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

Informazioni relative al progetto

I-CONSENT

ID dell’accordo di sovvenzione: 741856

DOI 10.3030/741856

Progetto chiuso

Data della firma CE 21 Aprile 2017

Data di avvio 1 Maggio 2017

Data di completamento 31 Marzo 2021

Finanziato da

• 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

Costo totale € 3 077 197,50

Contributo UE € 3 077 197,50

Coordinato da

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

Risultati finali

Documents, reports (8)

Legal issues concerning informed consent in translational/ clinical research and vaccination.
Ethical issues concerning informed consent in translational/ clinical research and vaccination.
Ethical and legal review of the informed consent.
Report on gender and age-related issues associated with the acquisition of informed consent
Patient involvement in vaccine research
Executive summary report on ICT-based strategies for increased patient involvement and improved informed consent process
Socio-cultural, psychological and behavioural perspectives toward IC process
Report on guidelines, standards and initiatives for improving informed consent in the healthcare context.

Open Research Data Pilot (3)

The impact of ICT on health literacy and comprehension of IC in different groups: gender, age groups, ethnic or religious
Systematic review of the use of digital technologies for IC

Open access scientific paper on systematic review of the use of digital technologies for IC

Validated guidelines for developing IC

Open access scientific paper on validated guidelines for developing IC

Websites, patent fillings, videos etc. (2)

Basic Communication Materials
Project website

Pubblicazioni

Peer reviewed articles (36)

Informed consent, clinical research, Covid-19 and contact tracing apps: some neuroethical concerns

Autori: Mirko Daniel Garasic
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2021, Pagina/e 85-95, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-848

Informed consent and group vulnerability in the context of the pandemic

Autori: Fabio Macioce
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2020, Pagina/e 17-33, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-844

Informed consent and artificial intelligence applied to RCT and Covid-19

Autori: Alberto Eugenio Tozzi, Giulia Cinelli
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2021, Pagina/e 97-108, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-849

Consenso informato alla ricerca clinica nell’ambito della pandemia covid-19: tra bioetica e biodiritto

Autori: L. Palazzani
Pubblicato in: BioLaw Journal. Rivista di BioDiritto, Numero n. 3/2020, 2020, ISSN 2284-4503
Editore: BioLaw Journal. Rivista di BioDiritto
DOI: 10.15168/2284-4503-710

Clinical trials in the time of a pandemic: implications for informed consent

Autori: Laura Palazzani
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2021, Pagina/e 35-50, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-845

The ethics of observational/epidemiological research conducted within the Covid-19 pandemic: implications for informed consent

Autori: Carlo Petrini
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2021, Pagina/e 51-60, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-846

The bioethical and bio-juridical debate regarding the use of biological samples and data for the purpose of genetic research on human health: open problems

Autori: Monica Toraldo di Francia
Pubblicato in: Biolaw Journal, Numero No 2S (2021). July 2021, 2021, Pagina/e 109-120, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-850

Digital tools in the Informed Consent process: a systematic review

Autori: Gesualdo, Francesco; Daverio, Margherita; Palazzani, Laura; Dimitriou, Dimitris; Diez-Domingo, Javier; Fons-Martinez, Jaime; Jackson, Sally; Vignally, Pascal; Rizzo, Caterina; Tozzi, Alberto Eugenio
Pubblicato in: BMC Medical Ethics, Numero 18, 2021, ISSN 1472-6939
Editore: BioMed Central
DOI: 10.21203/rs.2.10223/v1

Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies

Autori: Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Pubblicato in: BMC Medical Ethics, Numero 22/1, 2021, ISSN 1472-6939
Editore: BioMed Central
DOI: 10.1186/s12910-021-00708-1

Informed consent for clinical research in the context of the Covid-19 pandemic between bioethics and biolaw: a general overview

Autori: Laura Palazzani
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2019, Pagina/e 3-15, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-843

Ethical and regulatory issues in vaccine research in the pandemic context and in the case of human challenge studies: implications for informed consent

