Table 1.

Potential focus of DSMB monitoring, challenges, and next steps

Focus of monitoring	Challenges	Next steps
Individual participants	Risk may be minimal without need for more intensive monitoring of individual participants. Implementation trials typically do not collect data on safety or adverse events related to the evidence-based practice. Overwhelming benefit or futility will be difficult to assess.	Clarification of the role (if any) of DSMBs for implementation trials where individual participant risk is minimal.
Data quality and trial integrity	Beyond periodic review of trial accrual data and missing data, it is not clear what DSMBs might monitor in this context. Implementation trials typically collect data on multiple implementation outcomes often based on mixed methods. It is not clear how DSMBs would develop stopping rules based on these complex assessments. Stepped wedge designs involve both within and between wedge comparisons, further complicating trial integrity monitoring.	Clarification of the role of DSMBs in terms of monitoring data quality and trial integrity for implementation trials. What if any metrics are feasible and appropriate for DSMBs to monitor?
Groups and organizations	Organizational harms exist and should be monitored and reported per CONSORT. However, the Common Rule only covers individual participants, not groups.	These harms should be considered in planning and assessed based on CONSORT guidelines for pragmatic and/or cluster trials [25,26], but fall outside the Common Rule and DSMBs. Research is needed on best practices for selection of relevant measures for assessing potential harms to groups.
Indirect participants [21]	These participants could include staff who are not directly consented or targeted by the implementation trial, but who are indirectly affected by changes in workflow or work burden. Families could be affected by organizational-level interventions. Future patients could be affected by strategies targeting clinicians or processes. Indirect participants are not covered.	These impacts should be considered in the design of implementation trials but are unlikely to be addressable by DSMBs. Further research is needed on best practices for selection of measures related to adverse effects on indirect participants.
Collateral participants [21]	Patients and organizational and other stakeholder are often involved in implementation trials through CBPR. Some of these participants may be individual participants and covered under the Common Rule, others are not covered.	Participants protected under the Common Rule (i.e., they qualify as individual participants) are protected in the same way as other individual participants. Guiding ethical principles for CBPR [27,28] could provide some protection to participants when these principles are followed. However, to date, there is typically no means for external monitoring of enactment of these principles.

CBPR, community-based (engaged) participatory research; DSMB, data and safety monitoring board.