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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

"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

Subject: Legal, Ethics

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.

Format: Articles

Subject: Legal, Technologies

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.

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

City of Akron v. Akron Center for Reproductive Health (1983)

In the 1983 case City of Akron v. Akron Center for Reproductive Health the US Supreme Court ruled that certain requirements of the city of Akron’s “Regulation on Abortion” ordinance violated women’s rights to abortions. Despite the legalization of abortion in the 1973, with the US Supreme Court case Roe v. Wade, individual states passed legislation regulating certain aspects of abortion.

Format: Articles

Subject: Legal

Doe v. Bolton (1973)

In the 1973 court case Doe v. Bolton, the US Supreme Court in Washington, D.C., ruled that a Georgia law regulating abortion was unconstitutional. The Georgia abortion law required women seeking abortions to get approval for the procedure from their personal physician, two consulting physicians, and from a committee at the admitting hospital. Furthermore, under the statutes, only women who had been raped, whose lives were in danger from the pregnancy, or who were carrying fetuses likely to be seriously, permanently malformed were permitted to receive abortions.

Format: Articles

Subject: Legal, Reproduction

Griswold v. Connecticut (1965)

The landmark Supreme Court case, Griswold v. Connecticut (1965), gave women more control over their reproductive rights while also bringing reproductive and birth control issues into the public realm and more importantly, into the courts. Bringing these issues into the public eye allowed additional questions about the reproductive rights of women, such as access to abortion, to be asked. This court case laid the groundwork for later cases such as Eisenstadt v. Baird (1972) and Roe v. Wade (1973).

Format: Articles

Subject: Legal, Reproduction

Bowen v. American Hospital Association (1986)

The 1986 US Supreme Court decision Bowen v. American Hospital Association rejected the federal government's use of Section 504 of the Rehabilitation Act of 1973 to intervene in a hospital's treatment for neonates born with severe congenital defects. This case set a precedent for the role of government involvement in cases where parents refused consent for care of disabled newborns.

Format: Articles

Subject: Legal, Reproduction

Thesis: Dismantling Legal Constraints to Contraception in the 1900s

In the late nineteenth century, the Comstock Act of 1873 made the distribution of contraception illegal and classified contraception as an obscenity. Reflecting the predominant attitude towards contraception at the time, the Comstock Act was the first federal anti-obscenity law that targeted contraception. However, social acceptance of birth control changed at the turn of the twentieth century. In this thesis, I analyzed legislation, advocates, and literature pertinent to that social change to report on the events leading up to the decriminalization of contraception.

Format: Essays and Theses

Subject: People, Legal, Reproduction

The Comstock Law (1873)

The Comstock Law was a controversial law because it limited the reproductive rights of women and violated every person's right to privacy. This federal law was the beginning of a long fight over the reproductive rights of women which is still being waged. Reproductive rights are important to embryology because they lead to the discussions regarding the morality of abortion, contraceptives, and ultimately the moral status of the embryo.

Format: Articles

Subject: Legal, Reproduction

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

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

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

Subject: Legal, Outreach

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

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

“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.

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

Organic Seed Growers and Trade Association's suit against Monsanto, 2012 and 2013

In March 2011 the Organic Seed Growers and Trade Association and around sixty agricultural organizations (OSGATA et al.) filed a suit against Monsanto Company and Monsanto Technology L.L.C., collectively called Monsanto. The hearings for Organic Seed Growers and Trade Association (OSGATA) et al. v. Monsanto (2012) took place at the United States District Court for the Southern District of New York in Manhattan, New York. The district court's Judge Naomi Reice Buchwald dismissed OSGATA's suit.

Format: Articles

Subject: Legal

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.

Format: Articles

Subject: Ethics, Legal, Reproduction

Davis v. Davis [Brief] (1992)

This case was the first of its kind to address questions of personhood in the context of in vitro fertilization of a human embryo. It laid a foundation for future cases to work from: specifically, this case established the importance of prior written agreements for disposition of frozen embryos. This was also the first court decision to borrow the word "pre-embryo" from bioethics to describe the in vitro embryo. This terminology has been copied by many states.

Format: Articles

Subject: Legal, Reproduction

"Hybrids and Chimeras: A report on the findings of the consultation" by the Human Fertilisation and Embryology Authority in October, 2007

In 2007, the Human Fertilisation and Embryology Authority in London, UK, published Hybrids and Chimeras: A Report on the Findings of the Consultation, which summarized a public debate about research on, and suggested policy for, human animal chimeras. The HFEA formulated the report after conducting a series of surveys and debates from earlier in 2007. The HFEA issued a statement in September 2007, followed by an official report published on 1 October 2007. Their report on human-animal chimeras set a worldwide precedent for discussions of the ethical use of those embryos in labs.

Format: Articles

Subject: Publications, Legal, Outreach

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

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

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.

Format: Articles

Subject: Organizations, Ethics, Legal