Ethical Issues in Stem Cell Research

Abstract:

Stem cell research offers great promise for understanding basic mechanisms of human development
and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord
injury, Parkinson’s disease, and myocardial infarction. However, human stem cell (hSC) research also
raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from
oocytes and embryos is fraught with disputes about the onset of human personhood. The
reprogramming of somatic cells to produce induced pluripotent stem cells avoids the ethical
problems specific to embryonic stem cell research. In any hSC research, however, difficult dilemmas
arise regarding sensitive downstream research, consent to donate materials for hSC research, early
clinical trials of hSC therapies, and oversight of hSC research. These ethical and policy issues need to
be discussed along with scientific challenges to ensure that stem cell research is carried out in an
ethically appropriate manner. This article provides a critical analysis of these issues and how they are
addressed in current policies.

Introduction

STEM CELL RESEARCH offers great promise for understanding basic mechanisms of human
development and differentiation, as well as the hope for new treatments for diseases such as
diabetes, spinal cord injury, Parkinson’s disease, and myocardial infarction (1). Pluripotent stem cells
perpetuate themselves in culture and can differentiate into all types of specialized cells. Scientists
plan to differentiate pluripotent cells into specialized cells that could be used for transplantation.

However, human stem cell (hSC) research also raises sharp ethical and political controversies. The
derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes regarding
the onset of human personhood and human reproduction. Several other methods of deriving stem
cells raise fewer ethical concerns. The reprogramming of somatic cells to produce induced
pluripotent stem cells (iPS cells) avoids the ethical problems specific to embryonic stem cells. With
any hSC research, however, there are difficult dilemmas, including consent to donate materials for
hSC research, early clinical trials of hSC therapies, and oversight of hSC research (2). Table 11
summarizes the ethical issues that arise at different phases of stem cell research.

Multipotent stem cells

Adult stem cells and cord blood stem cells do not raise special ethical concerns and are widely used
in research and clinical care. However, these cells cannot be expanded in vitro and have not been
definitively shown to be pluripotent.

A. Cord blood stem cells

Hematopoietic stem cells from cord blood can be banked and are widely used for allogenic and
autologous stem cell transplantation in pediatric hematological diseases as an alternative to bone
marrow transplantation.

B. Adult blood stem cells

Adult stem cells can be isolated through plasmapheresis. They are already used to treat
hematological malignancies and to modify the side effects of cancer chemotherapy. Furthermore,
autologous stem cells are being used in clinical trials in patients who have suffered myocardial
infarction. Their use in several other conditions has not been validated or is experimental, despite
some claims to the contrary (3).

Embryonic Stem Cell Research

Pluripotent stem cell lines can be derived from the inner cell mass of the 5- to 7-d-old
blastocyst. However, human embryonic stem cell (hESC) research is ethically and politically
controversial because it involves the destruction of human embryos. In the United States, the
question of when human life begins has been highly controversial and closely linked to
debates over abortion. It is not disputed that embryos have the potential to become human
beings; if implanted into a woman’s uterus at the appropriate hormonal phase, an embryo
could implant, develop into a fetus, and become a live-born child.
Some people, however, believe that an embryo is a person with the same moral status as an
adult or a live-born child. As a matter of religious faith and moral conviction, they believe
that “human life begins at conception” and that an embryo is therefore a person. According to
this view, an embryo has interests and rights that must be respected. From this perspective,
taking a blastocyst and removing the inner cell mass to derive an embryonic stem cell line is
tantamount to murder (4).
Many other people have a different view of the moral status of the embryo, for example that
the embryo becomes a person in a moral sense at a later stage of development than
fertilization. Few people, however, believe that the embryo or blastocyst is just a clump of
cells that can be used for research without restriction. Many hold a middle ground that the
early embryo deserves special respect as a potential human being but that it is acceptable to
use it for certain types of research provided there is good scientific justification, careful
oversight, and informed consent from the woman or couple for donating the embryo for
research (5).
Opposition to hESC research is often associated with opposition to abortion and with the
“pro-life” movement. However, such opposition to stem cell research is not monolithic. A
number of pro-life leaders support stem cell research using frozen embryos that remain after a
woman or couple has completed infertility treatment and that they have decided not to give to
another couple. This view is held, for example, by former First Lady Nancy Reagan and by
U.S. Senator Orrin Hatch.
On his Senate website, Sen. Hatch states: “The support of embryonic stem cell research is
consistent with pro-life, pro-family values.
“I believe that human life begins in the womb, not a Petri dish or refrigerator … . To me, the
morality of the situation dictates that these embryos, which are routinely discarded, be used to
improve and save lives. The tragedy would be in not using these embryos to save lives when
the alternative is that they would be discarded” (6).
A. Existing embryonic stem cell lines

