When relying on an external or centralized IRB of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of record. In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail. However, the Principal Investigator must also follow all University of Iowa institutional policies as well as state and local laws governing human subjects research. The HawkIRB application is designed to capture the majority of the information necessary to identify the Human Research Protection Program review requirements and various institutional policies.
If you are interested in utilizing an External IRB model, please review the "Final SOP for General External IRB" for specific information on the process and contact the Human Subjects Office at firstname.lastname@example.org. We will help you determine which model may work best for your proposal (Lead IRB of record, relying IRB, commercial IRB models, etc.)
Advarra IRB is a commercial IRB like WCG. To receive UI approval to submit to Advarra for IRB review:
- Obtain all institutional and Human Research Protection Program (HRPP) committee approvals
- Obtain a per protocol IRB reliance agreement
- In Section I.1 of the HawkIRB New Project form, select “Other External” and enter “Advarra” in the free text field.
The UI research team will be responsible for adhering to all requirements of the IRB of record. All UI institutional policies and procedures as well as all Human Research Protection Program Committee(s) policies and procedures still apply to research conducted under a commercial IRB.
- To use Advarra as an IRB of Record, create a HawkIRB application and type Advarra in Section I.1, under “Other External IRB”.
- 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.
- Attach a copy of the draft Advarra application to the HawkIRB New Project form.
- Initiate a SmartIRB reliance form for each protocol submitted to Advarra.
- 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.
- Log into the CIRBI Advarra Portal to submit your project and the HSO approval memo.
- 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.
Contact the University of Iowa Human Subjects Office with questions regarding the application process or UI requirements.
Email: email@example.com(link sends e-mail)
Mail: 105 HLHS, Human Subjects Office
600 Newton Rd, University of Iowa, Iowa City, IA 52242
Contact Advarra with any questions regarding Advarra procedures or forms.
Mail: 6100 Merriweather Dr., Suite 600
Columbia, MD 21044