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Local research ethics committee approval for a national study in Scotland
K W Ah-See1, J MacKenzie, N S Thakker
1Department of Otolaryngology, City Hospital, Edinburgh, UK.
Journal of the Royal College of Surgeons of Edinburgh
|November 6, 1998
Summary
Ethics committee review processes for research proposals show significant variation across districts, causing delays in multicentre studies. Standardization of application forms and improved committee cooperation are needed for efficient research.
Area of Science:
- Medical Ethics
- Health Services Research
- Oncology Research
Background:
- Ethics committee review processes for research proposals exhibit considerable variability.
- Multicentre research projects are particularly susceptible to delays due to differing committee requirements.
- Previous calls for standardization have not fully resolved these inter-committee discrepancies.
Purpose of the Study:
- To assess the extent of variation in ethics committee handling of research proposals in Scotland.
- To identify specific areas of divergence in application procedures and approval timelines.
- To provide evidence supporting the need for enhanced standardization in ethics review.
Main Methods:
- A nationwide postal questionnaire study was conducted in Scotland.
- The study focused on young patients with oral or oropharyngeal cancer.
- Nineteen ethics committees were approached, with data collected on application forms, documentation requirements, and approval times.
Main Results:
- Significant variations were observed in ethics committee procedures across different districts.
- Fifteen out of 19 committees utilized unique application forms.
- The number of required documentation copies ranged from one to 20, and approval times varied from 39 to 182 days (mean 90 days).
Conclusions:
- Despite efforts towards standardization, substantial variations persist in ethics committee processes.
- There is a clear need for improved training and a standardized constitution for committee members.
- Implementing a uniform national application form and fostering better inter-committee cooperation are essential for streamlining research approvals.