The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic.

ABSTRACT: High quality health care research must involve patients and the public. This ensures research is important, relevant and acceptable to those it is designed to benefit. The world's first human challenge study with SARS-CoV-2 undertook detailed public involvement to inform study design despite the urgency to review and establish the study. The work was integral to the UK Research Ethics Committee review and approval of the study. Discussion with individuals from ethnic minorities within the UK population supported decision-making around the study exclusion criteria. Public review of study materials for consent processes led to the addition of new information, comparisons and visual aids to help volunteers consider the practicalities and risks involved in participating. A discussion exploring

SUBMITTER: Piggin M 

PROVIDER: S-EPMC9434955 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature