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Related Experiment Video

Updated: Jun 27, 2026

Qualitative and Quantitative Validation of Tools with Rating Scales Aimed at Assessing the Quality of University Service-Learning

Qualitative and Quantitative Validation of Tools with Rating Scales Aimed at Assessing the Quality of University Service-Learning

Published on: August 29, 2025

Determining the need for ethical review: a three-stage Delphi study.

J Reynolds¹, N Crichton, W Fisher

¹Institute of Primary Care & Public Health, London South Bank University, London, UK.

Journal of Medical Ethics

|December 2, 2008

Summary

Expert consensus on distinguishing research from audit in healthcare projects remains challenging. Developing a validated algorithm is needed to ensure appropriate ethical review by Research Ethics Committees (RECs).

Related Experiment Videos

Last Updated: Jun 27, 2026

Qualitative and Quantitative Validation of Tools with Rating Scales Aimed at Assessing the Quality of University Service-Learning

Qualitative and Quantitative Validation of Tools with Rating Scales Aimed at Assessing the Quality of University Service-Learning

Published on: August 29, 2025

Area of Science:

Healthcare ethics
Clinical research governance
Medical audit standards

Background:

Distinguishing between research and audit is complex within the National Health Service (NHS).
Current guidelines necessitate Research Ethics Committee (REC) approval only for research projects.
Confusion may lead to unnecessary REC applications or ethically unsound projects escaping review.

Purpose of the Study:

To explore expert opinions on differentiating research from audit.
To determine the necessity of REC review for various healthcare projects.
To develop consensus on classifying projects and assessing ethical concern.

Main Methods:

A three-stage Delphi method was employed.
Included semi-structured interviews and validated questionnaires with 24 experts.
Anonymized responses were analyzed for consensus on project classification and ethical review needs.

Main Results:

Consensus was achieved on 30.4% of questions regarding ethical concern levels.
Consensus was reached on 32.6% of questions concerning project types.
Significant inconsistency was found in defining and classifying studies beyond research or audit.

Conclusions:

Key discriminatory factors for project classification and ethical concern assessment were identified.
These factors can inform the development of an algorithm for determining the need for ethical review.
A weak correlation exists between perceived ethical concern and project classification, highlighting classification challenges.