Introduction

As the novel COVID-19 pandemic continues, its impact on healthcare institutions and the healthcare community is strongly felt. Researchers and research institutions around the world are trying to cope with the wide range of effects of the pandemic on clinical research.1

The impact of COVID-19 on clinical research will vary, depending on the disease under study, the study design and where the study is being conducted. While some clinical trials may have continued, recruitment to observational studies was almost ubiquitously stopped during the height of the pandemic in many countries. Lockdowns, site closures, quarantines, travel limitations, interruptions to the supply chain for investigational products, diversion of resources and site personnel or study subjects becoming infected with the virus will be major challenges.1 2 All these factors might have an impact on clinical studies.

An issue specific to gastrointestinal (GI) research is the possibility of viral transmission through aerosol-generating endoscopic procedures and faecal to oral route. This will result in amendments to or unavoidable deviations from original study protocols and the need for additional precautions and protective equipment.3 Many patients with COVID-19 can be asymptomatic or have mild symptoms.4 5 Therefore, screening all participants for COVID-19, with real-time, reverse PCR (rRT-PCR) or a combination of antibodies and rRT-PCR, may be necessary for areas with a high prevalence of the disease.6 If mandatory screening is to be implemented on all participants, this will have to be communicated to them and consent obtained from ethical review committees as this will involve collecting additional nasopharyngeal swabs and blood samples. …