Order Code RL31358
CRS Report for Congress
Received through the CRS Web
Human Cloning
Updated August 17, 2004
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Erin Williams
Specialist in Bioethical Policy
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

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Human Cloning
Summary
In February 2004 scientists in South Korea announced that they had created
human embryos using cloning procedures and had succeeded in isolating human stem
cells from a cloned embryo. In December 2002 a representative of Clonaid
announced the overseas birth of the first cloned human to a 31-year old American
woman. Clonaid’s claim remains unsubstantiated. These announcements have
rekindled debate in the 108th Congress on the moral and ethical implications of
human cloning as the disclosure by Advanced Cell Technology (ACT) did in the
107th Congress. In November 2001 ACT announced the creation of the first cloned
human embryos (which survived only for a few hours); the embryos were to be used
to derive stem cells for medical research on disease therapies.
President Bush announced in August 2001 that for the first time federal funds
would be used to support research on human embryonic stem cells, but funding
would be limited to “existing stem cell lines.” The statement indicated that federal
funds will not be used for the cloning of human embryos for any purpose, including
stem cell research. The President’s Council on Bioethics was established in
November 2001 to consider all of the medical and ethical ramifications of biomedical
innovation. In July 2002 the Council released its report on human cloning which
unanimously recommended a ban on reproductive cloning and, by a vote of 10 to 7,
a four-year moratorium on cloning for medical research purposes. The ethical issues
surrounding reproductive cloning (safety, identity, and commodification, etc.), and
therapeutic cloning (embryos’ moral status, relief of suffering, and creation for
destruction), impact various proposals for regulation, restrictions, bans, and uses of
federal funding.
In January 2002, the National Academies released Scientific and Medical
Aspects of Human Reproductive Cloning. It recommended that the U.S. ban human
reproductive cloning aimed at creating a child. It suggested the ban be enforceable
and carry substantial penalties. The panel noted that the ban should be reconsidered
within five years. However, the panel concluded that cloning to produce stem cells
should be permitted because of the potential for developing new therapies and
advancing biomedical knowledge.
The House passed H.R. 534 (Weldon), the Human Cloning Prohibition Act of
2003, on February 27, 2003. H.R. 534 would ban the process of human cloning as
well as the importation of any product derived from an embryo created via cloning.
Cloning could not be used for reproductive purposes or for research on therapeutic
purposes, which has implications for stem cell research. The House defeated a
substitute amendment, H.Amdt. 5, that would have banned only human reproductive
cloning; the ban would have sunset after 10 years. H.Amdt. 5 was similar to H.R.
801 (Greenwood). Supporters of H.R. 534 argue that a partial ban on human cloning,
such as H.R. 801, would be impossible to enforce. Critics of H.R. 534 argue that the
measure would curtail medical research and prevent Americans from receiving life-
saving treatments created overseas. In the Senate, S. 245 (Brownback) would ban
reproductive cloning and therapeutic or research cloning; S. 303 (Hatch) would ban
only reproductive cloning. This report will be updated as needed.

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Contents
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Seoul National University . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Clonaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Advanced Cell Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Others with Human Cloning Intentions . . . . . . . . . . . . . . . . . . . . . . . . . 3
Federal Policy Involving Human Embryo Research . . . . . . . . . . . . . . . . . . . 3
Ethics Advisory Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
NIH Human Embryo Research Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Dickey Amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Actions During the Current Bush Administration . . . . . . . . . . . . . . . . . 5
State Legislation on Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Federal Legislation on Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
International Actions on Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Ethical and Social Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Issues Involved in Cloning for Reproductive Purposes . . . . . . . . . . . . 16
Issues Involved in Cloning for Therapeutic Purposes . . . . . . . . . . . . . 19
Types of Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

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Human Cloning
Background
The term “cloning” is used by scientists to describe many different processes
that involve making copies of biological material, such as a gene, a cell, a plant or an
animal. The cloning of genes, for example, has led to new treatments developed by
the biotechnology industry for diseases such as diabetes and hemophilia. In the
context of this report, a human embryo produced via cloning involves the process
called somatic1 cell nuclear transfer (SCNT). In SCNT, the nucleus of an egg is
removed and replaced by the nucleus from a mature body cell, such as a skin cell.
In cloning, the embryo is created without sexual reproduction: there is no joining of
egg and sperm.
Concern over the possibility of producing a human clone increased with the
announcement on February 24, 1997, that scientists in Scotland had used SCNT in
1996 to produce the first cloned adult mammal, Dolly, the sheep. Scientists at the
Roslin Institute in Edinburgh removed the nucleus from a sheep egg and replaced it
with the nucleus of a mammary gland cell from an adult sheep. The resulting embryo
was then transferred to the uterus of a surrogate sheep. A total of 277 such embryos
were transferred, but only one lamb was born.2 Analyses of Dolly’s genetic material
confirmed that she was derived from the sheep mammary cell. Dolly was euthanized
on February 14, 2003, after developing a lung infection. Although some claim that
her somewhat early death at six years was related to being a clone, scientists at the
Roslin Institute believe her ailment may be due to the fact that she was raised indoors
(for security reasons) rather than as a pastured sheep, which can live to 11 or 12 years
of age.3
Although scientists have been successful in using SCNT to produce other
animals (such as a cat, goat, cow, horse, mule, pig, mouse, and rabbit), the efficiency
of the procedure is still very low and frequently results in abnormal development.
Proponents maintain that one day cloning may be very useful for a number of
agriculture applications, including the improvement of livestock. Currently, cloned
mice are used for basic research on human health applications.
1 A somatic cell is a body cell, as opposed to a germ cell, which is an egg or sperm cell.
2 I. Wilmut, et al., “Viable Offspring Derived From Fetal and Adult Mammalian Cells.”
Nature, v. 385, Feb. 27, 1997, pp. 810-813.
3 G. Kolata, “First Mammal Clone Dies; Dolly Made Science History,” The New York
Times, Feb. 15, 2003, p. A4.

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Seoul National University. In February 2004, scientists at the Seoul
National University in South Korea announced that they had created human embryos
via the SCNT process and had succeeded in isolating human stem cells from a cloned
embryo. The South Korean team obtained 242 eggs from 16 unpaid female
volunteers; 30 embryos survived to the one week old stage, and only one produced
a stem cell line. Although the team tried a number of different methods, the only
approach that worked was when both the egg and the adult cell were from the same
woman. The adult cell used was a cumulus cell, cells which cluster around the egg.
Clonaid. On December 27, 2002, a representative of Clonaid announced the
birth of the first cloned human, a seven pound baby girl nicknamed Eve. The baby
was born on December 26, 2002, at an undisclosed location outside the United
States. Although the company offered no proof of its claim, Dr. Brigette Boisselier,
Managing Director of Clonaid, stated that genetic tests would show that the baby is
the clone of the 31 year old American woman who is the birth mother. To date the
test results have not been released; the company claims that the parents fear the test
results could lead to legal actions and loss of custody of the child.4 The Clonaid
website indicates that “13 cloned babies are now alive,” and that “each month,
between 10 and 15 implantations will be performed” in the Clonaid laboratory.5
Clonaid was founded in 1997 by the leader of the Raelians, an international sect of
55,000 people in 84 countries, which claims that life on Earth was created via genetic
engineering by a human extraterrestrial race.6
The Food and Drug Administration (FDA) is investigating the company’s
actions; the agency would consider any human cloning activity to be illegal if
performed in the United States.7 In April 2001 FDA investigated a Clonaid
laboratory in Nitro, WV; the laboratory closed shortly thereafter.8
Advanced Cell Technology. On November 25, 2001, Advanced Cell
Technology (ACT) of Massachusetts announced that it had created the world’s first
human embryos produced via cloning.9 ACT used two techniques, SCNT and
parthenogenesis, to produce human embryos. ACT researchers obtained eggs from
seven women, ages 24 to 32, who were paid $3,000 to $5,000. In the SCNT
approach, scientists removed the nucleus from 19 eggs and replaced it with a nucleus
from another adult cell. The nucleus of a skin cell was used for 11 eggs, and for the
remaining eight eggs, cumulus cells were used. Eggs that received a skin cell nucleus
4 K. Chang, “Scientist in Clone Tests Says Hoax is Possible,” The New York Times, Jan. 7,
2003, p. A12.
5 [http://www.clonaid.com/news.php]
6 For further information, see [http://www.clonaid.com] and [http://www.rael.org].
7 L. Greenhouse, “FDA Exploring Human Cloning Claim,” The New York Times, Dec. 30,
2002, p. A10.
8 G. Kolata, and K. Chang, “For Clonaid, a Trail of Unproven Claims,” The New York
Times, Jan. 1, 2003, p. A13.
9 J.B. Cibelli, et al., “Somatic Cell Nuclear Transfer in Humans: Pronuclear and Early
Embryonic Development,” Journal of Regenerative Medicine, v. 2, Nov. 26, 2001, pp. 25-
31.

