de Medina-Moragas, Alejandro Jesús
Lima-Serrano, Marta http://orcid.org/0000-0003-3909-2718
Fernández-Fernández, María José
Lima-Rodríguez, Joaquín Salvador
Funding for this research was provided by:
Universidad de Sevilla
Article History
Accepted: 29 March 2024
First Online: 19 April 2024
Declarations
:
: All participants provided informed consent for inclusion before participating in the study after being appropriately informed. Ethical integrity was ensured by employing a multidisciplinary team, including mental health professionals, to rigorously and objectively evaluate the consent capacity of participants with SMI who were deemed unable to provide consent. Legal representatives were provided with regular training sessions to align their decisions with the participants’ interests, and communication barriers were addressed through iterative feedback processes. Simplified or adapted consent forms were used to facilitate participants’ understanding, and the study design allowed for the ongoing reassessment of consent and participant well-being. This comprehensive approach accommodated the complex needs of the SMI population while maintaining ethical standards. Appropriate steps were taken to ensure the provision of accurate information to participants through data confidentiality, archiving, and safekeeping of documents. This study was conducted in accordance with the ethical principles outlined in the 1964 Declaration of Helsinki and its later addenda. All procedures involving human participants were approved by the Biomedical Ethics Committee of Andalusia.
: Nothing to declare.