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 KEMRI 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 where one protocol was submitted to multiple review committees simultaneously . 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.

The hidden emotional labour behind ensuring the social value of research: Experiences of frontline health policy and systems researchers based in Kenya during COVID-19

“…Some research teams therefore re-strategized their research to include a COVID-19 research element. For example, the pandemic provided AHOP with a policy window to engage policy makers with priority evidence for real-time decision making on the COVID-19 response and containment measures [ 30 ]. Thus, several research teams submitted new COVID-19 related proposals or amendments to existing proposals (adding a COVID-19 lens) for science and ethics approval.…”

“…In Kenya, changes were made to the ethics review systems at the institutional (KWTRP) and national review levels to respond to the specific ethical issues raised by the COVID-19 pandemic. New guidance was developed for example for informed consent and participant recruitment and safety, and new review structures and processes introduced [ 30 ]. COVID-19 protocols were to be prioritised with a targeted turnaround time for initial review at the national review level to 14 days ( Fig 2 ).…”

“…COVID-19 protocols were to be prioritised with a targeted turnaround time for initial review at the national review level to 14 days ( Fig 2 ). A s documented elsewhere [ 30 ], between April 2020 and April 2021, 66 protocols were reviewed at KWTRP, of which 30 were COVID-19 related new protocols (n = 10) and amendments (n = 20). HPSR researchers experienced both opportunities and challenges in achieving timely review of COVID-19 proposals, and in implementing new guidance post approval, as outlined next.…”

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 [18], China [19], Ecuador [20], Egypt [21], Germany [22], India [23][24][25], Iran [10], Ireland [26], Kenya [27], Kyrgyzstan [28], Latin America [29], the Netherlands [30], Pakistan [31], South Africa [32,33], Turkey [34], and the United States [35][36][37]. 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.…”