Version
1.0
Date Updated
Thursday, May 26, 2016
Descripton

POLICY


  1. Principal Investigators (PIs) who wish to use an External IRB or a Central IRB as the IRB of record for the overall study must register the study with UIC OPRS.
  2. A Reliance Agreement or Memorandum of Understanding must be signed and executed before the study may be initiated at UIC as the role of the IRB of record, the role of UIC, and the role of the UIC Principal Investigator must be clearly explained.  
  3. A Coverage Analysis must be completed by the OVCR Clinical Trials Office for all clinical trials requesting use of an external IRB prior to the initiation of research at UIC so that the Principal Investigator and subject understand their responsibility regarding the costs of the research procedures and appropriate local context language is inserted in the consent document.
  4. The External IRB or Central IRB will be the IRB of record and, therefore, responsible for ensuring that the research satisfies the federal regulations.
  5. UIC is responsible for ensuring that the research is feasible and appropriate for the University and Community.  UIC is also responsible for ensuring that the research complies with UIC policies and procedures via registration and monitoring of the research. 
  6. Investigators who are utilizing the Chicago Area Institutional Review Board (CHAIRb) should also refer to the UIC HSPP policy CHAIRb Operations SOP.
  7. Investigators participating in a NIH-funded multi-site study are expected to rely on a Single Institutional Review Board (sIRB) to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46. Additional information can be found at: http://osp.od.nih.gov/sites/default/files/NIH_sIRB_Policy_Multi_site_Research_UPDATED2016.pdf
  8. OPRS will follow the NIH reimbursement guidance about activities associated with serving as a sIRB under the NIH Policy on the use of a Single Institutional Review Board for multi-site research.  PIs should include the OPRS fees as a direct charge on their budgets. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html