Ballesteros, Soledad
Rieker, Jennifer A.
Mayas, Julia
Prieto, Antonio
Toril, Pilar
Jiménez, María Pilar
Reales, José Manuel
Funding for this research was provided by:
MINECO (PSI2016-80377-R)
European Union H2020 (Nº 826506)
Article History
Received: 29 March 2019
Accepted: 30 March 2020
First Online: 14 May 2020
Ethics approval and consent to participate
: This clinical trial is registered on the ExternalRef removed database (NCT03823183). The Institutional Review Board of the Universidad Nacional de Educación a Distancia (UNED) approved the study protocol. All participants will sign a written consent form at the beginning of the study and will be informed that they can cease participation at any time. A written information form in Spanish will be provided to the participant during the first visit to the laboratory. The form includes information about the objectives of the study and a description of the investigation, as well as potential benefits and risks. The form invites the participant to ask the investigator all of the questions she/he considers necessary. The participant will be informed that participation in the study is voluntary and they can withdraw at any time for any reason. The written form will inform the participant that all personal data will be treated with confidentiality, according to the norms applicable to this type of study. The principal investigator will sign the information form. After answering all of the questions formulated by the participant, she/he will read the informed consent form. This form will assure that the participant has read the information form, has understood all its terms, has been sufficiently informed, and has been able to ask questions about the objectives and methodology of the study in which she/he is going to participate. The consent form will inform the participants of their right to refuse participation or to withdraw consent at any time as participation is voluntary and they can stop their participation at any time without giving explanations and without any undesirable repercussion. The form will include the name of the participant and the date on which the participant signs the informed consent form.The UNED Research Ethics Committee approved the study. The study will be conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013).
: None declared.