Review of the Medical Research Ethics Committee (MREC), National Research Center of Egypt, 2003–2011

AbdEl-Aal, Wafaa E.; Ghaffar, Esmat Abdel; El‐Shabrawy, O. A.

doi:10.1185/03007995.2013.815158

Cited by 10 publications

(11 citation statements)

References 10 publications

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“…An investigator’s need to make considerable revisions to a protocol can delay the Committee’s review process and create hurdles that investigators may inappropriately blame on the Committee [ 20 ]. Our findings comport with several studies that have shown that ethical and procedural issues are the primary reasons for RECs’ non-approval of protocols after first review [ 18 , 21 , 22 ]. Similar to these studies, we found that many applications not approved in the first review had issues that included violations of procedures, missing information, and discrepancies between different parts of the application, as well as grammatical and spelling errors [ 21 ].…”

Section: Discussionsupporting

confidence: 89%

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)

Sacarlal

Muchanga

Mabutana³

et al. 2018

BMC Med Ethics

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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.

show abstract

Section: Discussionsupporting

confidence: 89%

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)

Sacarlal

Muchanga

Mabutana³

et al. 2018

BMC Med Ethics

View full text Add to dashboard Cite

show abstract

“…In 4 studies, female membership was underrepresented (Ikingura et al, 2007; Matar & Silverman, 2013; Moodley & Myer, 2007; Nyika, Kilama, Chilengi, et al, 2009). Notably, 1 REC in Egypt reported more (10 of 17) female than male members (Abdel-Aal, Ghaffar, & El Shabrawy, 2013).…”

Section: Resultsmentioning

confidence: 99%

“…Eleven studies assessed training needs of RECs and reported that the majority of committee members needed more ethics training (Abdel-Aal et al, 2013; Ateudjieu et al, 2010; IJsselmuiden et al, 2012; Ikingura et al, 2007; Kass et al, 2007; Matar & Silverman, 2013; Milford et al, 2006; Moodley & Myer, 2007; Nyika, Kilama, Chilengi, et al, 2009; Oyedeji, 2011; Sleem et al, 2010). Two studies reported that REC members expressed a need for more training on evaluation of scientific design and determination of risks in clinical trials (Milford et al, 2006; Nyika, Kilama, Chilengi, et al, 2009).…”

Section: Resultsmentioning

confidence: 99%

Biomedical Research Ethics Committees in Sub-Saharan Africa

Silaigwana

Wassenaar

2015

Journal of Empirical Research on Human Research Ethics

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Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what is known and identifying gaps in our knowledge. We conducted a literature search of the EBSCO, PubMed, and Google Scholar electronic databases. Twenty-three empirical studies reporting on the structure, functions, and outcomes of African RECs were included in our analysis. The review yielded limited systematic data on RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs.

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“…The human medical research ethics committees are referred to as either Institutional Review Board (IRB) or Research Ethics Committee (REC). Some of the RECs may approve animal research protocols when needed such as the Medical Research Ethics Committee (MREC) of the National Research Center (NRC) [1]. Cairo University has been the incubator and disseminator of knowledge and culture in Egypt and the neighboring countries for the last century.…”

Section: Introductionmentioning

confidence: 99%

Establishing the first institutional animal care and use committee in Egypt

Fahmy

Gaafar

2016

Philos Ethics Humanit Med

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BackgroundAlthough animal research ethics committees (AREC) are well established in Western countries, this field is weakly developed and its concept is poorly understood in the Middle East and North Africa region.ObjectiveOur main objective was to introduce the concept and requirements of ethical approaches in dealing with experimental animal in research and teaching in Egypt.MethodsDue to its very recent inception, Cairo University, Faculty of Science IACUC decided to operate in accordance with Guide for the Care and Use of Laboratory Animals 8th Edition 2011 (the Guide) since Egypt has not yet compiled its own guide.ResultsFifty protocols were reviewed in 2013–2014. Only ten protocols were reviewed in 2013, but in 2014, forty protocols were reviewed. In 2013 all protocols were approved and in 2014, number of approvals were 35, the number of deferrals were 4, and one refused protocol. Master’s theses (MSc) research protocols constituted the majority of the total reviewed protocols. This is attributed to the decision of the Board of the Faculty of Science, Cairo University in September, 2013 that the approval of the IACUC is mandatory before conducting any research involving animals or theses registration.ConclusionThe first IACUC was established in the Cairo University, Faculty of Science, since 2012. The challenges encountered by the committee were diverse, such as the absence of laws that control the use of animal models in scientific research, lack of guidelines (protocols for experimental animals in research) and, mandatory ethical approval for any experimental animal research.

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Review of the Medical Research Ethics Committee (MREC), National Research Center of Egypt, 2003–2011

Abstract: Since 2005, the MREC in NRC Egypt has built up considerable experience of evaluating the ethical issues arising within the field of medical research.

Cited by 10 publications

References 10 publications

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)

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)

Biomedical Research Ethics Committees in Sub-Saharan Africa

Establishing the first institutional animal care and use committee in Egypt

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