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Title 1, Subtitle B, Parts I, II, and III of the “National Institutes of Health Revitalization Act of 1993” (1993)
In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm.
Moore v. Regents of the University of California (1990)
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.
“Reproductive Injustice: Racial and Gender Discrimination in U.S. Healthcare” (2014), by the Center for Reproductive Rights, the National Latina Institute for Reproductive Health, and SisterSong Women of Color Reproductive Justice Collective
In 2014, the Center for Reproductive Rights, SisterSong Women of Color Reproductive Justice Collective, and the National Latina Institute for Reproductive Health released a co-authored report titled “Reproductive Injustice: Racial and Gender Discrimination in U.S. Healthcare,” hereafter “Reproductive Injustice.” In “Reproductive Injustice,” the organizations evaluate trends in the US federal system concerning racial and gender discrimination in sexual and reproductive healthcare.
Subject: Publications, Organizations, Outreach, Legal
United States v. University Hospital (1984)
The US 2nd Circuit Court of Appeals' 1984 decision United States v. University Hospital, State University Hospital of New York at Stony Brook set a significant precedent for affirming parental privilege to make medical decisions for handicapped newborns, while limiting the ability of the federal government to intervene. The ruling stemmed from the 1983 case involving an infant born with severe physical and mental congenital defects; the infant was only identified as Baby Jane Doe.
Subject: Legal, Reproduction
"Ethical Issues in Human Stem Cell Research: Executive Summary" (1999), by the US National Bioethics Advisory Commission
Ethical Issues in Human Stem Cell Research: Executive Summary was published in September 1999 by The US National Bioethics Advisory Commission in response to a national debate about whether or not the US federal government should fund embryonic stem cell research. Ethical Issues in Human Stem Cell Research recommended policy to US President William Clinton's administration, which advocated for federal spending on the use of stem research on stem cells that came from embryos left over from in vitro fertilization (IVF) fertility treatments.
Nightlight Christian Adoptions, et al. v. Thompson, et al. (2001)
Nightlight Christian Adoptions et al. v. Thompson et al. was a lawsuit filed in the United States District Court for the District of Columbia on 8 March 2001. The suit was filed because Nightlight Christian Adoptions, a frozen embryo adoption agency, felt that the Guidelines for Research Using Human Pluripotent Stem Cells published by the National Institutes for Health were unlawful and violated the restrictions on human embryo research put into place by the Dickey-Wicker Amendment. Additional plaintiffs with this suit were the Christian Medical Association, adult stem cell researcher Dr.
Subject: Legal, Reproduction
South Korea's Bioethics and Biosafety Act (2005)
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.
Hwang Woo-suk's Use of Human Eggs for Research 2002-2005
Hwang Woo-suk, a geneticist in South Korea, claimed in Science magazine in 2004 and 2005 that he and a team of researchers had for the first time cloned a human embryo and that they had derived eleven stem cell lines from it. Hwang was a professor at Seoul National University in Seoul, South Korea. In the Science articles, Hwang stated that all of the women who donated eggs to his laboratory were volunteers who donated their eggs (oocytes) without receiving any compensation in return. In 2006, Hwang admitted that many of the results were fabricated.
Subject: Legal, Ethics, Reproduction
Frazer v. Schlegel (2007)
On 20 August 2007, in Frazer v. Schlegel, the United States Court of Appeals for the Federal Circuit decided that researchers Ian Frazer and Jian Zhou owned the rights to the vaccine patent for Human Papillomavirus, or HPV, instead of a research team led by Richard Schlegel. Frazer v. Schlegel reversed the decision that the Board of Patent Appeals and Interferences had previously made, awarding the patent to Schlegel on the basis that Frazer’s patent application contained inaccurate science.
Subject: Legal, Technologies
Sheppard-Towner Maternity and Infancy Protection Act (1921)
In November 1921, US Congress passed the National Maternity and Infancy Protection Act, also called the Sheppard-Towner Act. The Act provided federal funds to states to establish programs to educate people about prenatal health and infant welfare. Advocates argued that it would curb the high infant mortality rate in the US.
The Singapore Bioethics Advisory Committee
Established in tandem with Singapore's national Biomedical Sciences Initiatives, the Bioethics Advisory Committee (BAC) was established by the Singapore Cabinet in December 2000 to examine the potential ethical, legal, and social issues arising from Singapore's biomedical research sector, and to recommend policy to Singapore's government.
Subject: Organizations, Ethics, Legal
Thomson, et al. v. Thompson, et al. (2001)
Thomson, et al. v. Thompson, et al. was a lawsuit filed in the United States District Court for the District of Columbia on 8 May 2001 as Civil Action Number 01-CV-0973. This lawsuit was filed in hopes of gaining injunctive relief against a moratorium on the federal funding of stem cell research. The plaintiffs in the case were seven prominent scientists who performed embryonic stem cell research and three patients: James Thomson, Roger Pedersen, John Gearhart, Douglas Melton, Dan Kaufman, Alan Trounson, Martin Pera, Christopher Reeve, James Cordy, and James Tyree.
China's One-Child Policy
In September 1979, China's Fifth National People's Congress passed a policy that encouraged one-child families. Following this decision from the Chinese Communist Party (CCP), campaigns were initiated to implement the One-Child Policy nationwide. This initiative constituted the most massive governmental attempt to control human fertility and reproduction in human history. These campaigns prioritized reproductive technologies for contraception, abortion, and sterilization in gynecological and obstetric medicine, while downplaying technologies related to fertility treatment.
