The Structure and Function of Research Ethics Committees in Africa: A Case Study

Kass, Nancy E.; Hyder, Adnan A.; Ajuwon, Ademola J.; Appiah-Poku, John; Barsdorf, Nicola; Elsayed, Dya Eldin M.; Mokhachane, Mantoa; Mupenda, Bavon; Ndebele, Paul; Ndossi, Godwin; Sikateyo, Bornwell; Tangwa, Godfrey B.; Tindana, Paulina

doi:10.1371/journal.pmed.0040003

Cited by 106 publications

(110 citation statements)

References 25 publications

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“…Budgetary constraints, lack of training, expertise and lack of full time administrators have also been highlighted as major challenges to African RECs [7][8][9][10][11][12][13]. The findings of this survey revealed that the use of modern review technologies, can positively address the communication, storage, security and confidentiality issues as well as, cushion the RECs limited budgets by reducing their operational costs such as telephone, photocopying and protocol distribution costs.…”

Section: Discussionmentioning

confidence: 99%

Enhancing the Efficiency and Quality of African Research Ethics Review Processes – Through an Automated Review Platform

Mokgatla¹,

Bahati²,

Jsselmuiden³

2017

J AIDS Clin Res

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BackgroundHealth research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world [1]. This changing cascade of biomedical research poses new challenges for research ethics committees (RECs) review efficiency and quality. The sheer amount of research now being conducted in Africa has resulted in an unprecedented increase in RECs' workload [2] and the growing trend of multi-centre trials complicate the traditional, institutionoriented oversight system. This places a severe burden on RECs, which have always operated under significant resource constraints [3]. Majority (93% of the mapped 169 RECs in 37 African countries) use complex paper based review systems [4], which have proven to be problematic in terms of providing comprehensive oversight and tracking of submitted research protocols, monitoring and evaluation, effective communication, data storage and poor continuity of work due to the high turnover of REC membership [5]. The ChallengeThe etiology of REC inefficiency is complex. REC members spend a great deal of time preparing REC applications, amendments, renewals, and reports. Poorly functioning review systems can lead to inefficiencies or long review timelines which ultimately lengthens the time to licensure for new medicines, vaccines and medical technologies [6].169 RECs are reported to be operational in 37 African countries, with great variability in skills, membership, capacity and resources [4]. Most of these RECs are facing substantial challenges, including limited financial and human resources, insufficient training and inadequate standard operational procedures (SOPs), and lack of modernised information management technologies [3]. One of the major bottlenecks for ethical clearance is the complex paper based review systems widely used by African RECs, which are unable to absorb significantly increased submission volumes [4]. To address the latter, the Council on Health Research for Development (COHRED), working with partners in Africa, designed an intervention to address the need to provide much faster ethical review of research: the RHInnO Ethics, a cloud-based management information system for RECs (http:// www.rhinno.net) [1]. Since its first rollout in 2012, no study has been conducted to evaluate the platform's impact, nor has any study been conducted to evaluate the technological needs of RECs in Africa, hence the motivation for this survey. MethodologyAn online questionnaire was used to collect both qualitative and quantitative data from the 8 African countries currently using RHInnO Ethics. Enhancing the Efficiency and Quality of African Research Ethics Review Processes -Through an Automated Review PlatformBoitumelo Mokgatla*, Prince Bahati and Carel I Jsselmuiden International AIDS Vaccine Initiative (IAVI), Botswana AbstractBackground: The sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies have resulted in unprecedented ethics review tim...

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Section: Discussionmentioning

confidence: 99%

Enhancing the Efficiency and Quality of African Research Ethics Review Processes – Through an Automated Review Platform

Mokgatla¹,

Bahati²,

Jsselmuiden³

2017

J AIDS Clin Res

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“…Interpretation of these findings on temporal trends in approval timelines needs to be done with caution considering that approval timelines may be affected by many factors at play in different countries at different time points that may explain the observation that there was no significant difference in approval time by year of submission. These factors include: financial and human resources available to review boards in different countries at different time points [13,14]; capacity building structures of RECs in different countries [7] and complexity of study protocols submitted for ethical and regulatory review. In light of these factors and the fact that the analysis of temporal trends presented by our study and that by Geldenhuys et al [8] does not account for these potentially confounding factors, the interpretation of these findings from the analysis of temporal trends should be done with caution.…”

