02862nas a2200241   4500000000100000008004100001653002500042653001300067653002100080653001300101653002100114100001100135700001500146700001200161700001500173700001500188245013100203856008900334300001300423490000700436520216300443022001402606       2016                            d10aQualitative Research10aLiteracy10aInformed Consent10aEthiopia10aCultural aspects1 aAbay S1 aAddissie A1 aDavey G1 aFarsides B1 aAddissie T00aRapid ethical assessment on informed consent content and procedure in Hintalo-Wajirat, Northern Ethiopia: A qualitative study.  uhttp://journals.plos.org/plosone/article/asset?id=10.1371%2Fjournal.pone.0157056.PDF  ae01570560 v113 a<p><strong>BACKGROUND: </strong>Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study.</p>

<p><strong>METHODOLOGY: </strong>A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes.</p>

<p><strong>RESULTS: </strong>The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study.</p>

<p><strong>CONCLUSION: </strong>This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.</p>
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