Navigating Ethical Oversight in the Era of Artificial Intelligence: Perceived Factors and Operational Challenges Facing Health Research Ethics Committees in Tanzania
1
Bioethics and Health Professionalism, Muhimbili University of Health and Allied Sciences (MUHAS), Dar Es Salaam, Tanzania, United Republic of
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
BACKGROUND:
Health Research Ethics Committees (HRECs) play a pivotal role in protecting research participants and ensuring the ethical conduct of studies. The emergence of artificial intelligence (AI) in health research introduces complex ethical and operational challenges. However, evidence on factors shaping HREC functioning in this context remains limited in Tanzania. This study examined perceived factors and operational challenges influencing HREC effectiveness in the era of AI health-related research.
METHODS:
A convergent exploratory qualitative case study was conducted across five zones of mainland Tanzania, involving 15 HREC members and 10 secretariat staff. In-depth interviews were conducted using a semi-structured guide, transcribed verbatim, translated into English, and analyzed through content analysis. Coding was performed manually and supported by NVivo software, with triangulation across HREC members and secretariat perspectives to identify administrative, operational, capacity, and monitoring factors affecting ethical oversight.
RESULTS:
In our analysis, we identified 28 codes, which were organized into 10 subthemes and four overarching themes: (1) administrative and governance structures, (2) operational and resource constraints, (3) capacity and training gaps, and (4) monitoring and post approval oversight challenges. Key enablers of effective ethical review included clear policies, structured committee composition, and operational independence. In contrast, constraints such as limited funding, high workloads, insufficient expertise, and weak post approval monitoring hindered HREC performance. These findings reveal a dual reality: while structural strengths provide a solid foundation for ethical oversight, operational and capacity limitations restrict the committees’ ability to maintain robust governance, particularly in the context of AI health research.
CONCLUSIONS:
Tanzanian HRECs demonstrate foundational administrative and governance capacity but face significant operational and technical challenges in overseeing AI health-related research. Enhancing financial resources, continuous training, monitoring systems, and governance mechanisms is critical to strengthen ethical oversight, protect research participants, and support responsible conduct of AI-driven health research.
Health Research Ethics Committees (HRECs) play a pivotal role in protecting research participants and ensuring the ethical conduct of studies. The emergence of artificial intelligence (AI) in health research introduces complex ethical and operational challenges. However, evidence on factors shaping HREC functioning in this context remains limited in Tanzania. This study examined perceived factors and operational challenges influencing HREC effectiveness in the era of AI health-related research.
METHODS:
A convergent exploratory qualitative case study was conducted across five zones of mainland Tanzania, involving 15 HREC members and 10 secretariat staff. In-depth interviews were conducted using a semi-structured guide, transcribed verbatim, translated into English, and analyzed through content analysis. Coding was performed manually and supported by NVivo software, with triangulation across HREC members and secretariat perspectives to identify administrative, operational, capacity, and monitoring factors affecting ethical oversight.
RESULTS:
In our analysis, we identified 28 codes, which were organized into 10 subthemes and four overarching themes: (1) administrative and governance structures, (2) operational and resource constraints, (3) capacity and training gaps, and (4) monitoring and post approval oversight challenges. Key enablers of effective ethical review included clear policies, structured committee composition, and operational independence. In contrast, constraints such as limited funding, high workloads, insufficient expertise, and weak post approval monitoring hindered HREC performance. These findings reveal a dual reality: while structural strengths provide a solid foundation for ethical oversight, operational and capacity limitations restrict the committees’ ability to maintain robust governance, particularly in the context of AI health research.
CONCLUSIONS:
Tanzanian HRECs demonstrate foundational administrative and governance capacity but face significant operational and technical challenges in overseeing AI health-related research. Enhancing financial resources, continuous training, monitoring systems, and governance mechanisms is critical to strengthen ethical oversight, protect research participants, and support responsible conduct of AI-driven health research.
| eISSN: | 2654-1459 |
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