Gender assessment: European health research policies

Abstract

In the late 1980s concerns were raised in the United States that by conducting research mainly on white young men biomedical and health research was not adequately meeting the needs of women and for that matter of the elderly, children and persons from ethnic minorities. At this time insights emerged that the one-size ‘male norm’ in health research did not fit all people. Researchers thus started to realize that sex differences and gender effects were crucial in health research. An overview produced for the Canadian Institutes of Health Research lists the initiatives that have been implemented subsequently to promote or support research to take account of gender and sex differences (Caron, 2003; see also Chapter 24 by Armstrong). This includes initiatives in the USA taken by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) as well as initiatives in Canada and European countries. In the USA, NIH guidelines required the inclusion of women and (ethnic) minorities in clinical research (NIH, 1994). In 1993 the FDA had recommended that clinical studies should include enough men and women to detect clinically significant sex differences in drug efficacy and safety, and that sex differences should be reported.