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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