Consistency in decision making by research ethics committees: a controlled comparison.

Area of Science:

• Medical Ethics
• Clinical Research Governance

Background:

• Longstanding concerns exist regarding the consistency of decisions made by UK research ethics committees (RECs).
• Previous evidence primarily stems from single studies reviewed by multiple committees, limiting broader understanding.

Purpose of the Study:

• To systematically compare REC decisions on a selected set of research applications.
• To assess the level of agreement between different RECs reviewing the same applications.

Main Methods:

• A systematic comparison of decisions on 18 purposively selected research applications.
• Each application was independently reviewed by three distinct RECs within a single strategic health authority.
• Statistical analysis, including kappa coefficient, was used to measure inter-rater agreement.

Main Results:

• Decisions were consistent for 11 out of 18 applications.
• Disparities in decisions were observed among RECs for the remaining seven applications.
• The overall measure of agreement (kappa = 0.286) indicated a 'slight' level of agreement between RECs, though likely better than chance.

Conclusions:

• The study indicates a low level of consistency in decision-making among UK research ethics committees.
• The small sample size limits the generalizability and robustness of the findings.
• Further research is required to investigate the causes and implications of REC decision inconsistencies.