Single IRB Review/Reliance
Single IRB Review Heading link
Since January 25, 2018, single IRB review has been mandated for NIH-funded research conducted at more than one site within the United States (Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research). Effective January 20, 2020, the single IRB mandate has been extended to all multi-site research conducted in the U.S. that is supported by funding from any Common Rule agency.
National Institutes of Health (NIH) Grant Application/Contract Proposal Preparation
The NIH requires that the application/proposal for research funding include a plan describing the use of a single IRB that would be selected as the IRB of record for all study sites. The UIC investigator must contact the OPRS Point of Contact (POC) for single IRB (sIRB) review to request a Letter of Support for grant preparation.
The notice will not grant final approval for use of an external IRB, but will serve as a notification of intent to cede IRB review to the reviewing IRB.
UIC cannot guarantee its willingness to rely on a sIRB that has been selected without UIC consultation and approval.
Registration of Multi-Site Studies Approved by an External IRB (Initial Review Process) Heading link
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Registration of Multi-Site Studies Approved by an External IRB (Initial Review Process)
Single IRB requests must be submitted to the UIC OPRS via OPRS Live. When creating a new Initial Registration for External IRB review, select “Single IRB (sIRB) or Other External Reliance” as the External Review Agency to ensure that the submission is properly routed.
- Investigators must register with OPRS all multi-site studies for which IRB review and approval have been ceded to an external IRB. The following items are required:
- A Reliance Agreement or Memorandum of Understanding (MOU) must be signed and executed before the study may be initiated at UIC. The Agreement or MOU must clearly explain the role of the external IRB, the role of UIC, and the role of the UIC Principal Investigator.
- If the reviewing institution/external IRB has signed the SMART IRB Joinder Agreement, the executed Reliance Agreement is not required as the Joinder Agreement is on file.
- UIC OPRS form Request for Reliance on an External Institutional Review Board with the following attached:
- UIC form Appendix P- Co-Investigators/Other Key Research Personnel;
- Specific Submission Forms from the external IRB;
- IRB Approval from the external IRB (Note: The IRB Approval must be provided before OPRS can provide a Notification of Acknowledgement to Initiate the Research.);
- Research Protocol approved by the external IRB;
- Template Consent Document(s); and
- UIC specific consent document incorporating the required local language.
- A Reliance Agreement or Memorandum of Understanding (MOU) must be signed and executed before the study may be initiated at UIC. The Agreement or MOU must clearly explain the role of the external IRB, the role of UIC, and the role of the UIC Principal Investigator.
- The following items may be required dependent upon the nature of the study:
- Template Recruitment Material(s)
- UIC specific Recruitment Material(s)
- UIC form Appendix A1: Use of Drugs or Biologic Products in Research
- Documentation of Approval by Cancer Center (CC PRC), Clinical Research Center (CRC), Radiation Safety Committee (RSC) and/or Institutional Biosafety Committee (IBC)
- Investigators may be asked to provide documentation of training if it is not on file with OPRS. The training requirements can be found on the OPRS website Investigator Training.
- UIC OPRS will send a Request for Additional Information to the investigator if there are questions about the submission.
- Once all of the registration requirements have been met, OPRS will issue a Notification of Acknowledgement to Initiate the Research.
- The investigator may not begin the research (including initiating recruitment, voluntary informed consent, or collecting data) until the Notification of Acknowledgement to Initiate the Research has been issued by the UIC OPRS.
- The OPRS cannot release the approved documents until the Coverage Analysis has been completed.
- Investigators must register with OPRS all multi-site studies for which IRB review and approval have been ceded to an external IRB. The following items are required:
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Continuing Review
- Continuing Review information must be submitted directly to the external IRB.
- Following continuing review approval by the external IRB, the investigator is required to submit the following to the UIC OPRS for verification and documentation:
- UIC OPRS form External IRB Continuing Review Form
- Any documents specific to the UIC site that were submitted to the external IRB as part of the continuing review
- Any approved documents that have been revised since the initial or last continuing review (e.g., protocol, consent documents, recruitment materials, HIPAA Authorizations, etc.)
- Following verification, the OPRS will issue a Notification of Acknowledgement of the Continuing Review.
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Amendment
- Global amendments to the research or amendments that affect the entire research proposal should be submitted directly to the external IRB. Investigators are not required to notify UIC OPRS of revisions affected by global amendments.
- Local amendments should be submitted directly to UIC OPRS. These amendments are limited to the following:
- Research personnel changes,
- Changing the Principal Investigator,
- Changes to the informed consent document regarding injury language,
- The addition of or changes to an existing Conflict of Interest (COI) Disclosure; and
- Changes to the Reliance Agreement or Memorandum of Understanding.
- The investigator should prepare a submission to the UIC OPRS that includes the following:
- UIC OPRS form External IRB Form – Local Amendment to Previously Approved Research
- Tracked and clean versions of the applicable documents (e.g., Appendix P, consent documents, Significant Financial Interest – Disclosure and Management Plan (SFI-DMP), Reliance Agreement, etc.)
- UIC OPRS will confirm whether additional revisions are required and issue a request for additional information or an acknowledgment letter specific to the changes included in the amendment summary.
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Adverse Events/Unanticipated Problems
- Locally occurring Adverse Events/Unanticipated Problems must be reported to both the UIC OPRS and the external IRB via the form External IRB Prompt Reporting to OPRS
- 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 may differ from what is required by UIC HSPP. It is the investigator’s responsibility to be knowledgeable and in compliance with the reporting policy of the external IRB.
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Study Closure
- The investigator should follow the requirements of the external IRB for submitting the appropriate documentation to close the study after UIC participation is completed.
- After receiving the approval of the Final Report/Study Closure and to officially close the study at UIC, the investigator must submit the following:
- UIC OPRS form External IRB Study Closure at UIC
- Study closure notice from the external IRB
- Final or most recent annual report
- For all conditions noted above, UIC OPRS will confirm whether modifications are required and issue a Request for Additional Information or an Acknowledgment Notice of Study Closure to the investigator.
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UIC External IRB Local Context Language Template