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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

Stenberg v. Carhart (2000)

In Stenberg v. Carhart, the US Supreme Court ruled on 28 June 2000 that a Nebraska law banning partial birth abortions was unconstitutional. Though the US Supreme Court case Roe v. Wade in 1973 had set a precedent that constitutionally protected abortions, some states established limitations on certain types of abortion procedures. When NebraskaÕs state government criminalized partial birth abortions, physician LeRoy Carhart challenged the constitutionality of the case. Don Stenberg, an Attorney General located in Lincoln, Nebraska, represented the state of Nebraska.

Format: Articles

Subject: Legal

Roman v. Roman (2006)

In the case Randy M. Roman v. Augusta N. Roman (2006), the Court of Appeals of Texas followed courts in other states and upheld the validity and enforceability of in vitro fertilization (IVF) consent agreements. The Romans, a divorced couple, each sought different outcomes for their cryopreserved preembryos created during their marriage. Randy Roman sought to have them destroyed, and Augusta Roman sought to implant them in an attempt to have biological children.

Format: Articles

Subject: Legal

In re Agent Orange Product Liability Litigation (1979-1984)

In the legal case In re Agent Orange Product Liability Litigation of the early 1980s, US military veterans of the Vietnam War sued the US chemical companies that had produced the herbicide Agent Orange, and those companies settled with US veterans out of court. Agent Orange contains dioxin, a chemical later shown to disrupt the hormone system of the body and to cause cancer. As veterans returned to the US from Vietnam, scientists further confirmed that exposure to Agent Orange caused a variety of cancers in veterans and developmental problems in the veterans' children.

Format: Articles

Subject: 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.

Format: Articles

Subject: Legal

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

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

United States v. Milan Vuitch (1971)

In the 1971 court case United States v. Milan Vuitch, hereafter US v. Vuitch, the US Supreme Court ruled that a Washington, DC law was constitutional by overturning a 1969 district court decision. Beginning in the early twentieth century, Washington, DC, prohibited abortions except for abortions performed to preserve the life or health of the pregnant woman. In 1969, Milan Vuitch, a physician in Washington, DC, was convicted of criminal abortion for providing an abortion when the woman’s life was not endangered.

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

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

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

Planned Parenthood v. Danforth (1976)

On 1 July 1976, the US Supreme Court decided in the case Planned Parenthood v. Danforth that provisions of a Missouri law regulating abortion care were unconstitutional. That law, House Bill 1211, restricted abortion care by requiring written consent for each abortion procedure from the pregnant woman as written consent of the woman’s husband if she was married, or the written consent of her parents if she was unmarried and younger than eighteen. House Bill 1211 also required that physicians make efforts to preserve the lives of aborted fetuses.

Format: Articles

Subject: Legal

"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