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did not divide; seven of the eggs with the cumulus cell nucleus began to divide but
division stopped at the four-to-six-cell stage. In parthenogenesis, an egg cell is
treated with chemicals causing it to divide without being fertilized by a sperm. ACT
exposed 22 human eggs to the chemicals. After five days, six eggs had matured into
a larger mass of cells before division stopped. None of the embryos developed by
ACT divided sufficiently to produce stem cells.
The goal of ACT’s work was to produce human embryonic stem cells and
develop new therapies for diseases such as diabetes and Parkinson’s disease.10
Scientists believe that stem cells transplanted into a patient could treat disease or
injury by replacing damaged tissue. If the cell nucleus used in SCNT is from the
patient, the stem cells would be genetically identical to the patient, recognized by the
patient’s immune system, and would avoid any tissue rejection problems that could
occur in other stem cell therapeutic approaches. Because of this, many scientists
believe the SCNT technique may provide the best hope of eventually treating patients
using stem cells for tissue transplantation.
Others with Human Cloning Intentions. Within a year of the Dolly
announcement, concerns over human cloning were heightened when Dr. Richard
Seed, a Chicago scientist, announced on January 7, 1998, his intention to clone a
human being. In response, bills were introduced in the 105th Congress that would
have banned human cloning indefinitely or imposed a moratorium. The legislation
was opposed by a number of medical organizations, the biotechnology industry and
many scientists and was not enacted.
Others who have expressed an interest in reproductive cloning include Dr. Panos
Zavos, of the University of Kentucky, and Dr. Severino Antinori, director of a
fertility clinic in Rome. At one time, Dr. Zavos and Dr. Antinori were working
together to help infertile couples have children via cloning. In April 2002, there were
unconfirmed reports in the media that Dr. Antinori had implanted cloned human
embryos in women. Dr. Antinori claimed there were three such pregnancies of six
to nine weeks duration, two in Russia and one in an Islamic state. His claim was
disputed by his former partner Dr. Zavos. In January 2004 Dr. Zavos announced that
he had implanted a cloned embryo into a woman’s uterus; two weeks later he stated
that the pregnancy had failed.11
Federal Policy Involving Human Embryo Research
At the present time, no U.S. laws or regulations would prohibit all cloning
research. However, federal funding of any type of research involving human
embryos, starting with in vitro fertilization (IVF) then later cloning and the creation
of stem cell lines from embryos, had been blocked by various policy decisions dating
back 25 years.
10 For more information about stem cells, see CRS Report RL31015, Stem Cell Research,
by Judith A. Johnson and Erin Williams.
11 David Derbyshire and Oliver Poole, “I Am Doing God’s Work, Insists Maverick Fertility
Expert Who Wants to Clone Babies,” The Daily Telegraph, Feb. 14, 2004, p. 4.

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Ethics Advisory Board. Following the birth of the first IVF baby, Louise
Brown, in July 1978, the federal Ethics Advisory Board (EAB) was tasked with
considering the scientific, ethical, legal, and social issues surrounding human IVF.12
The EAB released its report on May 4, 1979, which found 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, the EAB was dissolved in
1980, and no other EAB was ever 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 so-called “de facto
moratorium” on human IVF research resulted. Other types of embryo research
ensuing from the development and use of IVF, such as cloning and stem cells, were
therefore also blocked. The de facto moratorium was lifted with the enactment of the
National Institutes of Health (NIH) Revitalization Act of 1993 (P.L. 103-43, Section
121(c)) which nullified the regulatory provision (45 CFR 46.204(d)) requiring EAB
review of IVF proposals.
NIH Human Embryo Research Panel. In response, the NIH established
the Human Embryo Research Panel to assess the moral and ethical issues raised by
this research and to 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. The panel
identified areas of human embryo research it considered to be unacceptable, or to
warrant additional review. It determined that certain types of cloning13 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 such cloning techniques followed by transfer to the uterus should
be unacceptable into the foreseeable future. The NIH Panel recommended that some
areas of human embryo research should be considered for federal funding, including
SCNT, stem cells and, under certain limited conditions, embryos created solely for
the purpose of research.14 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.” The President’s directive did not apply to research involving so-called
“spare” embryos, those that sometimes remain from clinical IVF procedures
performed to assist infertile couples to become parents. Nor did it apply to human
12 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). The EAB
was formed 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 10 reports, many of which formed the basis of federal regulations
for research involving human subjects (45 CFR 46).
13 These were blastomere separation, where a two- to eight-cell embryo is treated causing
the cells (blastomeres) to separate; and, blastocyst division, in which an embryo at the more
advanced blastocyst stage is split into two.
14 National Institutes of Health, Report of the Human Embryo Research Panel, Sept. 27,
1994.

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parthenotes, eggs that begin development through artificial activation, not through
fertilization. Following the Clinton December 2, 1994 directive to NIH, the agency
proceeded with plans to develop guidelines to support research using spare embryos.
Dickey Amendment. NIH plans to develop guidelines on embryo research
were halted on January 26, 1996, with the enactment of P.L. 104-99 which contained
a rider that affected FY1996 funding for NIH. The rider prohibited HHS from using
appropriated funds for the creation of human embryos for research purposes or for
research in which human embryos are destroyed. This same rider, often referred to
as the Dickey amendment, has been attached to the Labor, HHS and Education
Appropriations Acts for FY1997 through FY2004.15 For FY2004, the provision is
found in Section 510 of Division E, which is the Labor, HHS and Education division
of the FY2004 Consolidated Appropriation bill (P.L. 108-199). It prohibits HHS
from using FY2004 appropriated funds for:
(1) the creation of a human embryo or embryos for research purposes; or, (2)
research in which a human embryo or embryos are destroyed, discarded, or
knowingly subjected to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)). For purposes of this section, the
term “human embryo or embryos” includes any organism, not protected as a
human subject under 45 CFR 46 ... that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human gametes
[sperm or egg] or human diploid cells.
One month after the Dolly announcement, on March 4, 1997, President Clinton
sent a memorandum to the heads of all executive departments and agencies making
it “absolutely clear that no federal funds will be used for human cloning.” This
action extended the congressional ban beyond HHS to all federally supported
research. Clinton also urged the private sector to adopt a voluntary ban on the
cloning of human beings. The NIH Guidelines on Stem Cell Research, published by
the Clinton Administration in August 2000, would not have funded research in
which: human stem cells are used for reproductive cloning of a human; human stem
cells are derived using SCNT; or, human stem cells that were derived using SCNT
are utilized in a research project.
Actions During the Current Bush Administration. On August 9, 2001,
President Bush announced that for the first time federal funds would be used to
support research on human embryonic stem cells, but funding would be limited to
“existing stem cell lines.” In the speech, President Bush stated that he strongly
opposes human cloning. Although not mentioned specifically in the August 9
speech, a fact sheet on the White House website states that federal funds will not be
15 The original rider, introduced by Rep. Jay Dickey, is in Section 128 of P.L. 104-99; it
affected NIH funding for FY1996 contained in P.L. 104-91. For subsequent fiscal years, the
rider is found in Title V, General Provisions, of the Labor, HHS and Education
Appropriations Acts in the following public laws: FY1997, P.L. 104-208; FY1998, P.L.
105-78; FY1999, P.L. 105-277; FY2000, P.L. 106-113; FY2001, P.L. 106-554; FY2002,
P.L. 107-116; and FY2003, P.L. 108-7.

