Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human <scp>A</scp>frican Trypanosomiasis

Coleman, Carl H.; Ardiot, Chantal; Blesson, Séverine; Bonnin, Yves; Bompart, François; Colonna, P; Dhai, Ames; Ecuru, Julius; Edielu, Andrew; Hervé, Christian; Hirsch, François; Kouyaté, Bocar; Mamzer-Bruneel, M F; Maoundé, Dionko; Martinent, Eric; Ntsiba, H; Pelé, Gérard; Quéva, Gilles; Reinmund, Marie‐Christine; Sarr, Samba Cor; Sépou, A.; Tarral, Antoine; Tetimian, Djetodjide; Valverde, Olaf; Nieuwenhove, Simon Van; Strub‐Wourgaft, Nathalie

doi:10.1111/dewb.12068

Cited by 11 publications

(13 citation statements)

References 3 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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“…The assessment algorithm for inclusion of WoSuPs in various phases of drug development is described in Fig 1. To facilitate the analysis, it is recommended that a collaborative "prereview" of the ethical oversight is set-up, conducted by an ad hoc ethics committee including representatives from the target country or countries and from mature countries, in collaboration with internationally recognized scientific experts [41].…”

Section: First and Foremost Dndi Recommends Evaluating The Implicatimentioning

confidence: 99%

Inclusion of women susceptible to and becoming pregnant in preregistration clinical trials in low- and middle-income countries: A proposal for neglected tropical diseases

Couderc-Pétry¹,

Eléfant

Wasunna

et al. 2020

PLoS Negl Trop Dis

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The Drugs for Neglected Diseases initiative (DNDi) aims to conduct research and development of new, improved, and patient-focused treatments for neglected tropical diseases (NTDs). DNDi's goal is to address unmet medical needs in low-and middle-income countries (LMIC) where they are needed using the best regulatory approval strategy for effective, safe, and affordable new treatments. When NTDs affect women susceptible to and becoming pregnant (WoSuP), a major concern, shared by DNDi, is to ensure that there are available data to support the safety and efficacy of the treatments for these women and potentially for their babies. WoSuP are female patients, sometimes very young, who have reached menarche and could become pregnant during treatment or during a clinical study or trial. For several decades, there has been reluctance to include WoSuP in clinical trials because of the potential risk of exposing the fetus to investigational drugs. This has led to neglecting physiological differences between WoSuP and other adult populations. This trend is, however, changing with arguments in favor of the ethical need to have appropriate data on new treatments in any population including WoSuP before regulatory approval. One of the systematic mitigating precautions taken to allow recruitment of WoSuP in preapproval clinical trials is the use of contraception. However, contraception is not always widely available, culturally allowed, followed, or effective in preventing pregnancy. Women might become pregnant during a clinical trial of a new treatment. The purpose of this paper is not to discuss the inclusion of already identified pregnant women but to envisage how to include WoSuP and provide them with access to innovative drugs, while acknowledging and mitigating the risk that they might become pregnant during the trial. Understanding the existing limitations for the participation of WoSuP in clinical trials, DNDi suggests the use of appropriate measures to ensure that WoSuP are represented as far as possible in trials, in accordance with scientific and ethical standards. This paper describes DNDi's proposal, which is based on a benefit and/or risk assessment of participation versus nonparticipation of this population in clinical trials. The primary objective is to provide adequate and robust evidence of efficacy and safety in this population, while

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“…While double or multiple reviews of international research protocols are common, we are not aware of any successful mechanisms for joint ethics review (Meslin et al , 2014; Tierney et al , 2013), with a single reported exception from the field of human African trypanosomiasis. A ‘pre-review’ process of the protocols for DNDi and partners’ pivotal Phase II/III fexinidazole study brought together in 2012 the Ethics unit of WHO and representatives of ECs from six African countries with the aim of reducing duplication of efforts (Coleman et al , 2015). This model of joint ‘pre-review’ of the ethical challenges foreseeable within a whole research plan, may be feasible for a public health emergency, if representatives of relevant organizations are pre-identified, available to meet on short notice, the resultant consensus review is agreed in advance to be acceptable to all and some organization takes on the role of coordination and engagement with the researchers.…”

Section: Procedural Issues Faced By the Msf Erb During The West Africmentioning

confidence: 99%

Research Ethics Governance in Times of Ebola

Schopper¹,

Ravinetto²,

Schwartz³

et al. 2016

Public Health Ethics

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The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.

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Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis

Abstract: ABSTRACT

Cited by 11 publications

References 3 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

Inclusion of women susceptible to and becoming pregnant in preregistration clinical trials in low- and middle-income countries: A proposal for neglected tropical diseases

Research Ethics Governance in Times of Ebola

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