I-CONSENT SIGNED
Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective
Total Cost €
0EC-Contrib. €
0Partnership
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0I-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.
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 contact info |
| 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.
| # | ||||
|---|---|---|---|---|
| 1 | FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA | ES (VALENCIA) | coordinator | 1˙287˙519.00 |
| 2 | GLAXOSMITHKLINE SA | ES (TRES CANTOS MADRID) | participant | 370˙500.00 |
| 3 | OSPEDALE PEDIATRICO BAMBINO GESU | IT (ROMA) | participant | 322˙382.00 |
| 4 | LIBERA UNIVERSITA MARIA SS. ASSUNTA DI ROMA | IT (ROMA) | participant | 303˙356.00 |
| 5 | AND CONSULTING GROUP | BE (BRUSSELS) | participant | 267˙812.00 |
| 6 | ATENEO PONTIFICIO REGINA APOSTOLORUM | IT (ROME) | participant | 258˙250.00 |
| 7 | MENINGITIS RESEARCH FOUNDATION | UK (BRISTOL) | participant | 128˙006.00 |
| 8 | SYNECTIKA RESEARCH AND CONSULTING LTD | UK (KEYNSHAM) | participant | 100˙312.00 |
| 9 | SPARKS & CO | 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
| 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
| year | authors and title | journal | last update |
|---|---|---|---|
| 2019 |
Alberto GarcÃa Gómez, 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 Gómez, Mirko Daniel Garasic, MarÃa Cubillo DÃaz-Valdés Ethical issues concerning informed consent in translational/clinical research and vaccination bias and informed consent published pages: , ISSN: 0188-5022, DOI: |
Medicina y Ética Vol. 30 Núm. 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 minor’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 minor’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 participants’ 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 investigación de vacunas: una revisión sistemática published pages: 22, ISSN: , DOI: |
IX Congreso de la Asociación Española de VacunologÃa. “VacunologÃa: grandes logros, nuevos retosâ€. Libro de abstracts Annually | 2020-04-08 |
| 2018 |
Ellen Zhang Informed consent – 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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