What constitutes risk in implementation research? Perspectives from a qualitative key-informant study

Area of Science:

• Implementation Science
• Bioethics
• Health Services Research

Background:

• Implementation research in routine care requires appropriate ethical oversight.
• Current definitions of minimal risk may not capture unique implementation study risks.
• Empirical data on researchers' interpretation of minimal risk in implementation research is limited.

Purpose of the Study:

• To explore how implementation researchers interpret minimal risk.
• To identify risk-related concerns in implementation research.
• To understand researchers' experiences with regulatory review for risk assessment.

Main Methods:

• Semi-structured qualitative interviews with 11 experienced implementation researchers.
• Purposive sampling for participant recruitment.
• Thematic analysis using a grounded theory approach.

Main Results:

• Researchers found minimal risk application complex and context-dependent.
• Key themes included ambiguity in defining usual care, distinguishing strategy vs. intervention risks, clarifying who is at risk, and understanding risk types.
• Concerns were raised about underreporting and inconsistent review of strategy-related risks (e.g., staff burden).

Conclusions:

• Enhanced ethical review clarity is needed for implementation strategy-related risks and researcher responsibilities.
• Systematic documentation and publication of unintended harms from implementation strategies are recommended.
• Developing specific ethical frameworks and training is crucial for implementation science.