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used for “the cloning of human embryos for any purpose.”16 In his speech, President
Bush announced his intention to name a President’s council, chaired by Dr. Leon
Kass of the University of Chicago, “to consider all of the medical and ethical
ramifications of biomedical innovation.” The President’s Council on Bioethics, was
established for a period of up to two years by Executive Order 13237 on November
28, 2001. The White House announced the other 17 members of the council on
January 16, 2002.
The first topic addressed by the Council was human cloning.17 Although all
Council members voted in opposition to reproductive cloning, they could not come
to an agreement on articulating the precise nature of their objection, whether solely
safety concerns or which of the various moral objections were most important. In an
informal vote on the issue of therapeutic cloning, about half of the 18 members of the
Council voiced their support for the therapeutic use of human cloning. Dr. Kass
proposed that the Council’s final report reflect both the arguments supporting cloning
for the purpose of medical treatment and those against.
At the June 20, 2002, meeting, nine Council members voted to support cloning
for medical research purposes, without a moratorium, provided a regulatory
mechanism was established.18 Because one member of the Council had not attended
the meetings and was not voting, the vote seemed to be nine to eight in favor of
research cloning. However, the draft report sent to Council members on June 28,
2002, indicated that two of the group of nine members had changed their votes in
favor of a moratorium. Both made it clear that they have no ethical problem with
cloning for biomedical research, but felt that a moratorium would provide time for
additional discussion.19 The changed vote took many Council members by surprise,
and some on the Council believe that the moratorium option, as opposed to a ban,
was thrown in at the last minute and did not receive adequate discussion. In addition,
some on the Council believe that the widely reported final vote of 10 to 7 in favor of
a moratorium does not accurately reflect the fact “that the majority of the council has
no problem with the ethics of biomedical cloning.”20 The final report, Human
Cloning and Human Dignity: An Ethical Inquiry, was released on July 11, 2002.
In March 2001, the FDA sent letters to the research community stating that the
creation of a human being using cloning is subject to FDA regulation under the
Public Health Service Act and the Food, Drug and Cosmetic Act.21 FDA stated that
16 The White House Fact Sheet on embryonic stem cell research is available at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html].
17 Transcripts of the Council meetings and papers developed by staff for discussion during
the meetings can be found at [http://www.bioethics.gov].
18 S.S. Hall, “President’s Bioethics Council Delivers,” Science, v. 297, July 19, 2002, pp.
322-324.
19 Ibid., p. 324.
20 Ibid., p. 322.
21 The FDA position statement and letters to the research community are available at
[http://www.fda.gov/cber/genetherapy/clone.htm].

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such research could only occur when an investigational new drug application (IND)
is in effect. Some legal scholars believe that there is no legal basis for the regulation
of cloning by FDA.22 They find little evidence to support FDA’s position that cloned
human embryos are “drugs.” However, the biotechnology industry and the American
Society for Reproductive Medicine believe FDA has the authority to regulate cloning
and legislation is unnecessary because FDA regulation is preferred to any new action
by Congress.23
On January 18, 2002, the National Academies released its report entitled
Scientific and Medical Aspects of Human Reproductive Cloning.24 The panel
recommended that the U.S. ban human reproductive cloning. The panel was
concerned for the safety of both the woman and the fetus and judged the procedure
to be too dangerous for use in humans at the present time. The ban should be legally
enforceable, rather than voluntary, and carry substantial penalties. The ban should
be reconsidered in five years, but only if compelling new data on safety and efficacy
are presented and a national dialogue on the social and ethical issues suggests that a
review is warranted. However, the panel concluded that research using SCNT to
produce stem cells should be permitted because of the considerable potential for
developing new therapies and advancing biomedical knowledge. This position is in
agreement with a previous National Academies’ report entitled Stem Cells and the
Future of Regenerative Medicine which was released on September 11, 2001.25
The U.S. Supreme Court has recognized in past cases certain personal rights as
being fundamental and protected from government interference.26 Some legal
scholars believe a ban on human cloning may be struck down by the Supreme Court
because it would infringe upon the right to make reproductive decisions which is
“protected under the constitutional right to privacy and the constitutional right to
liberty.”27 Other scholars do not believe that noncoital, asexual reproduction, such
as cloning, would be considered a fundamental right by the Supreme Court. A ban
on human cloning research may raise other constitutional issues: scientists’ right to
personal liberty and free speech. In the opinion of some legal scholars, any
22 R. Weiss, “Legal Barriers to Human Cloning May Not Hold Up,” Washington Post, May
23, 2001, p. A1.
23 Ibid.
24 The National Academies are the National Academy of Sciences, the National Academy
of Engineering, the Institute of Medicine, and the National Research Council. The report
on human cloning is available at
[http://www.nap.edu/catalog/10285.html?onpi_topnews_011802].
25 The National Academies’ report on stem cell research is available at
[http://www.nap.edu/catalog/10195.html?onpi_topnews_091101].
26 For further discussion of these issues and their relationship to human cloning, see CRS
Report RL31422, Substantive Due Process and a Right to Clone, by Jon O. Shimabukuro.
27 L.B. Andrews, “Is There a Right to Clone? Constitutional Challenges to Bans on Human
Cloning,” Harvard Journal of Law and Technology, summer 1998, pp. 643-680.

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government limits on the use of cloning in scientific inquiry or human reproduction
would have to be “narrowly tailored to further a compelling state interest.”28
State Legislation on Cloning
As of March 12, 2004, nine states have passed laws which prohibit reproductive
cloning (Arkansas, California, Iowa, Michigan, New Jersey, North Dakota, Rhode
Island, South Dakota, Virginia).29 In addition, Louisiana has enacted legislation
prohibiting reproductive cloning but the law expired in July 2003. Five of the nine
states also prohibit cloning for research or therapeutic purposes (Arkansas, Iowa,
Michigan, North Dakota, South Dakota). The Virginia law may also prohibit
therapeutic cloning, “but it may be unclear because the law does not define the term
‘human being’ which is used in the definition of human cloning.”30 The California
and New Jersey laws specifically permit cloning for research purposes. The Rhode
Island law is silent on therapeutic cloning and cloning for research purposes, and has
a sunset date of July 7, 2010. Missouri “bans the use of state funds for human
cloning research which seeks to develop embryos into newborn children,” but does
not prohibit reproductive cloning or therapeutic cloning.31
Federal Legislation on Cloning
Congress addressed the issue of cloning and embryo research in the
Consolidated Appropriations Act of 2004 (P.L. 108-199) by including the Dickey
amendment which bans almost all publically funded human embryo research. The
act also bars the Patent and Trademark Office from spending money “to issue patents
on claims directed to or encompassing a human organism.” This restriction could
potentially deter human embryo research and stem cell research because researchers
might not be able to claim ownership of their work.
On February 27, 2003, the House passed H.R. 534 (Weldon), the Human
Cloning Prohibition Act of 2003 by a vote of 241-155. H.R. 534 amends Title 18 of
the United States Code and would ban the process of human cloning as well as the
importation of any product derived from an embryo created via cloning. Under this
measure, cloning could not be used for reproductive purposes or for research on
therapeutic purposes, which would have implications for stem cell research. H.R.
534 includes a criminal penalty of imprisonment of not more than 10 years and a civil
penalty of not less than $1 million.
H.R. 534 is essentially identical to the measure which passed the House in the
107th Congress (H.R. 2505). During floor debate on H.R. 534, an amendment,
H.Amdt. 4 (Scott), was agreed to by voice vote. H.Amdt. 4 requires that the
Government Accountability Office (GAO) (formerly General Accounting Office
28 Ibid., p. 667.
29 National Conference of State Legislatures, State Human Cloning Laws, Mar. 12, 2004,
at [http://www.ncsl.org/programs/health/genetics/rt-shcl.htm]
30 Ibid.
31 Ibid.

