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I-CONSENT SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
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I-CONSENT project word cloud

Explore the words cloud of the I-CONSENT project. It provides you a very rough idea of what is the project "I-CONSENT" about.

technologies perceptions clinicians stakeholders structure gender women frame wp2 read vulnerable presenting documents collection respiratory papilloma communication virus oral relationship specifics special generally perspective analyze ic workshops emphasis adolescents solutions society populations decide health inclusion pregnant medical hpv ethics stakeholder science human interaction proposing consent engagement subject wp1 private centre adults guidelines patient age academia wp4 ethic vaccines public wp3 informative preadolescent comprehension meningitis innovative especial smes plan syncitial disseminated ics difficult community citizens literacy language consents besides pharma informed maximize voluntarily participation alignment scope baseline written considerations

Project "I-CONSENT" data sheet

The following table provides information about the project.

Coordinator	FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA Organization address address: CALLE MICER MASCO 31 city: VALENCIA postcode: 46010 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Spain [ES]
Project website	https://i-consentproject.eu/
Total cost	3˙077˙197 €
EC max contribution	3˙077˙197 € (100%)
Programme	1. H2020-EU.5.g. (Take due and proportional precautions in research and innovation activities by anticipating and assessing potential environmental, health and safety impacts) 2. H2020-EU.5.f. (Develop the governance for the advancement of responsible research and innovation by all stakeholders, which is sensitive to society needs and demands and promote an ethics framework for research and innovation) 3. H2020-EU.5.c. (Integrate society in science and innovation issues, policies and activities in order to integrate citizens' interests and values and to increase the quality, relevance, social acceptability and sustainability of research and innovation outcomes in variou...) 4. H2020-EU.5.b. (Promote gender equality in particular by supporting structural change in the organisation of research institutions and in the content and design of research activities)
Code Call	H2020-SwafS-2016-1
Funding Scheme	CSA
Starting year	2017
Duration (year-month-day)	from 2017-05-01 to 2020-04-30

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA Organization address address: CALLE MICER MASCO 31 city: VALENCIA postcode: 46010 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (VALENCIA)	coordinator	1˙287˙519.00
2	GLAXOSMITHKLINE SA GLAXOSMITHKLINE SA Organization address address: C/ SEVERO OCHOA 2 PARQUE TECNOLOGICO DE MADRID city: TRES CANTOS MADRID postcode: 28760 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (TRES CANTOS MADRID)	participant	370˙500.00
3	OSPEDALE PEDIATRICO BAMBINO GESU OSPEDALE PEDIATRICO BAMBINO GESU Organization address address: PIAZZA SANT ONOFRIO 4 city: ROMA postcode: 165 website: www.ospedalebambinogesu.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	322˙382.00
4	LIBERA UNIVERSITA MARIA SS. ASSUNTA DI ROMA LIBERA UNIVERSITA MARIA SS. ASSUNTA DI ROMA Organization address address: VIA DELLA TRASPONTINA 21 city: ROMA postcode: 193 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	303˙356.00
5	AND CONSULTING GROUP AND CONSULTING GROUP Organization address address: MARCEL BROODTHAERSPLEIN 8 4TH FLOOR city: BRUSSELS postcode: 1060 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUSSELS)	participant	267˙812.00
6	ATENEO PONTIFICIO REGINA APOSTOLORUM ATENEO PONTIFICIO REGINA APOSTOLORUM Organization address address: VIA DEGLI ALDOBRANDESCHI 190 city: ROME postcode: 163 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROME)	participant	258˙250.00
7	MENINGITIS RESEARCH FOUNDATION MENINGITIS RESEARCH FOUNDATION Organization address address: NEWMINSTER HOUSE 27-29 BALWIN STREET city: BRISTOL postcode: BS1 1LT website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BRISTOL)	participant	128˙006.00
8	SYNECTIKA RESEARCH AND CONSULTING LTD SYNECTIKA RESEARCH AND CONSULTING LTD Organization address address: ALBERT ROAD 71 city: KEYNSHAM postcode: BS31 1AE website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (KEYNSHAM)	participant	100˙312.00
9	SPARKS & CO SPARKS & CO Organization address address: 66 AVENUE DES CHAMPS ELYSEES ESPACE 41 city: PARIS postcode: 75008 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	39˙058.00

Map

Project 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.

Deliverables

List of deliverables.
Socio-cultural, psychological and behavioural perspectives toward IC process	Documents, reports	2020-04-08 22:20:05
Project website	Websites, patent fillings, videos etc.	2020-04-08 22:20:05
Patient involvement in vaccine research	Documents, reports	2020-04-08 22:20:05
Report on gender and age-related issues associated with the acquisition of informed consent	Documents, reports	2020-04-08 22:20:05
Legal issues concerning informed consent in translational/ clinical research and vaccination.	Documents, reports	2020-04-08 22:20:05
Basic Communication Materials	Websites, patent fillings, videos etc.	2020-04-08 22:20:05
Ethical and legal review of the informed consent.	Documents, reports	2020-04-08 22:20:05
Ethical issues concerning informed consent in translational/ clinical research and vaccination.	Documents, reports	2020-04-08 22:20:05
Report on guidelines, standards and initiatives for improving informed consent in the healthcare context.	Documents, reports	2020-04-08 22:20:05

