect of issues of autonomy and individuality, the only "ethical" argument that finally carried weight with NBAC, was, as it were, the ethics of safety. So its recommendation was for a 3- to 5-year moratorium on cloning to produce babies--a position that with hindsight appears extraordinarily permissive, since there is near unanimity in public and political circles that this practice should simply be prohibited (10)

By contrast, the Bush administration has sought a legislative ban on human cloning for any purpose. In the Senate, a comprehensive cloning ban is proposed in S. 245, sponsored by Senators Brownback (Republican) and Landrieu (Democrat). (i) The bill parallels the House bill passed twice by large majorities, proposed by Dr. Dave Weldon (Republican) and Bart Stupak (Democrat), and mandates a civil penalty of at least $1 million and a criminal penalty of imprisonment of up to 10 years. (j)

Cloning has gripped the public imagination and offers a model of the fateful possibilities of biotechnology that may prove as potent as the enduring image of Mary Shelley's Frankenstein. While for some its use to mass produce embryos for purposes of research is benign and to be distinguished radically from the gestation and birth of cloned babies, for others these uses are conjoined. Its hold on the imagination has led to strenuous efforts on the part of those who favor research cloning to redefine the terms of the debate in a manner that avoids the use of the word, and instead employs such obscure alternatives as "nuclear transplantation." A bipartisan bill in the US Senate that seeks to prohibit baby cloning and, in the process, protect cloning for research goes so far as to define cloning formally as the implantation of a clonal embryo. The sponsors of S. 303 (k) include Senator Orrin Hatch, a conservative Republican who is against abortion, as well as pro-choice Democrats. The bill's novel definition of cloning is this: "implanting or attempting to implant the product of nuclear transplantation into a uterus or the functional equivalent of a uterus." Its supporters can therefore claim that it opposes all "cloning," while permitting and thereby protecting cloning for research purposes. Furthermore, the bill offers an abstract, new term for the clonal embryo, referring to it as an "unfertilized blastocyst," that is, "an intact cellular structure that is the product of nuclear transplantation." This creative neologism is curious, since blastocysts do not get fertilized; oocytes are fertilized and thereupon become blastocysts. The purpose of this coinage is plainly to seek to redefine the terms of the debate and deflect attention from the clonal embryo, which it seeks to protect as a subject of deleterious experimentation.

The state of New Jersey has gone further, in defining cloning by statute not even as implantation, but as live birth of the clonal fetus. In January 2004, New Jersey signed into law a bill that authorizes cloning for research and permits the gestation of an implanted embryo clone in the womb until birth. While claiming to "permit human stem cell research," it protects the experimental use of the implanted clonal fetus during pregnancy. All that is forbidden is for the baby to be born and survive. (l)

Perhaps the most bizarre example of these attempts at linguistic gerrymandering came to a head in the campaign around California's Proposition 71, intended to fund stem cell research and cloning. Proponents of the measure denied that it would fund cloning, and asked a judge to deny its opponents the right to use the term. But the judge ruled that opponents of the measure had the right to use the term in their rebuttal. Proponents of the measure denied that they would be funding cloning. Yet Proposition 71, as described in Section 2, Purpose and Intent, is unambiguous, and whether "somatic cell nuclear transfer" (SCNT) is used for the purpose of implantation or, as in Proposition 71, for research, the product of SCNT is a cloned human embryo. (m)

The President's Council on Bioethics, though divided on the issue of cloning for research, was unanimous in seeking honest language in the debate. The Council specifically voiced concern about "the temptation to solve the moral questions by artful redefinition or by denying to some morally crucial element a name that makes clear that there is a moral question to be faced." The report adopted the terminology "cloning-to-produce-children" and "cloning-for-biomedical-research" and defined "cloned human embryo" as "the immediate (and developing) product of the initial act of cloning, accomplished by successful SCNT [somatic cell nuclear transfer], whether used subsequently in attempts to produce children or in biomedical research." (3)

International Perspectives

As the cloning debate has already shown, the questions raised by biotechnology do not concern the same kind of issues as have traditionally divided American politics. In contrast, the European debate has tended more readily to bring together the two points of conscience of western culture, on the "right" and on the "left." However, a new politics is emerging in which the fate of human dignity in the face of advances in genetics and cybernetics will be determined in policy discussions that cut across traditional political divides. Partly as a result of the tendency of the media to present issues of biopolicy in the context of the abortion debate, there has been little US awareness of the global dimensions of the stem cell/cloning questions, since in other jurisdictions where abortion politics is of much less significance, global dimensions have taken a somewhat different course.

