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ACOG Issues Guidelines for Research Involving Women

August 31, 2007

Washington, DC -- The American College of Obstetricians and Gynecologists (ACOG) today reiterated its position on the critical importance of including women in research trials. In a committee opinion issued in the September issue of Obstetrics & Gynecology, ACOG emphasized that allowing women to participate in research is absolutely vital to understanding how gender differences affect disease with the ultimate goal of improving women's health.

"There are a number of medical conditions that manifest differently in women than in men," said Anne D. Lyerly, MD, chair of ACOG's Committee on Ethics. "Sex differences, the use of hormonal contraceptives, or varying levels of hormones at different times in a woman's menstrual cycle can also influence the efficacy of medications. It is unrealistic to assume that a treatment will affect a woman in a certain way just because it worked in a man. What's good for the goose is not always good for the gander."

Until recently, women were all but barred from participating in human research trials. Proponents of male-only clinical trials often cited concerns such as risk to the fetus, especially if a pregnancy was unrecognized, and possible harm to a woman's reproductive potential. However, ACOG says that the risk of harm to women involved in research can be minimized and does not justify their exclusion from medical trials that could improve women's health. Women should be eligible to participate in all human research trials except those solely focused on men.

"Including women in research helps ensure that women will reap the benefits of medical advancements in the same way that men do," Dr. Lyerly added. "Research involving pregnant women also is essential both to understanding the physiological changes and conditions unique to pregnancy, such as preeclampsia, and to establishing the safety and efficacy of medications needed during pregnancy."

In the revised position, ACOG also addressed the issue of contraceptive choice when contraception is required for research study participation. While ACOG acknowledges the right of researchers to insist that study participants use contraception in appropriate situations, it stresses that a woman should be able to choose the type of contraception that best suits her needs and values. "Respect for study participants is a basic premise of human research trials. That respect can be violated if, for example, a non-sexually active woman is told she cannot choose abstinence as her form of birth control," Dr. Lyerly noted.

Committee Opinion #377, "Research Involving Women," is published in the September 2007 issue of Obstetrics & Gynecology.

The American College of Obstetricians and Gynecologists is the national medical organization representing over 51,000 members who provide health care for women.