02566nas a2200253   4500000000100000008004100001653003900042653001700081653002100098653001300119653001700132653001100149100001900160700001400179700001300193700001500206700001300221700001200234700001400246700001900260700001500279245012800294520189000422       2017                            d10aNeglected tropical diseases (NTDs)10aPodoconiosis10aInformed Consent10aEthiopia10aFocus Groups10aEthics1 aGebresilase TT1 aDeresse Z1 aTsegay G1 aTessema TS1 aAseffa A1 aDavey G1 aNewport M1 aTekola-Ayele F1 aAddissie A00aRapid ethical appraisal: A tool to design a contextualized consent process for a genetic study of podoconiosis in Ethiopia.3 a<p>Background:<br />
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.<br />
Methods:<br />
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.<br />
Results:<br />
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.<br />
Conclusions:<br />
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.</p>