The UK government's Warnock Report, which in general took a permissive view of the technology, was divided 9 to 7 on the question of whether embryos should be permitted to be created for research purposes, with a smaller minority opposing also the use of so-called "supernumerary" embryos resulting from clinical use of in vitro fertilization for this purpose. But the British position is unusual in Europe. While Warnock came down narrowly in favor of creating embryos for research purposes, the Council of Europe's Convention on Human Rights and Biomedicine, opened for signature at Oviedo in Italy in 1997 and the only instrument of international law on bioethics (now signed by more than 30 states), forbids any creation of embryos for research purposes. (n) This position is common in continental Europe.

The European Commission, executive of the now 25-member European Union, instituted a moratorium on all funding for embryo stem cell research in July 2002, which expired in December 2003. The intention had been to devise a policy to permit limited funding, and with encouragement from Germany, Austria and Italy, a proposal was considered that would essentially follow the same line as the 2001 Bush decision--to fund work on cell lines already cultivated before a cut-off date. However, efforts to agree to this compromise were undercut, and, with the cessation of the moratorium, there is now no formal funding policy in place under the Sixth Framework.

The 2003 proposal followed adoption by Germany into federal law of the 2001 US approach. Germany's Stem Cell Law liberalized existing prohibitions on all embryo research by permitting the importation of cell lines from embryos destroyed before January 1, 2002. (o)

The 2004 Canadian Assisted Human Reproduction Act covers a wide range of issues relating to assisted reproduction technology, and, while permitting the use of supernumerary embryos for research purposes, specifically prohibits their being created for research by somatic cell nuclear transfer ("therapeutic cloning"). In this latter respect, Canada follows many other states, including France, Germany, Switzerland, Norway, and Australia, all of which have prohibited "therapeutic cloning." Their opposition to cloning as a means of generating embryonic stem cells is paralleled in the March 2005 decision of the United Nations General Assembly, which voted nearly 3:1 in favor of the UN Declaration on Human Cloning, which urges member states to prohibit all human cloning.

Cloning at the United Nations General Assembly

The US pressed for a parallel cloning prohibition through the United Nations General Assembly. In response to a 2001 joint initiative from Germany and France to initiate a process to write a convention to prohibit "human reproductive cloning," the US in common with other governments sought to expand the intended terms of the convention to include human cloning for any purpose, arguing that all cloning is in fact reproductive, and that the only way to ensure that there would be no birth of clonal babies would be to forbid the development of human cloning technology and the manufacture of large numbers of clonal embryos. The US worked in the Sixth (legal) Committee of the General Assembly meeting in February 2002 to build support for a wider convention, noting (a) that all cloning is in fact "reproductive"; and (b) that to secure a comprehensive prohibition on the birth of live-born cloned babies the use of somatic cell nuclear transfer in human beings should be prohibited (or else the technology and the supply of clonal embryos would materially aid and ensure the future birth of clonal children). (p)

The initial round of discussion in the Sixth Committee in 2002 led to a series of debates in which Costa Rica emerged as the formal sponsor of a ban on all cloning, with 66 cosponsors, against a Belgian proposal that superseded the German-French initiative and secured 22 cosponsors after Germany was forced to withdraw from its leading role by severe domestic pressure. In November 2003, the Sixth Committee voted by the narrowest of margins (80-79, and 15 abstentions) for a procedural motion to suspend the discussion until 2005, proposed by Iran on behalf of the Organization of the Islamic Conference (OIC). (q) In turn, this decision was revised by the General Assembly, where, after concentrated diplomatic debate, it was agreed to address the matter in the 59th session of the General Assembly in the fall of 2004.

