Midwifery Practice: Perception of Respect for Ethical Standards on Free and Informed Consent by Finalists of the Instituts Supérieurs Des Techniques Médicales Du Congo

Abstract

Background: Free and informed consent (FIC) is, first and foremost, a privileged process of exchange between the researcher and the participant, from the beginning to the end of the research and even beyond. The participant will confirm his or her willingness to participate, after having been informed of all aspects of the study. The ELC takes the form of a written, signed and dated form. It must contain 21 items and be placed in the appendices of the brief. Our study has two objectives: to analyze the perception of the ELC among students; and to propose solutions to facilitate the conduct and respect of the participant's dignity. This qualitative study took place from May 19, 2021 to March 10, 2022. Data collection was conducted through focus groups (FGs) and individual interviews in neutral locations based on an evolving interview guide. Transcription was manual and data analysis was performed by grounded theory, after the realization of context of enunciation. Triangulation of data and researchers was respected. Eight GD and two individual interviews (46 subjects) were carried out to reach data saturation. Low interest in respecting the elements of the ELC, different definitions and negative views of the ELC were noted in the statements of the respondents. The majority of the ELC process (70%) does not respect GCP. The understanding and production of the form raises several ethical issues. It is appropriate to train supervisors and students in research ethics, evaluation and monitoring of research protocols.