The US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus. In 1997, the FDA reversed that guidance, advising investigators to include women in early phase drug research, a decision that reflected changing views about a woman’s ability to decide whether to participate in drug trials and furthering research on the effects of drugs on women.
In re Marriage of Witten, decided by the Iowa Supreme Court in 2003, held that neither Tamera nor Arthur (Trip) Witten could use or destroy several cryopreserved preembryos created during their marriage using in vitro fertilization (IVF), unless the former couple could reach a mutual agreement. Tamera and Trip Witten, unable to conceive conventionally during their marriage, had attempted to start a family together using IVF at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska. When Trip sought to dissolve the marriage in April 2002, following several unsuccessful IVF attempts, seventeen of their preembryos were in storage at UNMC. The former couple disagreed about what should happen to the preembryos and asked the court for a resolution as part of the marital dissolution action. The high court of Iowa’s decision to restrict both individuals from using the cryopreserved preembryos without the other person’s consent reflected a belief that Tamera and Trip shared equal decision-making authority over the preembryos.
The South Korean government passed the Bioethics and Biosafety Act, known henceforth as the Bioethics Act, in 2003 and it took effect in 2005. South Korea's Ministry of Health and Welfare proposed the law to the South Korean National Assembly to allow the progress of biotechnology and life sciences research in South Korea while protecting human research subjects with practices such as informed consent. The Bioethics Act establishes a National Bioethics Committee in Seoul, South Korea. The Bioethics Act is the first law in South Korea to regulate research on embryonic stem cells and in vitro fertilization. Most South Korean bioethical policies rely on this act and its provisions.
In Gonzales v. Carhart (2007), the US Supreme Court held in a five-to-four decision that the 2003 Partial-Birth Abortion Ban Act passed by the US Congress was constitutional. Although the Court previously ruled in Stenberg v. Carhart (2000) that a Nebraska law that prohibited partial-birth abortions was unconstitutional, Gonzales reversed this decision. Gonzales created the precedent that anyone who delivers and kills a living fetus could be subject to legal consequences, unless he or she performed the procedure to save the life of the mother.
In A.Z. v. B.Z. (2000), the Supreme Judicial Court of Massachusetts in Boston, Massachusetts, affirmed a lower courtÕs decision, ruling that contracts that require a party to become a parent against his or her will are unenforceable and contrary to public policy. The case centered around A.Z. and B.Z., a divorced couple who had previously used in vitro fertilization (IVF) to start a family together during their marriage and had several preembryos cryopreserved as part of the process. While undertaking IVF, the couple signed multiple consent forms requiring them to decide what should happen to the cryopreserved preembryos in the event of certain listed contingencies, such as death or separation of the couple. The couple indicated their preference that B.Z., A.Z.Õs now former wife, could use the cryopreserved preembryos if the couple later separated. When their relationship deteriorated, however, A.Z. objected to B.Z.Õs attempt to have additional children using the preembryos, leading to a lengthy legal battle. The court case A.Z. v. B.Z. established Massachusetts public policy that people should not be forced to become a parent against their will, even if they previously agreed to provide their genetic material for reproduction.
The Uniform Anatomical Gift Act (UAGA or the Act) was passed in the US in 1968 and has since been revised in 1987 and in 2006. The Act sets a regulatory framework for the donation of organs, tissues, and other human body parts in the US. The UAGA helps regulate body donations to science, medicine, and education. The Act has been consulted in discussions about abortion , fetal tissue transplants , and Body Worlds , an anatomy exhibition. The 1968 UAGA set a legislative precedent for the donation of fetal organs and tissues and has been in the background of many debates regarding abortion and fetal tissue research.
In the 2008 court case In the Matter of the Marriage of Dahl and Angle, the Court of Appeals of Oregon upheld a written in vitro fertilization (IVF) consent form signed by Laura and Darrell Angle, who had each contributed their genetic material to the creation of several preembryos during their marriage. Its decision followed the general framework for resolving such disputes provided by the Supreme Court of Tennessee in Davis v. Davis in 1992, which was subsequently followed by many courts across the US. The decision by the Court of Appeals of Oregon reinforced the idea that agreements that reflect the couple's intent at the time of undertaking IVF should be upheld, regardless of a later change of heart.
On 9 July 1990, in Moore v. Regents of the University of California, the Supreme Court of California ruled in a four-to-three decision that individuals do not have rights to a share in profits earned from research performed on their bodily materials. In its decision, the Supreme Court of California ruled that cancer patient John L. Moore did not have personal property rights to samples or fluids that his physicians took from his body for research purposes. Moore created the precedent in California that although physicians are required to disclose their research interests to their patients, patients do not have property-related claims to any samples that their physicians take from their body. The Supreme Court of California’s decision in Moore v. Regents of the University of California enabled physicians and researchers to retain legal ownership on samples taken from their patients’ bodies so that they can conduct what the court describes as socially important medical research, such as work on reproductive cancers or developmental disorders.
The Assisted Human Reproduction Act (AHR Act) is a piece of federal legislation passed by the Parliament of Canada. The Act came into force on 29 March 2004. Many sections of the Act were struck down following a 2010 Supreme Court of Canada ruling on its constitutionality. The AHR Act sets a legislative and regulatory framework for the use of reproductive technologies such as in vitro fertilization and related services including surrogacy and gamete donation. The Act also regulates research in Canada involving in vitro embryos. The AHR Act was the first law in Canada to regulate the use of reproductive technologies and related research. Most other Canadian policies on AHR rely on the Act and its provisions. By 2015, Canada was one of only a few countries worldwide to comprehensively address assisted human reproduction through policy.