Sex and Gender in Biomedical Research : Introduction to Core Concepts for the Lesson
Today, policies of the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) require that biomedical research address sex, gender, and racial/ethnic representation in clinical studies. These policies are a result of the women's health movement of the 1980s and acknowledgment within the biomedical research community that a large number of unanswered questions about health seem to be related to sex and gender differences.
This lesson describes the role of sex and gender in research and health, and the role of policies requiring this approach. The first section defines the distinction between the terms "sex" and "gender" and discusses the importance of using these terms consistently.
The lesson then presents a brief history of the reasons women traditionally were excluded from research studies, and summarizes current FDA regulations and NIH policies that require including women in research.
In completing this lesson, the student will gain a broad knowledge of the role and requirements for sex and gender research applicable to studies funded by FDA and NIH. The lesson introduces the concepts that will be presented in detail in the subsequent five lessons of this course.
