Executive Summary of "Cloning Human Beings, June 1997"
The full report is not available on the Online Ethics
Center. It is available as a pdf on the Georgetown site Connect to National Bioethics Advisory
Commission Publications
Letter of
Transmittal to the President
June 9, 1997
The President
The White House
Washington, D.C. 20500
Dear Mr. President:
On February 24, 1997, in the wake of the announcement that
scientists in Scotland apparently had succeeded in cloning an
adult sheep, you asked the National Bioethics Advisory
Commission to review the legal and ethical issues associated
with the use of this technology and to report back within
ninety days with recommendations. A week later you instructed
the heads of executive departments and agencies that "no
federal funds shall be allocated for cloning of human beings"
thereby ensuring that precipitous steps would not be taken
while the Commission was studying the subject.
In this short interval, we have made every effort to consult
with ethicists, theologians, scientists, physicians, and other
citizens with interests and concerns in this area. Moreover, we
have invited inputs for the Commission's consideration from as
broad a cross-section of the community as time allowed.
Further, recognizing that science and medicine are
international activities with outstanding investigators and
facilities in many nations, we have attempted to review
relevant policies and proposals with respect to human cloning
in other countries. However, we do not view it as essential to
follow others in this area unless we find their proposals
compelling, since we have different political and cultural
traditions.
In this report, we address a very specific aspect of cloning
namely where genetic material would be transferred from the
nucleus of a somatic cell of an existing human being to an
enucleated human egg with the intention of creating a child. We
do not revisit either the question of the cloning of humans by
embryo-splitting or the issues surrounding embryo research. The
latter issue has, of course, recently received careful
attention by a National Institutes of Health panel, the
Administration, and Congress.
Not surprisingly, we have discovered that the potential
ability to clone human beings through the somatic cell nuclear
transfer techniques raises a whole host of complex and
difficult scientific, religious, legal and ethical issues--both
new and old. Indeed, the Commission itself is unable to agree
at this time on all the ethical issues that surround the issue
of cloning human beings in this manner. It seems clear to all
of us, however, given the current stage of science in this
area, that any attempt to clone human beings via somatic cell
nuclear transfer techniques is uncertain in its prospects, is
unacceptably dangerous to the fetus and, therefore, morally
unacceptable. At present, moral consensus on this issue should
be easily achieved. Furthermore, the continuing controversy
over the social and ethical issues raised by this new
development require more time for deliberation and the
accumulation of new scientific data. We therefore recommend
that the current moratorium on attempts to create children in
this manner be continued and that you immediately ask for
voluntary compliance in the private sector while federal
legislation banning the use of these techniques for creating
children is formulated and considered.
While we have been able to agree on this and certain other
recommended actions, we feel quite strongly that most of the
legal and moral issues raised can only be resolved, even
temporarily, by a great deal more widespread deliberation and
education. This type of national discussion is especially
necessary in our democratic and pluralistic society for the
following reasons: there is no universally accepted ethical
theory; Americans hold various religious and moral perspectives
on these issues; conflicting values are at stake; Americans
differ on the importance and meaning of particular traditions;
tolerance (agreeing to disagree) governs wide areas of our
national life; and given our historical traditions, we are
strongly inclined to leave to the individual conscience those
acts that do not harm others and on which there is no moral
consensus.
As a result, we must continue to build our understanding of
the widespread public concern that has been generated by these
recent developments. Some of this concern can be explained by
an inadequate understanding of the issues--sometimes even
confusing science and science fiction. This matter, however,
can be addressed over time through further public education.
Other concerns, however, run much deeper and range from the
implications for particular faith commitments, to views
regarding the appropriate sphere for human action, to concerns
regarding the future of the family, to cumulative apprehensions
about the real net benefit of a rapidly advancing technology
that some believe is too aggressively pushing aside important
social and moral values. As we move ahead to the next stage of
our national discussion, these are among the many issues that
need to be thoughtfully addressed.
