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.
Highlights
Mozambique has seen remarkable growth in biomedical research over the last decade
Profile of protocols evaluated In the period from March 14, 2013 to December 31, 2016, 356 human subject research protocols were submitted to the Comité Institucional de Bioética para Saúde (CIBS) Faculty of Medicine (FM) & Maputo Central Hospital (MCH) for review
Given that research is required of post-graduate students in other programs with -sized enrollments, this disproportionate use from the FM may reveal a lack of knowledge on the part of other disciplines about the need to follow specific ethical standards in the research they conduct, and represents an opportunity for the CIBS FM & MCH to educate faculty and students in University Eduardo Mondlane (UEM)’s other disciplines and programs about the research ethics review process and the responsible conduct of research
Summary
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. The CNBS (FWA00003139) was initially established in 2002, in line with international efforts to protect participants in biomedical research through formal evaluation of the ethical aspects of research protocols involving human subjects. The number of submitted protocols grew exponentially, for clinical trials on the treatment and prevention of infectious diseases [9]. This growth was accompanied by the expansion of postgraduate degree programs in the biomedical and behavioral sciences that required candidates to conduct research. Like many other new national research ethics committees (RECs) in recent years [10,11,12,13], the CNBS determined that international best practices and national regulations for human subjects research were sufficiently well recognized that protocols for certain kinds of research could be reviewed appropriately by authorities in the institutions from which the research originated, freeing the CNBS to concentrate on more complex and higher-risk protocols
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