General Introduction 9 1 General introduction and outline of the thesis The roots of sex- and gender-sensitive medicine The roots of sex- and gender sensitive medicine (SGSM) trace back more than 50 years to the feminist movements in the US and Europe. The focus on women’s health originated from the Women’s Health movement during the ’60 and ‘70s with its goals to improve care for all women through physical and sexual self-determination, and to gain control of their own reproductive rights.1 This first wave was followed in the ‘80s by the entry of larger numbers of women into the medical profession, which contributed to a broader awareness within- and outside medicine of the longstanding lack of research in women’s health. This coincided with a growing focus on differences in clinical signs and symptoms in women and men affected by the same condition, for numerous medical conditions.2 By the ’90s, ‘gender-specific’ research emerged as an innovative area of biomedicine, with an initial focus on filling the gap in knowledge about female symptoms and needs in a medical world that historically focused on male standards and on the identification of sex-linked differences in disease development and progression.3 Although it is beyond the scope of this introduction to include a comprehensive history of policies and initiatives that progressed the field of SGSM, some key initiatives are worth mentioning. With the adoption of the Health Revitalization Act in the US in 1993, the National Institutes of Health (NIH) established the first guidelines for the inclusions of women and underserved populations in clinical research.4 A decade later, in 2003, the EU Parliament resolution on gender mainstreaming offered a first blueprint on how to integrate sex and gender analysis into basic science.5 With this resolution, the EU required grantees to address “whether, and in what sense, sex and gender are relevant in the objectives and methodology of the research project”.6 Although the interest in- and attention towards the field of SGSM has increased in the past two decades, there is still a lack of robust and systematic instruments for the analysis of sex and, particularly, gender in (bio)medical research.7 The field of SGSM aims to differentiate between the incorporation of “information about how biological sex characteristics and sociocultural aspects of gender dimensions affect health and illness of people”.8,9 In the study of human subjects, the term ‘sex’ is used as a classification system based on biological attributes that are generally associated with male, female and intersex organisms (sex characteristics). From this perspective, individuals are often classified through the analysis of genes, gonads, and genitals (3G sex-system). This includes a focus on chromosomes, gene expression, hormone levels and function, and reproductive/sexual anatomy.10 The term ‘gender’ is used as an overarching concept that includes multiple sociocultural ideas, behaviours
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