Autori: Margherita Daverio
Pubblicato in: Biolaw Journal, Numero No 2S (2021); July 2021, 2021, Pagina/e 63-84, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-847

How Spanish biobanks have adapted the informed consent process during the Covid-19 pandemic

Autori: Pablo Enguer-Gosálbez, Jaime Fons-Martínez, Jacobo Martínez-Santamaría, Ana María Torres-Redondo, Cristina Villena-Portella, Aurora García-Robles, Javier Díez-Domingo
Pubblicato in: Biolaw Journal, Numero No 2S (2021), July 2021, 2021, Pagina/e 121-138, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-851

i-CONSENT: presentation of the project and the importance of participants’ perspective in the informed consent process

Autori: Jaime Fons-Martínez, Cristina Ferrer-Albero, Rosanna Russell, Elizabeth Rodgers, Linda Glennie, Javier Díez-Domingo
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 3-10, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f396

Contents of the minor’s assent in medical research: differences between the scientific literature and the legal requirements

Autori: Jaime Fons-Martínez, Fernando Calvo Rigual, Javier Díez-Domingo, Leonardo Nepi, Loredana Persampieri, Cristina Ferrer-Albero
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 37-52, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f399

Why informed consent requires attention once more?

Autori: Laura Palazzani
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 1-2, ISSN 2284-4503
Editore: University of Trento

Ethical issues concerning the informed consent process in paediatric clinical trials: European guidelines and recommendations on minor’s assent and parental permission

Autori: Leonardo Nepi
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 53-63, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f400

Informed consent, experimentation and emerging ethical problems

Autori: Laura Palazzani
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 11-22, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f397

Gender and informed consent in clinical research: beyond ethical challenges

Autori: Loredana Persampieri
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 65-87, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f401

New strategies for increasing participation of patients from diverse cultural and religious backgrounds in clinical trials

Autori: Laura Palazzani, Fabio Macioce, Margherita Daverio, Valeria Ferro, Loredana Persampieri
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 101-122, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f403

Informed consent procedures between autonomy and trust

Autori: Fabio Macioce
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 23-35, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f398

Informed consent in translational/clinical research. Ethical issues according to international guidelines

Autori: Margherita Daverio
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 123-138, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f404

Legal aspects of informed consent in clinical research: the case of vaccinations in the international legal framework

Autori: Valeria Ferro
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 139-149, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f405

Interreligious and cross-cultural perspectives on informed consent in the light of human rights and mental privacy

Autori: Alberto Garcia, Mirko Daniel Garasic
Pubblicato in: BioLaw Journal - Rivista di BioDiritto, Numero No 1 (2019): Special Numero 1/2019, 2019, Pagina/e 89-100, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503%2f402

Ethical issues concerning informed consent in translational/clinical research and vaccination bias and informed consent

Autori: Alberto García Gómez, Mirko Daniel Garasic, María Cubillo Díaz-Valdés
Pubblicato in: Medicina y Ética, Numero Vol. 30 Núm. 2 (2019), 2019, ISSN 0188-5022
Editore: Universidad Anhauca

Reflecting and Adapting Informed Consent to fit within an Islamic Moral Landscape and in Muslim Contexts

Autori: Aasim Padela
Pubblicato in: Studia Bioethica, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

New Considerations on Informed Consent

Autori: Mirko Garasic, Alberto García
Pubblicato in: Studia Bioethica, Numero VOL 11 NO 2 (2018), EDITORIAL, 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

Informed Consent and Clinical Trials - A Jewish Perspective

Autori: David Heyd
Pubblicato in: Studia Bioethica, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

Informed consent – A Critical Response from a Buddhist Perspective

Autori: Ellen Zhang
Pubblicato in: Studia Bioethica, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

A Neurobioethical Perspective on Informed Consent

Autori: Andrea Lavazza
Pubblicato in: Studia Bioethica, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

Multicultural and interreligious perspectives on informed consent. The Christian perspective

