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

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posted on 2023-06-21, 06:02 authored by Adamu Addissie, Serebe Abay, Yeweyenhareg Feleke, Melanie NewportMelanie Newport, Bobbie FarsidesBobbie Farsides, Gail DaveyGail Davey
Background Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process. Methods A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively. Result Study recruitment rates were 88.7 % and 80.7 % (p =?0.05), while study retention rates were 85.7 % and 70.3 % (p?

History

Publication status

  • Published

File Version

  • Published version

Journal

BMC Medical Ethics

ISSN

1472-6939

Publisher

BioMed Central

Issue

1

Volume

17

Page range

1-12

Article number

a40

Department affiliated with

  • BSMS Publications

Research groups affiliated with

  • Centre for Global Health Policy Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-11-09

First Open Access (FOA) Date

2016-11-09

First Compliant Deposit (FCD) Date

2016-11-09

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