Sex and Gender Defined for Use in Biomedical Disciplines

Sex and Gender in Biomedical Research : Sex and Gender Defined for Use in Biomedical Disciplines

What guidance is available to the biomedical disciplines regarding usage of these terms? Very few journals provide guidelines to authors regarding analysis of data by sex as a subpopulation. Many journals recommend following the Uniform Requirements for Manuscripts Submitted to Biomedical Journals approved by the International Committee of Medical Journal Editors. However, the uniform requirements are silent about describing age, sex, or other important characteristics of subjects in the statistics, results, or discussion sections of articles.

The Office of Research on Women's Health and the FDA encourage use of the definitions presented by three respected institutions: the Institute of Medicine of the National Academy of Sciences, the American Medical Association, and the World Health Organization.

Institute of Medicine

The 2001 Institute of Medicine report, Exploring the Biological Contributions to Human Health: Does Sex Matter?⁴ recommends that researchers specify in publications their use of the terms and suggests the following distinctions:

• In the study of human subjects, the term "gender" should be used to refer to a person's self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual's gender presentation.
• In the study of human subjects, the term "sex" should be used as a classification, generally as male or female, according to the reproductive organs and functions that derive from the chromosomal complement.
• In most studies of nonhuman animals, the term "sex" should be used.

The word "sex" is used when differences are primarily biological in origin and may be genetic or phenotypic (genetic or physiological characteristics of being male or female), and "gender" is used when referring to responses to social and cultural influences based on sex. Gender is rooted in biology and shaped by environment and experience.

The Institute of Medicine report accepts the definition of biology, as defined in Dorland's and Stedman's medical dictionaries, as the study of life and living organisms including the genetic, molecular, biochemical, hormonal, cellular, physiological, behavioral, and psychosocial aspects of life.