The single IRB (sIRB) requires certain types of federally-funded studies to use one single institution’s review board (IRB) to accomplish the IRB review and approval for all of the institutions involved in the study.

The NIH mandated single IRB guidelines two years ago, and now the Department of Health and Human Services (HHS) has followed suit, affecting funding processes across all HHS funding agencies (CDC, FDA, HRSA, and several others). At this month’s CCTS Research Seminar Series, Christina Blackmon, Education and Outreach Specialist for UAB’s Office of the Institutional Review Board (OIRB), described exactly what the mandate means for most investigators and study groups. Blackmon shared that the mandate affects research that
    • begins on or after January 20, 2020
    • falls under the scope of the revised common rule
    • is funded by any Federal Department or Agency
    • has multiple sites participating in the study (US Domestic Sites)
    • involves studies considered Full Board or Expedited Review (i.e.; non-exempt)

Blackmon also illustrated five steps for Single IRB and Grant Preparation:
1. Propose a single IRB. Identify the IRB of record, ensuring the IRB is willing and able to serve as review IRB, and obtain a letter of support.
2. Budget accordingly. Costs and fees associated with review should be included in the grant budget. How can you know what to budget? Here’s a helpful illustration of direct vs. indirect costs. (See also slide #11 in the slide deck).
3. Justify the budget. Provide adequate justification for the costs associated with single IRB. Sample language can be found here under Single IRB Support Costs.
4. Develop a single IRB plan. It is important to include in this plan the name of the reviewing IRB, indicate all sites who have agreed to rely on the proposed single IRB (including letters of support from any participating external sites), and develop a communication plan that indicates expectations from all parties.
5. Set up a pre-submission consultation with the Office of the IRB. Contact the UAB Office of the IRB at (205) 934-3789 and prepare ahead of time for any questions that might be asked during the consultation.

Blackmon went on to explain the requirements in place for the two options for single IRB studies at UAB: (1) when UAB is the reviewing IRB, and (2) when UAB acts as the relying site. To see Blackmon’s step-by-step plan for either option, review her slide deck here.

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blackmonChristina Blackmon, Education and Outreach Specialist for UAB's Office of the Institutional Review Board, presenting at the January 2020 installment of the CCTS Research Seminar Series.