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 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.)
PCORI Projects funded under this initiative are designed to improve patient care and outcomes through patient-centered comparative clinical research. If you are applying for PCORI funding for a study, first verify whether or not the grant requires the use of a centralized IRB model. If it does, you must contact the Human Subjects Office prior to seeking or submitting a grant request for a PCORI award. The Human Subjects Office will work with you to determine what centralized IRB model may work best for your research. PCORI awarded projects may have the University of Iowa as the IRB of record or an alternative IRB based on the grant structure and the award requirements.
Prior to selecting this option, an executed Reliance Agreement with the IRB of record must be in place prior to your HawkIRB submission.
Points to consider when pursuing PCORI funding can be found here.
GPC under PCORI
The University of Iowa is part of a PCORI Greater Plains Collaborative (GPC) focusing on three primary areas of patient centered outcomes research. However use of the GPC IRB Reliance model does not require research to be centered under these three primary areas of focus. The research proposal should include a Patient Centered Outcome focus and involve one or more of the ten institutions working under the GPC reliance model. If the University of Iowa is named as the IRB of record under a GPC endorsed study, the University of Iowa researcher will submit the project through the IRB-01 option in HawkIRB. Indicate in Section I. and VII.A of the HawkIRB application the study requests to use the Great Plains Collaborative model. When using any central IRB model, the University of Iowa Principal Investigator will be responsible for ensuring all sites involved in the project follow the University of Iowa IRB policies and procedures as well as their local institutional requirements. The University of Iowa PI is responsible for the overall conduct of the study at all participating sites.
In the event the University of Iowa is not the IRB of record for a GPC endorsed study, the HawkIRB submission should reflect the “GPC” option in section I.1. 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. 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 your project is eligible to use the GPC model, a formal GPC Governance approval is required with the submission in HawkIRB. More information on the GPC Governance review can be found on the GPC Trac site, Wiki. The GPC IRB Collaborative SOP below provides specific detail on the Review and approval process.
Current collaborating institutions in the GPC are The Children's Mercy Hospital, University of Kansas Medical Center, Medical College of Wisconsin, University of Nebraska Medical Center, University of Texas Southwestern Medical Center, The University of Iowa, Marshfield Clinic Research Foundation-A Division of Marshfield Clinic; University of Minnesota, University of Texas Health Sciences Center at San Antonio, University of Wisconsin-Madison, and University of Missouri.
Contact the University of Iowa's Human Subjects Office with questions regarding the GPC application process or UI requirements
Mail: 105 HLHS, Human Subjects Office
600 Newton Rd, University of Iowa, Iowa City, IA 52242