Background To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies. Methods Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes. Results Review identified 30 relevant studies. We (...) identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies. Conclusions This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies. Trial Registration This trial was not registered as scoping reviews can not be registered as per updated PROSPERO guidelines. (shrink)

School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential (...) threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents. (shrink)

Bien que le travail humanitaire soit lié à des questions éthiques parfois préoccupantes, aucune revue de la littérature n’a jusqu’à présent décrit ces questions et les réponses possibles. Suivant la méthode proposée par McCullough, Coverdale et Chervenak, une revue critique de la littérature a été réalisée afin de combler cette lacune dans la littérature existante. 83 articles ont été sélectionnés pour être analysés et 25 unités de sens ont émergé, qui ont été regroupées en trois grandes catégories de questions éthiques (...) : 1) expériences éthiques subjectives, 2) problèmes éthiques pratiques et 3) politique et pouvoir. En termes de réponses possibles à ces questions, six articles proposent des réponses de nature préventive ou réparatrice. Au final, bien que le corpus de textes étudiés soit dominé par les expériences souvent riches, parfois anecdotiques, des acteurs de terrain du travail humanitaire, peu de recherches empiriques ont été menées à ce jour pour identifier les enjeux éthiques liés à cette pratique et les réponses possibles à ces enjeux. De même, aucune des réponses proposées n’a été testée empiriquement afin d’en déterminer la pertinence et l’efficacité. (shrink)