Sources of <!g>Stem Cells and Guidelines for Use
Securing stem cells for research, whether from
children, adults, aborted fetuses, or embryos, must be done under conditions of
the most rigorous integrity for several reasons. These are to protect the interests of the donors, to reassure the
public that important boundaries are not being overstepped, to enable those who
are ethically uncomfortable with elements of this research to participate to
the greatest extent possible, and to assure the highest quality of research and
As already noted, there are three
different types of stem cells, derived from three different sources. Obtaining the
first type, adult stem cells, presents no new ethical problems. Whether from adults or from children,
protection of donors comes under the heading of research with human subjects,
where adequate protection and regulation exist.
The second source is cells
derived from aborted fetuses. Research
with fetal tissue of all types is already ongoing in both the private and
public sectors. Current federal regulations
that clearly separate the womans decision to have an abortion from her
decision to donate tissuefrom the aborted <!g>fetus appear adequate to cover the situation of fetal stem
cells as well, because the issues are the same.
The third source,
pre-implantation embryos, requires the greatest care. Human <!g>embryonic stem cells should be derived from two
sources. The first are so-called
spare embryos, those remaining after a couple has completed their family or
for some other reason decided that they have no further use for their stored
embryos. The second are embryos that
are not of sufficient quality to be candidates for transfer to the uterus.
There are tremendous emotional,
social, marital and financial strains associated with <!g>infertility. A couple grappling with infertility has very
difficult decisions to make. Therefore
it is necessary to adhere to the highest standards of protection for persons
who are considering donation of their excess embryos for research purposes, with
special concern for the <!g>informed consent and voluntariness of their decision.
Persons create embryos through
<!g>in vitro fertilization with the intent of transferring one or more of them to
the uterus, the hoped for outcome being a successful pregnancy and a healthy
baby. Because the process of procuring
eggs for <!g>IVF presents some risks to a womans health, many women attempt to
produce as many eggs from one cycle as possible. Because eggs cannot be frozen but embryos can, persons using IVF
usually aim to produce a group of stored, frozen embryos to support as many
attempts at pregnancy as necessary to achieve their goals. Often, they end up with more embryos than
they need to use. Persons with excess
embryos have the option of donating them to other infertile couples, destroying
them, or donating them for research purposes.
Informed consent requires that
the woman or couple, with substantial understanding and without inappropriate
influences, authorize the use of their spare embryos for research. Because assisted reproduction is such a
stressful and usually drawn-out process, informed consent should be secured in
two stages. Like the model of organ
procurement protocols, the consent process should also maintain a separation
between personnel working with the woman or couple desiring to get pregnant and
personnel requesting embryos for stem cell research.
At the beginning of the
process, personnel working with the persons who hope to become pregnant should
find out their preferences about what they want done with any possible spare
embryos left over from the assisted reproduction process. Once a couple has definitely decided that it
has completed its family, or for some other reason has no more use for the
remaining embryos, then they should be approached a second time to secure an
explicit consent to use the embryos in stem cell research.
Consonant with existing norms
of good research practice, policies for securing embryos should include at least the following points:
should not undergo extra cycles of ovulation and retrieval in order to produce
more spare embryos in the hope that some of them might eventually be donated
with our current practice for organ donation, there should be a solid wall
between personnel working with the woman or couple who hope to become pregnant,
and personnel requesting embryos for stem cell purpose;
and men, as individuals or as couples, should not be paid to produce embryos,
nor should they receive reduced fees for their infertility procedures for doing
reasonable efforts should be made to obtain the consent of both <!g>gamete donors.
If these norms are adhered to,
the procurement of embryos for the derivation of stem cells does not raise
ethical problems which constitute a
bar to research.
in order to allow persons who hold diverse moral positions on the status of the
early embryo to participate in stem cell research to the greatest degree
possible, stem cells (and stem cell lines) should be identified with respect
to their provenance. Patients and
researchers should be able to avoid participating in stem cell use if the cells
were derived in a way that they would consider to be unethical. As a matter of good scientific practice,
records are routinely maintained on the sources of biological materials. It is of utmost importance that
documentation of the original source of the stem cells can be made readily
available to researchers and to potential recipients of stem cell therapies.
There are constraints with respect to the implementation of
these policies. Fertility clinics, the primary source for <!g>embryonic stem cells,
operate with virtually no federal oversight.
It is important that policies and procedures be in place and that
personnel be adequately trained so that donors are treated in an ethical
manner. If the private sector fails to
adopt appropriate measures, then the states or the federal government should
consider establishing guidelines.
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