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(GAO), in consultation with the National Academy of Sciences, conduct a study on
the impact of the cloning ban on medical technology and assess the need (if any) for
modification of the cloning ban contained in the bill. A report to Congress with
findings and recommendations would be required within two years of enactment. An
amendment in the nature of a substitute, H.Amdt 5 (Greenwood), was not adopted
by a vote of 174 to 231. The amendment would have prohibited human SCNT
technology when used to initiate a pregnancy but allowed SCNT to be used in
medical research. H.Amdt 5 is similar to H.R. 801 (Greenwood) (see below).
H.R. 534 was introduced on February 5, 2003, and reported (19-12 vote) by the
House Judiciary Committee on February 12, 2003 (H.Rept. 108-18). During mark-
up, four amendments were defeated by 12-19 or by voice vote. The amendments
attempted to either limit the ban to three years, exempt the importation of medical
treatments, exempt the use of cloning in research, or in the creation of additional
stem cell lines. A fifth amendment that would add the GAO study was withdrawn
when Chairman Sensenbrenner assured his support if it was added to the bill during
floor debate.
A companion bill, S. 245 (Brownback), was introduced on January 29, 2003.
It is similar to H.R. 534, except that (1) it does not contain the ban on importation of
products derived from therapeutic cloning; and (2) it amends Title 4 of the Public
Health Service Act (42 U.S.C. 289 et seq.) instead of Title 18 of the United States
Code.32 S. 245 includes a criminal penalty of imprisonment of not more than 10
years and a civil penalty of not less than $1 million. It requires the GAO to conduct
a study to assess the need (if any) for any changes of the prohibition on cloning in
light of new developments in medical technology, the need for SCNT to produce
medical advances, current public attitudes and prevailing ethical views on the use of
SCNT and potential legal implications of research in SCNT. The study is to be
completed within four years of enactment. S. 245 has been referred to the Senate
Health, Education, Labor, and Pensions Committee.
H.R. 801 (Greenwood), the Cloning Prohibition Act of 2003, was introduced on
February 13, 2003. H.R. 801 would prohibit human reproductive cloning while
allowing cloning for medical research purposes, including stem cell research. The
bill includes a civil penalty of up to $10 million and a criminal penalty of up to 10
years in prison for those convicted of using SCNT for human reproductive purposes,
or for importing the products of human cloning if the products would be used to
initiate a pregnancy. The bill would amend the Food, Drug and Cosmetic Act (21
U.S.C. 301 et seq.) and would require that all researchers performing SCNT on
human cells must register their research activity with the Secretary; such registration
would most likely be submitted to the FDA.
H.R. 801 stipulates that all research involving human SCNT shall be conducted
in accordance with Part 50 (Protection of Human Subjects) and Part 56 (Institutional
Review Boards) of Title 21 of the Code of Federal Regulations (CFR). Under the
bill, individuals whose cells are used for such research (presumably the donor of the
32 By seeking to amend Title 18 of the U.S. Code rather than the Public Health Service Act,
S. 245 would likely be subject to different committee jurisdiction.

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unfertilized egg and the donor of the somatic cell) would be considered human
subjects for the purposes of Parts 50 and 56 of 21CFR. In addition to the
requirements under Parts 50 and 56 of 21CFR, the human cell donors must sign an
informed consent statement declaring that (1) the cells are donated for research
purposes; (2) the donor understands that federal law regulates SCNT and use of
SCNT to initiate a pregnancy is a criminal act; and, (3) the individual does not intend
for the donated cells to be used to initiate a pregnancy. A sunset provision states that
the prohibition would expire 10 years after enactment.
H.R. 801 would require the Secretary of HHS to request a study reviewing the
current state of knowledge on: (1) the biological properties of stem cells obtained
from embryos, fetal tissue, and adult tissue; (2) any biological differences of such
stem cells and the consequences for research and medicine; and (3) the ability of stem
cells to generate different types of tissue and their potential clinical uses. The study
must be conducted by the Institute of Medicine or another appropriate public or
nonprofit private entity.
S. 303 (Hatch), the Human Cloning Ban and Stem Cell Research Protection Act
of 2003, was introduced on February 5, 2003. Although S. 303 and H.R. 801 amend
different titles of the United States Code (S. 303 amends Title 18 and H.R. 801
amends Title 21), both bills have the same effect: human reproductive cloning would
be banned but cloning for medical research purposes would be allowed, including
stem cell research.33 S. 303 includes a criminal penalty of imprisonment of not more
than 10 years and a civil penalty of not less than $1 million.
S. 303 would require the Comptroller General to prepare a report within one
year of enactment that describes the actions taken by the Attorney General to enforce
the prohibition on human reproductive cloning, the personnel and resources used to
enforce the prohibition, and a list of any violations of the prohibition. The
Comptroller General must also prepare a report within one year of enactment on
similar state laws that prohibit human cloning and actions taken by the states’
attorney general to enforce the provisions of any similar state law along with a list
of violations. A report on the coordination of enforcement actions among the federal,
state and local governments must also be prepared by the Comptroller General within
one year of enactment, as well as a report on laws adopted by foreign countries
related to human cloning.
S. 303 also would amend the Public Health Service Act by requiring that nuclear
transplantation research be conducted in accordance with the ethical requirements
(such as informed consent, examination by an Institutional Review Board, and
protections for safety and privacy) contained in subpart A of 45CFR46, or Parts 50
and 56 of 21CFR. In contrast, H.R. 801 requires that all such research shall be
conducted in accordance with Part 50 and 56 of 21CFR and does not refer to subpart
A of 45CFR46.34
33 Ibid.
34 Subpart A 45CFR46, often referred to as the Common Rule, “applies to all research
involving human subjects conducted, supported or otherwise subject to regulation by any
(continued...)

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S. 303 contains a prohibition on conducting SCNT on fertilized human eggs
(oocytes), and states that “unfertilized blastocysts” shall not be maintained after more
than 14 days from its first cell division, aside from storage at temperatures less that
zero degrees centigrade. S. 303 stipulates that a human egg may not be used in
SCNT research unless the egg is donated voluntarily with the informed consent of the
woman donating the egg; H.R. 801 contains a similar egg donation and informed
consent provision. S. 303 also specifies that human eggs or unfertilized blastocysts
may not be acquired, received or otherwise transferred for valuable consideration if
the transfer affects interstate commerce. Under S. 303, SCNT may not be conducted
in a laboratory in which human eggs are subject to assisted reproductive technology
treatments or procedures, such as in vitro fertilization, for the treatment of infertility.
Violation of these provisions in S. 303 regarding ethical requirements would result
in a civil penalty of not more than $250,000. S. 303 has been referred to the Senate
Judiciary Committee.
Supporters of a ban on human cloning, such as that contained in H.R. 534,
argue that a partial ban on human cloning, like the one contained in S. 303, would be
impossible to enforce. Critics of the ban on human cloning argue that SCNT creates
a “clump of cells” rather than an embryo, and that the ban would curtail medical
research and prevent Americans from receiving life-saving treatments created
overseas.
International Actions on Cloning
On December 1, 1998, the Council of Europe (COE)35 introduced a measure to
prohibit reproductive but not therapeutic cloning. The measure, Additional Protocol
to the Convention for the Protection of Human Rights and Dignity of the Human
Being with regard to the Application of Biology and Medicine, on the Prohibition of
Cloning Human Beings, prohibits “[a]ny intervention seeking to create a human
34 (...continued)
federal department or agency which takes appropriate administrative action to make this
policy applicable to such research.” The Common Rule covers 18 federal agencies by force
of law or Executive Order. FDA has regulatory authority over research on the products the
agency regulates (food, drugs, medical devices) and applies its own set of regulations on the
protection of human subjects (21CFR 50, 56) that are generally but not entirely the same as
subpart A of 45CFR46. For further information, see National Bioethics Advisory
Commission, Ethical and Policy Issues in Research Involving Human Participants,
Appendix C: The Current Oversight System: History and Description, Aug. 2001.
35 Founded in 1949, the Council of Europe (COE) is the continent’s oldest political
organization. The COE groups together 45 countries, including 21 countries from Central
and Eastern Europe, and has granted observer status to five more countries, including the
United States. It is distinct from the 25-nation European Union, but no country has ever
joined the Union without first belonging to the Council of Europe.
[http://www.coe.int/T/e/Com/about_coe/].

