Beyond the five possibilities: Why was the international research in Darfur not submitted for ethical approval? A qualitative study

Abstract

Abstract Background We have conducted a systematic review of the eligible reports of the studies conducted in the war-roubles regions of Darfur, west Sudan between 2004 and 2012 and reported on the proportions of the studies that reported gaining ethical approval. The proportion of studies reporting ethical review was smaller than might be expected, so we suggest five explanations for these findings.Objective To examine whether the five possibilities we suggested in the previous review were a fair representation of the reasons why these studies did not report having ethical approval.Methods A qualitative case study was used that involved conducting interviews and focus groups with the relevant stakeholders, namely the representatives of the national and international non-governmental organizations, UN agencies, and the national humanitarian and research governance bodies in Sudan.Results 38 participants were involved (5 interviewees and 33 participants in the focus groups). The participants expressed a consensus on the need for an ethical oversight for research in the humanitarian settings in Sudan and particularly Darfur. However, there were eight reasons for not submitting the humanitarian research to ethical approval, which we are categorized under four main themes: I) lack consistency in defining research, II) time-related arguments and the low-risk nature of their studies, III) previous explicit or implied approval of the study or its used tools and IV) lack of awareness about or intention to apply for ethical review.Discussion We presented these themes and discussed both sides of each argument.Conclusion There is a need to revisit the mainstream ethical review governance mechanisms to meet the requirements of the humanitarian settings. Methodologically, this project provided additional insights and a model of how the qualitative methods can be used to complement our understanding of the quantitative data resulting from the systematic review alone.