Abstract
BackgroundRapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.MethodsMixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities.ResultsIn their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed.ConclusionThe study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.
Highlights
Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts
Study area The study was conducted between July and September 2012, in four major Ethiopian health research centres: Addis Ababa University (AAU), the Ethiopian Health and Nutrition Institute (EHNRI), Jima University (JU) and the University of Gondar (UoG)
Most (82.2%) were from the four target institutions AAU, EHNRI, JU and UoG; the rest were from the Armauer Hansen Research Institute (AHRI) the Federal Ministry of Health (FMOH), the Ministry of Science and Technology (MoST) or the Ethiopian Public Health Association (EPHA), who were collaborators on research projects with the four main target institutions
Summary
Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. As elsewhere, the consent process in lowincome settings is subject to influence from cultural beliefs and values. It is desirable to ensure that community members are involved in the local application of universal ethical values [3]. Assessment and monitoring of the process of informed consent are essential and are the joint responsibility of the local ethics review committee and the research sponsors. Whilst the concept and application of the doctrine of informed consent should be standardized and applied in the same way in any setting, the process of seeking consent quite appropriately varies. Researchers working collaboratively with local investigators and communities should be creative in designing approaches to acquiring informed consent in particular cultural environments [5]
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