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

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Researchers find defining minimal risk in implementation research complex. Greater clarity is needed on strategy-related risks and researcher responsibilities to protect communities and systems.

Keywords:
Dissemination and implementationEthicsIRBImplementation scienceImplementation strategiesMinimal riskPragmatic trials

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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.