Section: Discussionmentioning

confidence: 99%

Regulatory and Ethical Approval Timelines for HIV Vaccine Studies: An Analysis of International AIDS Vaccine Initiative (IAVI) Sponsored Studies in East and Southern Africa

Bahati¹,

Omungo²,

Bender³

et al. 2017

J AIDS Clin Res

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IntroductionEmerging markets in and out of Africa are hosting an increasing number of health research studies that use human subjects. About 40% of clinical trials are currently being conducted in Low and Middle Income Countries (LMIC) in Asia, Latin America and Africa [1]. This has been mainly attributed to the great burden of disease in these countries and also, thus in part, making it comparatively less expensive to conduct these studies in LMICs [2] and the increasing difficulty in finding sufficient numbers of eligible study participants in more developed economies [3].While conducting health research in Africa is important to the global research community and is beneficial to Africa [1], the efficiency with which these health research studies are conducted in Africa is increasingly becoming an important question because of both the public health cost related to delayed access to health products and increased costs related to longer timelines of health research. These timelines affect the overall efficiency of conducting health research, the overall cost of health research [4] and the productivity of pharmaceutical industries, including vaccine manufacturers [5]. Paradoxically, despite the influence of approval timelines on the efficiency of health research, there has been little systematic evaluation of the timelines of existing ethical and regulatory processes.Timelines are dependent on numerous factors, such as the complexity of the proposed study, the capacity of regulatory and review bodies, approval policies and procedures, the quality of the submitted proposal and the efficiency of the researcher in responding to internal review boards (IRB) queries. AbstractBackground: There has not been a systematic analysis of factors affecting ethics and regulatory timelines of HIV Vaccine trials and epidemiologic studies in Eastern and Southern Africa. We analyzed regulatory and ethics approval timelines and associated factors for HIV vaccine clinical trials and epidemiologic studies in Kenya, Uganda, Rwanda, South Africa and Zambia using data collected from seven Clinical Research Centers (CRCs) from 2001 to 2015.Methodology: Staff responsible for regulatory issues at CRCs provided archived data on ethical and regulatory review time-frames which were then validated with the sponsor central database. A semi structured questionnaires was administered to establish qualitative information on perceived factors affecting efficiency of approval processes and potential solutions. Quantitative data analysis was conducted using Excel. Qualitative data were analyzed using an open coding to analyze and elicit general themes.Findings: Data on submission for 23 clinical trials and 51 epidemiological study protocols were analyzed. Across all seven CRCs it took on average of 178 and 108 days to obtain full authorization to commence clinical trials and epidemiological studies, respectively. These timelines are shorter than the average found in other disease fields in Africa but seem longer than approval timelines in the USA an...

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“…[3] Sub-Saharan Africa has an admirable history related to the establishment of RECs and protecting human subjects involved in research activities; several reports suggest that a majority of countries have some procedures in place for ethical reviews. [4,5] We do know from the Kass case study [4] that South Africa (SA) established a REC in 1967 and at least eight other committees had been established since 2002. That said, during this time period and beyond, the African scientific community has been challenged with a variety of ethical issues.…”

Section: Articlementioning

confidence: 99%

Enhanced REC collaborative review through videoconferencing

et al. 2016

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As international collaborative health research activities increase, building research ethics committees (REC) infrastructure and capacity in lowand middle-income countries for efficient and thorough review of research protocols becomes more critical, especially in sub-Saharan Africa. International investigators may face multiple challenges when conducting research in these settings, an important one being the length of time involved in securing REC review and approval. We discuss an approach to the problem that involved organisation of 'rapid review' REC sub-committees who met via video-conference for collaborative review of research protocols. 2016;9(2) S Afr J Bioethics Law

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The Structure and Function of Research Ethics Committees in Africa: A Case Study

Abstract: Kass and colleagues explore the strengths and weaknesses of research ethics committees in Africa.

Cited by 106 publications

References 25 publications

Enhancing the Efficiency and Quality of African Research Ethics Review Processes – Through an Automated Review Platform

Enhancing the Efficiency and Quality of African Research Ethics Review Processes – Through an Automated Review Platform

Regulatory and Ethical Approval Timelines for HIV Vaccine Studies: An Analysis of International AIDS Vaccine Initiative (IAVI) Sponsored Studies in East and Southern Africa

Enhanced REC collaborative review through videoconferencing

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