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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 outcomes.

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 woman’s decision to have an abortion from her decision to donate tissuePublic Health Service Act (42 U.S.C. 289) Section 498A.from 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 woman’s 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:

  1. Women 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 for research;

  2. Analogous 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;

  3. Women 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 so;

  4. All 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 addition, 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.One model for this would be the recently established program to certify laboratories that provide assisted reproduction services. This program, initiated by the federal government, but up to the states...

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