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Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

Published version
Peer-reviewed

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Authors

Foy, Chris 
Hayden, Charlotte 
Al-Shahi Salman, Rustam 
Tebbutt, Stephen 

Abstract

OBJECTIVE: Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. DESIGN: Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. PARTICIPANTS: 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. RESULTS: Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. LIMITATIONS: This study was a non-randomised comparison cohort study. Some data were missing. CONCLUSIONS: An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision.

Description

Keywords

controlled study, process evaluation, quality improvement, research ethics, Biomedical Research, Cohort Studies, Decision Making, Ethics Committees, Research, Humans, Surveys and Questionnaires, Time Factors, United Kingdom

Journal Title

BMJ Open

Conference Name

Journal ISSN

2044-6055
2044-6055

Volume Title

6

Publisher

BMJ
Sponsorship
Wellcome Trust (097899/Z/11/Z)
The ethics officer pilot and the controlled evaluation was funded by the HRA. The process evaluation was conducted and funded separately by MD-W’s Wellcome Trust Investigator Award WT097899 with no HRA oversight or involvement beyond facilitating access to the database. MD-W’s contribution to this paper was also supported by University of Leicester study leave at the Dartmouth Institute for Health Policy and Clinical Practice. RA-SS was funded by a Medical Research Council senior clinical fellowship.