This issue of Hot Topics in Viral Hepatitis shifts the attention from viral hepatitis and hepatology to a more general issue: whether the basic principle of justice that should guide the conduct of human research—as stated in the Belmont Report in 1979—translates into the mere protection of vulnerable individuals or, more aptly, into an equitable access to the benefits of medical research. This topic pertains to the entire field of medicine and medical research, in particular. The participation of women in clinical trials is a perfect case-in-point. Although the US National Institutes of Health has issued guidelines since 1994 stating that women should be included in research (or their exclusion be duly justified), there is a wide perception that implementation of such guidelines is far from satisfactory, with similar concerns applying to children and other minorities. In other words, just to give a practical example, drugs should be tested on a range of patients as representative as possible of the population likely to receive the drug upon its approval. There are many significant quantitative differences among the different subgroups (eg, drug efficacy or risk of side effects) that justify such a comprehensive approach in drug development. Similarly, differences in the natural history of any given disease must be appropriately taken into consideration when tackling issues related to clinical management: the risk of developing hepatocellular carcinoma or the hormonal and metabolic changes surrounding menopause illustrate this point.
The current issue includes articles from distinguished female hepatologists who provide their point of view on this topic, taking their respective fi eld of study as a pretext. The goal is not to establish additional recommendations—they already exist (eg, in the guidelines to authors of European Commission grant applications)—but to increase awareness among the public about a problem that—surprisingly enough—is far from solved.