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 issues arise when the research involves particularly vulnerable subjects, such as women in some circumstances (i.e. specific physiological conditions, namely, fertility, pregnancy, breastfeeding, or socioeconomic vulnerabilities). If, on one hand, participation 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 challenge in terms of appropriateness, completeness and clarity of information and freedom of consent. This article will explore ethical issues surrounding women's participation 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. SUMMARY: 1. Introduction-2. Women as research actors and participants-3. Fair inclusion of women in clinical research: the US experience-4. Ethical research conduct-5. Rethinking women's specificities in clinical research: from "vulnerability" dimensions to "scientific complexity"-5.1. Fertility condition in women-5.2. Safety of clinical research with women: before, during and after pregnancy-5.3. Maternal and foetal health in pregnancy: balancing benefits and risks-5.4. The impact of socioeconomic conditions on freedom and self-determination-6. A gender approach to informed consent-7. Sensitive issues related to the acquisition of informed consent-7.1. The role of the pregnant woman's partner in the informed consent process-7.2. An ethical reflection on pregnancy/breastfeeding and the role of the man's pregnant partner or of childbearing potential in the informed consent process-8. Conclusions.
Informed consent is essential in ensuring the autonomy of participants in clinical research. However, informed consent documents are often complex and difficult to understand, and do not incorporate the patients' perspective. The informed consent process has become more focused on acquiring the participant's signature on the informed consent form, rather than being a contract that ensures the pa-tient's autonomy through clear and complete information about all relevant aspects of a trial. The i-CONSENT project aims to improve the information that potential participants receive when deciding whether or not to join a clinical trial through the development of a set of guidelines for the informed consent process. Involving potential participants during the preparation of the informed consent and its associated materials can be a key factor.
From an ethical and legal point of view, the assent of the minor to participate in a medical study is a subject of great importance. There is still a debate about the requirements to consider this assent valid and binding. This review analyses and compares the contents of the assent from the points of view of the legislation and the scientific literature.