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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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-12-01
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| Series: | Global Bioethics |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/11287462.2025.2487717 |
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| Summary: | 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. |
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| ISSN: | 1128-7462 1591-7398 |