Evidence map›Paper›PMID 29792193›Full record

ArticleBMC medical ethics2018

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

Jahit Sacarlal, Vasco Muchanga, Carlos Mabutana, Matilde Mabui, Arlete Mariamo, Assa Júlio Cuamba, Leida Artur Fumo, Jacinta Silveira, Elizabeth Heitman, Troy D Moon

Abstract read
In one paragraph

Article in BMC medical ethics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

10 authors.

Jahit SacarlalFaculty of Medicine, University Eduardo Mondlane, Maputo, Mozambique.
Vasco MuchangaFaculty of Medicine, University Eduardo Mondlane, Maputo, Mozambique.
Carlos MabutanaTraining Institute for Professors, Matola, Mozambique.
Matilde MabuiMaputo Central Hospital, Maputo, Mozambique.
Arlete MariamoMaputo Central Hospital, Maputo, Mozambique.
Assa Júlio CuambaFaculty of Medicine, University Eduardo Mondlane, Maputo, Mozambique.
Leida Artur FumoMaputo Central Hospital, Maputo, Mozambique.
Jacinta SilveiraMaputo Central Hospital, Maputo, Mozambique.
Elizabeth HeitmanUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Troy D MoonVanderbilt University Medical Center, Nashville, TN, USA. troy.moon@vanderbilt.edu.

Funding

VU-Mozambique Collaborative Research Ethics Education ProgramR25TW009722 · FIC · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ELIZABETH HEITMAN, D. Troy Moon · 2014 to 2026
$3.0M
FIC NIH HHS R25 TW009722FIC NIH HHS R25TW009722
6 · The paper itself

Abstract

backgroundMozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH.

methodsThis study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions.

resultsA total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS.

conclusionsOur results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Indexed as

Ethical AnalysisEthics Committees, ResearchHospitals, UniversityUniversitiesBioethicsBiomedical ResearchClinical ProtocolsEthics, ResearchHumansMozambiqueResearchResearch DesignRetrospective StudiesSocial SciencesEthicsLow-and middle-income countryMozambiqueResearch ethics committeeResearch ethics review

Identifiers

PMID29792193
PMCPMC5967046

What OpenQuestion holds

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LicenceCC BY
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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.