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Office of Research Compliance

Single IRB

Beginning January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research will be required to use a single IRB of Record (sIRB) for the review of human subject protections. Using a sIRB avoids duplicative review by multiple institutional review boards. The NIH policy applies to studies using the same protocol at multiple sites.

The Department of Health & Human Services (DHHS) Office of Human Research Protections (OHRP) implemented revisions to the regulations governing human subjects research (45 CFR 46 or the Common Rule) effective January 21, 2019. The revisions, also referred to as the 2018 requirements, included a mandate that new cooperative research projects subject to the 2018 requirements approved on or after January 20, 2020 require review by a single IRB. Cooperative research is defined as research projects that involve more than one institution.

Single IRB Review Process

When preparing submissions for funding from NIH or one of the Common Rule Agencies, the following steps will help ensure a smooth IRB review process when USC is the prime awardee of funding:

  1. Designate the single IRB of Record as part of the grant or contract application.  Identify an IRB  and ensure that the chosen IRB is willing and able to serve as the Reviewing IRB for the research (i.e., obtain a letter of support from the IRB identified as the Reviewing IRB for the cooperative research project)The Reviewing  IRB  may be USC IRB or an external IRB (either an accredited commercial or other academic IRB).  
  2. Budget Accordingly. Assess any costs associated with using the single IRB, such as fees for USC or commercial IRB to serve as the single IRB. As per NOT-OD-16-109, primary activities should be charged as indirect costs if those activities are included in an organization’s Federally-approved indirect cost rate agreement. Secondary activities may be charged as direct costs, with appropriate budget justification. 
  3. Work with the Reviewing IRB and the Relying IRB to request an IRB Authorization Agreement (a.k.a. "reliance agreement"). This is the legal contract negotiated between the IRBs. No one on the study team has the authority to negotiate or sign the IRB Authorization Agreement.

Costs of Single IRB Review

The costs for IRB review at a single institution by that institution’s IRB have typically been considered an indirect cost covered under an institution’s Facilities and Administration (F&A) rate (except for industry-initiated-and-sponsored studies).

However, NIH expects that many single IRBs will charge fees to review other sites. The fees are the responsibility of the prime site and should be included in the grant budget. 

Fees for external IRB as Reviewing IRB: It is the responsibility of the Principal Investigator (PI) to contact the Reviewing IRB and get an estimate of fees to include in the budget.

Fees for USC IRB as Reviewing IRB:The table below outlines the IRB fee schedule that must be built into your budget.
Service Provided USC IRB Fee

 Initial Review (Full Board or Expedited Review)

 $0 for USC site

$1,500 per site for the external sites

 Continuing Review (Full Board Review)

 $0 for USC site

$1,000 per site for external sites

Office of Research Compliance

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