Rapid Ethical Appraisal: A tool to design a contextualized consent process for a genetic study of podoconiosis in Ethiopia

Abstract

Obtaining genuine informed consent from research participants Background: 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.We used a Rapid Ethical Appraisal tool to assess local factors that Methods: 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.Most patients and healthy community members did not differentiate Results: 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. research is to be conducted facilitates the design of contextualized consent processes appropriate for all parties and will ultimately result in getting genuine consent.

Knowledge, attitude, and practice towards epilepsy among religious cleric and traditional healers of Addis Ababa, Ethiopia

“…Before data collection, study participants were given the choice of verbal or written consent, and all of the participants consented verbally. Verbal consenting is established as an appropriate and preferred mode of consenting for a given social and community structure in Ethiopia [34,35]. After data collection, study participants were allowed to discuss epilepsy issues with public health experts.…”

Replication of HLA class II locus association with susceptibility to podoconiosis in three Ethiopian ethnic groups

“…Written informed consent was obtained from each participant before enrolling them in the study. Rapid ethical appraisals was undertaken in all three study communities before sample collection began 58 , 59 . This qualitative approach used focus groups and in-depth interviews to explore the views and concerns of the community and other stakeholders regarding the study and research more generally.…”

Rapid Evaluations of Innovations: A Scoping Review

“…Finally, we found an example of a method of increasing rapidity by making part of a study more rapid which was only identi ed in LMIC contexts but may be particularly relevant to disadvantaged or marginalised participants in the UK. Six studies used preparatory methods to ensure informed consent so that enrolment for subsequent studies could be undertaken rapidly because necessary groundwork had been undertaken (99,(125)(126)(127)(128)(129). We note that some of our excluded studies from LMIC described their methods as 'rapid' but with limited information on what promoted rapidity.…”