Take a look to the deliverables list in detail: detailed list of I-CONSENT deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2019	Alberto GarcÃa GÃ³mez, Mirko Daniel Garasic DILEMMAS OF INFORMED CONSENT PROCESS IN CLINICAL RESEARCH FROM A MULTIRELIGIOUS PERSPECTIVE published pages: , ISSN: 2704-5870, DOI:	Good Health, Quality Education, Sustainable Communities, Human Rights	2020-04-08
2018	Laura Palazzani Multicultural and interreligious perspectives on informed consent. The Christian perspective published pages: , ISSN: 2281-504X, DOI:	Studia Bioeticha Vol 11 No 2 (2018)	2020-04-08
2018	Ruiping Fan A Confucian View of Informed Consent and the Issue of Vaccination published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica Vol 11 No 2 (2018)	2020-04-08
2018	Elisabetta Sirgiovanni Agency, autonomy and consent: cues from the neuroscience of self-control published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica Vol 11 No 2 (2018)	2020-04-08
2019	Alberto GarcÃa GÃ³mez, Mirko Daniel Garasic, MarÃa Cubillo DÃaz-ValdÃ©s Ethical issues concerning informed consent in translational/clinical research and vaccination bias and informed consent published pages: , ISSN: 0188-5022, DOI:	Medicina y Ã‰tica Vol. 30 NÃºm. 2 (2019)	2020-04-08
2018	Andrea Lavazza A Neurobioethical Perspective on Informed Consent published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica Vol 11 No 2 (2018)	2020-04-08
2018	Aasim Padela Reflecting and Adapting Informed Consent to fit within an Islamic Moral Landscape and in Muslim Contexts published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica Vol 11 No 2 (2018)	2020-04-08
2018	Mirko Garasic, Alberto GarcÃa New Considerations on Informed Consent published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica VOL 11 NO 2 (2018), EDITORIAL	2020-04-08
2019	Alberto Garcia, Mirko Daniel Garasic Interreligious and cross-cultural perspectives on informed consent in the light of human rights and mental privacy published pages: 89-100, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f402	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Jaime Fons-MartÃnez, Fernando Calvo Rigual, Javier DÃez-Domingo, Leonardo Nepi, Loredana Persampieri, Cristina Ferrer-Albero Contents of the minorâ€™s assent in medical research: differences between the scientific literature and the legal requirements published pages: 37-52, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f399	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Laura Palazzani, Fabio Macioce, Margherita Daverio, Valeria Ferro, Loredana Persampieri New strategies for increasing participation of patients from diverse cultural and religious backgrounds in clinical trials published pages: 101-122, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f403	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Laura Palazzani Why informed consent requires attention once more? published pages: 1-2, ISSN: 2284-4503, DOI:	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Margherita Daverio Informed consent in translational/clinical research. Ethical issues according to international guidelines published pages: 123-138, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f404	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Leonardo Nepi Ethical issues concerning the informed consent process in paediatric clinical trials: European guidelines and recommendations on minorâ€™s assent and parental permission published pages: 53-63, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f400	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Valeria Ferro Legal aspects of informed consent in clinical research: the case of vaccinations in the international legal framework published pages: 139-149, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f405	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Loredana Persampieri Gender and informed consent in clinical research: beyond ethical challenges published pages: 65-87, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f401	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Fabio Macioce Informed consent procedures between autonomy and trust published pages: 23-35, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f398	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Laura Palazzani Informed consent, experimentation and emerging ethical problems published pages: 11-22, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f397	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Jaime Fons-MartÃnez, Cristina Ferrer-Albero, Rosanna Russell, Elizabeth Rodgers, Linda Glennie, Javier DÃez-Domingo i-CONSENT: presentation of the project and the importance of participantsâ€™ perspective in the informed consent process published pages: 3-10, ISSN: 2284-4503, DOI: 10.15168/2284-4503%2f396	BioLaw Journal - Rivista di BioDiritto No 1 (2019): Special Issue 1/20	2020-04-08
2019	Fons-MartÃnez J, GarcÃa-Bayarri J, DÃez-Domingo J How to strengthen the recommendations for the informed consent process in health-related studies: The i-CONSENT project methodology published pages: 59, ISSN: , DOI:	III National Congress of Young Researchers in Biomedicine. Book of Abstracts 3, Annually	2020-04-08
2017	Ferrer Albero, C., Fons-Martinez, J., Calvo Rigual, F., DÃez Domingo, J. Elementos a considerar en un documento de asentimiento para menores en investigaciÃ³n de vacunas: una revisiÃ³n sistemÃ¡tica published pages: 22, ISSN: , DOI:	IX Congreso de la AsociaciÃ³n EspaÃ±ola de VacunologÃa. â€œVacunologÃa: grandes logros, nuevos retosâ€. Libro de abstracts Annually	2020-04-08
2018	Ellen Zhang Informed consent â€“ A Critical Response from a Buddhist Perspective published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica Vol 11 No 2 (2018)	2020-04-08
2018	David Heyd Informed Consent and Clinical Trials - A Jewish Perspective published pages: , ISSN: 2281-504X, DOI:	Studia Bioethica Vol 11 No 2 (2018)	2020-04-08

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More projects from the same programme (H2020-EU.5.g.;H2020-EU.5.f.;H2020-EU.5.c.;H2020-EU.5.b.)

I-CONSENT (2017)

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

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I-CONSENT SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

Views

I-CONSENT project word cloud

Project "I-CONSENT" data sheet

Partnership

Map

Project objective

Deliverables

Publications

More projects from the same programme (H2020-EU.5.g.;H2020-EU.5.f.;H2020-EU.5.c.;H2020-EU.5.b.)

I-CONSENT (2017)

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