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Variations in experience in obtaining local ethical approval for participation in a multi-centre study
N A Maskell1, E L Jones, R J O Davies
1Oxford Centre for Respiratory Medicine, Churchill Hospital, John Radcliffe NHS Trust, Headington, Oxford, UK. nickmaskell@doctors.org.uk
QJM : Monthly Journal of the Association of Physicians
|March 26, 2003
Summary
New guidelines for ethics approval in multi-centre trials did not improve efficiency. Many Local Research Ethics Committees (LRECs) failed to implement the guidance, causing delays and deterring future clinical trial participation.
Area of Science:
- Clinical research ethics
- Regulatory affairs in medicine
- Multicenter clinical trials
Background:
- The Department of Health introduced guidance for Local Research Ethics Committees (LRECs) on handling Multi-centre Research Ethics Committee (MREC)-approved applications.
- This process aimed to standardize and expedite ethical approval for clinical trials.
Purpose of the Study:
- To assess the efficiency of the implemented guidance for obtaining local ethical approval in multicenter trials.
- Evaluate the impact of new LREC/MREC interface guidelines on clinical trial administration.
Main Methods:
- A postal questionnaire survey was distributed to Local Investigators at 56 trial centers.
- Data collected focused on the experience of obtaining LREC approval for the Multi-centre Intrapleural Streptokinase Trial.
Main Results:
- 91% of centers responded, reporting significant resource use (25,296 paper sheets, 62 hours photocopying).
- Only 47% of LRECs had a 'fast track' system; approval times averaged 27 days, with investigators spending 3.27 hours per submission.
- 37% of investigators found the LREC/MREC interface inefficient, and 33% were deterred from future trial participation.
Conclusions:
- The Department of Health's guidance for LRECs has not been uniformly implemented across all committees.
- Significant variation in local ethical approval processes persists, impacting trial efficiency and investigator engagement.