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being genetically identical to another human being, whether living or dead.”36 Of the
50 counties in the COE, the protocol has been signed by 2937 and ratified by 14.38
On September 7, 2000, a separate European organization, the European
Parliament,39 voted 271 to 154 to reaffirm its support for a ban on both research and
reproductive human cloning.40 The Parliament’s resolution does not have authority
in the governments of the European Union, but rather seeks to guide the legislation
of those countries.41 The resolution calls for “each Member State to enact binding
legislation prohibiting all research into any kind of human cloning within its territory
and providing for criminal penalties for any breach.”
A third multinational organization, the United Nations General Assembly
(UNGA),42 suspended debate on the topic on November 6, 2003. After two years of
dialogue and no substantive action, the UNGA voted to suspend further any further
consideration of a proposal for an international treaty to ban reproductive human
cloning until late 2005.43 “A proposal by France and Germany to begin negotiations
on a treaty that would ban reproductive cloning, to be followed by consideration of
36 “Additional Protocol to the Convention for the Protection of Human Rights and Dignity
of the Human Being with regard to the Application of Biology and Medicine, on the
Prohibition of Cloning Human Beings,” Council of Europe, CETS No. 168, Dec. 1, 1998,
at [http://conventions.coe.int/Treaty/en/Treaties/Html/168.htm].
37 Signatories include Croatia, Cypress, Czech Republic, Denmark, Estonia, Finland, France,
Georgia, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova,
Netherlands, Norway, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Macedonia, and Turkey at
[http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=168&CM=8&DF=29/0
6/04&CL=ENG].
38 Croatia, Cypress, Czech Republic, Estonia, Georgia, Greece, Hungary, Lithuania,
Moldova, Portugal, Romania, Slovakia, Slovenia, and Spain have ratified the Protocol at
[http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=168&CM=8&DF=29/0
6/04&CL=ENG].
39 Governance of the European Union is shared by the European Parliament, directly elected
by the 374 million citizens of the member countries, and a Council of the European Union,
made up of delegates from each member country at
[http://www.europarl.eu.int/presentation/default_en.htm].
40 European Parliament Supports Full Cloning Ban,” Genetic Crossroads, no. 26, Nov. 22,
2002, p. 1, at [http://www.genetics-and-society.org/newsletter/archive/26.html#I2].
41 “European Parliament Wants Total Ban on Human Cloning,” ZENIT — The World Seen
From Rome, Nov. 21, 2002, p. 1,
at [http://www.zenit.org/english/visualizza.phtml?sid=27981].
42 The General Assembly is the main deliberative organ of the United Nations. It is
composed of representatives of all 191 member states, each of which has one vote.
Decisions on important questions, such as those on peace and security, admission of new
Members and budgetary matters, require a two-thirds majority. Decisions on other questions
are reached by a simple majority, at [http://www.un.org/ga/58/ga_background.html].
43 John T. Softcheck, “Petition to Expand Stem Cell Lines Gains Added Senate Support as
Scientists Launch an Education Effort,” Washington Fax, June 3, 2004, p. 1.

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a treaty addressing research cloning, was supported by at least 75 countries.
However, [the proposal to consider reproductive and therapeutic cloning
independently] was opposed by at least 35 countries, led by the United States and
Spain, that called for reproductive cloning and research cloning to be considered
simultaneously.”44 The vote to suspend discussion “was very close: 80 countries
voted for the suspension, 79 wished to continue negotiations, 15 formally abstained,
and 17 were not present.”45
A November 2003 survey of various country’s positions on cloning and other
genetic technologies revealed that, of the 192 countries surveyed, 23% prohibited
reproductive cloning, 16% prohibited cloning for research purposes, and 3%
expressly permitted cloning for research purposes.46 For example, according to the
survey and other updated sources, China47 and Australia48 prohibit cloning for
reproductive but not for research purposes. France,49 and Germany50 prohibit cloning
for both purposes. The United Kingdom51 and South Korea52 prohibit reproductive
cloning, but specifically permit and regulate cloning for research purposes. In
August 2004, the UK’s Human Fertilization and Embryology Authority granted to
Newcastle Centre for Life, the country’s first licence to conduct therapeutic cloning,
44 “United Nations Human Cloning Treaty,” Genetic Crossroads, no. 26, Nov. 22, 2002, p.
1, at [http://www.genetics-and-society.org/newsletter/archive/26.html#I2].
45 “Special Report on the UN cloning treaty negotiations,” Center for Genetics and Society,
46 Isasi Rosario, “National Polices Governing New Technologies of Human Genetic
Modification: A Preliminary Survey,” Center for Genetics and Society, Nov. 2003, at
[http://www.genetics-and-society.org/policies/survey.html#4].
47 “Guidelines on Assisted Reproductive Technologies for Human Beings,” Ministry of
Public Health, Oct. 2003, “Ethical Principles on Assisted Reproductive Technologies for
Human Beings and Human Sperm Bank”, Ministry of Health, Aug. 2003, The Human
Reproductive Technology Ordinance, An Ordinance No. 47 (Amended 2002). The
Government of the Hong Kong Special Administrative Region (Gazette, Legal Supplement
nos. 1 to 26, vol. 4, June 30, 2000, pp. A1691-A1777), Ministry of Science and Technology
and the Ministry of Public Health, Interim Measures for the Administration of Human
Genetic Resources (June 10, 1998).
48 Prohibition of Human Cloning Act No. 144- 2002, Jan. 7, 2003, “An Act to Prohibit
Human Cloning and Other Unacceptable Practices Associated with Reproductive
Technology and for Related Purposes,” Research Involving Embryos Act no. 145-2002, Jan.
7, 2003.
49 Law No. 94-653 of July 29 1994, on Respect for the Human Body; this law was updated
in July 2004, prohibiting therapeutic and reproductive cloning, but permitting embryonic
stem cell research. “France Says No to Human Cloning,” Cordis News, (July 9, 2004), at
[http://dbs.cordis.lu/cgi-bin/srchidadb?CALLER=NHP_EN_NEWS&ACTION=D&SES
SION=&RCN=EN_RCN_ID:22309], accessed July 15, 2004.
50 Federal Embryo Protection Law (1990).
51 Human Reproductive Cloning Act (2001), Human Embryology and Fertilization Act
(1990).
52 Life Ethics Law, Jan. 29 2004, South Korean Bioethics Advisory Commission,
Recommendations for Biotechnological Research and Application (May 18, 2001).

