Single IRB of Record Submission Process

The entity serving as the lead IRB of Record for a study can be referred to by many names such as Central, Single IRB, Reviewing IRB, etc.  A Central (or Single) IRB of Record is a single, registered Institutional Review Board that reviews research studies for multiple sites. Commonly, the sponsor determines study sites and suggests or requires the use of a Central (or Single) IRB selected to perform the centralized review. In this model, the UI may serve as either the IRB of Record or rely on another IRB. Note if you want Iowa to be the lead IRB, a pre-grant survey is required before submission through HawkIRB.  Submit requests for the UI to serve as a relying or a lead IRB of Record via the eResearch (HawkIRB) application. 

Depending on the role of the University of Iowa IRB and the study sponsor, a fee structure may apply.  The fees for Central (Single) IRB review for industry sponsored\initiated are outlined in the IRB Fee memo.  Contact the External IRB Program for additional information about fees when the University of Iowa IRB serves as the lead IRB for a federally funded study.  

If you are interested in pursuing human subjects research utilizing a Single IRB (sIRB) model, please contact the External IRB Program as soon as possible to discuss the project.  There are some instances where the UI IRB cannot serve as the single IRB of record or rely on an external IRB.  An example of this would be providing IRB oversight to private or non-profit organizations located in a state with more stringent human subjects research state laws.  

For more information about submitting a study where Iowa is serving as the lead IRB click here.

For more information about submitting a study where Iowa is relying on another IRB click here.

Complete a Pre Grant Submission Survey if:

  • You are preparing an initial grant proposal to a federal source that requires a Single IRB of Record (sIRB) model;
  • You received an award notice but you have not already completed the Pre-Grant Survey.  In this case, you need to:

A track change version reflecting the updates and a final version are located at the bottom of this page to learn specific information on the process and contact the Human Subjects Office at uirb-external@uiowa.edu(link sends e-mail). We will help you determine which model (see below) may work best for your proposal (Lead IRB of record, relying IRB, commercial IRB models, etc.)

The Iowa City VAHCS does not currently accept a single IRB of record model or a commercial IRB review without prior approval from the VA. If a Principal Investigator is interested in utilizing a central IRB model for a VAHCS study, he/she should contact the VA Research Office.  For the Iowa City VAHCS, IRB-03 will be the selected IRB of record unless VA Cooperative funding is in place.

Reliance

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 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 information necessary to identify the Human Research Protection Program review requirements and various institutional policies. This is completed by submitting an External IRB application selecting the external IRB of record in Section I.1 of HawkIRB. For IRBs not specified by name in Section I.1, select "Other" and add the name of the IRB in the free text field.

SMART IRB - The University of Iowa’s preferred method to achieve reliance with other institutions.  Numerous institutions have signed up on SMART IRB to facilitate the reliance process.

These are completed outside of SMART IRB. These require the University of Iowa’s Institutional Official’s signature.  Below are different types of reliance agreements:

  • Institution to Institution agreements 
  • Organizations without their own FWA
  • Individual Investigator agreements

Contact uirb-external@uiowa.edu for more information on establishing reliance outside of the SMART IRB platform.

These are groups that conduct collaborative research utilizing an sIRB model where Iowa will be a relying site. Click on each page for more information: 

Great Plains Collaborative (GPC/PCORI)

StrokeNet

NCI CIRB

These are IRBs who primarily focus on industry-sponsored collaborative research but can handle other forms of sponsored research.  Click on each page for more information:

Advarra

WCG  (WIRB)

Investigators seeking to use any other type of multi-site central IRB or other External IRB model not previously described should contact the Human Subjects Office via email(link sends e-mail). Please refer to the guidance document below for additional details.

What are the PI’s Responsibilities When Using a Single IRB Model?

