The UK will be the first country in the world to run a COVID-19 human challenge study (The Coronavirus Human Infection Challenge), having been approved by the Health Research Authority (HRA).
Using controlled doses of coronavirus, the aim of the study is to discover the smallest amount of virus needed to cause COVID-19 infection in controlled groups of healthy young people. This group, aged between 18 and 30 are at the lowest risk of harm. The valuable information gained from the research will form the basis of future vaccine studies.
The HRA brought together a group of experienced Research Ethics Committee members from around the UK, including Dr Kolstoe, to review the study.
Dr Kolstoe, Senior Lecturer and University Ethics Advisor, said: “COVID-19 is a massive challenge for all of us. New research will provide the solution, but it cannot be conducted at any ethical cost, especially if it could be dangerous for participants.
We spent a long time discussing this study, and while we cannot predict everything that might happen, we are confident that as many ethical and medical safeguards are in place to protect participants and ensure the research is valuable.
Dr Kolstoe also has a crucial role with Public Health England (PHE) supporting the rapid response of the research community to the coronavirus pandemic. He is Chair of PHE’s Research Ethics and Governance of Group (REGG), which was established to support the work of 5,500 scientists, researchers and public health professionals.
The REGG forms a key element of PHE’s overall quality and governance work and provides an appropriate level of authoritative and independent review of research and non-research public health activity that involves human participants, their data and/or their tissues.
Dr Kolstoe said: “Research is key for addressing the challenges of COVID-19, but even in a public emergency research needs to be ethical, rigorous and transparent. Universities have been playing a vital role supporting government in providing independent advice and expertise during this crisis.”