{"id":4192,"date":"2021-07-13T22:20:59","date_gmt":"2021-07-13T21:20:59","guid":{"rendered":"https:\/\/blogs.bmj.com\/medical-ethics\/?p=4192"},"modified":"2021-07-13T22:27:18","modified_gmt":"2021-07-13T21:27:18","slug":"the-review-of-the-global-first-sars-cov-2-human-infection-challenge-studies-hics","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/13\/the-review-of-the-global-first-sars-cov-2-human-infection-challenge-studies-hics\/","title":{"rendered":"The review of the global first SARS COV 2 Human Infection Challenge studies"},"content":{"rendered":"

By the UK ad hoc specialist Research Ethics Committee<\/p>\n

Expert and lay members of UK RECs recognised to review Clinical Trials of Investigational Medicinal Products (CTIMPs) or Phase 1 studies in healthy volunteers, particularly those with experience of vaccine studies, were invited to join an ad hoc Research Ethics Committee to review SARS COV 2 Human Infection Challenge studies (HICS).\u00a0 All were asked to attend two virtual HRA workshops before the first committee meeting (and all did!) and were provided with articles from both sides of the argument for further reading.\u00a0 Given the pandemic lockdown, we met virtually, ensuring broad representation across the UK nations, and that applicants were easily able to attend (of huge help to our review).<\/p>\n

The balance between benefits and harms was at the centre of review. The first HICS was to define the dose infectivity for further SARS COV-2 studies with wider therapeutic aims. Its acceptability, therefore, depended crucially on demonstrating purpose to these later studies, how they would contribute to the understanding and management of SARS COV2. The REC also wanted to be reassured that: –<\/p>\n