OBJECTIVES

: The Retrospective Chart Review (RCR) study design enables access to real world data for difficult-to-reach populations. This study sought to understand the ethical, regulatory and contracting landscape for the conduct and operationalisation of an anonymised RCR in the devolved nations of the United Kingdom.

METHODS

: The national and regional ethical and regulatory bodies in each devolved nation were approached for guidance on their requirements for the conduct and implementation of an anonymised RCR. Ethical and regulatory approval was sought in parallel with site set-up and contracting.

RESULTS : Approval to conduct a fully anonymised RCR involves an application to the Health Research Authority (HRA) for England and Wales. Scotland additionally requires applications for research and development permission, and data protection approval, to be submitted to the National Health Service (NHS) Research Scotland Permissions Coordinating Centre (NRSPCC), and local Caldicott Guardian (or Public Benefit and Privacy Panel for Health and Social Care if >1 site). Research ethical committee approval is not required for a fully anonymised RCR. Approval timelines varied across the devolved nations, with the permission for England received the quickest. Common hurdles included site requests to use the standard research agreement (‘model clinical trial agreement’ instead of a bespoke study contract), and a costing template, and to provide sponsor indemnity insurance (the latter two requests were not required after clarifying the study design). Site contracting was dependent on ‘site resource and capacity’ confirmation. Site staff faced internal bureaucratic processes that did not differentiate between the simplistic nature of an RCR design and that of clinical trials and prospective studies.

CONCLUSIONS

: The anonymised RCR design is poorly understood by research authorities and NHS sites. Bureaucratic processes that do not differentiate between study designs can hamper study conduct and lead to the need for additional operational input and increased study timelines.