INSTRUCTIONS – Request for use of an External Institutional Review Board for NIH Funded Research / Version 3.0 [01/24/2018]

Introduction

Registration of a research protocol is applicable for federally funded protocols that will cede UIC IRB review and approval to another IRB under the National Institutes of Health (NIH) single IRB mandate. If UIC will be the IRB of record, the protocol should be submitted to the UIC IRB for review.

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 Process

  1. The following documents are required when registering the protocol:
  2. Request for Use of an External Institutional Review Board for NIH Funded Research Form
  3. A signed Reliance Agreement or Memorandum of Understanding (MOU) provided by the External IRB. If the reviewing institution has signed the SMART IRB Joinder Agreement, the executed reliance agreement is not required as this document is currently on file.
  4. 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 Approval to Initiate the research)
  5. External/Central IRB specific submission forms
  6. Main (Sponsor) Research Protocol
  7. Template Consent Document(s) and Consent document(s) incorporating the required local UIC language, including the recommended Compensation for Injury option from the Coverage Analysis, if applicable
  8. Template recruitment materials and recruitment materials specific to UIC
  9. Appendix P – Co-Investigators/Other Key Research Personnel (Not PI or Faculty Sponsor)

2. The following documents should be submitted for review as applicable to the scope of the research

  • Appendix E – Drug Study Registration Form
  • Documentation of Approval by UICCancer Center Protocol Review Committee (CC PRC), Clinical Research Core, (CRC), Conflict of Interest (COI) Disclosure, Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC)
  • A copy of the Coverage Analysis

Note: Research may not begin; including initiating recruitment, voluntary informed consent, or collecting data on potential subjects, until you receive a written Notification of Approval to Initiate from OPRS.

Continuing Review

  1. Annual Review/Continuing Review should be submitted directly to the External IRB.

Following continuing review approval by the external IRB, the investigator is required to submit the following to OPRS:

  • External IRB Continuing Review of Research Form
  • Any document(s) specific to the UIC site submitted to the External 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

UIC OPRS will issue a continuing review acknowledgement letter.

Amendment

  1. Local amendments should be submitted directly to the UIC IRB. These amendments are limited to research personnel changes, conflict of interest disclosure,and informedconsent document revisions that modify thesubject injury language.

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 investigator initial and continuing education. Individuals involved in research using protected health information(PHI) must also complete the HIPAA investigator training requirement. The training requirements can be found on the OPRS website:

  1. For Amendments involving Research Personnel and/or a change of Principal Investigator, the investigator should prepare a submission that includes the following to OPRS:
  2. External IRB Amendment to Previously Approved Research Form
  3. Request for Use of an External Institutional Review Board for NIH Funded Research Form completed and signed by the new investigator, if applicable
  4. As applicable, tracked and clean versions of Appendix P, informed consent document(s), HIPAA Authorization(s), and recruitment materials
  1. For Amendments involving informed consent revisions that modify the subject injury language, the investigator should prepare a submission to UIC OPRS that includes the following:
  2. External IRB Amendment to Previously Approved Research Form
  3. Atracked and clean versions of the informed consent document that illustrate the modifications
  4. UIC OPRS will confirm whether the modifications require additional review. If adjustments are required, a Request for Additional Information will be issued to the investigator.
  1. For Amendments involving a Conflict of Interest (COI) Disclosure, the investigator should prepare a submission that includes the following to OPRS:
  2. External IRB Amendment to Previously Approved Research Form
  3. Tracked and clean versions of the informed consent document that illustrate the modifications, if applicable
  4. Significant Financial Interest - Disclosure and Management Plan (SFI-DMP) documentation of the COI officer’s recommendation for approval. Final approval of the amendment cannot be provided until the management plan is in place.
  1. For Amendments involving reliance agreement modifications, the investigator should prepare a submission to the UIC OPRS that includes the following:
  2. External IRB Amendment to Previously Approved Research Form
  3. Tracked and clean versions of the Reliance Agreement orMOU

For all conditions noted above, UIC OPRS will confirm whether modifications are required and issue a request for additional information or an acknowledgment letter specific to the changes included in the amendment summary.

Adverse Event / Unanticipated Problems

  1. Locally occurring Adverse Events / Unanticipated Problems must be reported to both the UIC OPRS and the External IRB. The UIC OPRS requires the investigator to submit a Prompt Report Form within at least 5 working daysof 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. Notification to the UIC OPRS should occur via the External IRB Prompt Reporting Form.
  2. Please note the reporting timelines, requirements and format for the external IRB may differ from the above. It is the investigator’s responsibility to be knowledgeable and in compliance with the reporting policy of the external IRBto ensure compliance.

Study Closure

The investigator should follow the requirements of the external IRB for submitting the appropriate documentation to close the study after UICparticipation is completed. Following submission to the external IRB, the investigator should prepare a submission that includes the following to OPRS:

  • External IRB Study Closure Form
  • Study closure notice from the external IRB
  • Final or most recent annual report
  • If the study closure notice and/or annual report is not included with the submission, a Request for Additional Information will be issued to the investigator

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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