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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.
Format: Articles
Subject: Legal
In the Matter of the Marriage of Dahl and Angle (2008)
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.
Format: Articles
Subject: Legal
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.
Format: Articles
Gonzales v. Carhart (2007)
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.
Format: Articles
Subject: Legal, Reproduction
Woman’s Right to Know Act in Texas (2003)
In 2003, the Texas state legislature passed the Woman’s Right to Know Act, hereafter the Act, as Chapter 171 of the state’s Health and Safety Code. The Act sets requirements that physicians must follow during the informed consent process for abortion, or a medical procedure to terminate pregnancy, in Texas. Lawmakers amended the Act and added several additional regulations that restrict access to abortion in 2011, 2013, 2015, and 2017.
Format: Articles
Subject: Legal
Litowitz v. Litowitz (2002)
In a dispute over the allocation of cryopreserved preembryos, the Supreme Court of Washington resolved the case of David J. Litowitz v. Becky M. Litowitz (2002) by reaching a decision that neither party wanted. David Litowitz sought to find adoptive parents for two cryopreserved preembryos created during his marriage to Becky Litowitz when the couple was attempting to have children using in vitro fertilization (IVF). Becky sought to implant the preembryos in a surrogate in an effort to parent a child.
Format: Articles
Subject: 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.
Format: Articles
Subject: Legal, Reproduction
Social Implications of Non-Invasive Blood Tests to Determine the Sex of Fetuses
By 2011, researchers in the US had established that non-invasive blood tests can accurately determine the gender of a human fetus as early as seven weeks after fertilization. Experts predicted that this ability may encourage the use of prenatal sex screening tests by women interested to know the gender of their fetuses. As more people begin to use non-invasive blood tests that accurately determine the sex of the fetus at 7 weeks, many ethical questions pertaining to regulation, the consequences of gender-imbalanced societies, and altered meanings of the parent-child relationship.
Format: Articles
Subject: Reproduction, Ethics, Legal
"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.
Format: Articles
Planned Parenthood Center of Tucson, Inc., v. Marks (1972)
In the 1972 case Planned Parenthood Center of Tucson, Inc., v. Marks, the Arizona Court of Appeals required the Arizona Superior Court to rehear the case Planned Parenthood Association v. Nelson (1971) and issue a decision on the constitutionality of Arizona's abortion laws. In 1971, the Planned Parenthood Center of Tucson filed the case Planned Parenthood Association v. Nelson asking for the US District Court to rule on the constitutionality of the Arizona Revised Statutes 13-211, 13-212, and 13-213, which made it illegal for anyone to advertise, provide, or receive an abortion.
Format: Articles
Subject: Legal
Simat Corp v. Arizona Health Care Cost Containment System (2002)
In the 2002 case Simat Corp v. Arizona Health Care Containment System, the Arizona Supreme Court ruled that the Arizona Health Care Containment System must pay for abortions when they are necessary to preserve the health of pregnant women in the system. In the case, the Court ruled that the Arizona Revised Statutes 35-196.02 and the Arizona Health Care Containment System (AHCCCS) policies, which banned public funds from being used for abortions, were unconstitutional. AHCCCS is Arizona's Medicaid insurance system, which enables low-income residents to receive medical care.
Format: Articles
Subject: Legal
Gonzales v. Planned Parenthood Federation of America, Inc. (2007)
Gonzales v. Planned Parenthood Federation of America, Inc. (Gonzales v. Planned Parenthood) was the 2007 US Supreme Court case in which the Court declared the Partial Birth Abortion Ban Act of 2003 constitutional, making partial birth abortions illegal. In 2003, the US Congress passed the Partial-Birth Abortion Ban Act, which prohibited an abortion technique called partial birth abortion. A partial birth abortion is similar to, but not the same as, a Dilation and Extraction or D&X abortion, which is what the Ban was intended to prohibit. Gonzales v.
Format: Articles
Subject: Legal
Nelson v. Planned Parenthood Center of Tucson (1973)
The 1973 case Nelson v. Planned Parenthood Center of Tucson established the legality of abortion in Arizona. The Arizona Court of Appeals ruled that the Arizona Revised Statutes 13-211, 13-212, and 13-213, collectively called the Arizona abortion statutes, were unconstitutional. The statutes had made illegal receiving, providing, or advertising abortions. After the Arizona Appeals Court heard the case, it decided that the Arizona abortion statutes were constitutional. However, two weeks later the US Supreme Court decided in Roe v.
