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This couple simply wants a healthy donor, but yesterday you had a couple who wanted to match the wife as closely as possible. They wanted their donor to be tall, blue-eyed and brunette, excellent at sports and "with musical ability." Though you were somewhat disturbed by their focus on certain traits (and worried they were setting themselves up for disappointment), you felt that it was ultimately their decision.
Your next appointment is more complicated. A 44-year-old mother of two adult children has remarried and wants to have a child with her new husband. They have not succeeded with in vitro fertilization (IVF) because the woman's eggs are not viable due to her age, and they would like to enlist the help of an egg donor. Because she would like a child that is genetically related to both her and her new husband, the woman wants her 20-year-old daughter to be the donor. The daughter has agreed, but you wonder whether she feels undue pressure to please her mother.
Later that day, you get a call from a 62-year-old single man. He has always wanted a family, but his wife died of cancer before they had a chance to try. Now that the technology is available, he would like to do it alone. He asks you to help him find a woman who would be willing to be impregnated with his sperm in combination with her own or a donated egg, and to carry and deliver his child. He is financially secure, has a close extended family and seems sincere in his desire to have a child.
Your last appointment is with a lesbian couple. They have been trying to conceive through artificial insemination with donor sperm for several years. Now they want to try IVF, and ask if both of them can play a role. In other words, one wants to provide the eggs and the other wants to carry any children conceived with those eggs and donor sperm.
All but the 62-year-old man (who could presumably find another mate) need medical help to conceive a child. Medical intervention also enables the couples to pursue alternative family structures, and you will play a central role in building those. Who among these patients are you willing to treat?
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| Should you and your colleagues be the gatekeepers of what kinds of families there should be? Do you think fertility specialists should have freedom in choosing which family structures they help come into existence? |
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| Context |
| The regulation of assisted reproductive technologies poses some quandaries. For example, we assume that the man and woman who have a one-night stand are the legal parents of any resulting child regardless of "intention." In fact, many children are born whose parents were trying not to have a child. Women may be criticized for getting pregnant to "catch" a man, but regulations do not prevent them from doing so. There are many reasons to have children, and we regulate none of those where heterosexual sex is involved.
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| Look Deeper |
| The patchwork of regulations addressing assisted reproductive technology (ART) provides little consistency or uniformity. Protection for individuals seeking to use ART begins with the federal constitutional right of privacy and reproductive choice, most recently affirmed in Planned Parenthood v. Casey (1992), where the Supreme Court "recognized protection accorded to liberty relating to intimate relationships, the family, and decisions about whether to bear and beget a child." At this time there is no federal regulation providing for a uniform system of health, safety and consumer protections for ART. However, the federal government is beginning to address the complicated issues of ART through guidelines issued by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), creating a national standard for screening ART donors.
Many states are also slowly filling this gap. For example, 42 states have laws regarding artificial insemination. Eleven states have enacted laws addressing egg donors. Many require that testing for diseases such as HIV be performed. About half the states and the District of Columbia have enacted laws or follow case law that addresses the practice of surrogacy. And to protect consumers and physicians, many states require printed disclosures of ART program success rates, as does the federal Fertility Clinic Success Rate and Certification Act. In addition, voluntary organizations such as the American Society for Reproductive Medicine (ASRM) have established guidelines to guide physician practice in this area.
The ASRM is the main professional body in the field of ART, with more than 8,500 members in over 100 countries. The ASRM has issued a set of medical as well as ethical guidelines for the use of ART, and while the guidelines are not binding, they represent the core of American ART policies and practices. ASRM members must adhere to these guidelines or risk being expelled from the organization. The Society for Assisted Reproductive Technology (SART), an affiliate of ASRM whose membership includes approximately 95% of fertility clinics, has strict membership requirements. As a condition of membership, clinics must report their outcome data to the CDC, have accredited embryology laboratories, adhere to the Ethics and Practice Committee Guidelines of the ASRM and have appropriately trained staff.
Additional self-regulation includes:
Board certification in reproductive endocrinology and infertility by the American Board of Obstetrics and Gynecology and an accreditation program for embryology laboratories developed by the College of American Pathologists and the American Society for Reproductive Medicine (ASRM).
As new technologies have become available, the ASRM has added to its basic guidelines for ART with further statements on the following:
- Donating spare embryos for research
- HIV
- Sex selection
- Cloning
- Paying donors
- Informed consent
- Disposition of unused embryos
- Egg donation for older women
- Embryo splitting
- Posthumous reproduction
Government regulations that relate to ART include:
- The Fertility Clinic Success Rate and Certification Act (FCSRCA), which calls on the CDC to develop model standards for embryology laboratory accreditation
- The Clinical Laboratory Improvement Act of 1988, which covers lab tests (such as semen and blood analysis) used in the diagnosis of infertility
- An FDA three-part rule on human cells, tissues and cellular and tissue-based products, which will include regulations pertaining to reproductive cells and tissues
- The American Association of Tissue Banks, a voluntary scientific peer group that issues guidelines and carries out programs of inspection and accreditation of tissue banking organizations and personnel
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| "None of us were trained to think of ourselves as gatekeepers." |
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Assisted reproductive technology (ART) has developed largely outside regulation. ART is regulated by the government insofar as medicine is regulated. For instance, all physicians—including those providing ART—must be licensed to practice in their states, where state medical boards determine licensing requirements. However, these licenses are not specific to any particular medical specialty. In addition, the Food and Drug Administration (FDA) must approve drugs and devices, but a licensed physician is free to prescribe any FDA-approved drug for any reason. In 1992, Congress passed the Fertility Clinic Success Rate and Certification Act, one of the few laws explicitly regulating ART. Implemented by the Centers for Disease Control and Prevention (CDC), this law requires clinics to collect and make public the outcome of their treatments. The CDC publishes an annual report with data detailing and summarizing infertility procedures and their success rates.
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