If you are planning to be the Overall Principal Investigator (PI), it is important to know the expectations when engaging in a multi-site research project utilizing a single IRB. For this reason, when in the planning stages you must schedule an appointment to review the reliance process with the External IRB Coordinator here at the University of Iowa. As the Lead PI it is your responsibility to know the expectations of both the lead and relying sites, which are outlined in the SMART IRB Agreement and Standard Operating Procedures manual. The University of Iowa applies the terms under version 1 of the SMARTIRB Reliance Agreement.  A few responsibilities as an Overall PI under the SMART IRB agreement are: 

  • Work in collaboration with the Reviewing IRB and POC to determine and document specific roles and responsibilities for communicating and coordinating key information to Relying Institutions and the Reviewing IRB as described throughout these SOPs and summarized in the Appendix: Additional Multi-Site Research Management Roles and Responsibilities.
  • Obtaining and collating information from Relying Site Study Teams and/or Relying Site Points of Contacts (depending on who is designated to provide that information at the Relying Institution) regarding local variations in study conduct, such as recruitment materials and process, consent process and language, and subject identification processes. 
  • Providing the Site Investigators with the IRB policies of the Reviewing Institution. This will include but is not limited to policies for reporting unanticipated problems, noncompliance, and subject complaints.
  • Providing participating Relying Site Study Teams with the IRB-approved versions of all study documents (e.g., consent and authorization forms, protocol, recruitment materials).
  • Assisting Relying Site Study Teams and/or POCs at the Relying Institution(s) (depending on who is designated to provide that information) in ensuring consent documents follow the Reviewing IRB’s template form and include applicable site-specific required language from each Relying Institution
  • When agreed upon in coordination with the Reviewing IRB, promptly reporting to the Site Investigator (or designee on the Relying Site Study Team) any unanticipated problems involving risks to subjects or others research-related subject injuries, or significant subject complaints that are related to or may affect subjects participating in the Research (i.e., the specific study or studies ceded to the Reviewing IRB) at the Relying Institution.
  • If a Relying Site Study Team does not provide the Lead Study Team (or designee) with the required information before the continuing review application is submitted to the Reviewing IRB, reporting the absence of this information as part of the continuing review and notifying affected Relying Site Study Team of lapse in approval for their site and any applicable corrective action plans.
  • Following all requirements of the Relying Institution with regard to ceded review, such as ensuring administrative requirements for documenting ceded review have been met before study activation occurs at a Relying Institution.

For more information, please review the “Overall Principal Investigator/Lead Study Team Checklist”.

If you are planning to be the PI relying on another IRB, you have responsibilities to both the UI IRB and Reviewing IRB. The UI IRB is responsible for conducting the Human Research Protections Program review.  This means you will submit application materials to the UI IRB for the initial review and for any modifications, continuing reviews or reportable events for the duration of the study. However, the IRB of Record is responsible for providing the regulatory oversight for the research protocol. The Reviewing IRB will provide the IRB review for the initial review, and any modifications, continuing reviews, or reportable events for the duration of the study. A few responsibilities as a relying site PI under the SMART IRB agreement are:

  • Following all requirements of their home institution with regard to ceded review, such as ensuring other reviews or sign-offs required by the institution have been completed before a study is activated.
  • Working with the Lead Study Team and the POC from their home institution, as applicable, to incorporate site-specific required language into the consent template to be used at their institution.
  • Providing the POC from their home institution with information regarding local Site Investigator or other Relying Site Study Team personnel changes.
  • Reporting to their home institution POC any changes in conflict of interest (COI) disclosures and resulting changes in COI management plans related to the Research (i.e., the specific study or studies ceded to the Reviewing IRB).
  • Reporting to the Lead Study Team (or designee) any changes (including funding changes and personnel changes), reportable events, and continuing review progress reports, for submission to the Reviewing IRB in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions.
  • Promptly reporting to the Overall PI via the Lead Study Team (or designee) any unanticipated problems involving risks to subjects or others, subject injuries related to the research, or significant complaints that could impact the conduct of the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions. Significant complaints are defined as those that cannot be resolved by the study team and a) suggest an increased or unexpected new risk or harm or b) change the risk/benefit ratio of the Research. Other complaints should be reported in accordance with the Reviewing IRB’s policies and procedures.
  • Promptly reporting to the Overall PI via the Lead Study Team (or designee) any potential noncompliance that occurs in relation to the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing of submission and content of such submissions.

For more information, please review the “Relying Institution Principal Investigator Checklist”.

External IRB SOPs:

 General External IRB SOP v.06142024 Clean.pdf

 General External IRB SOP v.06142024 Tracked.pdf