Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers
Introduction: Ethical considerations in clinical research extend beyond trial completion, emphasizing post-trial responsibilities to ensure participant well-being, particularly in resource-limited settings. This study explores the perspectives of researchers and Research Ethics Committee (REC) membe...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Global Bioethics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/11287462.2025.2487717 |
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| author | Rose Mwangi Sabina Mtweve Blandina T. Mmbaga Rachel Manongi |
| author_facet | Rose Mwangi Sabina Mtweve Blandina T. Mmbaga Rachel Manongi |
| author_sort | Rose Mwangi |
| collection | DOAJ |
| description | Introduction: Ethical considerations in clinical research extend beyond trial completion, emphasizing post-trial responsibilities to ensure participant well-being, particularly in resource-limited settings. This study explores the perspectives of researchers and Research Ethics Committee (REC) members in Tanzania regarding post-trial obligations and their alignment with key ethical frameworks such as the Belmont Report, CIOMS guidelines, and the Declaration of Helsinki. Methods: A qualitative phenomenographic case study was conducted, including a focus group discussion with 11 REC members from three Good Samaritan Foundation (GSF) institutions with a longstanding research collaboration with international partners world wide. Additionally, in-depth interviews were conducted with purposively selected researchers. Data saturation guided the sample size, and NVIVO 12 software facilitated thematic analysis. Results: Findings revealed significant gaps in post-trial care, particularly in maintaining access to interventions. RECs and researchers face challenges in fulfilling post-trial responsibilities calling for clear guidelines and sustainable post-trial mechanisms in resource poor settings. A disconnect exists between RECs’ ethical oversight and researchers’ practical realities. Community engagement is crucial for ethical research but is often inadequately sustained. Conclusion: Ethical frameworks must explicitly address post-trial obligations, particularly in low-resource settings. Strengthening communication between RECs, researchers, and sponsors, along with ongoing community engagement, is vital for equitable and sustainable global health research. |
| format | Article |
| id | doaj-art-fd9f82591e0e4f6f89bb29548affb915 |
| institution | OA Journals |
| issn | 1128-7462 1591-7398 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Global Bioethics |
| spelling | doaj-art-fd9f82591e0e4f6f89bb29548affb9152025-08-20T02:08:49ZengTaylor & Francis GroupGlobal Bioethics1128-74621591-73982025-12-0136110.1080/11287462.2025.2487717Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchersRose Mwangi0Sabina Mtweve1Blandina T. Mmbaga2Rachel Manongi3School of Public Health, KCMC University, Moshi, TanzaniaKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, TanzaniaPaediatric and Child Health Department, Kilimanjaro Christian Medical Centre, Moshi, TanzaniaSchool of Public Health, KCMC University, Moshi, TanzaniaIntroduction: Ethical considerations in clinical research extend beyond trial completion, emphasizing post-trial responsibilities to ensure participant well-being, particularly in resource-limited settings. This study explores the perspectives of researchers and Research Ethics Committee (REC) members in Tanzania regarding post-trial obligations and their alignment with key ethical frameworks such as the Belmont Report, CIOMS guidelines, and the Declaration of Helsinki. Methods: A qualitative phenomenographic case study was conducted, including a focus group discussion with 11 REC members from three Good Samaritan Foundation (GSF) institutions with a longstanding research collaboration with international partners world wide. Additionally, in-depth interviews were conducted with purposively selected researchers. Data saturation guided the sample size, and NVIVO 12 software facilitated thematic analysis. Results: Findings revealed significant gaps in post-trial care, particularly in maintaining access to interventions. RECs and researchers face challenges in fulfilling post-trial responsibilities calling for clear guidelines and sustainable post-trial mechanisms in resource poor settings. A disconnect exists between RECs’ ethical oversight and researchers’ practical realities. Community engagement is crucial for ethical research but is often inadequately sustained. Conclusion: Ethical frameworks must explicitly address post-trial obligations, particularly in low-resource settings. Strengthening communication between RECs, researchers, and sponsors, along with ongoing community engagement, is vital for equitable and sustainable global health research.https://www.tandfonline.com/doi/10.1080/11287462.2025.2487717Post-trial obligationsclinical trialsethical challengesresearch ethics committeesresearchers |
| spellingShingle | Rose Mwangi Sabina Mtweve Blandina T. Mmbaga Rachel Manongi Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers Global Bioethics Post-trial obligations clinical trials ethical challenges research ethics committees researchers |
| title | Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers |
| title_full | Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers |
| title_fullStr | Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers |
| title_full_unstemmed | Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers |
| title_short | Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers |
| title_sort | unspoken obligations perspectives on post trial responsibilities from tanzanian research ethics committee and researchers |
| topic | Post-trial obligations clinical trials ethical challenges research ethics committees researchers |
| url | https://www.tandfonline.com/doi/10.1080/11287462.2025.2487717 |
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