- 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.
- 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.
- 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.
- The External IRB or Central IRB will be the IRB of record and, therefore, responsible for ensuring that the research satisfies the federal regulations.
- 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.
- Investigators who are utilizing the Chicago Area Institutional Review Board (CHAIRb) should also refer to the UIC HSPP policy CHAIRb Operations SOP.
- 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
- 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
- Registration of Research Conducted under an IRB Approval from a Non-UIC Site:
- Investigators who are seeking to conduct research approved by an External IRB or Central IRB other than the Western IRB or NCI Central IRB (Refer to the Western IRB policy and procedurehttp://research.uic.edu/sites/default/files/0925.pdf) must prepare and complete the following prior to submitting via OPRS Live:
- A copy of the signed Reliance Agreement or Memorandum of Understanding provided by the External IRB, as this must be in place before the registration/submission process can be initiated.
- A copy of the Coverage Analysis completed by the OVCR Clinical Trials Office. It is recommended that this step be completed prior to attempting to register the study. Please contact the CTO at 312-413-1632 or email@example.com for additional information.
- UIC OPRS form Registration of Research Conducted under IRB Approval from a Non-UIC Site with the following attached:
- UIC HSPP form Appendix P- Co-Investigators/Other Key Research Personnel
- UIC HSPP form Appendix E – Drug Study Registration Form, if applicable
- Documentation of Approval by Investigational Drug Service (IDS), Cancer Center (CC PRC), Clinical Interface Core (CIC), Radiation Safety Committee (RSC) and/or Institutional Biosafety Committee (IBC), as appropriate
- External IRB or Central IRB Specific Submission Forms
- IRB Approval from the External IRB or Central IRB, if available. (Note if not currently available, the Final IRB Approval must be provided before OPRS can provide a Notification of Acknowledgement to Initiate the research)
- Main (Sponsor) Research Protocol
- Template Consent Document(s) and consent document incorporating the required local UIC language, including the recommended Compensation for Injury option from the Coverage Analysis.
- Template Recruitment Materials and recruitment materials specific to UIC, if applicable
- A signed and dated copy of the University of Illinois at Chicago Investigator Assurance for Use of an External Institutional Review Board.
- The Investigator Assurance describes the stipulations under which the research must be conducted and requires the Investigator to acknowledge their understanding of, and agreement to, follow these conditions.
- Failure of the Investigator to follow the eighteen (18) conditions represents non-compliance with the UIC Human Subject Protection Program.
- Account Number to be Charged
- Initial Review Process:
- Prior to submission to the External IRB or Central IRB, the Investigator must complete and submit the form Registration for Protocol Review by an External IRB to the UIC OPRS via OPRS Live.
- The application must include the appropriate appendices and related documents as specified in item I above.
- UIC OPRS will be in contact with the Investigator directly with questions about the submission.
- UIC OPRS will issue an Acknowledgement Letter which allows the Investigator to submit to the External IRB or Central IRB. The Acknowledgement Letter indicates UIC’s acknowledgement that this protocol may use an External IRB or Central IRB.
- Investigator will generally need to provide the following to the central IRB:
- Signed IRB authorization agreement or MOU
- Template consent with local context language, e.g. subject injury, costs, contact information
- Template HIPAA authorization form ( if research involves UIHHSS PHI)
- Signed acknowledgement letter (see 3. Above)
- After the External IRB or Central IRB has issued their final IRB Approval Notice, it must be submitted to the UIC IRB along with the approved consent and recruitment documents for verification that the appropriate language was utilized and that UIC OPRS has the approved documents on file.
- Following verification, the OPRS will issue a Notification of Acknowledgement to Initiate the Research. Research may not begin; including initiating recruitment, voluntary informed consent, or collecting data on potential subjects, until you receive a written Notification of Acknowledgement to Initiate the Research from OPRS.
- Annual Review/Continuing Review
- Annual Review/Continuing Review should be submitted directly to the External IRB or Central IRB.
