BMJ Open. 2026 Aug 26;16(8):e116200. doi: 10.1136/bmjopen-2026-116200.
ABSTRACT
BACKGROUND: Health research ethics committees (HRECs) provide the administrative backbone of ethical governance by safeguarding the rights, safety and well-being of research participants and ensuring the ethical conduct of health research. Effective ethical oversight depends not only on rigorous protocol review but also on robust governance, competent personnel, adequate infrastructure, sustainable institutional support and efficient administrative systems. Despite their critical role, evidence on the administrative functionality of HRECs in Tanzania remains limited.
OBJECTIVE: To assess the administrative functionality of HRECs in mainland Tanzania, with emphasis on governance, operational procedures, human resource capacity, training, infrastructure, documentation systems and institutional support.
DESIGN: Quantitative descriptive cross-sectional study.
SETTING: All active registered HRECs in clinical, research and training institutions in mainland Tanzania.
PARTICIPANTS: 10 administrative representatives responsible for HREC secretariat functions, one from each of the 10 active registered HRECs.
METHODS: A census approach included all 10 active registered HRECs in mainland Tanzania, with one administrative representative purposively selected from each committee. Data were collected using a semi-structured questionnaire and a document review checklist adapted from the Research Ethics Committee Assessment Toolkit. The assessment covered governance, committee membership, independence, training, decision-making procedures, administrative operations, financing, documentation practices and infrastructure. Document reviews verified standard operating procedures, meeting minutes, protocol-tracking systems, approval records and archival practices. Data were analysed using descriptive statistics.
RESULTS: All 10 HRECs participated. Administrative functionality was the highest for administrative operations (94%) and decision-making procedures (93%), followed by membership standards (86%). Compliance was lower for committee independence (75%) and training (50%). Key gaps included limited structured training, inadequate institutional financing, insufficient dedicated administrative staff, weak transparency mechanisms and inconsistent administrative and digital infrastructure. Electronic protocol-tracking systems were available in 60% of HRECs.
CONCLUSIONS: Tanzanian HRECs have established a solid administrative foundation for ethical governance. However, persistent gaps in training, committee independence, financing, staffing, infrastructure and digital systems may compromise the effectiveness, transparency and sustainability of ethical oversight. Strengthening administrative standards, institutional investment, continuous professional development and digital infrastructure is essential to reinforce the administrative backbone of ethical governance and improve research ethics oversight in Tanzania and other low-income and middle-income countries.
PMID:42648778 | DOI:10.1136/bmjopen-2026-116200
