Cuervo-Suarez, María Isabel
Cleves, Daniela
Duque-Nieto, Natalia
Claros-Hulbert, Angélica
Molina-Gómez, Karen
Bolaños-Lopez, Jhon Edwar
Tello-Cajiao, María Elena
Baker, Justin N
McNeil, Michael J.
García-Quintero, Ximena
Article History
Received: 12 August 2023
Accepted: 17 January 2024
First Online: 2 February 2024
Declarations
:
: Ethics approval: The Institutional Ethics Committee of the Fundación Valle de Lili reviewed and approved the research protocol for this study (Protocol No. 1160). Our study fully adheres to the relevant Colombian regulations: Article 11 of Resolution 8430 (1993) issued by the Colombian Ministry of Health stipulates that studies presenting no risks to participants are exempt from obtaining informed consent. Our research aligns with this classification, as it employs retrospective documentary research techniques, avoiding any intentional intervention or modification of biological, physiological, psychological, or social variables among the participants. These techniques encompass medical record reviews, interviews, questionnaires, and other approaches that neither identify nor address sensitive aspects of their behavior. Furthermore, Article 16, paragraph 1 of the same resolution empowers the ethics committee of the research institution to grant an exemption from obtaining informed consent when justified, specifically in the case of research devoid of risks. We wish to emphasize that our study underwent rigorous evaluation and received approval from the Ethics Committee of Fundación Valle del Lili (approval number 1160). This review process, conducted in strict accordance with these guidelines, confirmed the absence of any risk to the participants.
: Not applicable.
: The authors declare no competing interests.