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which will be used to generate embryonic stem cells.53 Japan permits embryo
research but banned cloning in 2001; however on June 23, 2004, a government panel
recommended permitting the limited cloning of embryos for scientific research.54
Ethical and Social Issues
The possibility of using cloning technology not just for therapeutic purposes but
also for reproducing human beings raises profound moral and ethical questions. As
previously mentioned, the Bush Administration and the National Academies have
made their positions clear. In July 2002, the President’s Council on Bioethics issued
its report, Human Cloning and Human Dignity, which contained two opinions and
sets of recommendations: one of the 10-7 majority, and one of the minority.55 The
majority and minority both opposed reproductive cloning. It was on the topic of
therapeutic cloning, which the majority opposed and the minority favored, that the
Council was split.
A predecessor to the President’s Council, the National Bioethics Advisory
Commission (NBAC), recommended, in Cloning Human Beings,56 the continuation
of a moratorium on federal funding for reproductive purposes with a call for
voluntary compliance from the private sector. It further recommended the enactment
of legislation with a three- to five-year sunset clause banning cloning for reproductive
53 Human Fertilization and Embryology Authority of the UK, “HFEA Grants the First
Therapeutic Cloning Licence for Research,” press release, Aug. 11, 2004 at
[http://www.hfea.gov.uk/PressOffice/Archive/1092233888].
54 The “Law Concerning Regulation Relating to Human Cloning Techniques and Other
Similar Techniques,” Nov. 2000, in effect since June 2001. Guidelines to the “Law
Concerning Regulation Relating to Human Cloning Techniques and Other Similar
Techniques,” Minister of Education and Science, Dec. 4, 2001; “Panel Urges Japan to
Permit Limited Cloning of Humans,” Orlando Sentinel, June 24, 2004, p. A4.
55 At the June 20, 2002 meeting, nine of 17 Council members voted to support cloning for
medical research purposes, without a moratorium, provided a regulatory mechanism was
established. Because one member of the Council had not attended the meetings and was not
voting, the vote seemed to be nine to eight in favor of research cloning. However, draft
versions of the Council report sent to Council members on June 28, 2002, indicated that two
of the group of nine members had changed their votes in favor of a moratorium. Both made
it clear that they have no ethical problem with cloning for biomedical research, but felt that
a moratorium would provide time for additional discussion. The changed vote took many
Council members by surprise, and some on the Council believe that the moratorium option,
as opposed to a ban, was thrown in at the last minute and did not receive adequate
discussion. In addition, some on the Council believe that the widely reported final vote of
10 to 7 in favor of a moratorium does not accurately reflect the fact “that the majority of the
council has no problem with the ethics of biomedical cloning.” (Transcripts of the Council
meetings and papers developed by staff for discussion during Council meetings can be found
at [http://www.bioethics.gov]; S.S. Hall, “President’sBioethics Council Delivers,” Science,
v. 297, July 19, 2002, pp. 322-324.) “Wise Words From Across the Pond?,” BioNews, no.
252, Mar. 29, 2004.
56 National Bioethics Advisory Commission, Cloning Human Beings, June 1997.

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purposes. However, it made clear that all measures taken should “be carefully
written so as not to interfere with other important areas of scientific research.”57
Various other organizations, individuals, and councils have issued opinions and
reports on cloning as well. Some, such as The United States Conference of Catholic
Bishops (USCCB)58 oppose human cloning for any purpose: “The cloning procedure
is so dehumanizing that some scientists want to treat the resulting human beings as
subhuman, creating them solely so they can destroy them for their cells and tissues.”59
Others, such as a group of forty Nobel Laureates,60 former First Lady Nancy
Reagan,61 and former President Gerald Ford,62 would allow regulated cloning for
therapeutic purposes, but disallow it for reproductive ones. Still others, such as such
as Dr. Severino Antinori, and Clonaid,63 favor cloning for reproductive purposes, and
even claim to have created human clones via SCNT.64
The human cloning debate centers around number of different ethical and
pragmatic issues. Exploration of these issues reveals variation in ethical and moral
as well as factual beliefs. The following discussion breaks down the arguments
surrounding human cloning according to these issues, demonstrating both the
complexity of the issues and the points of resonance among the groups.
57 Ibid., p. iv.
58 The United States Conference of Catholic Bishops is “ is an assembly of the hierarchy of
the United States and the U.S. Virgin Islands who jointly exercise certain pastoral functions
on behalf of the Christian faithful of the United States,” at
[http://www.nccbuscc.org/whoweare.htm].
59 Bishop Gregory, President of the United States Conference of Catholic Bishops, quoted
in “Bishops’ President Says Cloning Turns Human Reproduction into a Manufacturing
Process, United States Conference of Catholic Bishops Communications, Nov. 27, 2001, at
[http://www.usccb.org/comm/archives/2001/01-205.htm].
60 The American Society for Cell Biology statement by the 40 Nobel Laureates is available
at [http://www.ascb.org/publicpolicy/Nobelletter.html].
61 Complete text of a letter from Mrs. Reagan to Senator Orrin Hatch specifying her position
on cloning can be found at
[http://hatch.senate.gov/index.cfm?FuseAction=PressReleases.Detail&PressRelease_id=
674].
62 L. Hafner, “Revised Feinstein/Kennedy Cloning Bill Has Criminal and Civil Penalties,
Requires Research Review,” Washington Fax, May 2, 2002.
63 “CLONAID™ ,the first human cloning company in the world, was founded in Feb. 1997,
by RAËL and a group of investors who created the Valiant Venture Ltd Corporation based
in the Bahamas.” The organization was founded by the leader of the Raelian Movement,
“the world’s largest UFO-related organization.” “A historical background” Clonaid, at
[http://www.clonaid.com/content.php?content], visited July 1, 2004.
64 See, for example, “Alive and Well” Clonaid, at [http://www.clonaid.com/news.php],
visited July 1, 2004; Abu Dhabi, “Human Cloning Project Claims Progress,” Gulf News
Online Edition, Apr. 3, 2002, at
[http://www.gulf-news.com/Articles/news.asp?ArticleID=46275].

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Issues Involved in Cloning for Reproductive Purposes. As Clonaid
advertised and the President’s Council acknowledged, supporters of reproductive
cloning favor it because it might “allow infertile couples to have genetically-related
children,”65 enable families to avoid genetic disease in their genetically-related
children, facilitate the replication of specific persons (such as lost loved ones), or to
create ideal transplant donors.66 Likewise, the NBAC recognized that some of the
principles that underlie these purposes are a “presumption in favor of individual
liberty,” that “human reproduction [is] particularly personal and should remain free
of constraint, ... [and] as a society, we ought not limit the freedom of scientific
inquiry.”67 However, for a number of other reasons, the idea of cloning for
reproductive purposes is presently rejected by most groups and organizations,
including the President’s Council and NBAC. Of the groups and individuals listed
in the Ethical and Social Issues section, only Clonaid and Dr. Antinori favor
reproductive cloning at this time. Despite the apparent uniformity of views rejecting
reproductive cloning, there is a great deal of variation in the lines of reasoning
underlying such objections.
Procreation Without Conjugal Union. According to the USCCB, Donum
Vitae68 instructs that “attempts or hypotheses for obtaining a human being without
any connection with sexuality through ‘twin fission,’ cloning or parthenogenesis are
to be considered contrary to the moral law, since they are in opposition to the dignity
both of human procreation and of the conjugal union.”69 This objection to
reproductive cloning, that procreation should be limited to conjugal unions, is not
supported by most groups. If accepted, it would lead to a rejection of other forms of
assisted reproduction, such as in vitro fertilization (IVF). Of the groups and
individuals listed above, only UCCSB cites the need for a conjugal union as a
persuasive argument against reproductive cloning.
Safety. The most agreed upon objection to human reproductive cloning is one
of safety. The President’s Council on Bioethics concluded that, “[g]iven the high
rates of morbidity and mortality in the cloning of other mammals, we believe that
cloning-to-produce-children would be extremely unsafe, and that attempts to produce
65 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p.
xxvii. (Hereafter cited as President’s Council, Human Cloning.)
66 See, for example, President’s Council on Bioethics, Human Cloning and Human Dignity,
July 2002, p. xxvii; “Frequently Asked Questions,” Clonaid,at
[http://www.clonaid.com/content.php?content.6], visited July 9, 2004.
67 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 72.
68 Donum Vitae, (“The Gift of Life”), which addresses the Catholic view of morality of
many modern fertility procedures, was issued in 1987 by the Sacred Congregation for the
Doctrine of the Faith at [http://www.nccbuscc.org/prolife/tdocs/donumvitae.htm], visited
July 9, 2004.
69 John Haas, “Begotten Not Made: A Catholic View of Reproductive Technology,” United
States Conference of Catholic Bishops, Pro Life Activities, June 2003, at
[http://www.usccb.org/prolife/programs/rlp/98rlphaa.htm], visited July 9, 2004.