Finally, while our specific recommendations include
continuing the moratorium you announced in February of this
year, and a call for a specific federal legislation, the report
also includes important sections outlining the scientific,
religious, ethical and legal issues that are raised by these
new scientific developments. It is our hope that these
materials, by clarifying certain issues and highlighting
others, will form a useful initial basis for the ongoing
deliberations and educational dialogues that we believe are so
essential. We have been impressed by the difficulties caused by
the lack of knowledge about genetics and the science involved
in cloning revealed in the public and media responses to the
cloning of Dolly the sheep. We believe, therefore, that the
federal government should continue to actively encourage public
education in this area of science so that as public
deliberation takes place it is as informed as possible.
I would like to take this opportunity to thank all the
Commissioners and our very dedicated staff for the intensity
and depth of their commitment to the task that you assigned to
us.
Sincerely,
Harold T. Shapiro
The White House
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Letter from the President
February 24, 1997
Dr. Harold Shapiro
Chair
National Bioethics Advisory Commission
Suite 3C01
6100 Executive Boulevard
Bethesda, Maryland 20892-7508
Dear Dr. Shapiro:
As you know, it was reported today that researchers have
developed techniques to clone sheep. This represents a
remarkable scientific discovery, but one that raises important
questions. While this technological advance could offer
potential benefits in such areas as medical research and
agriculture, it also raises serious ethical questions,
particularly with respect to the possible use of this
technology to clone human embryos.
Therefore, I request that the National Bioethics Advisory
Commission undertake a thorough review of the legal and ethical
issues associated with the use of this technology, and report
back to me within ninety days with recommendations on possible
federal actions to prevent its abuse.
Sincerely,
Bill Clinton
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NBAC Roster
National Bioethics Advisory Commission
Harold T. Shapiro, Ph.D. - Chair
President
Princeton University
Princeton, New Jersey
Executive Summary
The idea that humans might someday be cloned—created
from a single somatic cell without sexual
reproduction—moved further away from science fiction and
closer to a genuine scientific possibility on February 23,
1997. On that date, The Observer broke the news that Ian
Wilmut, a Scottish scientist, and his colleagues at the Roslin
Institute were about to announce the successful cloning of a
sheep by a new technique which had never before been fully
successful in mammals. The technique involved transplanting the
genetic material of an adult sheep, apparently obtained from a
differentiated somatic cell, into an egg from which the nucleus
had been removed. The resulting birth of the sheep, named
Dolly, on July 5, 1996, was different from prior attempts to
create identical offspring since Dolly contained the genetic
material of only one parent, and was, therefore, a "delayed"
genetic twin of a single adult sheep.
This cloning technique is an extension of research that had
been ongoing for over 40 years using nuclei derived from
non-human embryonic and fetal cells. The demonstration that
nuclei from cells derived from an adult animal could be
"reprogrammed," or that the full genetic complement of such a
cell could be reactivated well into the chronological life of
the cell, is what sets the results of this experiment apart
from prior work. In this report the technique, first described
by Wilmut, of nuclear transplantation using nuclei derived from
somatic cells other than those of an embryo or fetus is
referred to as "somatic cell nuclear transfer."
Within days of the published report of Dolly, President
Clinton instituted a ban on federal funding related to attempts
to clone human beings in this manner. In addition, the
President asked the recently appointed National Bioethics
Advisory Commission (NBAC) to address within ninety days the
ethical and legal issues that surround the subject of cloning
human beings. This provided a welcome opportunity for
initiating a thoughtful analysis of the many dimensions of the
issue, including a careful consideration of the potential risks
and benefits. It also presented an occasion to review the
current legal status of cloning and the potential
constitutional challenges that might be raised if new
legislation were enacted to restrict the creation of a child
through somatic cell nuclear transfer cloning.
