The informed consent (IC) process allows the subject to voluntarily decide whether or not his/her participation in research. Generally, ICs are difficult to read documents that do not include all stakeholders’ perceptions. Therefore, informative IC should be a process that include needed information under a gender and age perspective, more importantly if these are vulnerable populations. The relationship between science and society should favour the engagement inclusion of citizens in the informed consent process, and this must be done with especial attention to gender and ethics considerations. The IC process should also improve health literacy in the citizens. The I-CONSENT project presents a simple work plan structure with a WP1 aimed to analyze baseline knowledge of IC, WP2 presenting innovative solutions and WP3 proposing new guidelines, disseminated in WP4. For this i-CONSENT consortium presents a multi-stakeholder community of partners from academia, public health, patient organizations, clinicians and private sector, including pharma and SMEs, and a set of activities that will maximize the collection (workshops) and dissemination (communication plan) of information. Specifically, and to ensure alignment with the Topic scope, the project will use a selection of 3 different vaccines as study frame to improve guidelines for informed consents. These do focus on vulnerable age populations with very special emphasis on gender: Human Papilloma Virus (HPV) vaccines (preadolescent and adolescents), Meningitis (adults) and Respiratory Syncitial Virus (pregnant women). Besides Gender and Ethic issues as centre of the proposal, the project will consider the interaction of age and gender, with its specifics as comprehension of medical information, oral and written language, and availability and use of new technologies will also be considered.

Influenza is a major public health problem. In a conservative estimate, influenza infects annually 60 of the 500 million inhabitants of the EU. Vaccines are the cornerstone for preventing influenza and its consequences. Current influenza vaccines have a moderate variable effect, given the mismatch between vaccine and circulating strains, waning immunity and interference from previous vaccination, among others. The single most important challenge in achieving VE studies for the various influenza vaccines put every year on the European market is the ability of the different stakeholders to work in collaboration. To enable a sustainable network of influenza vaccine VE studies, the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) main goal will be the development of a governance model between public and private entities. This model will ensure scientific independence in the studies and full transparency, allowing different stakeholders to fulfill their needs taking into account their respective obligations and statutes. A second challenge will be to reach the capacity to perform vaccine brand- specific effectiveness studies, which is agile enough to deliver the needed outputs in timely manner, and robust enough to provide results by different age and risk groups and flexible enough to utilize novel tools while at the same time aims to be sustainable. Combining these outputs, DRIVE will establish a sustainable platform for joint influenza vaccine effectiveness evaluation which will have a positive impact on European citizens public health.