Multiple ethical review in North–South collaborative research: the experience of the Ebola-Tx trial in Guinea

Crop, Maaike De; Délamou, Alexandre; Griensven, Johan van; Ravinetto, Raffaella

doi:10.20529/ijme.2016.022

Cited by 9 publications

(37 citation statements)

References 7 publications

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“…The open-label phase 2/3, non-randomized comparative trial was designed to evaluate the feasibility, safety and efficacy of convalescent plasma (CP) against EVD [ 5 , 6 , 23 , 24 , 25 , 26 ]. During the trial (2015), CP was collected through voluntary donations from EVD survivors and subsequently transfused to confirmed EVD patients at the Ebola Treatment Centre led by MSF.…”

Section: Methodsmentioning

confidence: 99%

What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea

Ronse¹,

Sáez²,

Gryseels³

et al. 2018

PLoS Negl Trop Dis

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IntroductionDuring the 2014 Ebola Virus Disease (EVD) epidemic, the Ebola-Tx trial evaluated the use of convalescent plasma (CP) in Guinea. The effectiveness of plasmapheresis trials depends on the recruitment of plasma donors. This paper describes what motivated or deterred EVD survivors to donate CP, providing insights for future plasmapheresis trials and epidemic preparedness.MethodsThis qualitative study, part of Ebola-Tx, researched and addressed emergent trial difficulties through interviewing, participant observation and focus group discussions. Sampling was theoretical and retroductive analysis was done in NVivo 10.ResultsWillingness or hesitance to participate in plasma donation depended on factors at the interface of pre-existing social dynamics; the impact of the disease and the consequent emergency response including the trial set-up. For volunteers, motivation to donate was mainly related to the feeling of social responsibility inspired by having survived EVD and to positive perceptions of plasmapheresis technology despite still unknown trial outcomes. Conversely, confidentiality concerns when volunteering due to stigmatization of survivors and perceived decrease in vital strength and in antibodies when donating, leading to fears of loss in protection against EVD, were main deterrents. The dynamic (dis)trust in Ebola Response Actors and in other survivors further determined willingness to participate and lead to the emergence/decline of rumours related to blood stealing and treatment effectiveness. Historic inter-ethnic relations in the health care setting further defined volunteering along socio-economic and ethnic lines. Finally, lack of follow-up and of dedicated care further impacted on motivation to volunteer.ConclusionsEbola-Tx was the first trial to solicit and evaluate blood-product donation as an experimental treatment on a large scale in Sub-Saharan Africa. An effective donation system requires directly engaging with emergent social barriers and providing an effective ethical response, including improved and transparent communication, effective follow-up after donation, assuring confidentiality and determining ethical incentives.

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Section: Methodsmentioning

confidence: 99%

What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea

Ronse¹,

Sáez²,

Gryseels³

et al. 2018

PLoS Negl Trop Dis

Self Cite

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“…Although many EC reviews were consistent, some were discordant [34, 62]. Consolidating reviews was explored but proved largely unfeasible.…”

Section: Scientific Data and Safety Monitoring And Ethical Reviewmentioning

confidence: 99%

Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic

et al. 2017

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BackgroundBetween 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies.WHO-ERC reviewsWHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented.ConclusionsTo accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care.

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“…In 2016, a WHO guidance document on ethical issues in outbreaks explicitly recommended that mechanisms must be developed to ensure rapid ethics review without undermining any of the substantive protections that a robust ethics review is designed to provide [7]. However, the guideline does not elaborate on what those mechanisms could be; and it is not clear for how long ethics review bodies may sustain the accelerated review timelines under emergency conditions [8, 28–30]. To the best of our knowledge, explicit mechanisms for rapid ethics review have not been put in place yet at the national level, or even piloted in any country.…”

Section: The Five Sessions Of the Who-alerrt Workhopmentioning

confidence: 99%

“…Prior training of ERC members on specific issues relevant for epidemics, and the availability of experts as advisors, was found to be helpful by the Liberian Ethics Committee. The ITM IRB and researchers observed that there is much more to be done to harmonize and streamline the multiple ethical reviews of the same research protocol [30]. Subsequently, participants worked in small groups around case-vignettes (i.e., brief scenarios developed for the purpose of the workshop), in order to discuss the barriers to implementation of the existing normative guidelines, and what would help the N(R)ECs to be better prepared for providing a rapid and robust review of research during an epidemic.…”

Section: The Five Sessions Of the Who-alerrt Workhopmentioning

confidence: 99%

Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel

et al. 2019

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Background Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research “ethics preparedness” constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. Main text A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. Conclusion It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks.

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Multiple ethical review in North–South collaborative research: the experience of the Ebola-Tx trial in Guinea

Cited by 9 publications

References 7 publications

What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea

What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea

Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic

Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel

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