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Instructions for an ICON External IRB Submission

  1. Create a new study in ICON

  2. External IRB protocols are made up of two sections: “STUDY” and “SITE.” This next section will cover completing the STUDY section of the icon submission.  

    1. On the "Basic Information" page:

      1.  Enter the title of the study in question number 1. 

      2. Enter a short title in question number 2.

      3. Enter a brief description of the study in question number 3.

      4. Keep yourself listed as PI (or make sure the appropriate PI is listed if you are completing on behalf of the PI) in question number 4

      5. Select any UH sites that will be involved in the research in question number 5.

      6. Please indicate if there is a financial interest in this research by any member of the research team in question number 6. If one exists, the UH COI committee must review the interest and the team member’s role in the protocol to determine whether a plan to manage any potential conflict is required. The UH IRB provides any required management plan to the external IRB.

      7. Please answer “yes” to question number 7: “Will an external IRB act as the IRB of record for this study?”

      8. Attach the external IRB-approved protocol in answering question number 9

    2. Save and continue to the “External IRB” section:

      1. Select the external IRB.  If it is not listed, please select “other.”  

      2. Add the external IRB protocol number or ID in question number 2.

      3. Attach the external IRB approval letter in answering question number 3. Please ensure that documentation is provided to UH IRB showing that the external IRB has approved UH’s role in the research. 

      4. Enter the approval date granted by the external IRB in question number 4.

      5. Enter the approval expiration date granted by the external IRB in question number 5.

      6. In answering question number 6, please explain to the UH IRB the reason for the request for IRB reliance. (For example, that the reviewing institution is the primary recipient of grant funds, or that subjects will be recruited from a clinic/hospital for which the other institution serves as the IRB). Please be specific and also explain whether UH’s portion of the research will be limited to a certain part of the approved protocol (for example, data analysis).

      7. Please select “pre-2018” in question number 7 if the study approved by the external IRB was initially approved prior to January 21, 2019.  Otherwise, select “2018.”

      8. Please select “HHS” in question number 8.  Please also select “FDA” if the study involves the investigation of a drug or device.

      9. Skip question number 9.

      10. Select the best answer that applies in question number 10.

      11. Select the best answer that applies in question number 11.

      12. Please select any options which apply in question number 12.

    3. Save and continue to the “Funding Sources:”

      1. Indicate any funding sources for the parent study (funding to the institution on which UH is relying).

    4. Save and continue to the “Study Scope:”

      1. Answer “yes” or “no” to questions related to FDA and HIPAA oversight

    5. Save and continue to “Study-Related Documents:”

      1. Question number 1: add the external IRB-approved template

      2. Question number 2: add any study recruitment materials approved by the external IRB for the parent study

    6. Save and continue to the “Final Page:”

      1. Select "Finish"

  3. External IRB protocols are made up of two sections: “STUDY” and “SITE.” This next section will cover completing the SITE section of the icon submission.

    1. Basic information section:

      1. Enter the title of the study in question number 1.

      2. Enter a short title in question number 2.

      3. Enter a brief description of UH’s portion of the research in question number 3.

      4. Keep yourself listed as PI (or make sure the appropriate PI is listed if you are completing on behalf of the PI) in question number 4.

    2. Funding Sources:

      1. Indicate any funding sources here for UH’s portion of the study. Please reference a subcontract if that is the source of UH’s funding.

    3. Study Team Members:

      1. List all participating UH personnel in question number 1. If this is a student-led protocol, be make sure to also add the faculty sponsor here.

      2. List participating external PI in question number 2. Please note: in the external team member template, it is not required to indicate the date of their human subjects protections training since the external IRB is responsible for training compliance of those individuals.

    4. Research Locations:

      1. List the external IRB here. Please make sure to add an IRB contact for that institution.

    5. Local Site Documents:

      1. Attach the external IRB-approved consent forms, assent forms, (and HIPAA authorizations if separate from the consent form) in question number 1. These consent forms and assent forms should be the documents approved by the external IRB for use in recruiting local subjects by the UH site. If UH will not be recruiting, consenting or obtaining assent from subjects, UH-specific consents and assent documents do not need to be attached in this section.

      2. Attach any external IRB-approved recruitment materials that will be used to recruit local subjects by the UH site in question number 2. 

  4. Select your applicable ancillary reviewers in ICON before you submit the protocol.

  5. Once you have submitted your external reliance protocol in ICON, it will be routed to the IRB office for final processing.

  6. Once all documentation is verified and any remaining issues have been addressed, the reliance protocol will be formally acknowledged in ICON and a letter will be provided.

  7. Once the acknowledgment letter is received by the PI, UH engagement in the research may begin.

Please note: Some external IRBs will not provide an amendment approval letter for personnel changes. Personnel changes will still need to be updated in the ICON protocol even if the IRB of Record does not provide a letter. UH as an institution is still responsible for compliance and training of our personnel involved in research.

Continuing Reviews:
The UH PI will need to provide to the reviewing site PI any necessary enrollment information needed for the renewal submission to the reviewing IRB. The UH PI will need to obtain a continuing review approval letter from the reviewing site PI and submit this updated letter in ICON:

  1. From the protocol homepage, select “Report Continuing Review Data.”

  2. Enter the UH enrollment total. Then complete the remainder of the page.

  3. Add the new continuing review approval letter received from the reviewing site PI in the “Supporting Documents section.”

A letter will be sent through ICON acknowledging the receipt of continuing review or modification information.

Should an unanticipated problem involving risks to subjects or others occur at the UH site, please go into the study page in ICON and select “Report New Information.” It is recommended that you contact the UH IRB office immediately, so that we may work with the reviewing IRB to assess and report this information to the applicable parties.