Background The increasing number of clinical trials in developing countries providing solutions to the high burden of diseases leads to the vulnerability of study participants and their communities and access to the trial results. In CIOMS, Post-trial access (PTA) is defined as the obligation of sponsors, researchers, host government and other relevant stakeholders, including the community and the research ethics committees to make any intervention or product developed, and knowledge generated, for the study participants or community available as soon as possible. This study explores the stakeholders’ perspectives on post-trial access and how PTA arrangements could be feasibly and sustainably incorporated into clinical trials in Ethiopia.

Methods A qualitative study was conducted on stakeholders involving principal investigators, institutional review board (IRB) members; regional ethics review committee (RERC) members; national ethics review committee (NEC), regulatory agency members, and funding organization using face-to-face in-depth interviews and thematically analysed.

Results Our analysis shows that the majority of the study participants do not know about PTA and its implementations, responded lack of binding regulations/laws, the weak collaboration between different stakeholders, and the lack of follow-up of clinical trials. Moreover, most participants pointed out the possibility of study participants and their community exploitation because of PTA statements in the current clinical trial approval and authorization processes.

Conclusion Therefore, we recommend revising the available working documents/guidelines by including PTA, capacity building at different levels, and establishments of independent bodies facilitating the arrangements of PTA and follow-up of its implementations.