Open Access BASE2021

Guidelines for Tailoring the Informed Consent Process in Clinical Studies

Diez-Domingo, Javier; Fons-Martínez, Jaime; García-Bayarri, Júlia; Calvo Rigual, Fernando; Petrova Dobreva, Dafina; Vázquez-Moreno, Mónica; Morales Cuenca, Valle; Ferrer-Albero, Cristina; Egea-Ferrer, Miguel; García Gómez, Alberto; Montefusco, Serena; Palazzani, Laura; Macioce, Fabio; Daverio, Margherita; Garasic, Mirko Daniel; Nepi, Leonardo; Persampieri, Loredana; Martínez-Casares, Olga María; Boceta Muñoz, M. Reyes; Diaz-Valdes, María Cubillo; Rubio Pomar, Francisco Javier; López Santos, Elena; Dimitriou, Dimitris; Rebera, Andrew; Lorenzo Pérez, Silvia; Glennie, Linda; Russell, Rosanna; Rodgers, Elizabeth; Tozzi, Alberto; Jackson, Sally

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Abstract

These guidelines have been designed to provide information and evidence to assist with the development, or review of the consent process for use in clinical studies with human participants. These guidelines do not deal with issues related to informed consent in clinical practice. The guidelines have been developed by the i-CONSENT consortium. i-CONSENT (H2020, Grant Agreement number 741856) is a European Union H2020 funded program that aims to improve the information that individuals receive when deciding whether or not to take part in clinical studies.

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