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.
Highlights
Since the onset of the COVID-19 pandemic in Wuhan China in late December 2019, there has been an unsurprising surge in publications and reports on the virus and its impact worldwide[1,2]
The documents included research logs of protocols submitted to the KWTRP Centre Scientific Committee (CSC) between April 1st 2020 and March 31st 2021; feedback from KWTRP CSC and national-level review committee (NRC) on ten new COVID-19 protocols (n=42 review forms); minutes of sixteen KWTRP CSC and nineteen Research Coordinating Committee (RCC) meetings held between April-November 2020; and four guidelines developed by KWTRP and NRC before and during the COVID-19 pandemic as well as international guidelines described previously
We describe the changes made to the review system at KWTRP CSC and nationallevel review committee, the turn-around time for feedback and respondents’ views and experiences
Summary
Since the onset of the COVID-19 pandemic in Wuhan China in late December 2019, there has been an unsurprising surge in publications and reports on the virus and its impact worldwide[1,2]. Based on experiences from previous public health emergencies, it is clear that research review systems are central to expediency of key research questions needed to guide pandemic responses, and that this expedience is challenged by the practical and ethical considerations that need to be made under pressure. Some of these challenges emanate from novelty of the pathogen, and the little data available to inform decisions about balance of risks, harms and burdens against benefits, and difficulties in determining appropriate standard-of-care, fair selection of participants, and the quality and legitimacy of informed consent[8–10]. Changes to the review system included strengthening the online system for version 2
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
