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

Objective

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.

Call for proposal

H2020-SwafS-2016-1
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Coordinator

FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA
Address
Calle Micer Masco 31
46010 Valencia
Spain
Activity type
Research Organisations
EU contribution
€ 1 264 910,64

Participants (8)

ATENEO PONTIFICIO REGINA APOSTOLORUM
Italy
EU contribution
€ 258 250
Address
Via Degli Aldobrandeschi 190
00163 Rome
Activity type
Higher or Secondary Education Establishments
LIBERA UNIVERSITA MARIA SANTISSIMAASSUNTA
Italy
EU contribution
€ 313 356,56
Address
Via Della Traspontina 21
00193 Roma
Activity type
Higher or Secondary Education Establishments
GLAXOSMITHKLINE SA
Spain
EU contribution
€ 360 500
Address
C/ Severo Ochoa 2 Parque Tecnologico De Madrid
28760 Tres Cantos Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SYNECTIKA RESEARCH AND CONSULTING LTD

Participation ended

United Kingdom
EU contribution
€ 100 312,61
Address
Albert Road 71
BS31 1AE Keynsham
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SPARKS & CO

Participation ended

France
EU contribution
€ 39 058,11
Address
66 Avenue Des Champs Elysees Espace 41
75008 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MENINGITIS RESEARCH FOUNDATION
United Kingdom
EU contribution
€ 150 615
Address
Newminster House 27-29 Balwin Street
BS1 1LT Bristol
Activity type
Research Organisations
OSPEDALE PEDIATRICO BAMBINO GESU
Italy
EU contribution
€ 322 382,19
Address
Piazza Sant Onofrio 4
00165 Roma
Activity type
Research Organisations
AND CONSULTING GROUP
Belgium
EU contribution
€ 267 812,39
Address
Marcel Broodthaersplein 8 4Th Floor
1060 Brussels
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)