Subject: Ethics, Legal, Reproduction
“Improving Women’s Health”: Section 3509 of the Affordable Care Act of 2010
In 2010, US Congress enacted section 3509 of the Patient Protection and Affordable Care Act or ACA, to target issues relating to women’s health. The ACA, signed into law by US President Barack Obama, aimed to increase people’s access to high-quality healthcare in the United States.
Barry Morris Goldwater (1909–1998)
Barry Morris Goldwater was a Republican Arizona Senator and US presidential candidate in the twentieth-century whose policies supported the women's reproductive rights movement. Goldwater, a businessman and Air Force reservist, transitioned into politics in the 1950s. He helped align popular support for a conservative Republican Party in the 1960s. Throughout his life, he worked to maintain personal liberty and to limit governmental intrusion into citizens' private lives. Goldwater, influenced by his wife Margaret (Peggy) Goldwater, supported women's rights to abortions.
Subject: People, Reproduction, Legal, Religion
Bailey v. Blue Cross Blue Shield of Virginia (1994)
In 1994, the Eastern Virginia District court case Bailey v. Blue Cross Blue Shield of Virginia established that insurance companies could not deny coverage for experimental stem cell therapy treatments. The plaintiff, Mary Bailey, was diagnosed with advanced stage breast cancer and sought treatment involving high-dose chemotherapy and an advanced stem cell treatment, which was a novelty at the time. Stem cells are cells that have the potential to develop into several different types of cells in the body.
US Regulatory Response to Thalidomide (1950-2000)
Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution.
Subject: Legal, Reproduction
The Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984), by Mary Warnock and the Committee of Inquiry into Human Fertilisation and Embryology
The Report of the Committee of Inquiry
into Human Fertilisation and Embryology, commonly called the Warnock
Report after the chair of the committee Mary Warnock, is the 1984
publication of a UK governmental inquiry into the social impacts of
infertility treatment and embryological research. The birth of Louise
Brown in 1978 in Oldham, UK, sparked debate about reproductive and
embryological technologies. Brown was conceived through in vitro
fertilization (IVF), a process of fertilization that occurs outside of
Subject: Publications, Legal, Ethics
Ferguson v. City of Charleston (2001)
The US Supreme Court case Ferguson v. City of Charleston (2001) established that public hospitals couldn't legally drug test pregnant women without their consent when those women sought prenatal care at those hospitals. The court held that such searches violated the pregnant women's protections under the Fourth Amendment to the US Constitution. The decisions also indicated those circumstances that qualified as special needs exceptions to the Fourth Amendment, and it highlighted the extent to which pregnant women are sovereign individuals in the eyes of the Court. Ferguson v.
Roe v. Wade (1973)
In the 1973 case of Roe v. Wade, the US Supreme Court ruled that laws banning abortion violated the US Constitution. The Texas abortion laws, articles 1191–1194, and 1196 of the Texas penal code, made abortion illegal and criminalized those who performed or facilitated the procedure. Prior to Roe v. Wade, most states heavily regulated or banned abortions. The US Supreme Court decision in Roe v. Wade secured women's rights to terminate pregnancies for any reasons within the first trimester of pregnancy.
Subject: Legal, Reproduction
Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993)
In its 1993 decision Daubert v. Merrell Dow Pharmaceuticals, Inc., the US Supreme Court established the Daubert Standard for evaluating the admissibility of scientific knowledge as evidence in US federal courts. When it began in trial court, the case addressed whether or not Bendectin, an anti-nausea medication taken during pregnancy, caused birth defects. However, after the trial court dismissed the case for lack of admissible evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc.
Golden Rice was engineered from normal rice by Ingo Potrykus and Peter Beyer in the 1990s to help improve human health. Golden Rice has an engineered multi-gene biochemical pathway in its genome. This pathway produces beta-carotene, a molecule that becomes vitamin A when metabolized by humans. Ingo Potrykus worked at the Swiss Federal Institute of Technology in Zurich, Switzerland, and Peter Beyer worked at University of Freiburg, in Freiburg, Germany. The US Rockefeller Foundation supported their collaboration.
Americans with Disabilities Act (1990)
In 1990, the United States Congress passed the Americans with Disabilities Act, or the ADA, which prohibits discrimination against people with disabilities by employers, governments, or public accommodations. Following gains made during the civil rights movements of the 1900s, people with disabilities sought similar anti-discrimination legislation. The ADA was the culmination of decades of protest and advocacy from the disability rights movement. After the ADA, federal law protected people with an impairment that limited major life functions like sight or mobility from discrimination.
Subject: Disorders, Organizations, Legal
45 CFR 46: Protection of Human Subjects under United States Law (1974)
In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. 45 CFR 46 created a common federal policy for the protection of such human subjects that was accepted by the Office of Science and Technology Policy and issued by each of the departments and agencies listed in the document.
Barack Obama Executive Order 13505, November 2008
On 20 November 2009 Democrat Barack Obama replaced Republican George W. Bush as president of the United States. Obama soon initiated changes to Bush's 2001 executive order concerning scientific research involving human stem cells. Stem cell research remains a controversial issue in the US. Some individuals consider it immoral to experiment with an embryo because they regard embryos as human beings from the moment of conception, while others believe stem cell research could lead to great scientific advancements.