CORDIS
EU research results

CORDIS

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

Project information

Grant agreement ID: 741856

Status

Ongoing project

  • Start date

    1 May 2017

  • End date

    31 March 2021

Funded under:

H2020-EU.5.g.

H2020-EU.5.f.

H2020-EU.5.c.

H2020-EU.5.b.

  • Overall budget:

    € 3 077 197,50

  • EU contribution

    € 3 077 197,50

Coordinated by:

FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA

Spain

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.

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

LIBERA UNIVERSITA MARIA SS. ASSUNTA DI ROMA

Italy

EU Contribution

€ 313 356,56

GLAXOSMITHKLINE SA

Spain

EU Contribution

€ 360 500

SYNECTIKA RESEARCH AND CONSULTING LTD

United Kingdom

EU Contribution

€ 100 312,61

SPARKS & CO

France

EU Contribution

€ 39 058,11

MENINGITIS RESEARCH FOUNDATION

United Kingdom

EU Contribution

€ 150 615

OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 322 382,19

AND CONSULTING GROUP

Belgium

EU Contribution

€ 267 812,39

Project information

Grant agreement ID: 741856

Status

Ongoing project

  • Start date

    1 May 2017

  • End date

    31 March 2021

Funded under:

H2020-EU.5.g.

H2020-EU.5.f.

H2020-EU.5.c.

H2020-EU.5.b.

  • Overall budget:

    € 3 077 197,50

  • EU contribution

    € 3 077 197,50

Coordinated by:

FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA

Spain