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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

Thesis: The Dynamic Landscape of Abortion Law in the United States

Much change has occurred in abortion laws over the past 50 years, this thesis tracks those changes principally through Supreme Court Cases, such as United States v. Milan Vuitch, Roe v. Wade, and Gonzales v. Planned Parenthood among others. The landscape of abortion law in the US continues to shift today, as recently as 2017 with Plowman v. FMCH cases were being heard in courts that wrought subtle yet important changes in abortion law.

Format: Essays and Theses

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

Women’s Right to Know Act (2019) by Americans United for Life

In 2019, Americans United for Life, hereafter AUL, published a model legislation, called the Women’s Right to Know Act, in their annual publication Defending Life. The goal of the model legislation, which AUL annually updates, is to help state governments enact enhanced informed consent laws for abortion. The Women’s Right to Know Act requires physicians to provide specific information to women before they may consent to having an abortion.

Format: Articles

Subject: Legal, Publications, Reproduction

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

George W. Bush Executive Order 13455, June 2007

On 20 January 2001, Republican George W. Bush was sworn in as the forty-third president of the United States, replacing Democrat William J. Clinton. During his eight years in office, Bush issued many executive orders, often altering previous policy. By signing Order 13435 on 22 June 2007, he changed how stem cell research would be performed in America.

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

United States v. Dennett (1930)

In the 1930 US federal court case United States v. Dennett, Mary Coffin Ware Dennett was cleared of all charges of violating the anti-obscenity Comstock Act, a charge she had incurred by distributing her sex education pamphlet called The Sex Side of Life: An Explanation for Young People. The United States Postal Service charged Dennett under the Comstock Act, which prohibited the distribution of sex-related materials through the mail.

Format: Articles

Subject: Legal

Thesis: Informed Consent Laws for Abortion: What Do Women Have a "Right to Know?

The objective of this project was to determine the importance of informed consent laws to achieving the larger goal of dismantling the right to abortion. I found that informed consent counseling materials in most states contain a full timeline of fetal development, along with information about the risks of abortion, the risks of childbirth, and alternatives to abortion. In addition, informed consent laws for abortion are based on model legislation called the “Women’s Right to Know Act” developed by Americans United for Life (AUL).

Format: Essays and Theses

Subject: Legal, Ethics

Skinner v. Oklahoma (1942)

In 1942, the United States Supreme Court Case of Skinner v. Oklahoma ruled that states could not legally sterilize those inmates of prisons deemed habitual criminals. Skinner v. Oklahoma was about the case of Jack Skinner, an inmate of the Oklahoma State Penitentiary in McAlester, Oklahoma, who was subject to sterilization under the Oklahoma Habitual Criminal Sterilization Act of 1935. The case, decided on 1 June 1942, determined that state laws were unconstitutional if those laws enabled states to forcibly sterilize inmates deemed to be habitual criminals.

Format: Articles

Subject: Ethics, Legal

Eugenical Sterilization in the United States (1922), by Harry H. Laughlin

Eugenical Sterilization in the United States is a 1922 book in which author Harry H. Laughlin argues for the necessity of compulsory sterilization in the United States based on the principles of eugenics. The eugenics movement of the early twentieth century in the US focused on altering the genetic makeup of the US population by regulating immigration and sterilization, and by discouraging interracial procreation, then called miscegenation.

Format: Articles

Subject: Outreach, Legal, Ethics, Publications

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

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.

Format: Articles

Subject: Legal, Ethics

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.

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

Title X Family Planning Program (1970–1977)

The Family Planning Services and Public Research Act of 1970, often called Title X Family Planning Program, is a US federal law that provides federal funding for family planning services to low income or uninsured families. The US federal government passed the law, Public Law 91-572, in 1970 as an amendment to the Public Health Services Act of 1944. The Act created the Office of Population Affairs (OPA) under the Secretary of Health, Education, and Welfare (here called the Secretary).

Format: Articles

Subject: Reproduction, 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

Burwell v. Hobby Lobby (2014)

In the 2014 case Burwell v. Hobby Lobby, the US Supreme Court ruled that the contraceptive mandate promulgated under the Patient Protection and Affordable Care Act violated privately held, for-profit corporations’ right to religious freedom. The contraception mandate, issued in 2012 by the US Department of Health and Human Services, required that employer-provided health insurance plans offer their beneficiaries certain contraceptive methods free of charge.

Format: Articles

Subject: Legal, Reproduction

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

Sterilization Act of 1924

The passage of the Virginia Sterilization Act of 1924 demonstrates how science has been used to drive policy throughout history. In the case of the Virginia sterilization law, the science used to draft the law was based on the principles of eugenics. With the help of Harry Laughlin's Model Sterilization Law, the state of Virginia was able to pass its own law allowing sterilization of the feebleminded, expressing sterilization as a health issue that needed to be protected from the public.

Format: Articles

Subject: Legal, Reproduction

Bowen v. Kendrick (1988)

On 29 June 1988, in Bowen v. Kendrick, the US Supreme Court ruled in a five-to-four decision that the 1981 Adolescent Family Life Act, or AFLA, was constitutional. Under AFLA, the US government could distribute federal funding for abstinence-only sexual education programs, oftentimes given to groups with religious affiliations. As a federal taxpayer, Chan Kendrick challenged the constitutionality of AFLA, claiming it violated the separation of church and state.

Format: Articles

Subject: Legal, Ethics, Outreach

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.

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

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