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

Project Information

I-CONSENT

Grant agreement ID: 741856

DOI 10.3030/741856

Project closed

EC signature date 21 April 2017

Start date 1 May 2017

End date 31 March 2021

Funded under

• 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

Total cost € 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

Deliverables

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

Publications

Peer reviewed articles (36)

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

Author(s): Mirko Daniel Garasic
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2021, Page(s) 85-95, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503-848

Informed consent and group vulnerability in the context of the pandemic

Author(s): Fabio Macioce
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2020, Page(s) 17-33, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503-844

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

Author(s): Alberto Eugenio Tozzi, Giulia Cinelli
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2021, Page(s) 97-108, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503-849

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

Author(s): L. Palazzani
Published in: BioLaw Journal. Rivista di BioDiritto, Issue n. 3/2020, 2020, ISSN 2284-4503
Publisher: BioLaw Journal. Rivista di BioDiritto
DOI: 10.15168/2284-4503-710

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

Author(s): Laura Palazzani
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2021, Page(s) 35-50, ISSN 2284-4503
Publisher: 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

Author(s): Carlo Petrini
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2021, Page(s) 51-60, ISSN 2284-4503
Publisher: 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

Author(s): Monica Toraldo di Francia
Published in: Biolaw Journal, Issue No 2S (2021). July 2021, 2021, Page(s) 109-120, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503-850

Digital tools in the Informed Consent process: a systematic review

Author(s): Gesualdo, Francesco; Daverio, Margherita; Palazzani, Laura; Dimitriou, Dimitris; Diez-Domingo, Javier; Fons-Martinez, Jaime; Jackson, Sally; Vignally, Pascal; Rizzo, Caterina; Tozzi, Alberto Eugenio
Published in: BMC Medical Ethics, Issue 18, 2021, ISSN 1472-6939
Publisher: 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

Author(s): Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Published in: BMC Medical Ethics, Issue 22/1, 2021, ISSN 1472-6939
Publisher: 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

Author(s): Laura Palazzani
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2019, Page(s) 3-15, ISSN 2284-4503
Publisher: 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

Author(s): Margherita Daverio
Published in: Biolaw Journal, Issue No 2S (2021); July 2021, 2021, Page(s) 63-84, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503-847

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

Author(s): Pablo Enguer-Gosálbez, Jaime Fons-Martínez, Jacobo Martínez-Santamaría, Ana María Torres-Redondo, Cristina Villena-Portella, Aurora García-Robles, Javier Díez-Domingo
Published in: Biolaw Journal, Issue No 2S (2021), July 2021, 2021, Page(s) 121-138, ISSN 2284-4503
Publisher: 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

Author(s): Jaime Fons-Martínez, Cristina Ferrer-Albero, Rosanna Russell, Elizabeth Rodgers, Linda Glennie, Javier Díez-Domingo
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 3-10, ISSN 2284-4503
Publisher: 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

Author(s): Jaime Fons-Martínez, Fernando Calvo Rigual, Javier Díez-Domingo, Leonardo Nepi, Loredana Persampieri, Cristina Ferrer-Albero
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 37-52, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503%2f399

Why informed consent requires attention once more?

Author(s): Laura Palazzani
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 1-2, ISSN 2284-4503
Publisher: 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

Author(s): Leonardo Nepi
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 53-63, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503%2f400

Informed consent, experimentation and emerging ethical problems

Author(s): Laura Palazzani
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 11-22, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503%2f397

Gender and informed consent in clinical research: beyond ethical challenges

Author(s): Loredana Persampieri
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 65-87, ISSN 2284-4503
Publisher: 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

Author(s): Laura Palazzani, Fabio Macioce, Margherita Daverio, Valeria Ferro, Loredana Persampieri
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 101-122, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503%2f403

Informed consent procedures between autonomy and trust

Author(s): Fabio Macioce
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 23-35, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503%2f398

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

Author(s): Margherita Daverio
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 123-138, ISSN 2284-4503
Publisher: 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

Author(s): Valeria Ferro
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 139-149, ISSN 2284-4503
Publisher: 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

Author(s): Alberto Garcia, Mirko Daniel Garasic
Published in: BioLaw Journal - Rivista di BioDiritto, Issue No 1 (2019): Special Issue 1/2019, 2019, Page(s) 89-100, ISSN 2284-4503
Publisher: University of Trento
DOI: 10.15168/2284-4503%2f402

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

Author(s): Alberto García Gómez, Mirko Daniel Garasic, María Cubillo Díaz-Valdés
Published in: Medicina y Ética, Issue Vol. 30 Núm. 2 (2019), 2019, ISSN 0188-5022
Publisher: Universidad Anhauca

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

Author(s): Aasim Padela
Published in: Studia Bioethica, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

New Considerations on Informed Consent

Author(s): Mirko Garasic, Alberto García
Published in: Studia Bioethica, Issue VOL 11 NO 2 (2018), EDITORIAL, 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

Informed Consent and Clinical Trials - A Jewish Perspective

Author(s): David Heyd
Published in: Studia Bioethica, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

Informed consent – A Critical Response from a Buddhist Perspective

Author(s): Ellen Zhang
Published in: Studia Bioethica, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

A Neurobioethical Perspective on Informed Consent

Author(s): Andrea Lavazza
Published in: Studia Bioethica, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

Multicultural and interreligious perspectives on informed consent. The Christian perspective

Author(s): Laura Palazzani
Published in: Studia Bioeticha, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

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

Author(s): Elisabetta Sirgiovanni
Published in: Studia Bioethica, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: Pontifical Athanaeum Regina Apostolorum

A Confucian View of Informed Consent and the Issue of Vaccination

Author(s): Ruiping Fan
Published in: Studia Bioethica, Issue Vol 11 No 2 (2018), 2018, ISSN 2281-504X
Publisher: 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

Author(s): Andrea Parziale, Giovanni Comandé, Denise Amram
Published in: Biolaw Journal, Issue No2S (2021); July 2021, 2021, Page(s) 139-155, ISSN 2284-4503
Publisher: 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

Author(s): Sally M. Jackson, Margherita Daverio, Silvia Lorenzo Perez, Francesco Gesualdo, Alberto E. Tozzi
Published in: Frontiers in Pediatrics, Issue 8, 2021, ISSN 2296-2360
Publisher: 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?