On September 21, 2004, George W. Bush, the President of the United States, addressed the General Assembly in these terms:

Because we believe in human dignity, we should take seriously the protection of life from exploitation under any pretext. In this session, the U.N. will consider a resolution sponsored by Costa Rica calling for a comprehensive ban on human cloning. I support that resolution and urge all governments to affirm a basic ethical principle: no human life should ever be produced or destroyed for the benefit of another. (11)

The Sixth Committee continued the debate in October 2004. The Committee was faced with two resolutions. The first, introduced by Costa Rica, called for a total ban on human cloning, including both therapeutic and reproductive cloning. The second, introduced by Belgium, called for a total ban of reproductive cloning while leaving open the question of therapeutic cloning and allowing states to decide whether to ban it, impose a moratorium on it, or regulate it. (11)

The United States held fast to the need for a total ban. The United States representative argued, "A ban that differentiates between human, reproductive and experimental cloning essentially authorizes the creation of a human embryo for the purpose of destroying it." She further stated, "experimental embryonic cloning would turn nascent human life into a resource or commodity to be mined and exploited, eroding the sense of worth and dignity of the individual." (11)

The German representative noted "recent developments in the field of human cloning had shown that international regulations were needed to be put in place most urgently." He further stated, "Germany had very serious doubts that the goal of a universally ratified legal instrument could be achieved by a split vote." He noted that while Germany's national laws prohibited all forms of cloning, it remained committed to a consensus to achieve a universally binding instrument. (11)

However, as discussion proceeded, Germany subsequently changed its view to one of support for the United States' position, and spoke in favor of the text that was finally approved by the General Assembly as the United Nations Declaration on Human Cloning which calls on all states to prohibit all forms of human cloning "inasmuch as they are incompatible with human dignity." Potential ambiguity in the term "inasmuch as" was noted, since it is sometimes used to mean "in proportion as" rather than (more usually) "because."

After the vote, the representative for the United States stated: "the international community had confirmed its abhorrence of cloning and declared its respect for human dignity." She further stated, "The action of the Committee is an important step on the path of achieving a culture of life, making sure that scientific advances served human dignity." She also called for member states to issue national legislation banning human cloning and encouraged member states to support a ban on human cloning. She reiterated the United States' position that "No human life should ever be produced to be destroyed for the benefit of another." (12)

The United Nations Declaration on Human Cloning was adopted on March 23, 2005, at the recommendation of the Sixth Committee with a recorded vote of 84 in favor, (r), 32 (s) against, and 37 (t) abstentions. (13,14)

"Subsequently, the delegations of Antigua and Barbuda, The Gambia, Kyrgyzstan, the Libyan Arab Jamahiriya, Nigeria, Peru and the Russian Federation informed the Secretariat that they had intended to vote in favor; the delegation of Greece informed the Secretariat that it had intended to vote against; the delegations of Botswana and Mali informed the Secretariat that they had intended to abstain." (14)

After the recorded vote, the representative from the United Kingdom clarified any lingering ambiguity in the use of the term "inasmuch," by admitting defeat and declaring: "The United Kingdom voted against the draft Declaration on Human Cloning because of the reference to human life, which we consider can be interpreted as a call for a total ban on all forms of human cloning."

Conclusion

The cloning debate is essentially unresolved. Pressure for the use of embryonic stem cells from clonal embryos, and a growing push for "reproductive" use of cloning, have met stiff resistance from many parts of the religious-cultural spectrum. A strong desire has emerged to embrace technologies that can bring cures for disease, but to do so without dispensing with serious ethical constraints. This very healthy debate has set the tone for the "biotech century."

Acknowledgments

I would like to express my thanks to Dawn M. Willow, legal fellow at the Institute, who contributed significantly to parts of this article.

References

1. Fukuyama F. Our Posthuman Future: Consequences of the Biotechnology Revolution. New York, Farrar, Straus, and Giroux, 2002.

2. Kass LR. Life, Liberty and the Defense of Dignity. New York, Free Press, 2002.

3. President's Council on Bioethics. Human Cloning and Human Dignity: An Ethical Inquiry. 2002. Available at: http://www.bioethics.gov/reports/cloningreport. Accessed November 3, 2006.