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a cloned child would be highly unethical.”70 The National Bioethics Advisory
Commission reached a consensus in its objection to reproductive cloning “because
current scientific information indicate[d] that this technique [was] not safe in
humans....”71 The National Academies agrees with this line of reasoning, given that
animal experimentation has demonstrated that “only a small percentage of attempts
are successful,” “many of the clones die during gestation,” and “newborn clones are
often abnormal, or die.”72 While these objections about safety are widely held, they
may be temporary in nature. As research advances, it may become less risky, and
thus some may find it less objectionable to attempt reproductive human cloning.
Unlike concerns about safety, other types of objections, while not so widely
held, may be more lasting because they are not likely to be alleviated by scientific
progress. These tend to be philosophical in nature. These concerns, listed in the
following paragraphs, have been acknowledged by the President’s Council, NBAC,
UCSSB, and the National Academies. According to the President’s Council,
“[d]ifferent Council members give varying moral weight to [the following] different
concerns.”73 Only the UCSSB found the concerns persuasive in total.
Identity. Some objections to reproductive cloning are based upon fears that
cloned children will have difficulty with their identities “because each will be
genetically virtually identical to a human being who has already lived and because
the expectations for their lives may be shadowed by constant comparisons to the life
of the ‘original.”’74 These concerns are dismissed by others, who point out that this
argument rests largely on “the crudest genetic determinism.”75 They cite both the
effect that environment plays on individual development, and the lack of difficulty
with identity experienced by naturally occurring identical twins.76
70 President’s Council, Human Cloning, p. xxiii.
71 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. iii.
72 The National Academies are the National Academy of Sciences, the National Academy
of Engineering, the Institute of Medicine, and the National Research Council, p. 93. The
report on human cloning is available at
[http://www.nap.edu/catalog/10285.html?onpi_topnews_011802].
73 The number of Council members who give moral weight to each argument, and the
amount of weight they give to each issue is not specified. President’s Council on Bioethics,
Human Cloning and Human Dignity, July 2002, p. xxviii.
74 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p.
xxviii.
75 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 65.
Note: genetic determinism is the idea that a person’s identity and development are primarily
or entirely the result of his or her genetic makeup. Genetic determinism is generally viewed
as a flawed concept because of its failure to acknowledge the impact of environmental
factors, and the opportunity for individual choice.
76 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p. 103.

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Commodification. Other philosophical objections have to do with a fear that
cloned children “might come to be considered more like products of a designed
manufacturing process than ‘gifts’ whom their parents are prepared to accept as they
are. Such an attitude toward children could also contribute to increased
commercialization and industrialization of human procreation.”77 This, in turn, may
fuel a new eugenics in which parents select not only whether to have a child, but
which child to have.78 Others point out that these types of concerns were raised about
most forms of assisted reproduction (such as in vitro fertilization and preimplantation
genetic diagnosis), which have not led to objectification. In addition, if being born
is a considered to be a benefit to the one born, “to the extent that the technology is
used to benefit the child ... no objectification of the child takes place.”79
Familial Relationships. A complicated lineage has also been introduced as
an objection to reproductive cloning: “By confounding and transgressing the natural
boundaries between generations, cloning could strain the social ties between them.
Fathers could become “twin brothers” to their “sons”; mothers could give birth to
their genetic twins; and grandparents would also be the “genetic parents” of their
grandchildren. Genetic relation to only one parent might produce special difficulties
for family life.”80 Others point out that children “born through assisted reproductive
technologies may also have complicated relationships to genetic, gestational, and
rearing parents ... [yet] there is no evidence that confusion over family roles has
harmed children born through assisted reproductive technologies, although the
subject has not been carefully studied.”81
Societal View of Children. Concerns have been voiced about the effects of
cloning on society: “Cloning-to-produce-children would affect not only the direct
participants but also the entire society that allows or supports this activity. Even if
practiced on a small scale, it could affect the way society looks at children and set a
precedent for future nontherapeutic interventions into the human genetic endowment
or novel forms of control by one generation over the next.”82 This objection is
rejected by others, who argue that “people can, and do, adapt in socially redeeming
ways to new technologies ... [A] child born through somatic cell nuclear transfer
could be loved and accepted like any other child....”83
77 Ibid., pp. xxviii-xxix.
78 Ibid., p. xxix.
79 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 70.
80 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p. xxix.
81 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 66.
82 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p. xxix.
83 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 67.

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Issues Involved in Cloning for Therapeutic Purposes.84 Cloning for
therapeutic purposes is more broadly supported than reproductive cloning, and the
issues involved are somewhat different. The safety concerns of reproductive cloning
do not apply in therapeutic cloning, placing much of the scientific community, such
as the National Academies, in favor of it. In addition, the NBAC, a minority of the
President’s Council, the group of Nobel Laureates, Nancy Reagan, and Gerald Ford
also generally support cloning for therapeutic purposes. Opponents include a
majority of the President’s Council, and the USCCB.
Relief of Human Suffering and Moral Status of Cloned Embryos.
The central debate over therapeutic cloning rests on the relative weight ascribed to
potential research benefits, and that ascribed to cloned embryos themselves. All
sides generally agree that research involving cloning may generate biomedical
advancements that relieve human suffering. As described the President’s Council,
the research “may offer uniquely useful ways of investigating and possibly treating
many chronic debilitating diseases and disabilities, providing relief to millions.”85
Yet a majority of Council members were dissuaded from the research, arguing that
“[i]f we permit this research to proceed, we will effectively be endorsing the
complete transformation of nascent human life into nothing more than a resource
tool.”86 Similar arguments are made by the USCCB.
The Council’s minority offered an opposing viewpoint: “We believe there are
sound moral reasons for not regarding the embryo, in its earliest stages as the moral
equivalent of a human person” but rather as having a “developing and intermediate
moral worth that commands our special respect.”87 The minority based its opinion
on the fact that, at the blastocyst stage (the one useful for stem cell research, for
example), the cells are still undifferentiated and could still be split and develop into
two separate twinned embryos, “suggesting that the earliest stage embryo is not yet
an individual.”88 Furthermore, they note that the possibility for the development of
a human child from a cloned embryo would require its transference to a uterus, as is
currently the case with IVF.89 IVF often results in the creation of embryos that
remain unimplanted, and is permitted in the United States. For all of the above
reasons, the Council minority, NBAC, Nancy Reagan, Gerald Ford, and the Nobel
Laureates support therapeutic cloning.
Dr. Hwuang, the South Korean scientist who cloned human embryos to extract
stem cells, summarized another argument in favor of research on cloned embryos.
84 For purposes of this section, the term “therapeutic purposes” is meant to include the use
of cloning technology for both the research underlying treatments, and the treatments
themselves.
85 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, pp.
xxxi, xxxiii.
86 Ibid., p. xxxiii.
87 Ibid., p. xxxi
88 Ibid., p. 136.
89 Ibid.

