HSO

1. To use Advarra as an IRB of Record, create a HawkIRB application and select Advarra in Section I.1, under “Commercial IRBs”.
2. Insert UI required template language into the Sponsor’s consent template.  Note specifically that the UI Compensation for Injury and Authorization to Use and Disclose Information for Research Purposes (HIPAA) language sections cannot be removed or altered. Download the Informed Consent Document template on the Attachments page in the HawkIRB New Project form.  You can also find additional information below under the "Informed Consents for Advarra: Best Practices" section.
3. Attach a copy of the draft Advarra application to the HawkIRB New Project form.
4. Attach all other necessary documents including:
   1. Additional consent forms (insert UI required language as necessary).
   2. Investigator Brochures.
   3. Copy of the Protocol, along with Protocol Letters and Clarifications.
   4. Iowa-specific recruiting documents (i.e. Mass Email or letters to subjects).
   5. IDEs or device brochures for device studies.
   6. Other documents as required by HSO.
5. After the HSO has reviewed your application and determined all UI requirements are met, an approval memo will be sent to the PI and contact person.  You can now submit your project to Advarra for review.  HSO no longer requires all HRPP approvals to be in place before you are allowed to submit a new study submission to Advarra.  This mirrors the current process in place with WCG, and means HSO can provide you with an “external IRB exception memo” memo prior to all HRPP committee approvals being in place.  HSO reserves the right to require certain approvals or completion of certain steps before allowing a study to go forward to Advarra. 

Advarra

1. Log into the CIRBI Advarra Portal to submit your project and the HSO approval memo.
2. Advarra will review the study.  Before approving, Advarra sends the consent forms for Institutional Sign-Off.  HSO is responsible for providing this sign-off.  However, HSO will wait for up to 72 hours (3 business days) to allow research teams to review the consents and notify HSO of any changes.  Once the time period passes, HSO will provide sign-off or notify Advarra of any issues. 
3. If your project is approved by Advarra, the "Notice of Approval" document will generate in the CIRBI Advarra Portal. CIRBI will house all documents moving forward.

NOTE:  Even after Advarra issues its new study approval, you are not allowed to begin your study until the project is released in HawkIRB. This requirement applies to new study submissions only and not post-approval submissions. 

Similar to WCG, if an HRPP committee identifies items that require correction after Advarra approved the study, you will be able to submit a modification on top of the pending New Study submission in HawkIRB to address this.  Both the new project form and modification form will be released in HawkIRB upon the HRPP’s approval.   

New Projects

• Obtain the Advarra-approved template consent for the "protocol level" (overall study approval).
• Track in University of Iowa required language into the Advarra-approved template consent ensuring "tracked changes" are turned on. Ensure the site/sponsor does not turn off tracked changes or "accept" changes during review. All changes to the template must be shown as "tracked changes" when submitting to Advarra.
  • University of Iowa language could include the following. Most language is included in the downloadable informed consent template during creation of your HawkIRB application, with exception of committee-specific language:
    • Add HawkIRB number within the title page (Ex: Institutional Number: 202512345)
    • HIPAA section (Authorization to use and disclose information for research purposes) (Institutional policy)
    • Compensation for Injury (Institutional policy)
    • SSN collection: for compensation purposes (if compensation if greater than $100 per payment or $1999 or more in a calendar year) (IRS regulations/Grant Accounting Policy) Note: increase in compensation amount from $599 to $1999 based on 2026 tax reporting changes.
    • SSN collection for any other reason is required by the University to be disclosed in the consent
    • Legally Authorized Representative (LAR) order of authority list (Iowa law/Institutional policy)
    • Pregnancy testing for females under the age of 18 (UIHC policy)
    • HIV/Hepatitis reporting requirements (Iowa law)
    • Medical Radiation Protection Committee required changes outlined in the eMRPC form (Institutional policy)
    • Note: Institutional committees and the Human Subjects Office reserve the right to require changes outside of the items listed above
• Once this is complete, upload this version to the "Tracked Change" Consent Document category within the HawkIRB application for HSO review
  • Note: It is preferred the HSO reviews your consent documents in HawkIRB PRIOR to sending to the sponsor so the HSO reviewer can verify all required changes are incorporated when to sending on to the sponsor. This reduces confusion and unnecessary back and forth with the sponsor.
• Once all workflow is addressed within the HawkIRB application, an "external IRB exception memo" will be issued for the study approving it to be submitted to the external IRB. When submitting consent forms, please submit the most recent tracked change versions that have been negotiated in HawkIRB. 

Modifications

Sponsored-initiated changes

• Sponsors typically submit consent form changes on the "protocol level" when the changes affect all sites. Once approved at this level, modifications are automatically created for sites. Advarra will send an email to the PI, all team contacts and the Human Subjects Research contacts with the tracked changes version of the site-specific consent requesting the HSO contact to provide sign-off for the changes.

  The University of Iowa has an agreement with Advarra IRB that new consent documents must have HSO "Institutional Sign Off" approval to continue processing. When this notice is received you can do one of two things:

• Forward the message to UI-Advarra@uiowa.edu that the changes are acceptable and can proceed

  OR

• If the version Advarra sent requires changes, make tracked changes to the CLEAN version of the consent Advarra sends via the CIRBI portal, forward the message to UI-Advarra@uiowa.edu attaching the tracked version created indicating that changes are required.
• The HSO contact will then review the consents and any changes the team sends if applicable, and complete sign off. If the HSO requires other changes, these will be sent for team review prior to sign off.
• Once Advarra has fully approved the consent modification, submit this as a modification to HawkIRB.

Site-initiated changes

• Download the most recent approved version of the consent from Advarra CIRBI.
• Make any tracked changes necessary.
• Initiate a modification in Advarra CIRBI for the study and submit for approval.
• Advarra will send an "Institutional Sign Off" notice. Forward this message to UI-Advarra@uiowa.edu indicating the changes can proceed (or provide a tracked-changes consent with your required edits to HSO). The HSO will then provide sign off for the modification.
• Once Advarra has fully approved the modification, create a HawkIRB modification for the study implementing the changes and submit the modification to the HSO.

Additional Considerations:

• This process could differ between sponsors. Please communicate with the sponsor of your research project how they will handle sponsor-initiated changes.
• The research team is responsible for understanding when UI required language and UI HRPP reviews may apply to their research. For example, changes like adding a new consent form, study arm/cohort additions or new risks may require approval from one or more UI HRPP committees. A modification can be submitted in HawkIRB for these items to be reviewed prior to submitting to the commercial IRB. This reduces the number of back-and-forth submissions that can occur either between you and your sponsor, or you and the commercial IRB. To do this, answer "No" to EXT.2 to indicate the changes are not yet approved by the commercial IRB
  • Upload the tracked changes versions of the consents and any other necessary updates that apply to the changes
  • Properly answer the questions in XIV to trigger committee reviews. Once committee reviews are completed and the committees have approved the consent with or without changes, follow the instructions above to continue processing the modification with the commercial IRB.
• Once the commercial IRB approves new consent documents or materials, those materials should be used immediately. Do not wait until HawkIRB has approved new materials to use new IRB-approved materials, this could lead to non-compliance.
• Please submit modifications in HawkIRB for required Post-Approval Submissions as soon as possible to notify the HSO and HRPP of any changes to the research. There are institutional requirements to update the institution’s research system in a timely manner when using an External IRB of Record. Not submitting required updates in HawkIRB could affect the funding and clinical trial status if not updated in a timely manner. 

For post-approval submission requirements, click here.