- Following annual review/continuing review approval by the External IRB or Central IRB, the Investigator is required to submit the following to the UIC OPRS for verification and documentation:
- UIC OPRS form External IRB Continuing Review of Research
- Any document specific to the UIC site submitted to the External IRB or Central IRB as part of the continuing review
- Approved Research Protocol, if revised since the initial or last continuing review.
- Consent Document(s), if revised since the initial or last continuing review
- HIPAA Authorization(s), if revised since the initial or last continuing review
- Recruitment Material(s), if revised since the initial or last continuing review
- Recent DSMB or annual report
- Following verification, the OPRS will issue a Notification of Acknowledgement of the Annual Report/Continuing Review.
- Amendments to the research should be submitted directly to the External IRB or Central IRB following the guidelines provided by the External IRB or Central IRB, with the exception of research personnel changes and changing the Principal Investigator. Investigators are not required to notify the UIC OPRS of amendments that do not involve changes to the Principal Investigator and/or research personnel.
- Amendments involving changes to Research Personnel and/or change in Principal Investigator, the Investigator should prepare a submission to the UIC OPRS that includes the following:
- UIC HSPP form External IRB Amendment to Previously Approved Research
- Track and clean versions of an updated Appendix P
- Track and clean versions of the updated informed consent document(s), if applicable
- Track and clean versions of the updated HIPAA Authorization(s), if applicable
- Track and clean versions of the updated recruitment material(s), if applicable
- A new UIC HSPP form Appendix E – Drug Study Registration Form, if applicable, signed by the new Principal Investigator
- A copy of the amended Reliance Agreement or Memorandum of Understanding provided by the External IRB or Central IRB indicating the change in Principal Investigator, if applicable
- A signed and dated copy of the University of Illinois at Chicago Investigator Assurance for Use of an External Institutional Review Board for the new Principal Investigator
- Documentation of the completion of the required training, if not on file with UIC OPRS.
- UIC HSPP mandates that all individuals who are engaged in research, including but not limited to, being involved in the conduct, review, or oversight of human subject research, complete initial and continuing education. Individuals involved in research using Protected Health Information (PHI) must also complete the HIPAA research training requirement. The training requirements can be found on the OPRS website: http://research.uic.edu/compliance/irb/education-training.
- UIC OPRS will issue an Acknowledgement letter specific to the changes in Research Personnel and/or change in Principal Investigator.
- Adverse Events/Unanticipated Problems
- Adverse Events/Unanticipated Problems must be reported to both the UIC OPRS and the External IRB or Central IRB. The UIC OPRS requires the Investigator to submit a UIC HSPP form External IRB Prompt Reporting to the IRB, along with any supplemental documentation, within at least 5 working days of becoming aware of any of the following issues:
- unanticipated problems involving risks to subjects or others,
- significant subject complaints,
- protocol violations or deviations, or
- suspension or termination of the research.
- Following verification and documentation of the report, the OPRS will issue either a Notification of Acknowledgement of the Adverse Event/Unanticipated Problem or a letter requesting additional information regarding the event. As UIC is responsible for monitoring the research, it is within UIC’s purview to request additional information, require additional monitoring, and/or request an audit of the research.
- Please note the reporting timelines, requirements and format for the External IRB or Central IRB may differ from the above. It is the Investigator’s responsibility to be knowledgeable of the reporting policy of the External IRB or Central IRB, and to ensure they are followed.
- Study Closure
- The Investigator should follow the requirements of the External IRB or Central IRB for submitting the appropriate documentation to close the study after their participation is completed.
- After receiving the approval of the Final Report/Study Closure, a copy of it should be submitted to the UIC OPRS along with the UIC HSPP form External IRB Study Closure to officially close the study at UIC.
- Use of External IRB or Central IRB Fees:
- The UIC OVCR charges the Investigator’s Department for research coordination and monitoring associated with the use of the External IRB or Central IRB according to the following schedule:
Execution of Reliance Agreement $1,500.00
Initiation of Study $2,400.00
Annual Monitoring Fee $1,500.00
Study Closure $500.00
- An account number to be charged is required as part of the Registration application.
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