Browsing by Author "Burgess, Lesley Jean"

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    Determination of the pathogenetic mechanisms for, and the diagnostic implications of, raised adenosine deaminase (ADA) levels in tuberculous exudates
    (Stellenbosch : Stellenbosch University, 1999) Burgess, Lesley Jean; Stellenbosch University. Faculty of . Dept. of .
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    An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature
    (Dove Medical Press, 2019) Burgess, Lesley Jean; Gerber, Berna; Coetzee, Kathleen; Terblanche, Marli; Agar, Gareth; Kotze, Theunis J. V. W.
    Introduction: The informed consent process is a fundamental part of clinical trials and is driven by both a legal and ethical agenda. The process may be seriously compromised if trial participants sign the informed consent document without fully understanding its contents. In developing countries such as South Africa, this concern is important due to the potential vulnerability of these patients and their risk for research exploitation. Aim: To evaluate the understanding of 11 important components and concepts related to clinical research by adult trial participants in a developing country at the time of providing consent for trial participation. Methods: 46 consecutive adult patients who qualified and consented to being enrolled in ongoing cardiovascular risk clinical trials at TREAD Research in the Western Cape, South Africa, were included in this study. After giving informed consent, participants were subjected to both a close-ended (self-report) and an open-ended method (descriptive narrative) to assess their understanding of various components and concepts related to clinical research pertaining to the initial informed consent document. The descriptive narrative was recorded and then later transcribed and assessed by two independent assessors. Results: There was a marked difference between the two methodologies used to assess patient comprehension of the various components. With the exception of concepts voluntariness and right to withdraw, trial participants’ understanding of the informed consent document was poor – especially with regard to the following concepts: randomization, risks, placebo and blinding. Higher levels of comprehension were obtained for the participant self-reports and lower levels for the narrative descriptions. Conclusion: The participant comprehension at this site was poor, and the process for taking informed consent subsequently needs to be modified so as to improve informed consent comprehension.
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    The South African clinical trial industry : implications of problems with the issuing of human tissue export permits
    (Health & Medical Publishing Group, 2013-06-21) Burgess, Lesley Jean; Pretorius, Deodanda
    ENGLISH ABSTRACT: The National Health Act requires a valid permit before human biological tissue samples are exported from South Africa. However, delays in issuing export permits make it difficult for many researchers and pharmaceutical companies to comply. There are misconceptions about who is responsible for obtaining such a permit. Delays have caused many new trials to start without a permit, and biological samples from ongoing trials have been exported using expired permits. This could have detrimental consequences for the South African trial industry, especially with the country’s history of vulnerable populations in developing areas. Medicine Control Council inspections have listed findings related to export permits for several trial sites. Researchers must be aware that it remains their responsibility to apply for such a permit. The most important steps to ensure a smoother approval process are for applicants to (i) familiarise themselves with the permit issue process and (ii) recognise the importance of correctly completing and signing application forms.