Guidelines

Guidelines for tailoring the Informed Consent Process in Clinical Research

Deliverables

D1.1 Report on guidelines, standards and initiatives for improving informed consent in the healthcare context.

D1.3 Ethical and legal review of the informed consent.

D1.5 Legal issues concerning informed consent in translational/clinical research and vaccination.

D1.2 Report on gender and age-related issues associated with the acquisition of informed consent.

D1.4 Ethical issues concerning informed consent in translational/clinical research and vaccination

D1.6 Patient involvement in vaccine research.

D1.7 Socio-cultural, psychological and behavioural perspectives towards informed consent process.

Publications

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

Spanish National Asociation of Research Ethics Commitees (ANCEI) V Congress. Text in Spanish.

Contenidos del asentimiento del menor en investigación médica: diferencias entre la literatura científica y el requisito legal. [Communication award]

Spanish National Asociation of Research Ethics Commitees (ANCEI) V Congress. Text in Spanish.

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

Medicina y Ética.

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Dilemmas of informed consent process in clinical research from a multireligious perspective

Good Health, Quality Education, Sustainable Communities, Human Rights.

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

ConBioPreVal Book of Abstracts.

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La perspectiva de género en el proceso de Consentimiento Informado en la Investigación Médica

Spanish National Asociation of Research Ethics Commitees (ANCEI) VI Congress. Text in Spanish.

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El proceso de Consentimiento Informado en investigación clínica: propuesta del proyecto i-CONSENT

Spanish National Asociation of Research Ethics Commitees (ANCEI) VI Congress. Text in Spanish.

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Proyecto i-CONSENT: Desarrollo de guías para mejorar los procesos de Consentimiento Informado implicando a todas las partes interesadas en el proceso de investigación

Spanish National Asociation of Research Ethics Commitees (ANCEI) VI Congress. Text in Spanish.

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El uso de las Redes Sociales para el reclutamiento de participantes en ensayos clínicos: perspectiva de los Comités de Ética (CEI/CEIm)

Spanish National Asociation of Research Ethics Commitees (ANCEI) VI Congress. Text in Spanish.

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

BioLaw Journal. Rivista di BioDiritto.

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Informed consent, experimentation and emerging ethical problems

BioLaw Journal. Rivista di BioDiritto.

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Why informed consent requires attention once more?

BioLaw Journal. Rivista di BioDiritto.

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

BioLaw Journal. Rivista di BioDiritto.

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

BioLaw Journal. Rivista di BioDiritto.

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Informed consent procedures between autonomy and trust

BioLaw Journal. Rivista di BioDiritto.

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Gender and informed consent in clinical research: beyond ethical challenges

BioLaw Journal. Rivista di BioDiritto.

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

BioLaw Journal. Rivista di BioDiritto.

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

BioLaw Journal. Rivista di BioDiritto.

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

BioLaw Journal. Rivista di BioDiritto.

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

BioLaw Journal. Rivista di BioDiritto.

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Il Consenso Informato. Informed Consent in Clinical Research: Interdisciplinary and Cross-Cultural Perspectives

Studia Bioethica. Rivista della Facoltà di Bioethica dell’Ateneo Pontificio Regina Apostolorum.

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El concepto terapéutico errado en ensayos clínicos

Cuadernos de Bioética, oficial publication from the Spanish Asociation of Bioethics and Medical Ethics. Text in Spanish.

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Informed consent in biomedical research in the pandemic context: between bioethics and biolaw

BioLaw Journal. Rivista di BioDiritto. Text in Italian. 

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

Frontiers in Pediatrics. 

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Digital tools in the informed consent process: a systematic review

BMC Medical Ethics

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Premature consent and patient duties

Medicine, Health Care and Philosophy journal

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Informed Consent in clinical trials in the context of the COVID-19 pandemic. Ethical and legal challenges

Special issue (12 articles) in BioLaw Journal. Rivista di BioDiritto. 

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

BMC Medical Ethics

Posters

V Congreso ANCEI
36th ESPID Annual Meeting 2018
ConBioPreVal 2019
VI Congreso ANCEI
VI Congreso de ANCEI
38th ESPID Annual Meeting 2020
38th ESPID Annual Meeting 2020