Evidence map›Paper›PMID 42648778›Full record

ArticleBMJ open2026

How strong is the administrative backbone of ethical governance? A descriptive cross-sectional study of health research ethics committees in Tanzania.

Lazaro Amon Solomon Haule, Muhsin Aboud, Doreen Mloka

Abstract read
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Lazaro Amon Solomon HauleBioethics and Health Professionalism, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, Tanzania, United Republic of haulelazaro@gmail.com.ORCID http://orcid.org/0000-0003-2349-9425
Muhsin AboudDepartment of Surgery, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of.
Doreen MlokaDepartment of Pharmaceutical Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of.

Funding

Educating and Developing Bioethicists in Tanzania (ENGAGE)D43TW011809 · FIC · UNIVERSITY OF PENNSYLVANIA · PI ULRICH, CONNIE MARIE · 2021 to 2025
$1.4M
FIC NIH HHS D43 TW011809
6 · The paper itself

Abstract

backgroundHealth 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.

objectiveTo 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.

designQuantitative descriptive cross-sectional study.

settingAll active registered HRECs in clinical, research and training institutions in mainland Tanzania.

participants10 administrative representatives responsible for HREC secretariat functions, one from each of the 10 active registered HRECs.

methodsA 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.

resultsAll 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.

conclusionsTanzanian 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.

Indexed as

Ethics Committees, ResearchCross-Sectional StudiesHumansSurveys and QuestionnairesTanzaniaETHICS (see Medical Ethics)HealthHealth policyHealth & safetyMEDICAL ETHICS

Identifiers

PMID42648778
PMCPMC13536160

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.