Submitting an Applicable NIH Grant Requiring sIRB

How it works

The NIH sIRB policy requires that multi-site studies are reviewed by a single IRB to promote efficient and expeditious research.

If you are submitting a grant application for a multi-site that will use the same protocol to conduct non-exempt human subjects research at more than one institution, you are expected to include a plan for the use of the sIRB in the application/proposal submitted to NIH. The NIH’s acceptance of the plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award.

As the institution applying for the grant, IU has institutional responsibilities that must be met. As the office responsible for IRB review, HRPP staff members are ready to help you draft your sIRB plan and identify an appropriate sIRB. You must contact HRPP staff immediately if you are planning to submit an applicable grant application to NIH.

Please contact Ryan Ballard at rcballar@iu.edu or 317-278-7812 as soon as possible prior to submitting your grant proposal to avoid any delays in grant processing.

Identifying the sIRB (the IRB that will provide review for all sites) is an important part of the sIRB process. The NIH policy does not define which IRB should serve as the Reviewing IRB, and the decision should be made on a study-by-study basis after discussion with the HRPP and the participating sites, depending on the specific needs of the study.

Consider the following options:

  • IU IRB: IU IRB is willing to serve as the Reviewing IRB when IU is engaged in the research; however, there are other options you may want to consider. You must contact HRPP staff before indicating that the IU IRB will serve as the Reviewing IRB. Please consider the following:
    • Site contacts cannot access KC IRB directly. An intermediary must collect information from the sites, make submissions to the IRB on behalf of the sites, and distribute IRB-approved documents.
    • KC IRB does not support multiple study submissions at the same time, limiting how quickly site additions and changes to site-specific documents can be approved.
    • Study teams using the IU IRB are required to utilize the CTSI sIRB Project Manager, who can help mitigate some of the above factors by facilitating communication between the IU IRB and the participating sites and completing IRB submissions on behalf of participating sites. For more information, contact Amy Trullinger (ajtrull@iupui.edu) or Christine Caldwell (csego@iu.edu).    
  • Independent IRB: Independent IRBs have the infrastructure and electronic systems to allow for a quick and efficient IRB review. However, the ease of use of independent IRBs must be balanced with the high cost associated with their use.
    • Independent IRBs do charge for their services but may be willing to offer lower fees for NIH-funded studies. We encourage all investigators to request a budget quote from at least one independent IRB before deciding on a Reviewing IRB.
    • Independent IRBs have electronic systems which support efficiency
      • Allow site contacts to access the system and make submissions directly, without an intermediary
      • Distribute IRB-approved documents directly to site contacts
      • Allow for multiple amendments or submissions at the same time
  • Academic IRB, other than IU: Many academic IRBs are willing to serve as the Reviewing IRB and some have extensive experience. Consider having the IRB of a participating academic site serve as the Reviewing IRB if:
    • human subjects will not be enrolled at IU
    • the IRB is already serving as the Reviewing IRB for another related multisite study or consortia
    • the IRB utilizes an electronic system which supports multi-site review and allows sites to access the system directly or receive documentation directly from the IRB
    • the site is already serving as a coordinating center for the study

HRPP staff will work with the investigators to identify the Reviewing IRB and will assure that the identified Reviewing IRB is qualified to review the applicable research.

The NIH recognizes that sIRB review requires additional costs for the reviewing IRB, and allows the Reviewing IRB to charge direct costs for its review. Once you have identified the Reviewing IRB, request information regarding IRB fees and ensure any fees are included in your budget.

In addition to the normal staffing requirements for conduct of your study, you must budget for adequate coordinator and regulatory staff to manage the unique requirements of sIRB review.  This person should fulfill the task of acting as a liaison between the participating site study teams and the IU IRB. Additionally, the individual should be responsible for communicating any changes or updates to the participating sites and ensure the participating sites understand IU’s policies and procedures. Experience has shown that these activities can be extremely resource-intensive and should not be added to the duties of an existing research coordinator.

Additionally, you must budget for use of the CTSI sIRB Project Manager unless an exception is granted by CTSI and the HRPP.  Contact CTSI staff (Amy Trullinger at ajtrull@iupui.edu or Christine Caldwell at csego@iu.edu) for more information regarding budget considerations.

Once the Reviewing IRB is identified, all sites must agree to rely on the proposed Reviewing IRB. If a site is requesting an exception to the policy for this particular study, the institution should provide the reason and/or compelling justification for inclusion in the sIRB plan.

