The awareness of the need of studying the influence of sex and gender on diseases started to spread in the ’90s but, almost 30 years later, progress in this area is not sufficient to rule out concerns about a possible inequality in medicine. In order to understand the difficulties behind the persisting gap in knowledge, it is important to be aware of the reasons that led to the regular exclusion of women from clinical research. This paper presents a historical reconstruction of the ethical debate about the involvement of women in research: from the protectionist approach of the ’70s to the demands for inclusion of the ’80s and the ’90s. Such reconstruction shows that the main ethical arguments in favour of inclusion, i.e. the principles of beneficence and justice, also justify the need for a gender-specific medicine. The paper discusses some elements that could have hampered the efforts to reduce the male bias, such as the emphasis on the issue of women inclusion in research, instead of the focus on women’s health needs. Moreover, it is argued that a participatory approach to research – i.e. an approach that considers women as partners who can offer a contribution at all levels of biomedical research – is the most effective in order to achieve the goal of including attention to women’s health into the research agenda
