HSO

1. To use Advarra as an IRB of Record, create a HawkIRB application and type Advarra in Section I.1, under “Other External IRB”.
2. Insert UI required template language (UI Compensation for Injury and ”Authorization to Use and Disclose Information for Research Purposes) into the Sponsor’s consent template. This language cannot be removed or altered. Download the Informed Consent Document template on the Attachments page in the HawkIRB New Project form.
3. Attach a copy of the draft Advarra application to the HawkIRB New Project form.
4. 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.

Advarra

1. Log into the CIRBI Advarra Portal to submit your project and the HSO approval memo.
2. 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.

Modifications to Advarra projects are managed in the HawkIRB system by initiating a Modification Form and answering all applicable committee questions.  All applicable committee reviews are the responsibility of the PI. Continuing reviews for  Advarra projects are to be initiated by the PI in HawkIRB.

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 $600 or more in a calendar year) (IRS regulations/Grant Accounting Policy)
    • 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 typically automatically created for sites. Advarra will send an email to the PI and all team contacts with the tracked changes version of the protocol level template stating:

  "Due to the policies established between the Institution and Advarra IRB, please note that the request to review the information for this investigator has been withdrawn, but will resume processing once the site has sent to Advarra IRB a request for review of the information outlined above. "

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

• Review the tracked changes version of the protocol level template, verify that none of the changes affect UI language or HRPP committee reviews. If this is true, you can reply to this email from Advarra stating the modification can resume processing. Advarra will then apply the tracked changes to the site-level consent and contact the HSO if any of the language deviates from the University of Iowa template language on file. This is typically the better option when the tracked changes do not affect any local requirements and the research team does not require any additional changes outside of what is outlined in the tracked changes.
• Download the most recent clean approved version of the consent from Advarra Connexus, make the tracked changes shown in the version of the protocol level template Advarra sent in their email, and respond to their email attaching the version created. This is typically the better option when the team needs to make changes outside of the changes outlined in the protocol level template. Examples below:
  • Local contact information updates
  • Changes prompt UI-required template language
    • New changes add an LAR signature line, therefore prompting UI and state law LAR language
    • Sponsor adds an entity to the consent they will be sharing PHI with therefore prompting changes to the second paragraph of the UI HIPAA section

OR

• 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 Connexus.
• Make any tracked changes necessary.
• Initiate a modification in Advarra Connexus for the study and submit for approval
• 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.