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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