Is my project research? Determining which projects require review by a research ethics committee

Area of Science:

• Health Services Research
• Research Ethics
• Regulatory Science

Background:

• Research ethics review is vital for protecting participants' rights and safety.
• Distinguishing between research requiring ethics review and other activities (e.g., quality improvement) is challenging.
• Current practices may mislabel projects, impacting regulatory oversight.

Purpose of the Study:

• To differentiate activities necessitating research ethics committee review from those that do not.
• To propose a clear framework for identifying research requiring ethics oversight.
• To avoid confusion between research ethics review and broader definitions of research.

Main Methods:

• Development of a pragmatic, heuristic solution.
• Collaboration with three UK government agencies.
• Focus on clarifying criteria for research ethics review.

Main Results:

• A practical framework has been developed to guide decisions on ethics review.
• The approach aids in identifying projects that require formal ethics review.
• Clarification of scope for research ethics review processes.

Conclusions:

• The distinction between research ethics review and general research definitions is critical.
• The proposed solution offers a pragmatic approach to identifying research requiring ethics review.
• This framework has implications for UK research and international regulatory practices.