As implementation research increasingly occurs within routine care settings, determining what constitutes minimal risk is critical to ensuring that ethical oversight is appropriate and proportional. Current regulatory definitions often do not reflect the unique features of implementation studies, including implementation strategy-related risks and system-level effects. Yet, little empirical evidence exists on how researchers themselves interpret minimal risk in this context. We conducted semi-structured qualitative interviews with 11 key informants, including investigators with experience in domestic and global implementation research. Participants were recruited through purposive sampling. Interviews explored how participants interpret the concept of minimal risk, identify risk-related concerns, and experience regulatory review processes as they relate to risk assessment. Data were analyzed thematically using a grounded theory approach. Participants generally accepted the U.S. Federal Policy for the Protection of Human Subjects (Common Rule) definition of minimal risk but viewed its application to implementation research as complex and context-dependent. Four major themes emerged: (1) ambiguity in defining usual care, especially in low-resource or inequitable settings; (2) distinguishing between strategy-related and intervention-related risks, (3) clarifying who or what is at risk, and (4) understanding the types of risks most likely to arise in implementation research contexts. Participants expressed concern that strategy-related risks, such as staff burden or organizational disruption, are poorly conceptualized, underreported, and inconsistently reviewed by ethics review committees. At the same time, they raised unresolved questions about who should bear responsibility for monitoring risks tied to the evidence-based intervention itself. Greater clarity is needed to guide ethical review, particularly regarding implementation strategy-related risks and the responsibilities of researchers for intervention-related harms. We recommend that implementation researchers begin systematically documenting and publishing on unintended harms related to implementation strategies, and that the field invest in building ethical frameworks and training specific to these challenges. Without such efforts, implementation science risks undermining the very systems and communities it seeks to improve.
Tetteh et al. (Fri,) studied this question.