Table 3 Implementation research themes, challenges and process aids
From: Human subjects protection issues in QUERI implementation research: QUERI Series
Theme | Challenge | Approach | Process Aid(s) |
|---|---|---|---|
Implementation-specific | External validity considerations | é Clearly explain & support issues. é Use layperson language. | é Implementation Evaluation Theory: Stetler Model of Research Utilization & RE-AIM |
|  | PDSA intervention adaptation cycles | é Discuss with IRB and select component approach or modification approach. |  |
|  | Risk-benefit issues (minimal risk) | é Request exemption or expedited review. é Consider opinion letters. é Clearly explain & support issues. é Use lay person language. |  |
|  | Multiple roles of researchers/facilitators & subject/participants | é Clearly explain roles and risk appropriate to each. |  |
|  | System-level unit of analysis | é Clearly delineate various levels, risk appropriate, and justification for each. |  |
Multiple health care systems/sites | Transparency of system/researcher ethical responsibilities | é Specify division of responsibilities between researchers and site clinical staff. | é Project Implementation Charter & Site Memorandum of Agreement |
|  | Relationships among IRB and participating organizations | é Research through websites or personal contacts. é Inquire about nature of oversight relationships. | é IRB Contact Questionnaire |
|  | Maintaining accountability across systems/sites | é Centralize records retention at a single administrative site. | é IRB Relational Database |
Multiple local site PIs | Recruitment | é Communicate responsibilities, requirements, and level of commitment. | é Project Implementation Charter & Site Memorandum of Agreement |
|  | Varying levels of experience & limited time | é Orient to role responsibilities. é Provide high level of administrative support. | é Site PI Orientation Checklist |
|  | Varying ethics certification requirements | é Investigate required trainings. é Document approved trainings. | é IRB Relational Database |
|  | Varying levels of involvement | é Invite participation in project related activities. |  |
Multiple IRBs | Lack of standardized procedures and forms | é Create template text to distribute to research team. |  |
|  | Communication with IRB/R&D Administrators | é Consider administrators integral members of research team. é Communicate multi-site nature of project. | é IRB Contact Questionnaire |
|  | Multiple, competing renewal deadlines | é Budget time for form changes. é Create deadline reports from database. | é IRB Relational Database |
|  | Variable AE definitions and reporting requirements | é Collect definitions, reporting requirements, etc. | é IRB Contact Questionnaire |
|  | Coordination & consistency in IRB related tasks | é Consider budgeting for an IRB Specialist position. é Budget for sufficient resources. é Use regular conference calls. | é IRB Specialist Position Description é IRB Call Minute Template |