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

Obtaining valid informed consent from research participants in low-income settings can be difficult, partly due to participants' limited familiarity with scientific research concepts. The situation is complicated when conducting genomic research on a stigmatizing familial disease.

We used Rapid Ethical Appraisal as a tool to assess local factors that were barriers to obtaining valid 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 care coordinators (charity staff who support treatment clinics).

Most patients and healthy community members did not differentiate research from routine clinical care (therapeutic misconception). Participants felt comfortable when approached in the presence of trusted community members. Regarding the mode of consent, field workers and care coordinators preferred verbal consent, whereas the majority of patients and healthy community members suggested the use of both verbal and written consent to accommodate varying literacy levels. Participants better understood genetic susceptibility concepts when analogies drawn from their day-to-day experience were used. Field workers and care coordinators considered the type of biological sample sought and gender were the most critical 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.

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 obtaining valid consent.