Abstract
BackgroundInformed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment (REA) to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial.MethodsThis REA was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach.ResultMost of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized.ConclusionThrough REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient.
Highlights
Informed consent is a universally accepted precondition for scientific researches involving human participants
A study conducted in Ethiopia revealed that 95.4% of health researchers and regulators asserted the need to contextualize consent to the study setting and the need to conduct Rapid Ethical Assessment (REA) during the pre-test phase of studies was suggested in settings where the ethical issues were not already mapped out [6]
The REA enabled the understanding of the community, their research awareness, expectation, and the cultural norms relevant to the scientific ethical standards
Summary
Informed consent is a universally accepted precondition for scientific researches involving human participants. Various factors influence the process of obtaining authentic informed consent, and researchers working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment (REA) to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial. In Ethiopia, for example, 84.6% of health researchers and regulators reported a lack of satisfaction with the current informed consent process This may be related to their evaluation where they thought that the consent process and the information given were not adequately understood by study participants and the best interests of study participants were not sufficiently considered. They reported a lack of clarity and inadequacy of information, inappropriate use of language and terminologies, failure to consider cultural differences, power imbalances, coercion, and undue expectations of the community in the consent process of the Ethiopian medical research context [6]
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