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 will also be required to continue to 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 pursuing human subjects research 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 uirb-external@uiowa.edu . We will help you determine which model may work best for your proposal (Lead IRB of record, relying IRB, commercial IRB models, etc.)
Quorum Review IRB is a commercial IRB like WIRB. Currently submissions to Quorum are restricted to specific specialized trials. The Quorum submission process will require all institutional and HRPP committee reviews be complete prior to receiving approval to submit to Quorum for IRB review. Principal Investigators interested in using Quorum as an IRB of Record should contact the Human Subjects Office if they are not already part of the specialized signature trial series of studies already under Quorum review. If a researcher elects to use Quorum, a per protocol IRB reliance agreement will be required prior to final institutional signoff to submit to Quorum. Section I.1 in the HawkIRB application should indicated Quorum for any study requesting to use this commercial IRB.
The University of Iowa research team will be responsible for adhering to all IRB requirements of the IRB of record. All University of Iowa institutional policies and procedures as well as all Human Research Protection Program Committee(s) policies and procedures will still apply to research conducted under this option.
Submission process
HSO
- Only specific specialized trials can be submitted in HawkIRB.
- Quorum has negotiated language (UI Compensation for Injury and HIPAA) and a personalized institutional cover page. Neither can be revised.
- 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 Quorum for review.
Quorum
- Log into the OnQ Quorum Portal to submit your project and the HSO approval memo.
- If your project is approved by Quorum, the "Notice of Approval" document will generate in the OnQ portal. OnQ portal will house all documents moving forward.
- Modifications to Quorum 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 to Quorum projects are be initiated by either the PI or HSO in HawkIRB.
Quorum Fees
The charge for the coordination of your Quorum submission by the HSO is a one-time fee of $1,000. The University of Iowa $1,000 Quorum submission coordination fee will be deducted from your research account by the HSO upon receiving a finalization of contract notice from the DSP. Therefore, this fee should also be included in your budget. There will be no F&A assessed on this $1,000 fee.
Contact Information
Contact the University of Iowa's Human Subjects Office with questions regarding the application process or UI requirements.
Phone: 319-335-6464
Fax: 319-335-7310
Email: uirb-external@uiowa.edu
Mail: 105 HLHS, Human Subjects Office
600 Newton Rd, University of Iowa, Iowa City, IA 52242
Contact Quorum with any questions regarding Quorum procedures or forms.
Phone: 877-472-9883
Fax: 206-448-4193
Email: sitesupport@quorumreview.com
Mail: 1501 Fourth Avenue, Suite 800
Seattle, WA 98101