From: White, Ryan (ryan@dvelco.com)
Date: Sat Jul 29 2000 - 17:27:52 MDT
http://bioethics.gov/pubs.html#form
Cloning Human Beings, June 1997
Executive Summary
Volume I. Report and Recommendations
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:
I. 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.
II. 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.
III. 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.
IV. 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.
V. 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.
Note:
1 The Commission also observes that the use of any other technique to create
a child genetically identical to an existing (or previously existing)
individual would raise many, if not all, of the same non-safety-related
ethical concerns raised by the creation of a child by somatic cell nuclear
transfer.
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