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Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting
Thesis (MPhil)--Stellenbosch University, 2026.
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| Format: | Thesis |
| Language: | English |
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Stellenbosch : Stellenbosch University
2026
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| _version_ | 1867614092494110720 |
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| access_status_str | Open Access |
| author | Ilett, Chiara Dianta |
| author2 | Hall, Susan |
| author_browse | Hall, Susan Ilett, Chiara Dianta |
| author_facet | Hall, Susan Ilett, Chiara Dianta |
| author_sort | Ilett, Chiara Dianta |
| collection | Thesis |
| dc_rights_str_mv | Stellenbosch University |
| description | Thesis (MPhil)--Stellenbosch University, 2026. |
| format | Thesis |
| id | oai:scholar.sun.ac.za:10019.1/136069 |
| institution | Stellenbosch University (South Africa) |
| language | English |
| last_indexed | 2026-06-10T12:46:32.674Z |
| license_str | Other — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from SUNScholar — Stellenbosch University Repository |
| publishDate | 2026 |
| publishDateRange | 2026 |
| publishDateSort | 2026 |
| publisher | Stellenbosch : Stellenbosch University |
| publisherStr | Stellenbosch : Stellenbosch University |
| record_format | dspace |
| source_str | SUNScholar — Stellenbosch University Repository |
| spelling | oai:scholar.sun.ac.za:10019.1/136069 Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting Ilett, Chiara Dianta Hall, Susan Stellenbosch University. Faculty of Arts and Social Sciences. Dept. of Philosophy. Thesis (MPhil)--Stellenbosch University, 2026. Ilett, C. D. 2026. Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting. Unpublished masters thesis. Stellenbosch: Stellenbosch University [online]. Available: https://scholar.sun.ac.za/items/da9de78a-5790-4b3a-b1f2-53803f136820 South Africa’s semi-urban contexts, such as East London, present unique challenges and opportunities for conducting clinical trials, especially concerning the ethical principle of informed consent. This thesis critically explores the applicability and limitations of the Western-based principle of respect for autonomy within South African semi-urban communities, drawing on Francis Akpa‑Inyang and Sylvester C. Chima’s cross-cultural qualitative study on traditional South African values and beliefs surrounding informed consent. Informed consent, broadly defined as the process ensuring participant autonomy through disclosure, comprehension, voluntariness, competence, and authorization, contains the core element of “reasonable understanding.” This thesis evaluates each of these elements using the framework provided by Beauchamp and Childress, appraising their relevance and challenges in South African semi-urban research settings marked by communal values, language barriers, and socio-economic complexities. A historical overview traces the evolution of clinical trials globally and within South Africa, outlining the progressive development of informed consent guidelines, particularly the International Council for Harmonisation (ICH) guidelines and their adaptation in local contexts. The demographic and cultural characteristics of semi-urban populations are considered crucial in understanding the social dynamics that influence an individual’s role in decision-making. Competence and capacity, often conflated, are differentiated and assessed as applied in current South African settings, noting the absence of standardized tools for evaluating competence in clinical research participation. Voluntariness is examined through the lens of coercion, persuasion, and manipulation prevalent in socio-economically vulnerable semi-urban communities, emphasizing structural inequities that may undermine genuine consent. Disclosure practices in clinical trials are contrasted between the “reasonable doctor” and “reasonable person” standards, highlighting challenges in translating complex trial information for participants. The role of investigators and trial sponsors in shaping disclosure and the boundaries of therapeutic privilege are scrutinized. Recommendations within informed consent discussions are differentiated from coercion, considering socio-economic influences that may unduly sway participant decisions. Understanding is analysed beyond mere information delivery, acknowledging cultural beliefs, educational barriers, and linguistic challenges that affect processing and acceptance of trial information. Autonomy is re-conceptualized within a relational framework reflective of South African communal values, challenging dominant global North paradigms of individual agency in decision-making. Legal authorization, especially for minors and vulnerable persons, is discussed in the context of ICH and South African Good Clinical Practice guidelines. Finally, the thesis proposes the development of a culturally appropriate South African assessment tool for “reasonable understanding” in informed consent processes targeting resource-limited and semi-urban settings. Such a tool should aim to balance protection of participant rights with respect for traditional value systems. Masters 2026-04-21T13:35:31Z 2026-04-21T13:35:31Z 2026-03 Thesis https://scholar.sun.ac.za/handle/10019.1/136069 en Stellenbosch University 68 pages application/pdf Stellenbosch : Stellenbosch University |
| spellingShingle | Ilett, Chiara Dianta Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting |
| title | Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting |
| title_full | Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting |
| title_fullStr | Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting |
| title_full_unstemmed | Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting |
| title_short | Reasonable Understanding: Considerations for Informed Consent in Clinical Research in a Semi-Urban South African Setting |
| title_sort | reasonable understanding considerations for informed consent in clinical research in a semi urban south african setting |
| url | https://scholar.sun.ac.za/handle/10019.1/136069 |
| work_keys_str_mv | AT ilettchiaradianta reasonableunderstandingconsiderationsforinformedconsentinclinicalresearchinasemiurbansouthafricansetting |