4. Stevens MLT. Bioethics in America: Origins and Cultural Politics. Baltimore, Johns Hopkins, 2000.

5. National Institutes of Health. Embryo Research Panel Report. September 27, 1994.

6. Ethics Advisory Board to the Department of Health, Education and Welfare. Federal Register. 44. June 18, 1979.

7. National Bioethics Advisory Commission. Ethical Issues in Human Stem Cell Research. Rockville, The National Bioethics Advisory Commission. Available at: http://www.georgetown.edu/research/nrcbl/nbac/execsumm.pdf.

8. Doerflinger RM. Confronting technology at the beginning of life. In: Colson CW, de S. Cameron NM, eds. Human Dignity in the Biotech Century. Downers Grove, InterVarsity Press, 2004.

9. Report of the Committee of Inquiry into Human Fertilisation and Embryology. Cmnd. 9314, 1984.

10. National Bioethics Advisory Commission Report. Available at: http://www.bioethics.gov. Accessed November 3, 2006.

11. President Speaks to the United Nations General Assembly. September 21, 2004. Available at: http://www.whitehouse.gov/news/releases/2004/09/20040921-3.html. Accessed November 3, 2006.

12. Press Release. Legal Committee Recommends UN Declaration on Human Cloning to General Assembly. February 18, 2005. GA/L/3271. Available at: http://www.un.org/News/Press/docs/2005/gal3271.doc.htm. Accessed November 3, 2006.

13. Ad Hoc Committee on an International Convention Against the Reproductive Cloning of Human Beings. Available at: http://www.un.org/law/cloning/. Accessed November 3, 2006.

14. United Nations. United Nations Declaration Against Human Cloning. March 23, 2005.

I think, at a child's birth, if a mother could ask a fairy godmother to
endow it with the most useful gift, that gift should be curiosity
--Eleanor Roosevelt

Nigel M. de S. Cameron, PhD

From the Institute on Biotechnology and the Human Future, Chicago-Kent College of Law, Illinois Institute of Technology, Chicago, IL.

Reprint requests to Nigel M. de S. Cameron, PhD, Research Professor of Bioethics and President, Institute on Biotechnology and the Human Future, Chicago-Kent College of Law, Illinois Institute of Technology, 565 W. Adams Street, Chicago, IL 60661. Email: [e-mail]

(a) "Man the maker," a term used by anthropologists to focus on our capacity to use tools to make things.

(b) This approach epitomizes the general method of mainstream bioethics in, essentially, preparing the way for new technologies by a mixture of approval, delay, and regulation, as has been eloquently argued by M. L. Tina Stevens in her narrative, Bioethics in America. (4)

(c) I am indebted for these references to Richard M. Doerflinger.

(d) The EAB was created in 1978 by the Department of Health Education and Welfare (HEW), the forerunner of the Department of Health and Human Services (HHS), at the recommendation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission operated from 1974 to 1978 and issued ten reports, many of which formed the basis of federal regulations for research involving human subjects (45 CFR 46).

(e) Statement, 30 Weekly Comp. Pres. Doc. 2459, December 2, 1994.

(f) Letter from HHS General Counsel, Harriet Rabb, to Harold Varmus, Director, NIH, January 15, 1999.

(g) Letter from Secretary Shalala to the Honorable Jay Dickey, February 23, 1999.

(h) 64 Federal Register 67576 (1999), 65 Federal Register 51976 (2000), respectively.

(i) S. 245 amends the Public Health Service Act to prohibit human cloning; the bill was introduced on January 29, 2004, sponsored by Senator Brownback (R-KS), and had 28 cosponsors. Available at: http://thomas.loc.gov.

(j) Two striking examples of private projects that are actively pursuing cloning research are to be found in Advanced Cell Technologies, the Massachusetts private company which, in November 2001, announced that it had successfully cloned the first human embryos and Stanford University, which, in December 2002, announced plans to establish a privately funded institute that will use expertise in stem cell biology and cancer biology to develop novel treatments for cancer and other diseases.

(k) S. 303 prohibits human cloning and protects stem cell research. The bill was introduced on February 5, 2003 by Senator Hatch (R-UT) and had 10 cosponsors. Available at: http://thomas.loc.gov.

