Gender and Informed Consent in Clinical Research: Beyond Ethical Challenges

Informed consent for clinical research is both a communication process and a document to inform individuals about relevance, scope, benefits and risks of their involvement in research and to obtain consent for participation in a study. Critical is-sues arise when the research involves particularly vulnerable subjects, such as wom-en in some circumstances (i.e. specific physiological conditions, namely, fertility, pregnancy, breastfeeding, or socio-economic vulnerabilities). If, on one hand, partici-pation of particularly vulnerable subjects in clinical research requires special care and safeguards to protect the person’s rights and reduce risks of undue inducement and therapeutic misconception; on the other, a vulnerability-based exclusion would result in discrimination and a barrier to possible health benefits deriving from advances in scientific research. In this context, gender-related issues may become a huge chal-lenge in terms of appropriateness, completeness and clarity of information and free-dom of consent. This article will explore ethical issues surrounding women’s partici-pation in clinical research, with a specific focus on gender considerations in informed consent, through a narrative review of soft law at the European level and beyond on this topic. Concerns on the role of the male/female partner in the informed consent process will also be addressed.