Back ground: Informed consent is a corner stone in researches involving human participants. The process of obtaining informed consent is a challenge for low-literacy and resource-limited settings. Potential research participant should be assisted with interventions to improve their comprehension. Rapid Ethical Assessment (REA) is an intervention developed to contextualize consent processes in low-income setting. An interventional study was done to evaluate the effects REA on recruitment rate, compliance rate, comprehension level and quality of the informed consent process among participants of biomedical research.rnMethods: A community based qualitative study followed by institutional based interventional study was employed among pregnant women of age 18-45 years in Wukiro kilte-awulaelo and Hintalo-wajirat districts, Tigray regional state, Ethiopia from July 8 to August 20, 2013. The intervention was modifications in the informed consent content and process based on community based qualitative REA findings. This qualitative REA study was done among key informants in the intervention site concerning biomedical research, cancer in general and cervical cancer particularly, communication channel, socio-cultural dynamics, sample collection and how to find informed volunteer participants with fully understanding for the parent study. We did a total of 11 formal recorded In-depth Interviews (IDIs), and 5 Focused Group Discussions (FGDs) with key informants. A total of 300 healthy pregnant women who were eligible for the Parent Study were included in this study. One hundred fifty were allocated in to intervention group with modified and 150 in to control group with the standard informed consent forms and procedures. In both group comprehension levels and quality of consent process were measured using Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively.rnResult: The initial recruitment rate to participate in the parent study for the intervention and control groups were 88.7% and 80.7%, respectively. The compliance rate to show follow-up 12 days after initial consent were 85.7% for the intervention group and 70.3% for control group. Overall mean score of informed consent comprehension for the intervention and control groups were 73.1% and 45.2%, respectively. Mean difference in comprehension score was 27.9% (P