Sex/Gender-Responsive Health Research: New Funding Guidelines of the USA National Institutes of Health Can Bring a New Impetus to Germany

Abstract

In June 2015, the National Institutes of Health (NIH) of the USA published a new funding guideline entitled "Consideration of Sex as a Biological Variable in NIH-funded Research". This guideline is part of the NIH policy to enhance quality and generalizability of health research. Its core element is the classification of sex as a key element of rigorous study designs. The requirement is that sex be defined as a biological variable, and taking the potentially relevant sex/gender related anatomical and physiological characteristics into account. In Germany, the "Guidelines and recommendations to assure good epidemiological practice" (GEP) of 1998 specify that the study design and research methods are to be designed so that sex/gender-specific aspects of the research question can be adequately detected. Mostly health research is restricted to the categorization of the study population into men and women and to the consideration of the sex/gender variable (man*woman) in the analyses. Research in accordance with the NIH guideline as well as with the German GEP needs to investigate differences and similarities between men and women, and also to look for factors that explain in what way being a man or a woman poses a risk or is protective against the development of diseases. This scientific basis is essential for the development and implementation of sex/gender equitable prevention, health promotion and health care, which in turn enables statutory health insurances to take sex/gender differences into account regarding the medical services they provide. The latter is a consequence of the current legal position in Germany, which is based on the Prevention law that was passed in 2015. In addition to the categorical sex/gender variable (man*woman), there is therefore the need to analytically differentiate between the dimensions sex (the biological factors) and gender (the socio-cultural ascriptions) as well as their interaction. For conceptual clarity, this paper proposes that the terms sex and/or gender be used only where the biological and/or socio-cultural aspects of being a man or a woman are explicitly taken into account. For the common sex/gender variable man*woman (based on self-reports, register data etc.) the term Survey sex (German: Erhebungsgeschlecht) can be used. Further, the establishment of a Federal Institute "Geschlecht und Gesundheit - Sex/Gender and Health" is recommended.