Collection and use of human materials during TB clinical research; a review of practices
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Date
2021
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Publisher
Research Square
Abstract
Human biological materials are usually stored for possible uses in future research because
they preserve valuable biological information, save time and resources which would have been spent on
collection of fresh samples and are less burdensome to sample sources. However, use of these materials
may pose ethical challenges like disclosure of genetic information about an individual or a community
which may lead to dire consequences. Others include, stigma, psychological harm, discrimination or biosecurity
implications rendering sample sources vulnerable, lack of control over the materials or
associated data, storage, who owns them, how they are used, for what, by whom and how benefits are
shared if any. We evaluated how the tuberculosis (TB) clinical research protocols that were used to collect
and store biological materials for future use conform to the requirements stated in the Uganda national
guidelines for research involving humans as participants.
Methods: This was a retrospective review of TB clinical research projects approved by the Uganda
National Council for Science and Technology (UNCST) from 2011 to 2015, on whether they fulfilled the
requirement for ethical collection and use of human materials. Data was abstracted from review of the
project protocols and collected using a template developed based on the informed consent and the
Materials Transfer Agreement (MTA) requirements in the national guidelines.
Results: Out of 55 research protocols reviewed most of the protocols, 46 (83.6%), had been used to collect
the stored samples (sputum, blood and sometimes urine), 13 (28%) had a section on specimen collection
and 24% mentioned ownership of the biological materials.
Description
Keywords
clinical research, human materials, tuberculosis
Citation
Ochieng, J., Kwagala, B., & Sewankambo, N. (2021). Collection and use of human materials during TB clinical research; a review of practices. Research Square. DOI: https://doi.org/10.21203/rs.3.rs-400696/v1