Submitting an Applicable NIH Grant Requiring sIRB

Quick guide: Submitting an Applicable NIH Grant Requiring sIRB

The Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research is effective for grants submitted after January 25, 2018. The policy applies to NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subject research and requires that a single IRB (sIRB) provide IRB approval for all participating sites.

The policy applies to domestic awardees and participating domestic sites only; foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
Exceptions to the policy can be requested, based on law or regulation, or due to some other compelling reason.

sIRB is not a new concept; many IU investigators already utilize sIRB processes via the KC IRB Reliance Request. The NIH policy has important implications for investigators submitting applicable NIH grants and even for investigators who are simply participating sites in grants submitted by external investigators.

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. Awardees may delegate the tasks associated with these responsibilities.

Reviewing IRB – The IRB that will be reviewing research from all participating sites

Communication plan – A written plan that details the flow of documents and communication between the lead study team and participating sites

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

sIRB – The selected Reviewing IRB that conducts the ethical review for participating sites of the multi-site study

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, HSO staff is ready to help you draft your sIRB plan and identify an appropriate sIRB. You must contact HSO 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 sIRB, and the decision should be made after discussion with HSO, based on IRB expertise and resources. The IU IRB may not be the most appropriate to serve as the sIRB; investigators should not assume that the IU IRB will serve in this role simply because IU investigators are submitting the grant application. HSO staff will work with the investigators to identify the sIRB and will assure that the identified sIRB is qualified to review the applicable research.

Once the sIRB is identified, all sites must agree to rely on the proposed sIRB. 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, and a separate file should be attached for each study outlined in the application. Required elements and associated guidance follows.

Required elements and associated guidance of the sIRB plan
Required Elements	Guidance
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 necessary.
Provide the name of the IRB that will serve as the sIRB of record.	The sIRB of record should be determined prior to the application submission, based on IRB expertise and resources. Contact the HSO for help identifying an appropriate and qualified sIRB.
Indicate that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.	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 sIRB will be handled.	Draft a communication plan using HSO's Communication Plan Template and review with HSO staff and the sIRB prior to grant submission. The actual communication plan document should not be included in the application.
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 sIRB 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 sIRB when the awardee is not serving as the sIRB.
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.

Additional Resources

Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Single IRB Policy for Multi-Site Research (NIH) – includes additional guidance provided by NIH
Single IRB & Exceptions Process Webinar (NIH)