Pandemic preparedness and responsiveness of research review committees: lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya

Abstract

Background: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the Kenya Medical Research Institute - Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees. Methods: A document review and in-depth interviews with researchers, regulators and research reviewers were conducted. Documents reviewed included research logs of all protocols submitted between April-1-2020 and March-31-2021, feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 research review meetings. Fifteen in-depth interviews were conducted with respondents purposively selected because of their experience of developing or reviewing COVID-19 protocols at the institution level (n=9 researchers, engagement officers and regulators) or their experience in reviewing proposals at a national-level (n=6 committee members). Data were managed and analyzed using MS Excel and NVivo12. Results: Between April-1-2020 and March-31-2021, 30 COVID-19-related submissions by KWTRP researchers were approved. Changes to the review system included strengthening the online system for protocol submission and review, recruiting more reviewers, and trialing a joint review process. The turnaround time from submission to national approval/rejection over this period was faster than pre-pandemic, but slower than the national committee’s target. COVID-19-specific ethics questions centred on: virtual informed consent and data collection; COVID-19 prevention, screening and testing procedures; and the challenges of study design and community engagement during the pandemic. Conclusions: The unprecedented challenges of the pandemic and added bureaucratic requirements created a more complex review process and delayed final approval of research protocols. The feasibility of conducting joint review of research during public health emergencies in Kenya needs further investigation. Consideration of the unique COVID-19 ethics issues raised in this paper might aid expedience in current and future reviews.

A scoping review of ethics review processes during public health emergencies in Africa

“…As shown in Table 3, most (6/9) of the included articles are discussion papers published in peer-reviewed journals [23,[56][57][58][59]61]. Two original research articles were included: a qualitative methods paper [62] and a mixed method paper with a strong qualitative element [52]. Six articles covered issues related to ethics review and EVD considerations [23,56,57,[59][60][61]; three covered issues linked to COVID-19, including (informed) consent [58], stakeholder engagement [62] and research and ethics review [52]; three commented on virtual modalities for review (meetings), consultations or obtaining consent [23,52,58]; and five described review timelines during public health disasters [52,57,[59][60][61].…”

“…These were the countries most affected by EVD between 2014 and 2016. One article drew on South African experience [58] and another on Kenyan experience [52] during the COVID-19 pandemic. The remaining two articles reference Africa broadly [62] or extrapolated from an African experience to make comments about ethics review processes during PHEs across low-and middle-income countries [60].…”

“…The reviewed articles describe different aspects of processes, procedures, and frameworks set up or implemented during PHEs. Five studies describe experiences of establishing or reviewing clinical trial(s) or intervention studies and some the procedural aspects of ethics review [52,56,57,59,61]. Three articles emphasise preparing review bodies [23,52] or their members in LMICs [60] for reviewing study proposals during outbreaks through skills audit and training.…”

“…Documented ethical issues in conducting research during PHEs include preparing RECs for accelerated review of studies, for instance through the establishment of ad hoc committees [3,6,[23][24][25][26][27][28][29][30]; ensuring appropriate research designs for scientific validity, social value and fair selection of participants [31]; promoting inclusive and adequate stakeholder engagement and informed consent processes [2,[32][33][34]; dealing with the specific ethical conundrum of clinical trials and human challenge studies during emergencies [35][36][37][38][39][40][41]; supporting appropriate data collection, storage and future use, including those relating to children [33,[42][43][44][45]; and maintaining mechanisms for ethics review whether in person or virtual [40,[46][47][48][49][50][51]. However, few studies specifically consider ethics review processes, procedures and governance frameworks for epidemics and public health emergencies in Africa [52].…”

Research ethics review during the COVID-19 pandemic: An international study

“…Several of these contributions focus exclusively on one ERC, usually associated with an academic or health care institution. The literature includes descriptions of ERC operations during the pandemic in Central America and the Dominican Republic [17], China [18], Ecuador [19], Egypt [20], Germany [21], India [22–24], Iran [10], Ireland [25], Kenya [26], Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34–36]. Most of these studies reported results from surveys, interviews, focus groups, and documentary analysis, including review of research protocols, ERC meeting minutes, and existing SOPs.…”