Author(s): Federico de Montalvo Jääskeläinen
Published in: Biolaw Journal, Issue No 2S (2021), July 2021, 2021, Page(s) 157-167, ISSN 2284-4503
Publisher: Editor University of Trento
DOI: 10.15168/2284-4503-853

Premature consent and patient duties

Author(s): Andrew P. Rebera, Dimitris Dimitriou
Published in: Medicine, Health Care and Philosophy, 2021, ISSN 1386-7423
Publisher: 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

Author(s): Dimitriou, Dimitris; Lorenzo Pérez, Silvia
Published in: 2020
Publisher: i-CONSENT Consortium
DOI: 10.5281/zenodo.4729581

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

Author(s): Dimitriou, Dimitris; Lorenzo Pérez, Silvia; Diez-Domingo, Javier
Published in: 2020
Publisher: i-CONSENT Consortium
DOI: 10.5281/zenodo.4729579

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

Author(s): Dimitriou, Dimitris; Rebera, Andrew
Published in: 2019
Publisher: 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

Author(s): Fons-Martínez J, Calvo Rigual F, Díez-Domingo J, Nepi L, Persampieri L, Ferrer Albero C.
Published in: 5º congreso ANCEI- Asociación Nacional de Comités de Ética de la Investigación. Libro de ponencias y comunicaciones., Issue 5. Annually, 2018, Page(s) 129-133, ISBN 978-84-17194-37-6
Publisher: Asociación Nacional de Comités de Ética de la Investigación

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

Author(s): Calvo Rigual F, Fons-Martínez J, Díez-Domingo J, Ferrer Albero C
Published in: 5º congreso ANCEI- Asociación Nacional de Comités de Ética de la Investigación. Libro de ponencias y comunicaciones., Issue 5, Annually, 2018, Page(s) 189-194, ISBN 978-84-17194-37-6
Publisher: 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

Author(s): Ferrer Albero, C., Fons-Martinez, J., Calvo Rigual, F., Díez Domingo, J.
Published in: IX Congreso de la Asociación Española de Vacunología. “Vacunología: grandes logros, nuevos retos”. Libro de abstracts, Issue 9, Annually, 2017, Page(s) 22
Publisher: 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)

Author(s): Fons-Martinez J, Quesada AJ, Fernández de Uzquiano E, Ugalde Diez M, Hernández Gil A, Cubillo Díaz-Valdés M.
Published in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Issue 6, Annually, 2019, Page(s) 77-82, ISBN 978-84-17844-10-3
Publisher: ANCEI

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

Author(s): Fons-Martinez J, Cubillo Díaz-Valdés M, Ferrer-Albero C, Díez-Domingo J.
Published in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Issue 6, Annually, 2019, Page(s) 145-150, ISBN 978-84-17844-10-3
Publisher: ANCEI

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

Author(s): Fons-Martinez J, Cubillo Díaz-Valdés M, Russell R, Ferrer-Albero C, Díez-Domingo J.
Published in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Issue 6, Annually, 2019, Page(s) 151-156, ISBN 978-84-17844-10-3
Publisher: ANCEI

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

Author(s): Fons-Martínez J, García-Bayarri J, Díez-Domingo J
Published in: III National Congress of Young Researchers in Biomedicine. Book of Abstracts, Issue 3, Annually, 2019, Page(s) 59
Publisher: 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.

Author(s): Fons Martínez J, Ferrer Albero C, Russell R, Díez Domingo J.
Published in: VI Congreso ANCEI. Trabajando juntos para mejorar el debate ético en la investigación biomédica, Issue 6, Annually, 2019, Page(s) 3-8, ISBN 978-84-17844-10-3
Publisher: ANCEI

El concepto terapéutico errado en ensayos clínicos

Author(s): M. Cubillo Díaz-Valdés, C. Ferrer Albero, J. Fons-Martínez, R. Boceta-Muñoz, O. Martínez-Casares, D. Dimitriou
Published in: Cuadernos de Bioética: Fundamentos de bioética, Issue No. 100, September 2019. Pg. 341, 2019, Page(s) 341-341
Publisher: Cuadernos de Bioética
DOI: 10.30444/cb.43

Book chapters (1)

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

Author(s): Alberto García Gómez, Mirko Daniel Garasic
Published in: Good Health, Quality Education, Sustainable Communities, Human Rights. The scientific contribution of Italian UNESCO Chairs and partners to SDGs 2030, 2019, Page(s) 47-56, ISSN 2704-5870
Publisher: Firenze University Press
DOI: 10.5281/zenodo.3753980

Monographic books (2)

Guidelines For Tailoring The Informed Consent Process In Clinical Studies

Author(s): i-CONSENT Consortium
Published in: 2021, ISBN 978-84-482-6547-2
Publisher: Generalitat Valenciana
DOI: 10.5281/zenodo.4563938

Cross-Cultural and Religious Critiques of Informed Consent

Author(s): Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic (Editors)
Published in: Routledge Focus on Religion, 2022, ISBN 9781003213215
Publisher: Routledge
DOI: 10.4324/9781003213215