bryos. National regulations vary from eternal preservation to 5-year and 10-year preservation limits (Moutel et al., 2002; Grubb, 1996).

In addition to excess blastocysts, there might be excess gametes—oocytes and sperm that have been collected for IVF procedures from the couples themselves or from donors—that are no longer needed for reproductive purposes. Women not seeking infertility treatments might elect to donate oocytes for research purposes as an adjunct to a clinical intervention (such as oophorectomy) or as a straightforward altruistic donation specifically for research.

A number of studies have shown that some couples are willing to donate unneeded blastocysts for research purposes—as many as 25 percent in some studies (Bangsboll et al., 2004; Burton and Sanders, 2004; Klock, 2004; McMahon et al., 2003). The attitudes of couples who have undergone IVF range from almost parental concern for the embryos to regarding them as medical byproducts with little relationship to a couple’s having a living child. Respondents positively disposed to donation commented on their desire not to waste blastocysts, a desire to help infertile couples, or a desire to advance scientific knowledge. Those with negative views commented on the embryo as a potential child and expressed concerns about a perceived lack of control over the type of research to be performed (McMahon et al. 2003).

Ethical principles dictate that potential donors of gametes or blastocysts for human embryonic stem cell (hES cell) research be able to make voluntary and informed choices about whether and how to donate their materials for research and that there be a clear option of “informed refusal,” that is, the right to preclude any research use of embryos. Because of concerns about possible coercion or exploitation of potential donors and controversy regarding the moral status of embryos, it is important that precautions be taken in recruiting donors and ensuring their informed voluntary consent. Some of the protections offered through existing federal regulations can be adapted for application to hES cell research, such as adherence to principles of informed consent and a requirement that an Institutional Review Board (IRB) review the consent process. In addition, Food and Drug Administration (FDA) regulations should be considered for some types of research, specifically if there is a need to retain identifying information about the donors. That has implications for the consent process and for plans to protect confidentiality and privacy of information. Because of privacy concerns, certain provisions of the Health Insurance Portability and Accountability Act (HIPAA) might also apply. (Those regulatory requirements were discussed in Chapter 4.)

In this chapter, the committee makes specific detailed recommendations for IRB review of procurement (as recommended in the previous chapter); for the consent processes for obtaining somatic cells, gametes, and blastocysts for use in hES cell research; and for storing and maintaining cell lines once derived. Important safeguards must be in place to ensure that materials are collected ethically and that, once obtained, they are used for scientifically meritorious research (see also Chapters 2 and 3) with the confidentiality of donors protected.

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