Table 3.

Implementation research themes, challenges and process aids

Theme	Challenge	Approach	Process Aid(s)
Implementation-specific	External validity considerations	▪ Clearly explain & support issues. ▪ Use layperson language.	▪ Implementation Evaluation Theory: Stetler Model of Research Utilization & RE-AIM
	PDSA intervention adaptation cycles	▪ Discuss with IRB and select component approach or modification approach.
	Risk-benefit issues (minimal risk)	▪ Request exemption or expedited review. ▪ Consider opinion letters. ▪ Clearly explain & support issues. ▪ Use lay person language.
	Multiple roles of researchers/facilitators & subject/participants	▪ Clearly explain roles and risk appropriate to each.
	System-level unit of analysis	▪ Clearly delineate various levels, risk appropriate, and justification for each.
Multiple health care systems/sites	Transparency of system/researcher ethical responsibilities	▪ Specify division of responsibilities between researchers and site clinical staff.	▪ Project Implementation Charter & Site Memorandum of Agreement
	Relationships among IRB and participating organizations	▪ Research through websites or personal contacts. ▪ Inquire about nature of oversight relationships.	▪ IRB Contact Questionnaire
	Maintaining accountability across systems/sites	▪ Centralize records retention at a single administrative site.	▪ IRB Relational Database
Multiple local site PIs	Recruitment	▪ Communicate responsibilities, requirements, and level of commitment.	▪ Project Implementation Charter & Site Memorandum of Agreement
	Varying levels of experience & limited time	▪ Orient to role responsibilities. ▪ Provide high level of administrative support.	▪ Site PI Orientation Checklist
	Varying ethics certification requirements	▪ Investigate required trainings. ▪ Document approved trainings.	▪ IRB Relational Database
	Varying levels of involvement	▪ Invite participation in project related activities.
Multiple IRBs	Lack of standardized procedures and forms	▪ Create template text to distribute to research team.
	Communication with IRB/R&D Administrators	▪ Consider administrators integral members of research team. ▪ Communicate multi-site nature of project.	▪ IRB Contact Questionnaire
	Multiple, competing renewal deadlines	▪ Budget time for form changes. ▪ Create deadline reports from database.	▪ IRB Relational Database
	Variable AE definitions and reporting requirements	▪ Collect definitions, reporting requirements, etc.	▪ IRB Contact Questionnaire
	Coordination & consistency in IRB related tasks	▪ Consider budgeting for an IRB Specialist position. ▪ Budget for sufficient resources. ▪ Use regular conference calls.	▪ IRB Specialist Position Description ▪ IRB Call Minute Template