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IU Health System-wide IRB

IU Health System-wide IRB. Edye Taylor, JD, MA, CIP Senior Compliance Project Manager Clinical Research Compliance Office IU Office of Research Compliance. Goals of System-wide IRB:. Short-term

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IU Health System-wide IRB

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  1. IU Health System-wide IRB Edye Taylor, JD, MA, CIP Senior Compliance Project Manager Clinical Research Compliance OfficeIU Office of Research Compliance

  2. Goals of System-wide IRB: • Short-term • Complete the final phase (training) for the first four identified sites, and the assessment process of the fifth and final identified site • Long-term • Establish a streamlined approach to recruit and perform clinical trials research at IU Health facilities in coordination with IU Health Physicians and Indiana University.

  3. Current Status • Completed for all IUH Bloomington, Ball, Arnett and Goshen: • Site visit followed by full evaluation of site by CRCO • Prepare report of findings and recommendations for each location based on evaluation at each location • Determine individualized needs/requirements for training at each location • In Progress at these sites (examples of Training): • Executing IRB Authorization Agreements • Instituting/Revising COI Policies • Creating CITI accounts • Revisions of SOPs and forms • IND/IDE and vulnerable population training

  4. Next Steps • Completing the Assessment Process: • La Porte – special case • Continuing proposed plan for each site to move forward (Phases): • V -Training • VI –Maintenance • Looking Ahead: • Only one application and approval would be needed to conduct multi-site research within IU and IU Health locations • First protocol has been approved – Cook Trial

  5. Current Process:New Studies • Complete IRB Authorization Agreement with IU IRB • Outside institution defers to IU IRB review and approval • IU Health Ball, Bloomington, Goshen and Arnett have this in place • Ensure all co-investigators from outside sites are listed on IRB application • Co-investigators required to: • Complete IU Conflict of Interest Disclosure Form • Complete CITI modules or provide verification of education completion via the outside institution

  6. Current Process:Existing Studies • Add co-investigators to existing IU-IRB/IUH Statewide approved study • Co-Investigator Update • Complete IU Conflict of Interest Disclosure Form • Co-investigator(s) complete CITI modules • For Key Personnel: • Submit update via Amendment or Continuing Review form, and an Investigator List form for approval • For Non-Key Personnel: • Submit update via Investigator List form and no need for approval • Defining Personnel: • http://www.researchadmin.iu.edu/HumanSubjects/hsdocs/IRB_Updates_February_2012_PPT.pdf

  7. Current Process:Existing Studies • Add co-investigators and site to existing IU-IRB/IUH Statewide study • Minor Amendment • Complete Amendment Form to indicate minor amendment and co-investigator addition(s) • Complete IU Conflict of Interest Disclosure Form • Co-investigator(s) complete CITI modules

  8. Questions? Contact: Edye Taylor tayloret@iu.edu 278.5926

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