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.
Authors
- Sabina Mtweve
- Rachel Nathaniel Manongi (ORCID: https://orcid.org/0000-0003-3841-974X)
- Rose Mwangi (ORCID: https://orcid.org/0000-0002-8496-9921)
- Blandina Theophil Mmbaga (ORCID: https://orcid.org/0000-0002-5550-1916)
Institutions
- Kilimanjaro Christian Medical Centre (TZ)
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
- Field-Weighted Citation Impact
- 0.00