(l) Governor James E. McGreevey signed the "Stem Cell Research" bill (A. 2840/S. 1909). The bill establishes that "research involving the derivation and use of human embryonic stem cells, human embryonic germ cells and human adult stem cells, including somatic cell nuclear transplantation, shall ... be permitted." The "cloning of a human being" is prohibited, but is defined as "the replication of a human individual by cultivating a cell with genetic material through the egg, embryo, fetal and newborn stages into a new human individual." This takes the redefinition of the term cloning to a new level: the Hatch bill in the U.S. Senate defines it as implantation; this New Jersey bill effectively defines it as birth.

(m) Arguments and rebuttals. Available at: http://www.ss.ca.gov/elections/bp_nov04/prop_71_entire.pdf; see also http://www.cloningproposition.org and http://www.noonprop71.org.

(n) Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo, 1997), Ch. 5, Art. 18 (2): "The creation of human embryos for research purposes is prohibited."

(o) Available at http://217.160.60.235/BGBL/bgbllf/BGB1102042s2277.pdf.

(p) International Convention Against the Reproductive Cloning of Human Beings: Report of the Ad Hoc Committee, Official Records of the General Assembly, Fifty-Seventh Session, Supp. No. 51 (A/57/51); revised information document prepared by the Secretariat (A/AC. 263/2002/INF/1/Rev. 1). The writer served as bioethics adviser on the US delegation, but these comments are made in his personal capacity.

(q) On November 6, 2003, the delegation of Iran, on behalf of the member States of the OIC, moved, under Rule 116 of the Rules of Procedure of the General Assembly, to adjourn the debate on the agenda item until the 60th session of the General Assembly (i.e. September 2005). No action was taken on the proposals before the Committee. It should be noted that some 15 OIC states had cosponsored the Costa Rican resolution, against only one (Turkey) on the Belgian list of sponsors.

(r) Afghanistan, Albania, Andorra, Australia, Austria, Bahrain, Bangladesh, Belize, Benin, Bolivia, Bosnia and Herzegovina, Brunei Darussalam, Burundi, Chile, Comoros, Costa Rica, Cote d'Ivoire, Croatia, Democratic Republic of the Congo, Djibouti, Dominican Republic, Ecuador, EI Salvador, Equatorial Guinea, Eritrea, Ethiopia, Georgia, Germany, Grenada, Guatemala, Guyana, Haiti, Honduras, Hungary, Iraq, Ireland, Italy, Kazakhstan, Kenya, Kuwait, Lesotho, Liberia, Liechtenstein, Madagascar, Malta, Marshall Islands, Mauritius, Mexico, Micronesia (Federated States of), Monaco, Morocco, Nicaragua, Palau, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Sierra Leone, Slovakia, Slovenia, Solomon Islands, Sudan, Suriname, Switzerland, Tajikistan, the former Yugoslav Republic of Macedonia, Timor-Leste, Trinidad and Tobago, Uganda, United Arab Emirates, United Republic of Tanzania, United States of America, Uzbekistan, and Zambia.

(s) Belarus, Belgium, Brazil, Bulgaria, Cambodia, Canada, China, Cuba, Cyprus, Czech Republic, Democratic People's Republic of Korea, Denmark, Estonia, Finland, France, Gabon, Iceland, India, Jamaica, Japan, Lao People's Democratic Republic, Latvia, Lithuania, Luxembourg, Netherlands, New Zealand, Norway, Republic of Korea, Singapore, Spain, Sweden, Thailand, Tonga and United Kingdom of Great Britain, and Northern Ireland.

(t) Algeria, Angola, Argentina, Azerbaijan, Bahamas, Barbados, Burkina Faso, Cameroon, Cape Verde, Colombia, Egypt, Indonesia, Iran (Islamic Republic of), Israel, Jordan, Lebanon, Malaysia, Maldives, Mongolia, Myanmar, Namibia, Nepal, Oman, Pakistan, Republic of Moldova, Romania, Serbia and Montenegro, Somalia, South Africa, Sri Lanka, Syrian Arab Republic, Tunisia, Turkey, Ukraine, Uruguay, Yemen, and Zimbabwe.