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 firstname.lastname@example.org 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 Kuali Protocols directly. An intermediary must collect information from the sites, make submissions to the IRB on behalf of the sites, and distribute IRB-approved documents.
- Kuali Protocols has only a limited ability to create and process 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 may be 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. However, use of the CTSI sIRB Project Manager will need to be included in your study budget. For more information, contact Amy Trullinger (email@example.com) or Christine Caldwell (firstname.lastname@example.org).
- 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, or
- 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 email@example.com or Christine Caldwell at firstname.lastname@example.org) 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
|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.|