Record #202783 - GSI Repository

I-CONSENT

Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective

Coordinator	ATENEO PONTIFICIO REGINA APOSTOLORUM ; SPARKS & CO ; SYNECTIKA RESEARCH AND CONSULTING LTD ; AND CONSULTING GROUP ; LIBERA UNIVERSITA MARIA SS. ASSUNTA DI ROMA ; GLAXOSMITHKLINE SA ; Meningitis Research Foundation ; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana ; OSPEDALE PEDIATRICO BAMBINO GESU
Grant period	2017-05-01 - 2021-03-31
Funding body	European Union
Call number	H2020-SwafS-2016-1
Grant number	741856
Identifier	G:(EU-Grant)741856

Note: 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.

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Record created 2017-06-14, last modified 2023-02-08

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