Raising the Standards of Public Involvement in Clinical Trials

Blackburn, Steven; Rhodes, Carol; Higginbottom, Adele; Campbell, Laura; User Group, Research; Foster, Nadine; Dziedzic, Krysia

Abstract

Introduction: The UK National Standards for Public Involvement in
research have recently been launched to improve the quality of
public involvement. Keele University is one of the ten test sites
nationally developing ways to put the six National Standards into
practice. This paper presents some of the approaches and resources developed to implement the National Standards for use
with clinical trials.

Methods: In partnership with Keele Research User Group (RUG), we
used the Standards to audit current trial processes and co-produce
new resources to improve public involvement practices. Over 12
months, we adopted a Plan-Deliver-Review-Act approach to implement each Standard across the Research Institute and Clinical Trials Unit.

Results: The audit highlighted areas for improvement in how we deliver public involvement. We have developed new resources and practices for the six Standards, including: Standard 1 (Inclusive Opportunities): A Diversity and Inclusion policy and new recruitment plan to ensure fair opportunities for public involvement Standard 2 (Working Together): Clear role descriptions for all public involvement roles (Trial Steering Committees, Public Co-applicants, Advisory Groups) Standard 3 (Support and Learning): Induction sessions for new public contributors and a ‘RUG-Buddy’ peer-mentoring scheme with more experienced members supporting new members Standard 4 (Communications): a brief guide for researchers to encourage clear, two-way communication with public contributors, including improved feedback Standard 5 (Impact): Tips on capturing and evaluating the impact of public involvement in trials
Standard 6 (Governance): A developing Public Involvement and Engagement Strategy, and Funding formula to ensure appropriate public involvement budgets.

Discussion: We have used the National Standards to reflect on current practices and develop new resources to improve public involvement in research. They are helping to drive a culture change towards doing better public involvement. More is to be done on encouraging wide-spread awareness and adoption of the Standards across studies.

• Presentation Conference Type: Poster
• Conference Name: 5th International Clinical Trials Methodology Conference (ICTMC 2019)
• Conference Location: Brighton, UK
• Start Date: Oct 6, 2019
• End Date: Oct 9, 2019
• Deposit Date: Jun 27, 2023
• DOI: https://doi.org/10.1186/s13063-019-3688-6
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3688-6
• Additional Information: Part of;; Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)