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While he believes that life begins when egg and sperm meet, and is opposed to
abortion, he pointed out that cloned embryos do not have the capacity to develop into
children. In fact, he described reproductive human cloning as “impossible.”
Therefore, he concluded that, because cloned embryos do not have the capacity to
develop into children even if they were implanted into a uterus, cloned embryos
deserve no more moral consideration than other groups of cells.90 This argument is
linked inversely to safety concerns related to reproductive cloning. If researchers
ever perfect human reproductive cloning techniques, anti-reproductive cloning
arguments based upon safety will be diminished, while anti-therapeutic cloning
arguments based on the ability of cloned embryos to develop will be strengthened.
Deliberate Creation for Use/Destruction. A second set of considerations
underlying the debate have to do with a moral aversion to the prospect of creating life
in order to destroy it. As a majority of the President’s Council pointed out, cloning
for therapeutic purposes requires “the creation of human life expressly and
exclusively for the purpose of its use in research, research that necessarily involves
its destruction, ... transform[ing] nascent human life into nothing more than a
resource tool.”91 The USCCB agrees with this characterization.
The Council minority countered that the “embryos would not be ‘created for
destruction,’ but for use in the service of life and medicine.”92 Further, the”practice
of sacrificing the life of the unborn in order to save the live of the pregnant woman
— while not a moral parallel to the case of using cloned embryos for biomedical
research — shows that there is some moral precedent for subordinating nascent
human life to more developed human life.”93 The NBAC, Nancy Reagan, Gerald
Ford, and the Nobel Laureates agree with this characterization.
Moral Harm or Benefit to Society. The effect of therapeutic cloning upon
society has been debated by opponents and proponents alike. The President’s
Council majority fear negative effects, such as the subjugation of weak members of
society, or genetic manipulation of developing life: “As much as we wish to alleviate
suffering now and to leave our children in a world where suffering can be more
effectively relieved, we also want to leave them in a world ... that honors moral
limits, that respects all life whether strong or weak, and that refuses to secure the
good of some human beings by sacrificing the lives of others.”94 Approving
therapeutic cloning would harm society by “crossing the boundary from sexual to
90 Dr. Wu-Suk Hwuang, “Overview of Research,” Presentation to the Gijon Medical School,
Gijon, Spain (July 12, 2004).
91 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p.
xxxiii.
92 Ibid., p. xxxi.
93 Ibid., pp. 137-138.
94 Ibid., p. xxxiv.

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asexual reproduction, thus approving in principle the genetic manipulation and
control of nascent human life.”95 USCCB also shares this point of view.
Counter arguments have been made by those who note that “[h]istorically,
scientific inquiry has been protected and even encouraged because of the great
societal benefit the public recognizes in maintaining the sanctity of knowledge and
the value of intellectual freedom.”96 In addition, they note that cloning is replication,
rather than transformation: “In an important sense, cloning is not the most radical
thing on the horizon. Much more significant ... would be the ability to actually alter
or manipulate the genome of offspring, ... which could then lead to a child being born
with characteristics other than it would have had....”97 The Council minority, NBAC,
Nancy Reagan, Gerald Ford, and the Nobel Laureates share this perspective.
Going Too Far or Drawing Appropriate Limitations. Some, such as the
majority of the President’s Council and USCCB, believe that policies allowing
therapeutic cloning would create a slippery slope, “opening the door to other moral
hazards, such as cloning-to-produce-children or research on later-stage embryos and
fetuses.”98 Others, such as the Council minority, NBAC, Nancy Reagan, Gerald
Ford, and the Nobel Laureates, believe that it is possible to circumscribe acceptable
practices with good policy. “Both the federal government and the states already
regulate the researchers’ methods in order to protect the rights of research subjects
and community safety.”99 Government might regulate, “the secure handling of
embryos, licensing and prior review of research projects, the protection of egg
donors, and the provision of equal access to benefits.”100
Types of Restrictions. One final set of arguments center around the types
of actions that the government may take with respect to therapeutic and/or
reproductive cloning. These include permitting, regulating, funding, discouraging,
and temporarily or permanently banning the practices. As a starting point, NBAC
offers: “In the United States, governmental policies that prohibit or regulate human
actions require justification because of a general presumption against governmental
interference in individual activities.”101 As may be expected, the opinions regarding
appropriate courses of action are largely linked to points of view about the
appropriateness of the various endeavors.
The most permissive approach available, permitting cloning with no restrictions,
is not supported by any of the individuals or organizations referenced herein. By
95 Ibid., p. xxxiv.
96 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 75.
97 J.A. Robertson, “A Ban on Human Cloning Research is Unjustified,” Testimony before
the National Bioethics Advisory Commission (Mar. 14, 1997), in National Bioethics
Advisory Commission, Cloning Human Beings, June 1997, p. 68.
98 President’s Council, Human Cloning, p. xxxiv.
99 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 75.
100 President’s Council, Human Cloning, p. xxxviii.
101 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 78.

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contrast, the next most permissive approach, regulating cloning, is supported by
Council minority, NBAC, Nancy Reagan, Gerald Ford, and the Nobel Laureates as
appropriate for therapeutic cloning, so as to enable it to continue in accordance with
socially accepted scientific research practices. As summarized by the Council
minority, “We believe that this research could provide relief to millions of
Americans, and that the government should therefore support is, within sensible
limits imposed by regulation.”102
A voluntary prohibition, the third most permissive approach, was recommended
by NBAC as the appropriate immediate response to reproductive cloning by the
private sector. NBAC called for “an immediate request to all firms, clinicians,
investigators, and professional societies in the private and non-federally funded
sectors to comply voluntarily with the intent of the federal moratorium.”103
As a longer term approach, NBAC recommended the fourth most permissive
approach, a temporary ban on reproductive cloning. “Federal legislation [should] be
enacted to prohibit anyone from attempting, whether in a research or clinical setting,
to create a child through somatic cell nuclear transfer. It is critical, however, that
such legislation include a sunset clause to ensure that Congress will review the issue
after a specified time period (three to five years) in order to decide whether the
prohibition continues to be needed.”104 Readers may be interested to note that, if
enacted in 1997 when NBAC’s report was published, a five-year ban on reproductive
cloning would have expired in 2002. The National Academies also recommended
a ban on reproductive cloning, and did not call it temporary but did add that it should
be reconsidered every five years. On the topic of therapeutic rather than reproductive
cloning, a majority of the Council recommended a temporary moratorium as the
proper approach, because it would “reaffirm the principle that science can progress
while upholding the community’s moral norms, and would therefore reaffirm the
community’s moral support for science and biomedical technology.”105
The most restrictive approach to cloning, a permanent ban, was proposed by the
Council minority and majority, and Nancy Reagan as appropriate for reproductive
cloning. “By permanently banning cloning-to-produce children, this policy gives
force to the strong ethical verdict against [it], unanimous in the Council ... and widely
supported by the American people.”106 This approach is also favored by the USCCB
not only for reproductive cloning, but also for therapeutic cloning.
One related issue, that of the use of federal funding for therapeutic cloning, has
also been discussed. No proposals have been made by any of the groups or
individuals listed above for the use of federal funding for reproductive cloning.
Opponents of funding therapeutic cloning, such as the Council majority, have
102 President’s Council, Human Cloning, p. xxxviii.
103 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 105.
104 Ibid.
105 President’s Council, Human Cloning, p. xxxvii.
106 President’s Council, Human Cloning, p. xxxiv.

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expressed concern that use of federal funding for therapeutic cloning would put “the
federal government in the novel and unsavory position of mandating the destruction
of nascent human life.”107 Proponents of federal funding for therapeutic cloning,
such as the Council minority, NBAC, Nancy Reagan, Gerald Ford, and the Nobel
Laureates, cite as support the advancements that might be powered by the infusion
of federal dollars into the research, as well as the ethical protections that would attach
with the money.
107 President’s Council, Human Cloning, p. xxxvi

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