Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers

<i>Introduction</i>: 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. <i>Methods</i>: 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. <i>Results</i>: 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. <i>Conclusion</i>: 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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Publication Details

Journal
Global Bioethics
Published
2025-04-07
DOI
https://doi.org/10.1080/11287462.2025.2487717
Primary Topic
Ethics in Clinical Research
Type
article
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article

Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers

Sabina Mtweve, Rachel Nathaniel Manongi, Rose Mwangi, Blandina Theophil Mmbaga
1 links
Global Bioethics
Ethics in Clinical Research
article

Unspoken obligations: perspectives on post-trial responsibilities from Tanzanian research ethics committee and researchers

Sabina Mtweve, Rachel Nathaniel Manongi, Rose Mwangi, Blandina Theophil Mmbaga
article en

Abstract

<i>Introduction</i>: 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. <i>Methods</i>: 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. <i>Results</i>: 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. <i>Conclusion</i>: 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.

Global BioethicsVol. 36(1)
Kilimanjaro Christian Medical Centre (TZ)
Openalex Percentile: Top 90%
Ethics in Clinical Research
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