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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-2016-17

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Sub call

H2020-SwafS-2016-1

Coordinator

FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA
Net EU contribution
€ 1 171 860,64
Address
Calle Micer Masco 31
46010 Valencia
Spain

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Region
Este Comunitat Valenciana Valencia/València
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (10)

Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

FUNDACION UNIVERSIDAD CATOLICA DE VALENCIA SAN VICENTE MARTIR
Spain
Net EU contribution
€ 93 050,00
Address
Calle Quevedo 2
46001 Valencia

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Region
Este Comunitat Valenciana Valencia/València
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ATENEO PONTIFICIO REGINA APOSTOLORUM
Italy
Net EU contribution
€ 258 250,00
Address
Via Degli Aldobrandeschi 190
00163 Rome

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Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
LIBERA UNIVERSITA MARIA SANTISSIMAASSUNTA
Italy
Net EU contribution
€ 313 356,56
Address
Via Della Traspontina 21
00193 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
GLAXOSMITHKLINE SA
Spain
Net EU contribution
€ 298 625,00
Address
C/ Severo Ochoa 2 Parque Tecnologico De Madrid
28760 Tres Cantos Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

GLAXOSMITHKLINE INVESTIGACION Y DESARROLLO SL
Spain
Net EU contribution
€ 61 875,00
Address
C/ Severo Ochoa Numero 2 Parque Tecnologico De Mad
28760 Tres Cantos Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
SYNECTIKA RESEARCH AND CONSULTING LTD

Participation ended

United Kingdom
Net EU contribution
€ 100 312,61
Address
Albert Road 71
BS31 1AE Keynsham

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bath and North East Somerset, North Somerset and South Gloucestershire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
SPARKS & CO

Participation ended

France
Net EU contribution
€ 39 058,11
Address
66 Avenue Des Champs Elysees Espace 41
75008 Paris

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
MENINGITIS RESEARCH FOUNDATION
United Kingdom
Net EU contribution
€ 150 615,00
Address
Newminster House 27-29 Balwin Street
BS1 1LT Bristol

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bristol, City of
Activity type
Research Organisations
Non-EU contribution
€ 0,00
OSPEDALE PEDIATRICO BAMBINO GESU
Italy
Net EU contribution
€ 322 382,19
Address
Piazza Sant Onofrio 4
00165 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Non-EU contribution
€ 0,00
AND CONSULTING GROUP
Belgium
Net EU contribution
€ 267 812,39
Address
Marcel Broodthaersplein 8 4th Floor
1060 Brussels

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00