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Table 8 Comparison of mean quality of informed consent process (QuIC) score from the participant’s perspective by intervention group in WukiroKilte-Awulaelo and Hintal-wajiratdistricts, Tigray region, Northern Ethiopia, July 2013

From: Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting

Informed consent process components Quality of IC (Mean %)  
Intervention (n = 114) Control (n = 85) Mean difference (95 % CI) P value
There was sufficient time for consent discussion. [Agree] 93.9 82.4 11.5 (2.7, 20.3) 0.010
Agreed to participate in this study voluntarily and with full understanding. [Agree] 100 87.1 12.9 (6.7, 19.2) <0.001
Enrolment decision made mainly by me the respondent. [Agree] 99.1 92.9 6.2 (1.0, 11.3) 0.019
Discussed about the research with other patients or participants. [Agree] 91.2 17.6 8.9 (0.5, 18.2) 0.062
Consent form read or explained carefully. [Agree] 82.5 81.2 1.3 (-9.7 , 12.2) 0.818
Consent form was important source of information. [Agree] 92.1 88.2 3.9 (-4.5 , 12.2) 0.361
Consent form was easy to understand. [Agree] 97.4 90.6 6.8 (0.4, 13.2) 0.039
Consent form was important to the decision. [Agree] 95.6 95.3 0.3 (-5.6, 6.2) 0.915
Pressure from provider to sign/agree consent form. [Disagree] 95.6 76.5 19.1 (10.1, 28.2) <0.001
Sufficient opportunity to ask questions. [Agree] 95.6 67.1 28.6 (18.8, 38.3) <0.001
Questions answered thoroughly by the consent provider. [Agree] 99.1 74.1 25.0 (16.6, 33.4) <0.001
Satisfied with informed consent process. [Agree] 99.1 81.2 17.9 (10.4, 25.5) <0.001
Decision to participate was easy or very easy. [Agree] 99.1 87.1 12.1 (5.5, 18.6) <0.001
Mean score of Quality of informed consent 89.06 78.53 10.5 (6.8, 14.2) <0.001