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Oversight of Assisted Reproductive Technologies The Last Twenty Years C H A P T E R T H R E E Assisted reproductive technologies (ARTs) refer to in vitro fertilization (IVF) and its variations, such as embryo freezing, gamete and embryo donation , intracytoplasmic sperm injection (ICSI), and preimplantation genetic diagnosis (PGD). Oversight falls into two general and sometimes overlapping categories. In public oversight, governmental officials weigh the scientific, legal, societal, and ethical dimensions of ARTs to craft rules and regulations enforceable by the government. In private oversight, professionals in the private sector weigh similar dimensions to develop voluntary guidelines for the application of new technologies. For the purposes of this chapter, four groups of public and private policymakers are identified: the U.S. Congress, state legislatures , the Food and Drug Administration (FDA), and professional societies. Oversight of ARTs extends beyond the practice of ARTs in fertility clinics to include developments arising before and after clinical practice. As such, this chapter divides ART development and practice into three stages: innovation, clinical practice, and assessment. The first, innovation, involves the process by which prospective ART procedures move from the preclinical setting, where animal or human cells and tissues are studied, to the clinical setting, where procedures are used with small and later larger numbers of patients. For example, ICSI was introduced clinically without systematic experiments using animal models (Leese and Whittall 2001; Powell 2003). Although ICSI has come to be generally regarded as safe and effective, its nearly serendipitous first use has raised concerns about the premature use of ARTs and the prospect A N D R E A L . B O N N I C K S E N of experimentation taking place in the clinic rather than the laboratory. Some oversight issues thus address the adequacy of criteria and guidelines for determining when it is appropriate to offer ARTs to patients. The use of ARTs in the clinical setting comprises a second stage of oversight . One aspect of oversight at this stage is the scientific concern for quality control, which mirrors oversight of the practice of medicine generally. A second aspect involves questions geared to the ethics of ART practices. For example , if egg donation is safe and efficacious for recipients and offspring and is performed under rigorous quality control, questions still arise about the ethics of the practice, such as what level of compensation is appropriate for egg donors and what information must be conveyed to the donor for her to make an informed decision about proceeding. A third stage of ART development and practice involves assessment. Here, short- and long-term data collection and analysis allow ARTs to be monitored over time for safety and efficacy. The Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA) has facilitated collection of pregnancy success rates and other data by professional associations. Although FCSRCA’s primary purpose is to inform patients who are deciding whether to try ARTs and where, the data can also be used to assess the frequency and outcomes of reproductive technologies. Other data gathering is conducted by researchers who conduct controlled studies for analysis and publication in professional journals. In reviewing the forms and conduct of oversight over the past twenty years in this chapter, I use these three stages as an organizing device to suggest ways in which the nature of oversight varies across stages and among groups of policymakers . This approach helps to identify areas of oversight that are carefully covered by existing regulatory mechanisms and those that are less fully covered . Moreover, the historical oversight patterns in ART yield some implications for future reprogenetic technologies, which I take up at the end of the chapter. U.S. CONGRESS When one thinks of policymaking, it is natural to look to the U.S. Congress. As the nation’s central legislative body, Congress is a potential location for constructing a uniform approach to issues of public interest such as ART oversight . Yet the past twenty years of ART oversight reveal a distinctly different pattern. Divisive politics relating to abortion and fundamentally different views about the moral status of the human embryo have contributed to a ConO V E R S I G H T O F A S S I S T E D R E P R O D U C T I V E T E C H N O L O G I E S 6 5 [18.216.94.152] Project MUSE (2024-04-19 21...

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