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

Abstract

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.

Making Emergency Use of Experimental Vaccines Safer

“…4 Although the World Health Organization (WHO) Research Ethics Review Committee guided implementation of trials during that outbreak and requested amendments to the protocol to include members of these populations as subjects, it later relented, as further review was seen as delaying trial initiation and "potential benefit for all." 5 In 2019, the DRC National Ethics Committee approved inclusion of pregnant or lactating women and children in a large experimental rVSV vaccination campaign that was underway but required close follow-up and limited distribution to areas where Ebola was being actively transmitted. 6 This committee's decision highlights that comparing vulnerable community members' risk of harm from EVD to their risk of harm from rVSV tends to be considered in decisions about whether, where, and with whom to use experimental vaccines.…”

2019 meeting of the global virus network

“…Clinical research during epidemics is crucial to build an urgent response and, yet, requires thoughtful oversight by research ethics committees to ensure the protection of vulnerable subjects facing health uncertainties. To appropriately address the regulatory aspect should be cultivated in anticipation of epidemics and pandemics, rather than in response to them (Alirol et al, 2017). The University of Nebraska Medical Center (UNMC) institutional review board (IRB) response during the 2014-2015 Ebola epidemic provided an example of research ethics review under a rapid response model.…”

Neurology in the Light of Genomics: Application of NGS and GWAS in Understanding Complex Neurological Disorders

“…Similarly, data generation and data sharing with permission is another important issue [106]. Disease outbreak, especially viral and other infectious diseases also require proper ethical concerns and protocol in relation to quarantine, testing or application of unapproved medication during any emergency situation [107].…”