SMARTIRB Reliance Model

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 "General External IRB SOP" 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.)

What is SMART IRB?

SMART IRB, the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform, is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS) and intended to serve as a roadmap for institutions to implement The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multisite Research.

Who can use the SMART IRB reliance platform? 

The University of Iowa has signed the SMART IRB agreement allowing any investigator at the University of Iowa the ability to propose the use of SMART IRB for his/her research study. Nationally, all CTSA hubs and over 1100+ institutions have signed the SMART IRB agreement and the number of institutions who have signed the agreement continues to grow. View the list of current participating institutions here: https://smartirb.org/participating-institutions/ 

How does it work?

It is up to the IRB of Record to determine what method will be used to obtain reliance.  The University of Iowa’s preference is to enter into reliance via SmartIRB, although Iowa can be flexible if the IRB of Record prefers a different method. 

The Overall Principal Investigator (PI) of a multisite study works with the Points of Contact (POCs) for each participating institution involved in the study to determine an appropriate reliance arrangement. Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research. Additional details on these processes are available in the SMART IRB SOPs on "Establishing Reviewing IRBs and Relying Institutions" and "Initial Review Submission and Review Process."  Speak with the External IRB Coordinator in the Human Subjects Office as soon as a decision is made to use the SMART IRB model!  The HSO can help plan and streamline the IRB Reliance process. 

SMART IRB Webpage 

Visit SMART IRB’s website at www.SmartIRB.org for the latest documents and guidance. 

Who to Contact?

Email: uirb-external@uiowa.edu
Fax: 319-335-7310
Mail: 105A HLHS, Human Subjects Office
          600 Newton Rd, University of Iowa, Iowa City, IA 52242