Interventional study on the effect of rapid ethical assessment on informed consent comprehension and quality of informed consent process, and associated factors in biomedical research in Wukiro kilte-awulaelo and Hintalo-wajirat districts, Tigray, Ethiopia
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Date
2014-04
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Addis Abeba Universty
Abstract
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.
Methods: 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.
Result: 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<0.000, 95% CI= 24.0%-33.4%).
Educational level of secondary and above (AOR= 6.68, 95% CI=1.01- 44.03), Previous participation in any biomedical research (AOR=2.77, 95% CI=1.01-7.58), being Merchants by occupation (AOR=5.43, 95% CI=1.78-16.60) and having monthly income less than 1000.00 Ethiopian birr (AOR= 0.38, 95%
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CI=0.15-0.96) were found significantly associated with comprehension score status. Concerning the quality of informed consent process the mean scores for the intervention group was 89.1% and for control group was 78.5%. The mean difference in quality of informed consent process was 10.5% (P<0.000, 95% CI =6.8-14.2). No significant association was found between socio-demographic variables and quality of informed consent process taking a mean score of 75% as a cut point.
Conclusion and recommendation: The level informed consent comprehension, recruitment rate, compliance rate and quality of consent process among the control group were low as compared to the intervention group. These were improved through modifying the consent form and information sheet locally and contextually tailored to the study area based on REA findings. This implies that potential study participant in a research can be assisted to comprehend consent components, and subsequently comply with further tasks to be performed. Therefore, it is recommended that REA to be further used to address gaps on comprehension and quality of informed consent process.
Key words: modified and standard consent forms, recruitment rate, compliance rate, Informed consent comprehension level, Quality of informed consent process, Rapid Ethical Assessment (REA), Ethiopia
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Keywords
modified and standard consent forms, recruitment rate, compliance rate, Informed consent comprehension level, Quality of informed consent process, Rapid Ethical Assessment (REA), Ethiopia