Abstract
Background:Obtaining genuine informed consent from research participants in developing countries can be difficult, partly due to poor knowledge about research process and research ethics. The situation is complicated when conducting genomic research on a disease considered familial and a reason for stigmatisation.Methods:We used a Rapid Ethical Appraisal tool to assess local factors that were barriers to getting genuine informed consent prior to conducting a genetic study of podoconiosis (non-filarial elephantiasis) in two Zones of Ethiopia. The tool included in-depth interviews and focus group discussions with patients, healthy community members, field workers, researchers/Institutional Review Board (IRB) members, elders, religious leaders, and podoconiosis administrators who work closely with patients.Results:Most patients and healthy community members did not differentiate research from routine clinical diagnosis. Participants felt comfortable when approached in the presence of trusted community members. Field workers and podoconiosis administrators preferred verbal consent, whereas the majority of patients and healthy community members prefer both verbal and written consent. Participants better understood genetic susceptibility concepts when analogies drawn from their day-to-day experience were used. The type of biological sample sought and gender were the two most important factors affecting the recruitment process. Most researchers and IRB members indicated that reporting incidental findings to participants is not a priority in an Ethiopian context.Conclusions:Understanding the concerns of local people in areas where research is to be conducted facilitates the design of contextualized consent processes appropriate for all parties and will ultimately result in getting genuine consent.
Highlights
Informed consent is a prerequisite for conducting ethical research on human participants
Therapeutic misconception occurs when participants do not understand the distinction between research and clinical care, and believe the purpose of their participation is to get some form of treatment rather than to generate new data
Ethical consideration Ethical approval was obtained from the Armauer Hansen Research Institute (AHRI)/All Africa Leprosy and Tuberculosis Rehabilitation and Training Centre (ALERT) Ethics Review Committee, Addis Ababa, Ethiopia and the National Research Ethics Review Committee, Addis Ababa, Ethiopia before conducting the study
Summary
Informed consent is a prerequisite for conducting ethical research on human participants. It is considered valid when participants (i) receive appropriate and comprehensive information, (ii) understand essential aspects of the research, (iii) voluntarily participate without any form of coercion, and (iv) agree to participate by giving either written or verbal consent Even though these principles are endorsed by many international and national ethics guidelines, the reality is far from this, and there is still a gap in achieving genuine informed consent, especially in studies conducted in developing countries. Some of the reasons for such misconceptions are high disease burden, poor access to health care, and low literacy levels in these countries[1] Another issue affecting the consent process is the extent to which a community or family interferes with the autonomous decision-making capacity of an individual. Conclusions: Understanding the concerns of local people in areas where research is to be conducted facilitates the design of contextualized consent
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