Medical Research Oversight and Conduct During COVID-19 Pandemic: A Case Study of the Kenya Medical Research Institute

Abstract

The containment measures introduced by the government of Kenya to minimise the spread and impact of SARS-CoV-2 inadvertently disrupted both the conduct of research and research oversight. At the Kenya Medical Research Institute (KEMRI) Scientific and Ethics Review Unit (SERU), submission of paper-based research protocols for review and in-person committee meetings were disrupted. In response, the KEMRI SERU changed operations from in-person to virtual meetings and from paper-based to e-mail submission of research protocols. This paper examines the continuity of research conduct and oversight during the COVID-19 pandemic. This was a cross-sectional study that utilised a qualitative approach. We successfully conducted 50 in-depth interviews with the following: KEMRI SERU committee members (18), KEMRI SERU-based research administrators (8), principal investigators affiliated with KEMRI (18) and principal investigators from other research institutes who utilise KEMRI SERU for review (NON-KEMRI affiliated PIs) (6). The participants were purposively sampled. Data was analysed thematically using Dedoose, with selected quotations chosen to illustrate key themes and sub-themes presented in text form. The study found that the adoption of e-mail submission of research protocols and virtual meetings ensured continuity of research conduct and oversight during the COVID-19 pandemic. The virtual meetings increased members’ attendance at the KEMRI SERU committee meetings, reduced travel and saved time and other costs related to in-person meetings. The email submission eliminated the need for physical storage of paper documents, enhanced flexibility, and saved resources like printing and handling bulky paper documents. The challenges included unstable internet connectivity and unfamiliarity with online platforms during virtual meetings. Despite some challenges, the transition to email submission and virtual meetings enabled research conduct and oversight continuity