The sIRB plan must be attached to the grant application as a PDF file.  If multiple projects are included in a single grant proposal, a separate file should be attached for each project outlined in the application. Required elements and associated guidance is below, as well as suggested template language.

Required elements and associated guidance of the sIRB plan
Required ElementsGuidance
Describe how you will comply with the NIH Policy on the Use of sIRB for Multi-Site Research.Provide a statement that awardees will comply with the policy pursuant to the sIRB plan.

For delayed onset studies, provide a statement that awardees will comply with the policy and communicate the sIRB plan prior to initiating the study. No additional information at time of grant application is necessa
Provide the name of the IRB that will serve as the Reviewing IRB of record.The Reviewing IRB should be determined prior to the application submission, based on IRB expertise and resources. Contact the HRPP for help identifying an appropriate and qualified Reviewing IRB.
Indicate that all identified participating sites have agreed to rely on the proposed Reviewing IRB and that any sites added after award will rely on the Reviewing IRB.Sites may submit letters of support providing the confirmation, but such letters are not required to be included in the grant application.
Briefly describe how communication between sites and the Reviewing IRB will be handled.Provide an overview of how you plan for the Reviewing IRB to communicate with sites, and vice versa. There is no need to draft a formal communication plan at this stage; however, one will be required at time of initial IRB review.
Indicate that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the Reviewing IRB and participating sites.Reliance agreements are completed by the participating sites’ IRB offices. Agreements should not be included in the application.
Indicate which institutions or entity will maintain records of the authorization/reliance agreements and of the communication plan.This is the responsibility of the awardee institution, but may be delegated to the Reviewing IRB when the awardee is not serving as the Reviewing IRB.
For studies with Legal, Regulatory, or Policy based claims for Exception.Include specific citation to the applicable rule which requires local IRB review.
For sites requesting an exception based on compelling justification.Identify the site and the reason for exception, including a compelling justification.

Suggested/template language for the NIH proposal, section 3.2.1

This study will comply with the NIH Policy on the Use of sIRB for Multi-Site Research. The [name of identified single IRB] has agreed to serve as the sIRB of record for human subjects research under this grant. All participating sites will rely on the proposed sIRB and any sites added after award will rely on the sIRB. The proposed IRB will maintain records of the reliance agreements and the communication plan.

The lead study team will be responsible for ensuring ongoing communication with all participating sites via teleconferences and regular emails throughout the study. Key communication points will occur to:
  • Disseminate IRB determinations and IRB-approved documents
  • Educate study teams regarding the approved study and amendments to the study
  • Alert study teams to problems that may affect the conduct of the study or the rights and welfare of research participants, such as unanticipated problems.
  • Inform study teams of any changes in study status or new information
    • Facilitate submissions to the Reviewing IRB, including:
    • Inclusion of site-specific requirements in consent documents
    • Identification of any variability in study implementation across sites that must be communicated to the IU IRB
    • Collection of information from participating sites to include in continuing review reports to the IU IRB
    • Site-specific amendments
    • Personnel updates (as required by the IU IRB)
    • Reportable events (e.g., noncompliance, unanticipated problems)
    • Closure reports
    • Ensure revisions to applicable conflict of interest management plans are provided to the IU IRB

This project will use the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (SMART IRB Agreement) to support single IRB review. SMART IRB is an online reliance platform designed to streamline and advance reliance through a common IRB authorization agreement. The SMART IRB Agreement outlines the responsibilities of all Participating Institutions, the Reviewing IRB, and Relying Institutions, and provides templates for communication between the Reviewing IRB and Relying Institutions. All sites in this study are members of SMART IRB and will indicate reliance and willingness to invoke the SMART IRB agreement prior to IRB review.

Words to know

Awardees - Awardees are responsible for ensuring that authorization agreements are in place; copies of authorization agreements and other necessary documentation should be maintained in order to document compliance with this policy, as needed. As appropriate, awardees are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established. At IU, responsibility for the communication plan is delegated to the PI.  The IU Human Subjects Office will review the communication plan and provide feedback on carrying out these responsibilities.

Reviewing IRB - The IRB responsible for review and oversight of a research project. Also known as the IRB of record or the single IRB (sIRB).

Multi-site study - Research that uses the same protocol to conduct non-exempt human subject research at more than one site

Participating site – In a multi-site study, an entity that will rely on the sIRB to carry out the site's IRB review of human subjects research for the multi-site study