De Brauwer, Isabelle
Cornette, Pascale
D’Hoore, William
Lorant, Vincent
Verschuren, Franck
Thys, Frédéric
Aujoulat, Isabelle
Article History
Received: 26 January 2021
Accepted: 30 August 2021
First Online: 14 September 2021
Declarations
:
: All methods were performed in accordance with the relevant guidelines and regulations. The study, its qualitative method and the written informed consent process with the emergency department Head was approved by the IRB Biomedical Ethics Commission Hospital-Faculty of UCLouvain (2010/25jui/81). The ethical officials of the three anonymized hospitals in which the observations were conducted gave their written approval to the study.The study used naturalistic observations conducted in collectivities, i.e. emergency departments. This implies adaptation of ethical consent [CitationRef removed–CitationRef removed].First, an informed consent form has been submitted to the relevant institutional officials following recommendations for naturalistic observation of a process. Written informed consent was obtained from the ED head, as representative of the emergency department staff, after a presentation of the study to the staff of the departments, as a group.Second, the researcher (IDB), a geriatrician, was an overt non-participant. Professionals, patients, and/or relatives were informed about the researcher’s role; a written research summary, including contact information, was available on request. Verbal consent was systematically and directly requested by IDB from all those present during the study, including ED staff, patients and their family/carers, prior to observation. Contact information and prolonged immersion in the wards allowed to create the conditions to exercise free informed consent at any time. This respects the key principle of human autonomy. Moreover, potential harms arising from participation in the research were considered as no greater than those arising under usual practice.Specifically, and although they were not direct subjects of the research, the patients were an important concern throughout the observation process. We supported a not strictly normative ethical attitude, which sought to preserve the principle of autonomy and non-maleficence towards patients. IDB therefore systematically informed patients about her presence, the aim and modalities of the study, answered any questions, asked for verbal consent, and made her contact details available. When patients suffered from overt cognitive impairment, this process was performed with a relative, present on site. If this could not be achieved, the observations were directed towards the professionals rather than the patients themselves, aiming to respect their intimacy, while not soliciting them for the research (<i>primum non-nocere</i>).Finally, all data were pseudonymized and remained confidential.
: Written informed consent was obtained from the emergency department head.
: The authors declare that they have no competing interests.