The Commission began its discussions fully recognizing that
any effort in humans to transfer a somatic cell nucleus into an
enucleated egg involves the creation of an embryo, with the
apparent potential to be implanted in utero and developed to
term. Ethical concerns surrounding issues of embryo research
have recently received extensive analysis and deliberation in
the United States. Indeed, federal funding for human embryo
research is severely restricted, although there are few
restrictions on human embryo research carried out in the
private sector. Thus, under current law, the use of somatic
cell nuclear transfer to create an embryo solely for research
purposes is already restricted in cases involving federal
funds. There are, however, no current federal regulations on
the use of private funds for this purpose.
The unique prospect, vividly raised by Dolly, is the
creation of a new individual genetically identical to an
existing (or previously existing) person—a "delayed"
genetic twin. This prospect has been the source of the
overwhelming public concern about such cloning. While the
creation of embryos for research purposes alone always raises
serious ethical questions, the use of somatic cell nuclear
transfer to create embryos raises no new issues in this
respect. The unique and distinctive ethical issues raised by
the use of somatic cell nuclear transfer to create children
relate to, for example, serious safety concerns, individuality,
family integrity, and treating children as objects.
Consequently, the Commission focused its attention on the use
of such techniques for the purpose of creating an embryo which
would then be implanted in a woman's uterus and brought to
term. It also expanded its analysis of this particular issue to
encompass activities in both the public and private sector.
In its deliberations, NBAC reviewed the scientific
developments which preceded the Roslin announcement, as well as
those likely to follow in its path. It also considered the many
moral concerns raised by the possibility that this technique
could be used to clone human beings. Much of the initial
reaction to this possibility was negative. Careful assessment
of that response revealed fears about harms to the children who
may be created in this manner, particularly psychological harms
associated with a possibly diminished sense of individuality
and personal autonomy. Others expressed concern about a
degradation in the quality of parenting and family life.
In addition to concerns about specific harms to children,
people have frequently expressed fears that the widespread
practice of somatic cell nuclear transfer cloning would
undermine important social values by opening the door to a form
of eugenics or by tempting some to manipulate others as if they
were objects instead of persons. Arrayed against these concerns
are other important social values, such as protecting the
widest possible sphere of personal choice, particularly in
matters pertaining to procreation and child rearing,
maintaining privacy and the freedom of scientific inquiry, and
encouraging the possible development of new biomedical
breakthroughs.
To arrive at its recommendations concerning the use of
somatic cell nuclear transfer techniques to create children,
NBAC also examined long-standing religious traditions that
guide many citizens' responses to new technologies and found
that religious positions on human cloning are pluralistic in
their premises, modes of argument, and conclusions. Some
religious thinkers argue that the use of somatic cell nuclear
transfer cloning to create a child would be intrinsically
immoral and thus could never be morally justified. Other
religious thinkers contend that human cloning to create a child
could be morally justified under some circumstances, but hold
that it should be strictly regulated in order to prevent
abuses.
The public policies recommended with respect to the creation
of a child using somatic cell nuclear transfer reflect the
Commission's best judgments about both the ethics of attempting
such an experiment and its view of traditions regarding
limitations on individual actions in the name of the common
good. At present, the use of this technique to create a child
would be a premature experiment that would expose the fetus and
the developing child to unacceptable risks. This in itself
might be sufficient to justify a prohibition on cloning human
beings at this time, even if such efforts were to be
characterized as the exercise of a fundamental right to attempt
to procreate.
Beyond the issue of the safety of the procedure, however,
NBAC found that concerns relating to the potential
psychological harms to children and effects on the moral,
religious, and cultural values of society merited further
reflection and deliberation. Whether upon such further
deliberation our nation will conclude that the use of cloning
techniques to create children should be allowed or permanently
banned is, for the moment, an open question. Time is an ally in
this regard, allowing for the accrual of further data from
animal experimentation, enabling an assessment of the
prospective safety and efficacy of the procedure in humans, as
well as granting a period of fuller national debate on ethical
and social concerns. The Commission therefore concluded that
there should be imposed a period of time in which no attempt is
made to create a child using somatic cell nuclear
transfer.1
Within this overall framework the Commission came to the
following conclusions and recommendations:
- The Commission concludes that at this time it is morally
unacceptable for anyone in the public or private sector,
whether in a research or clinical setting, to attempt to
create a child using somatic cell nuclear transfer cloning.