Autori: Laura Palazzani
Pubblicato in: Studia Bioeticha, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

Agency, autonomy and consent: cues from the neuroscience of self-control

Autori: Elisabetta Sirgiovanni
Pubblicato in: Studia Bioethica, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

A Confucian View of Informed Consent and the Issue of Vaccination

Autori: Ruiping Fan
Pubblicato in: Studia Bioethica, Numero Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Editore: Pontifical Athanaeum Regina Apostolorum

How Covid-19 unveils the blurred borderlines between research and clinical practice monitoring: the use case of data protection and consent

Autori: Andrea Parziale, Giovanni Comandé, Denise Amram
Pubblicato in: Biolaw Journal, Numero No2S (2021); July 2021, 2021, Pagina/e 139-155, ISSN 2284-4503
Editore: University of Trento
DOI: 10.15168/2284-4503-852

Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach

Autori: Sally M. Jackson, Margherita Daverio, Silvia Lorenzo Perez, Francesco Gesualdo, Alberto E. Tozzi
Pubblicato in: Frontiers in Pediatrics, Numero 8, 2021, ISSN 2296-2360
Editore: Frontiers
DOI: 10.3389/fped.2020.520803

Ethical and legal requirements for biomedical research involving health data in the context of the Covid-19 pandemic: is informed consent still playing the leading role?

Autori: Federico de Montalvo Jääskeläinen
Pubblicato in: Biolaw Journal, Numero No 2S (2021), July 2021, 2021, Pagina/e 157-167, ISSN 2284-4503
Editore: Editor University of Trento
DOI: 10.15168/2284-4503-853

Premature consent and patient duties

Autori: Andrew P. Rebera, Dimitris Dimitriou
Pubblicato in: Medicine, Health Care and Philosophy, 2021, ISSN 1386-7423
Editore: Kluwer Academic Publishers
DOI: 10.1007/s11019-021-10024-5

Other (3)

Ethical, privacy, and data protection issues associated with the use of ICT for obtaining informed consent. Scene-Setting Report

Autori: Dimitriou, Dimitris; Lorenzo Pérez, Silvia
Pubblicato in: 2020
Editore: i-CONSENT Consortium
DOI: 10.5281/zenodo.4729581

Rethinking informed consent: Emerging challenges in the digital era (Workshop report)

Autori: Dimitriou, Dimitris; Lorenzo Pérez, Silvia; Diez-Domingo, Javier
Pubblicato in: 2020
Editore: i-CONSENT Consortium
DOI: 10.5281/zenodo.4729579

WP 1 Synthesis. A multi-layered approach to informed consent

Autori: Dimitriou, Dimitris; Rebera, Andrew
Pubblicato in: 2019
Editore: i-CONSENT Consortium
DOI: 10.5281/zenodo.4729622

Conference proceedings (9)

Contenidos del asentimiento del menor en investigación médica: diferencias entre la literatura científica y el requisito legal

Autori: Fons-Martínez J, Calvo Rigual F, Díez-Domingo J, Nepi L, Persampieri L, Ferrer Albero C.
Pubblicato in: 5º congreso ANCEI- Asociación Nacional de Comités de Ética de la Investigación. Libro de ponencias y comunicaciones., Numero 5. Annually, 2018, Pagina/e 129-133, ISBN 978-84-17194-37-6
Editore: Asociación Nacional de Comités de Ética de la Investigación

La comprensión de los documentos de asentimiento en investigación con menores: una revisión sistemática.

