Embryo Project Encyclopedia

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. Between 1979 and 1993, several other US governmental agencies urged investigators to increase the number of women in their clinical research to improve the state of women’s healthcare. After Congress passed the National Institutes of Health Revitalization Act, hereafter Revitalization Act of 1993, investigators who used NIH funds for clinical research were required to include both women and minorities in their clinical research. The Revitalization Act established the Office of Research on Women’s Health headquartered in Washington, DC and required investigators to include women in their clinical research, thus improving the quality of women’s health research.

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. Planned Parenthood eventually reached the Supreme Court, where the Court ruled that the Ban was constitutional. In Gonzales v. Planned Parenthood, the Court ruled for the first time that it was constitutional to ban a method of abortion without providing an exception for cases where a pregnant woman’s life was endangered.

On 2 July 1979, the United States Supreme Court decided Bellotti v. Baird, ruling that a Massachusetts law that prohibited minors from obtaining abortions without parental consent was unconstitutional. That law prohibited minors from receiving abortions without permission from both of their parents or a superior court judge. Under that law, if one or both of the minor’s parents denied consent, the minor could petition a superior court judge who would determine whether the minor was competent enough to make the decision to abort on her own. In addition to judging the minor’s competency, a superior court judge could also determine whether the abortion was in the minor’s best interest. The Supreme Court upheld a lower court’s decision and ruled that the existing Massachusetts law was unconstitutional. The Supreme Court’s ruling on Bellotti v. Baird affirmed that minors had the right to choose an abortion and that the decision to abort was personal and could not be overridden or vetoed by a third party.

Richard Doll was an epidemiologist and public figure in the twentieth and early twenty-first centuries. Working primarily at the University of Oxford, in Oxford, England, Doll established a definitive correlation between cigarette smoking and lung cancer. Furthermore, Doll’s work helped legitimize epidemiology as a scientific discipline. Doll’s research also helped establish modern guidelines for oncological studies, as well as for contemporary and future research on the effect of smoking on pregnancy and fetal development. In addition to studying the health effects of smoking, Doll also studied cervical cancer and contraceptives.

The US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus. In 1997, the FDA reversed that guidance, advising investigators to include women in early phase drug research, a decision that reflected changing views about a woman’s ability to decide whether to participate in drug trials and furthering research on the effects of drugs on women.