Perspective and Experiences of Researchers regarding Informed Consent for Biorepositories in Ethiopia: A Qualitative Study
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Date
2024-07
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Addis Ababa University
Abstract
Background: Informed consent in biorepository-based research is a highly debated issue in the
scientific community. Unlike one-time consent for a specific study, broad consent is required for
future use of biospecimens. However, providing sufficient information about future research poses
ethical challenges, making informed consent complex. Additionally, the use of complex procedures
and terminology can make it difficult for individuals to fully comprehend the scope of their consent.
As a result, the question of whether informed consent can be considered valid is a contentious and
multifaceted issue. Given the significant increase in genomics and biorepository-based studies in
Ethiopia, it is crucial to gain insight into the perspectives and experiences of researchers, sample
donors, ethics committees, and other stakeholders involved in biorepositories.
Objective: This study aims to explore and understand the perspective and experiences of researchers
concerning informed consent for biorepository-based studies in Ethiopia.
Methods: A qualitative study was conducted among 15 participants recruited using purposive
intensity sampling. Face-to-face and virtual in-depth interviews were conducted with the study
participants are well-experienced in biomedical research that involved collecting and storing human
biospecimens from Addis Ababa University, College of Health Sciences, Ethiopian Public Health
Institute, and Armauer Hansen Research Institute. Data were organized using NVivo version 20 and
analyzed thematically.
Results: The study reveals that while information is clearly stated on the information sheet, the
informed consent process is not flawless, due to complexity of the study, lack of scientific knowledge,
traditional beliefs, and communication flaws during information delivery. Moreover, the absence of
a standardized informed consent model specifically tailored to genetics and other biorepository-based
research emerged as another primary challenge.
Conclusion: Overall, the researchers viewed the informed consent paper positively, yet the consent
process was perceived negatively due to participants' poor comprehension. This informs the need for
testing comprehension levels before obtaining consent. Future multi-site studies shall be conducted
to generate evidence on the opinions and experiences of ethics committees, study participants, and
other key stakeholders on informed consent for biorepositories.
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Keywords
Consent models, Informed consent process, Biorepository, Genetics, Researchers, Ethiopia