In 2001, President Bush, who holds strong pro-life views, allowed federal National Institutes of
Health (NIH) funding for stem cell research using embryonic stem cell lines already in existence at
the time, while prohibiting NIH funding for the derivation or use of additional embryonic stem cell
lines. This policy was a response to a growing sense that hESC research held great promise for
understanding and treating degenerative diseases, while still opposing further destruction of human
embryos. NIH funding was viewed by many researchers as essential for attracting scientists to make
a long-term commitment to study the basic biology of stem cells; without a strong basic science
platform, therapeutic breakthroughs would be less likely.

President Bush’s rationale for this policy was that the embryos from which these lines were
produced had already been destroyed. Allowing research to be carried out on the stem cell lines
might allow some good to come out of their destruction. However, using only existing embryonic
stem cell lines is scientifically problematic. Originally, the NIH announced that over 60 hESC lines
would be acceptable for NIH funding. However, the majority of these lines were not suitable for
research; for example, they were not truly pluripotent, had become contaminated, or were not
available for shipping. As of January 2009, 22 hESC lines are eligible for NIH funding. However, these
lines may not be safe for transplantation into humans, and long-standing lines have been shown to
accumulate mutations, including several known to predispose to cancer. In addition, concerns have
been raised about the consent process for the derivation of some of these NIH-approved lines (7).
The vast majority of scientific experts, including the Director of the NIH under President Bush,
believe that a lack of access to new embryonic stem cell lines hinders progress toward stem cell-
based transplantation (8). For example, lines from a wider range of donors would allow more
patients to receive human leukocyte agent matched stem cell transplants (9).

Currently, federal funds may not be used to derive new embryonic stem cell lines or to work with
hESC lines not on the approved NIH list. NIH-funded equipment and laboratory space may not be
used for research on nonapproved hESC lines. Both the derivation of new hESC lines and research
with hESC lines not approved by NIH may be carried out under nonfederal funding. Because of these
restrictions on NIH funding, a number of states have established programs to fund stem cell
research, including the derivation of new embryonic stem cell lines. California, for example, has
allocated $3 billion over 10 yr to stem cell research.

Under President Obama, it is expected that federal funding will be made available to carry out
research with hESC lines not on the NIH list and to derive new hESC lines from frozen embryos
donated for research after a woman or couple using in vitro fertilization (IVF) has determined they
are no longer needed for reproductive purposes. However, federal funding may not be permitted for
creation of embryos expressly for research or for derivation of stem cell lines using somatic cell
nuclear transfer (SCNT) (10,11).
B. New embryonic stem cell lines from frozen embryos

Women and couples who undergo infertility treatment often have frozen embryos remaining after
they complete their infertility treatment. The disposition of these frozen embryos is often a difficult
decision for them to make (12). Some choose to donate these remaining embryos to research rather
than giving them to another couple for reproductive purposes or destroying them. Several ethical
concerns come into play when a frozen embryo is donated, including informed consent from the
woman or couple donating the embryo, consent from gamete donors involved in the creation of the
embryo, and the confidentiality of donor information.