Collection and use of human materials during TB clinical research; a review of practices
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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.
- Medical and Health Sciences