title: A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.
abstract: BACKGROUND
  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. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.
  
  
  METHODS
  Mixed 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.
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Brighton and Sussex Medical School, Falmer, UK. adamuaddis@yahoo.com.
authors.forename: Adamu
authors.initials: A
authors.lastname: Addissie
authors.forename: Gail
authors.initials: G
authors.lastname: Davey
authors.forename: Melanie J
authors.initials: MJ
authors.lastname: Newport
authors.forename: Thomas
authors.initials: T
authors.lastname: Addissie
authors.forename: Hayley
authors.initials: H
authors.lastname: MacGregor
authors.forename: Yeweyenhareg
authors.initials: Y
authors.lastname: Feleke
authors.forename: Bobbie
authors.initials: B
authors.lastname: Farsides
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D017041:Ethics Committees; D005002:Ethiopia; D007722:Health Knowledge, Attitudes, Practice; D006302:Health Services Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D008297:Male; D008875:Middle Aged; D000091402:Prohibitins; D036301:Qualitative Research; D012108:Research Personnel / Q000941:ethics*; D035842:Research Subjects; D011795:Surveys and Questionnaires