Abstract
Background: Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Bio-repository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a short informed consent statement (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda. Methods: A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental draft ICF for this study was developed and attached to the Laboratory investigation form. Results: Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. HCUs who did not understand the draft ICF were 90% less likely to accept broad consent compared to those who understood (OR=0.10, CI [0.03-0.32] while those who partly understood the ICF were 73% less likely to accept broad consent compared to those who understood (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health. Conclusion: Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.
Highlights
Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research
Understanding of the essential elements of experimental draft informed consent form The current study found that most HCUs understood the essential elements of the draft informed consent form
Our study showed high HCUs acceptance of broad consent for storage of biological materials for future unspecified research uses
Summary
Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Bio-repository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a short informed consent statement (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda. Uganda adopted a centralized model of testing to scale-up its national Health programmes such as HIV Early Infant Diagnosis (EID) and HIV viral load monitoring (VL) programmes Human biological materials such as dried blood spots (DBS) and plasma are collected from remote health facilities in Uganda and delivered to HUBS. The total national coverage of both EID and VL for over 150,000 HIV exposed infants and 1,200,000 HIV patients on Antiretroviral Therapy (ART) has resulted in the collection of over 1,500,000 remnant biological materials in a bio-repository for future research
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