The Commission reached a consensus on this point because
current scientific information indicates that this technique
is not safe to use in humans at this point. Indeed, the
Commission believes it would violate important ethical
obligations were clinicians or researchers to attempt to
create a child using these particular technologies, which are
likely to involve unacceptable risks to the fetus and/or
potential child. Moreover, in addition to safety concerns,
many other serious ethical concerns have been identified,
which require much more widespread and careful public
deliberation before this technology may be used.
The Commission, therefore, recommends the following for
immediate action:
- A continuation of the current moratorium on the use of
federal funding in support of any attempt to create a child
by somatic cell nuclear transfer.
- 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. Professional and scientific
societies should make clear that any attempt to create a
child by somatic cell nuclear transfer and implantation into
a woman's body would at this time be an irresponsible,
unethical, and unprofessional act.
The Commission further recommends that:
- 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
cloning. 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. If state legislation is enacted, it should also
contain such a sunset provision. Any such legislation or
associated regulation also ought to require that at some
point prior to the expiration of the sunset period, an
appropriate oversight body will evaluate and report on the
current status of somatic cell nuclear transfer technology
and on the ethical and social issues that its potential use
to create human beings would raise in light of public
understandings at that time.
The Commission also concludes that
- Any regulatory or legislative actions undertaken to
effect the foregoing prohibition on creating a child by
somatic cell nuclear transfer should be carefully written so
as not to interfere with other important areas of scientific
research. In particular, no new regulations are required
regarding the cloning of human DNA sequences and cell lines,
since neither activity raises the scientific and ethical
issues that arise from the attempt to create children through
somatic cell nuclear transfer, and these fields of research
have already provided important scientific and biomedical
advances. Likewise, research on cloning animals by somatic
cell nuclear transfer does not raise the issues implicated in
attempting to use this technique for human cloning, and its
continuation should only be subject to existing regulations
regarding the humane use of animals and review by
institution-based animal protection committees.
- If a legislative ban is not enacted, or if a legislative
ban is ever lifted, clinical use of somatic cell nuclear
transfer techniques to create a child should be preceded by
research trials that are governed by the twin protections of
independent review and informed consent, consistent with
existing norms of human subjects protection.
- The United States Government should cooperate with other
nations and international organizations to enforce any common
aspects of their respective policies on the cloning of human
beings.
The Commission also concludes that different ethical and
religious perspectives and traditions are divided on many of
the important moral issues that surround any attempt to create
a child using somatic cell nuclear transfer techniques.
Therefore, the Commission recommends that:
- The federal government, and all interested and concerned
parties, encourage widespread and continuing deliberation on
these issues in order to further our understanding of the
ethical and social implications of this technology and to
enable society to produce appropriate long-term policies
regarding this technology should the time come when present
concerns about safety have been addressed.
Finally, because scientific knowledge is essential for all
citizens to participate in a full and informed fashion in the
governance of our complex society, the Commission recommends
that:
- Federal departments and agencies concerned with science
should cooperate in seeking out and supporting opportunities
to provide information and education to the public in the
area of genetics, and on other developments in the biomedical
sciences, especially where these affect important cultural
practices, values, and beliefs.
Footnotes
Cite this page:
"Executive Summary of "Cloning Human Beings, June 1997""
Online Ethics Center for Engineering
7/25/2006
National Academy of Engineering
Accessed: Thursday, February 09, 2012
<www.onlineethics.org/Topics/RespResearch/ResResources/nbacindex/cindex.aspx>