Autori: Calvo Rigual F, Fons-Martínez J, Díez-Domingo J, Ferrer Albero C
Pubblicato in: 5º congreso ANCEI- Asociación Nacional de Comités de Ética de la Investigación. Libro de ponencias y comunicaciones., Numero 5, Annually, 2018, Pagina/e 189-194, ISBN 978-84-17194-37-6
Editore: Asociación Nacional de Comités de Ética de la Investigación

Elementos a considerar en un documento de asentimiento para menores en investigación de vacunas: una revisión sistemática

Autori: Ferrer Albero, C., Fons-Martinez, J., Calvo Rigual, F., Díez Domingo, J.
Pubblicato in: IX Congreso de la Asociación Española de Vacunología. “Vacunología: grandes logros, nuevos retos”. Libro de abstracts, Numero 9, Annually, 2017, Pagina/e 22
Editore: Asociación Española de Vacunología

El uso de las redes sociales para el reclutamiento de participantes en ensayos clínicos: perspectiva de los comités de ética (CEI/CEIm)

Autori: Fons-Martinez J, Quesada AJ, Fernández de Uzquiano E, Ugalde Diez M, Hernández Gil A, Cubillo Díaz-Valdés M.
Pubblicato in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Numero 6, Annually, 2019, Pagina/e 77-82, ISBN 978-84-17844-10-3
Editore: ANCEI

La perspectiva de género en el proceso de consentimiento informado en investigación médica

Autori: Fons-Martinez J, Cubillo Díaz-Valdés M, Ferrer-Albero C, Díez-Domingo J.
Pubblicato in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Numero 6, Annually, 2019, Pagina/e 145-150, ISBN 978-84-17844-10-3
Editore: ANCEI

El proceso de consentimiento informado en investigación clínica: propuesta del proyecto i-CONSENT

Autori: Fons-Martinez J, Cubillo Díaz-Valdés M, Russell R, Ferrer-Albero C, Díez-Domingo J.
Pubblicato in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Numero 6, Annually, 2019, Pagina/e 151-156, ISBN 978-84-17844-10-3
Editore: ANCEI

How to strengthen the recommendations for the informed consent process in health-related studies: The i-CONSENT project methodology

Autori: Fons-Martínez J, García-Bayarri J, Díez-Domingo J
Pubblicato in: III National Congress of Young Researchers in Biomedicine. Book of Abstracts, Numero 3, Annually, 2019, Pagina/e 59
Editore: Centro de Investigación Príncipe Felipe

Proyecto i-CONSENT: desarrollo de guías para mejorar el proceso de elaboración de consentimientos informados implicando a todas las partes interesadas en el proceso de investigación.

Autori: Fons Martínez J, Ferrer Albero C, Russell R, Díez Domingo J.
Pubblicato in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Numero 6, Annually, 2019, Pagina/e 3-8, ISBN 978-84-17844-10-3
Editore: ANCEI

El concepto terapéutico errado en ensayos clínicos

Autori: M. Cubillo Díaz-Valdés, C. Ferrer Albero, J. Fons-Martínez, R. Boceta-Muñoz, O. Martínez-Casares, D. Dimitriou
Pubblicato in: Cuadernos de Bioética: Fundamentos de bioética, Numero No. 100, September 2019. Pg. 341, 2019, Pagina/e 341-341
Editore: Cuadernos de Bioética
DOI: 10.30444/cb.43

Book chapters (1)

DILEMMAS OF INFORMED CONSENT PROCESS IN CLINICAL RESEARCH FROM A MULTIRELIGIOUS PERSPECTIVE

Autori: Alberto García Gómez, Mirko Daniel Garasic
Pubblicato in: Good Health, Quality Education, Sustainable Communities, Human Rights. The scientific contribution of Italian UNESCO Chairs and partners to SDGs 2030, 2019, Pagina/e 47-56, ISSN 2704-5870
Editore: Firenze University Press
DOI: 10.5281/zenodo.3753980

Monographic books (2)

Guidelines For Tailoring The Informed Consent Process In Clinical Studies

Autori: i-CONSENT Consortium
Pubblicato in: 2021, ISBN 978-84-482-6547-2
Editore: Generalitat Valenciana
DOI: 10.5281/zenodo.4563938

Cross-Cultural and Religious Critiques of Informed Consent

Autori: Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic (Editors)
Pubblicato in: Routledge Focus on Religion, 2022, ISBN 9781003213215
Editore: Routledge
DOI: 10.4324/9781003213215