Unspoken obligations: Perspectives on Post-Trial Responsibilities from a Tanzanian Research Ethics Committee and Researchers

Introduction : In the evolving landscape of medical research, ethical considerations extend beyond the duration of clinical trials, particularly concerning the post-trial care of participants. This study explores the perceived responsibilities of researchers and Research Ethics Committees (RECs), in ensuring participants’ well being after trials conclude. Guided by ethical frameworks such as the Belmont Report and the Declaration of Helsinki, the research highlights the imperative to provide continued access to beneficial interventions, especially in resource-poor settings. Methods : This qualitative phenomenographic case study, involved two primary data collection methods: Focus group discussions (FGD) and in-depth interviews. The FGD involved of REC members from three institutions with extensive experience in of externally funded clinical research in collaboration with international partners: (Kilimanjaro Christian Medical Centre [KCMC], Kilimanjaro Clinical Research Institute [KCRI] and Kilimanjaro Christian Medical University College [KCMUCO]. Additionally, in-depth interviews were conducted with researchers from these institutions. REC members and were eligible to participate in the FGD while researchers were selected purposively based on the principle of saturation. The interviews and FGD were transcribed and translated into English. NVIVO 12 software was used for data management and analysis, including familiarization with data, coding and theme identification. Results : The analysis revealed key themes related to post-trial responsibilities, including challenges in implementing ethical principles and ensuring continued participant care. Significant gaps and inconsistencies in post-trial support, particularly in low resource settings were identified. Conclusion : The findings highlight the urgent need to re-evaluate and improve post-trial participant care within clinical research. The study advocates for the development of strong support mechanisms, equitable distribution of research benefits, and enhanced ethical oversight to uphold participants' rights and welfare. These insights contribute to advancing bioethics and promoting a research environment that prioritizes ethical considerations and participant well-being.