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

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.

Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt.

Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are "controlled" by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases. Traditionally, HIS have been conducted primarily in high-income countries (HICs) but are now increasingly being conducted in low-and-middle income countries (LMICs). In LMICs settings, HIS are likely to raise concerns among various stakeholders including participating populations and regulatory bodies, that are unfamiliar with this type of research. Deliberately infecting a healthy individual with a disease-causing pathogen seems to go against the normal practice of medicine of "do no harm". Such types of studies can give rise to increased rumors and jeopardize research participation in study activities, including non-HIS research. Community engagement can be one approach to address particular issues that HIS studies raise through meaningfully engaging with communities, where views and voices inform the conduct of HIS studies. In addition, engagement can inform the ethical conduct and acceptability of HIS studies in LMICs settings and provide opportunities for sharing information, listening to, and responding to concerns and views from potential participants, and the larger community in which the study would be conducted. Despite community engagement being an important aspect to consider, very few published and gray literature cover the types of approaches that have been used, and lessons learnt in engagement for HIS. This article outlinesthe community engagement approaches that were used to engage stakeholders and communities for malaria HIS-controlled human malaria infection (CHMI), undertaken in Kilifi, Kenya. It outlines the engagement activities across the research cycle, from activities conducted during protocol development, to planning, and implementation of the study. We discuss the challenges experienced, lessons learnt, and provide some recommendations for engagement around HIS.