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  6. appendix-b

Compliance

Instructions for an ICON External IRB Submission

    1. Create a new study in ICON
      1. On the Basic Study Information page, please complete the following questions:
        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 answered 鈥測es,鈥� this will prompt the COI office to send the team member a request for disclosure. (The research UH COI committee must review the interest and the team member鈥檚 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 鈥測es鈥� to question number 鈥淲ill an external IRB act as the IRB of record for this study?鈥�
        8. Please indicate 鈥淲hat kind of study is this?鈥� Please note the following:
          A multi-site study is when more than one site engaged in research will conduct the entire study.
          A collaborative study is when each site engaged in research will conduct a portion of the study.
        1. Save and continue to the 鈥淏asic Site Information鈥� page.

      2. On the Basic Site Information page, complete the following:
        1. Provide a brief description of activities this site will perform.
        2. Please enter "ALL" if this site will perform all procedures in the protocol.
        3. Save and continue to the 鈥淓xternal IRB鈥� section.

      3. In the External IRB Section:
        1. Select the external IRB.  If it is not listed, please select 鈥渙ther.鈥�
        2. Add the external IRB protocol number or ID in question number 2.
        3. Specify the reason the study should be reviewed by an external IRB. In answering question number 3, please explain to the UH IRB the reason for the request for IRB reliance. For example:
          1. The reviewing institution is the primary recipient of grant funds
          2. 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鈥檚 portion of the research will be limited to a certain part of the approved protocol (for example, data analysis).

        4. Attach the external IRB approval letter. Please ensure that documentation is provided to UH IRB showing that the external IRB has approved UH鈥檚 role in the research.
        5. Enter the approval date granted by the external IRB in question number 5.
        6. Enter the approval expiration date granted by the external IRB in question number 6. Ensure that the approval has not expired. 
        7. Save and continue to 鈥淔unding Sources.鈥�

      4. Funding Section
        1. Study Funding Sources: Indicate any funding sources for the parent study (funding to the institution on which UH is relying).
          1. Upload a copy of the grant, contract/scope of work and/or any other supporting documentation relating to study funding.
          2. Please also provide the 鈥淕rant office ID鈥� from PeopleSoft Grants
          3. If the study is not funded, please indication 鈥淯nfunded鈥� within this section.
            Funding Section
        2. Additional Local Funding Sources: Identify each organization supplying funding for the local site (UH site).
          1. Upload a copy of the grant, contract/scope of work and/or any other supporting documentation relating to study funding.
          2. Please also provide the 鈥淕rant office ID鈥� from PeopleSoft Grants
          3. If the study is not funded, please indication 鈥淯nfunded鈥� within this section.
        3. Save and continue to the 鈥淪tudy Team Members鈥� page.

      5. Study Team Members Section
        1. Identify each additional person involved in the design, conduct, or reporting of the research (locally at the UH site).
        2. Provide all the external team member information within the clickable external team template (template states 鈥淐lick here to download the External Team member template).
        3. Save and continue to the 鈥淪tudy Scope鈥� page.

      6. In the Study Scope Section, please answer the questions related to
        1. Study Drugs/Biologics
        2. Humanitarian Use Device (HUD)
        3. Use of Protected Health Information (PHI) from a HIPAA-covered entity
        4. Save and continue to the 鈥淪tudy-Related Documents鈥� page.

      7. Study-Related Documents
        1. Attach the study-wide IRB-approved consent/parental permission/assent forms, (and HIPAA authorizations if separate from the consent form) in question number 1.
        2. Add any study-wide recruitment materials approved by the external IRB.
        3. Upload any other supporting documents within this section, including study tools, if not included in the external IRB鈥檚 protocol document.
        4. Save and continue to 鈥淟ocal Site Documents.鈥�

      8. Local Site Documents
        1. If UH will be obtaining consent/assent from subjects, attach the UH-specific consent/assent form approved by the external IRB; often this is the same as the study-wide form, just on UH letterhead. Otherwise, just re-attach the study-wide consent form if UH personnel will be using it with no changes.
        2. If UH is not obtaining consent/assent, you do not need to upload any documents in this section.
        3. If UH-specific recruitment documents exist, upload them in this section.
        4. If UH is not recruiting subjects, you do not need to upload any documents in this section.
        5. Please provide any other UH specific documents within this section.
        6. Save and continue and press 鈥淔inish.鈥�

    2. Continuing Review
      1. Please note: The UH PI will need to provide the reviewing site PI any necessary enrollment information needed for the renewal submission to the reviewing IRB. When the continuing review process is completed at the reviewing site, the UH PI must be provided a copy of the continuing review approval letter.
      2. From the protocol homepage, select 鈥淩eport Continuing Review Data.鈥�
      3. Enter the UH enrollment total. Then complete the remainder of the page.
      4. Enter enrollment totals at the reviewing institution鈥檚 sites since last approval:
      5. Check the items that are true for this site since the last IRB approval: (initial review or last continuing review).
        1. Add the new continuing review approval letter received from the reviewing site PI in the 鈥淪upporting Documents section.鈥�
        2. If you have any comments related to this site or the lead site, please provide them in question 5.
      6. This process confirms for UH that the study remains approved. A letter will be sent through ICON acknowledging the receipt of continuing review or modification information.

    3. Reportable New Information
      1. 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 鈥淩eport New Information.鈥� 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. The agreement UH signed with the reviewing IRB will determine how the institutions investigate and/or report to federal agencies, if necessary.//

    4. Modifications
      1. Update the protocol with any modifications approved at the reviewing site. 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 remains responsible for compliance and training of our personnel involved in externally reviewed research.