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Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

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Published on: May 15, 2020

Research governance delays for a multicentre non-interventional study.

Andrew A Mallick¹, Finbar J K O'Callaghan

¹Bristol Institute of Child Life and Health, Academic Unit of Child Health, Level 6, UBHT Education Centre Upper Maudlin Street, Bristol BS2 8AE, UK.

Journal of the Royal Society of Medicine

|May 7, 2009

Summary

Research governance approval for multicentre studies in the UK experiences significant delays, averaging 43 working days. This impacts the timely initiation of ethically approved research, highlighting a need for process improvements.

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Area of Science:

Medical Research
Health Services Research
Clinical Trials Management

Background:

Research governance approval is a critical step for initiating studies.
Delays in this process can significantly impact research timelines and outcomes.
Understanding the extent and reasons for these delays is essential for improving research infrastructure.

Purpose of the Study:

To quantify the delay in obtaining research governance approval for a non-interventional, multicentre study.
To identify factors contributing to these delays within the UK healthcare system.

Main Methods:

Prospective recording of time from application to approval for an observational study of childhood stroke.
Data collected from 92 acute NHS Trusts in the United Kingdom.
Median delay in working days was the primary outcome measure.

Main Results:

The median delay for research governance approval was 43 working days (IQR: 27-62).
For 44 trusts, delays exceeding 43 working days were inexplicable in 70% (30 trusts).
A wide range of delays was observed (0-147 working days).

Conclusions:

Significant variability exists in research and development processes across NHS Trusts.
These variations lead to substantial delays in commencing ethically approved studies.
Improvements in the research approval system are necessary to facilitate research initiation.