Format: Articles
Subject: Legal
Whole Woman's Health v. Hellerstedt (2016)
In the 2016 case Whole Woman's Health v. Hellerstedt, the US Supreme Court ruled unconstitutional the Texas requirements that abortion providers have admitting privileges at local hospitals and that abortion facilities meet ambulatory surgical center standards. Whole Woman’s Health represented abortion care providers in Texas and brought the case against the commissioner for the Texas Department of State Health Services, John Hellerstedt.
Format: Articles
Subject: Legal, Reproduction
Dickey-Wicker Amendment, 1996
The Dickey-Wicker Amendment is an amendment attached to the appropriations bills for the Departments of Health and Human Services, Labor, and Education each year since 1996 restricting the use of federal funds for creating, destroying, or knowingly injuring human embryos. The Dickey-Wicker Amendment began as a rider (another name for an amendment) attached to House Resolution (H.R.) 2880. H.R.
Format: Articles
Subject: Legal
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.
Format: Articles
Subject: Legal
Human Fertilisation and Embryology Act (1990)
The Human Fertilisation and Embryology Act 1990 established the legal framework that governs infertility treatment, medical services ancillary to infertility treatment such as embryo storage, and all human embryological research performed in the UK. The law also defines a legal concept of the parent of a child conceived with assisted reproductive technologies.
Format: Articles
Subject: Legal, Reproduction, Ethics
The Food and Drug Administration’s Pregnancy and Lactation Labeling Rule (2014)
In 2014, the United States Food and Drug Administration published the Pregnancy and Lactation Labeling Rule to amend previous guidelines for the prescription of drugs for pregnant and lactating women. The 2014 Pregnancy and Lactation Labeling Rule was intended to increase the safety and efficacy of prescription drugs by making drug labels easier for physicians to understand and utilize.
Format: Articles
Subject: Legal
United States v. One Package of Japanese Pessaries (1936)
In the 1936 case United States v. One Package of Japanese Pessaries, the US Court of Appeals for the Second Circuit in New York City, New York, confirmed that physicians had the right to distribute contraceptives to patients for medical purposes. In January 1933, US Customs confiscated a package of contraceptives imported from Japan by US physician Hannah Stone.
Format: Articles
Subject: Legal
President George W. Bush's Announcement on Stem Cells, 9 August 2001
On 9 August 2001, US President George W. Bush gave an eleven-minute speech from his ranch in Crawford, Texas, on the ethics and fate of federal funding for stem cell research. Bush also announced the creation of a special council to oversee stem cell research. In the speech President Bush acknowledged the importance of issues surrounding stem cell research to many Americans, presented different arguments in favor of and opposing embryonic stem cell research, and explained his decision to limit but not completely eliminate potential federal funding for embryonic stem cell (ESC) research.
Format: Articles
Subject: Legal
The Baby Doe Rules (1984)
The Baby Doe Rules represent the first attempt by the US government to directly intervene in treatment options for neonates born with congenital defects. The name of the rule comes from the controversial 1982 case of a Bloomington, Indiana infant Baby Doe, a name coined by the media. The Baby Doe Rules mandate that, as a requirement for federal funding, hospitals and physicians must provide maximal care to any impaired infant, unless select exceptions are met. If a physician or parent chooses to withhold full treatment when the exceptions are not met, they are liable for medical neglect.
Format: Articles
Subject: Legal, Reproduction
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.
Format: Articles
Subject: Legal, Reproduction
Physician Labeling Rule (2006)
In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity.
Format: Articles
Subject: Legal
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.
Format: Articles
Subject: Legal
NuvaRing
The NuvaRing is a self-administered hormonal contraceptive device in the form of a flexible plastic ring that is inserted into the vagina. It releases the hormones etonogestrel and ethinylestradiol, which are synthetic forms of the female reproductive hormones progesterone and estrogen, respectively. The pharmaceutical company Organon first made NuvaRing in the Netherlands in 1980s. The Netherlands first approved it for use in February of 2001, and the United States did the same in October of that year.
Format: Articles
Subject: Technologies, Reproduction, Legal