Case Study for Single Institutional Review Board (sIRB) Policy

Disclaimer

This fictional case study is based on various real-life scenarios. The exercise includes three sections covering single institutional review board (sIRB) requirements, budgets and protocols, and exception requests—each with associated questions to consider. Review each section, answer the questions, and then check your answer by expanding the question. For background, refer to the NIH Single IRB (sIRB) Policy page where you can find sIRB Frequently Asked Questions, sIRB Determination Workflow , related NIH and Common Rule policy notices, and other resources.


Section 1. sIRB Requirements

In this fictional case study, a principal investigator (PI) submitted a competing R01 application for a due date of September 1, 2017. NIH awarded a grant to the PI's institution. The award supports one ongoing non-exempt human subjects research study that is being conducted at three U.S. sites. Each site relies on its own local IRB for review and approval for the ongoing study. NIH plans to fund the PI's competing renewal award next month. NIH asks the PI for Just-In-Time (JIT) information, including the name of the sIRB of record for the multi-site study.

Sections 1 Questions

YES. The study is subject to the NIH sIRB policy because the study involves non-exempt human subjects research at more than one U.S. site and the competing renewal application was submitted for a due date after January 25, 2018. This is true even though the study is ongoing and has not previously used a sIRB. The sIRB should be in place before the new award is funded.

NO. The initial IRB approval date is not a consideration for determining if the study is subject to the NIH single IRB Policy requirement.

Section 2. Justifications for an Exception to the NIH sIRB Policy

The PI initially requested a budget for the renewal application without considering the cost associated with an sIRB. The PI now finds that sIRB costs will exceed the proposed budget and sends the Program Official (PO) an exception request to the sIRB requirement. In the request, the PI justifies the exception request by explaining that the original award budget would not cover the cost of an sIRB. Furthermore, because all the participating sites already have their own protocol documents, informed consent documents, and recruitment procedures, the PI believes that the sites are not conducting the same research protocol and therefore are not subject to the NIH sIRB Policy requirement.

Section 2 Questions

NO. Applicants or offerors must include all necessary sIRB costs in the proposed budget of the NIH application or contract proposal. An Insufficient amount in the award budget is not a compelling justification for an sIRB exception to the NIH sIRB Policy. Check the NIH Single IRB for Multi-Site or Cooperative Research website for additional information.

NO. NIH considers protocols that address the same research questions, involve the same research methodologies, and evaluate the same outcomes to be the “same research protocol.” Sites that are accruing research participants for studies that are identical except for variations due to local context consideration, such as different recruitment procedures and different informed consent forms, are also conducting the “same research protocol.” See FAQ A2 on the NIH sIRB for Multi-Site or Cooperative Research FAQ page for additional information.

NO. The NIH sIRB Policy is clear that this study would need a single IRB at the time of the next competitive renewal. Recipients are responsible for initiating the steps with enough time to have the sIRB in place by the time of the competing renewal award.

Section 3. Next Steps

Ultimately, the PI's exception request is denied for the following reasons:

  • NIH does not consider the cost associated with a sIRB as a compelling justification.
  • NIH considers the sites to be conducting the same research protocol, even when there are variations in site procedures due to local context considerations. Thus, the NIH sIRB policy requirements apply to all sites in this study.

Section 3 Questions

The PI should contact their PO to discuss next steps. As soon as possible, the PI should begin steps to establish a single IRB for this study.

Summary

The study described in this case is subject to the NIH single IRB Policy requirement.

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This page last updated on: August 20, 2024
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