Document is current

Article History

Received: 15 February 2020

Accepted: 14 December 2020

First Online: 11 January 2021

Ethics approval and consent to participate

: The Ethics and Research Committee of Malaga granted the approval for this trial. The regulations on Good Clinical Practice will be observed at all times, as well as the ethical principles established for the research on human beings stipulated in the Declaration of Helsinki and further amendments thereto. The clinical information will remain separate from the identification details, and the databases will be coded and stored in specific computers solely intended for the project. All the records will be made observing all the dispositions from the legislation in force with regard to personal data protection according to the Act 15/1999 dated 13 December, as well as on safety files which may store personal data information, and more specifically, with regard to the access through communication networks (Royal Decree 994/1999 dated 11 June) and access to confidential information for scientific purposes from the Commission Regulation CE No. 831/2002 by the European Union and Act 41/2002 dated 14 November, which is considered the legal standard on Patient’s Autonomy and Rights and Duties in terms of Clinical Information and Documentation. The staff responsible for such purpose will manage the data according to the instructions provided by the person responsible for the treatment. Such data will not be applied or used for a different purpose than those stated in the respective authorization; neither will they be reproduced to other people even for registration purposes. Once the aim of the trial has been carried out, the personal data collected will be destroyed, deleted, or given back to the person responsible for the treatment, along with any other media or documents containing any personal data related to the project. Every patient will be informed verbally and in writing about the objectives of the project and its methodology. Each individual will sign the respective informed consent form. On the consent form, participants will be asked if they agree to the use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the Universities taking part in the research or from regulatory authorities, where relevant. This trial involves collecting biological specimens for storage.

: All the authors gave their consent to take part in the study.

: The authors declare that they have no competing interests.