Single IRB Mandate

The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all participating sites.

The Two Policies

The NIH Policy, effective January 25, 2018

  • Applies to: NIH funded studies in which the sites are all using the same research protocol. These will typically be clinical trials, but can include observational studies.
  • Exceptions: VA sites; international sites; site involving tribal nations.
  • Details: NIH Single IRB Policy for Multi-site Research

The Common Rule Regulation, effective January 19, 2020

  • Applies to: Federally funded cooperative research – that is, studies that involve more than one institution.
  • Exceptions: VA sites; international sites; site involving tribal nations.
  • All information below applies only to the NIH policy. More information about the Common Rule regulation will be posted as it becomes available.

NIH Single IRB FAQs and Requirements

1. What studies must follow the NIH policy?

The NIH policy applies to all studies that are:

  • Funded through grants, cooperative agreements, contracts, or the NIH Intramural Research Program, and
  • Involve non-exempt human subjects research, and
  • Involve multiple sites, all of which are conducting the same protocol.

The policy does not apply to studies that are:

  • Funded to foreign awardees and/or conducted at foreign sites, or
  • Funded through career development, research training or fellowship awards, or
  • Where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy, or
  • Collaborative projects in which multiple sites are involved, but different sites may complete different parts of the study.

NIH will consider other requests for exceptions if there is a compelling justification, but expects these kinds of exceptions to be infrequent.

2. What happens on January 25, 2018?

All competing NIH grant applications with receipt dates on or after January 25, 2018 (new, renewal, revision, or re-submission) that meet the above requirements for the sIRB policy are required to include a plan describing the use of a sIRB for the study.

3. Who will serve as the sIRB?

Any IRB with a federalwide assurance, or registration, filed with the Office for Human Research Protections (OHRP) can serve as a sIRB. This includes IRBs that are not affiliated with the institutions involved in the study. It also includes the “independent” IRBs such as WIRB and Quorum that are not affiliated with any institution.

In most situations, the lead PI, in collaboration with the IRB office at the lead PI’s institution, will select the sIRB. The selected IRB must be willing to serve as the sIRB and all of the participating sites must agree to rely on the sIRB. Finally, NIH must concur with the selection.

The FIU IRB will not serve as the sIRB for multi-site studies except in rare cases. In most cases we use a pre-selected list of independent IRBs (e.g., WIRB) unless a collaborating institution is adequately equipped for serving as the sIRB. This is consistent with the approach of many FIU peer institutions.

4. How will sIRB review be paid for?

The costs for IRB review have traditionally been included as indirect costs under an institution’s Facilities and Administration (F&A) rate and could not be described separately. The NIH sIRB policy expects that sIRBs will charge fees. Those fees will be the responsibility of the lead site. NIH has provided guidance on which IRB review fees should be charged as direct vs. indirect costs under different IRB review scenarios.

5. What do I need to do before the grant is submitted?

FIU is a participating site (not the lead site)

You must provide the lead PI a preliminary letter of support from ORI indicating that the FIU is willing to consider relying on the chosen sIRB (or on an sIRB to be selected at a future date). This must be included in the grant proposal. Contact ORI at ori@fiu.edu at least (2) two weeks before the grant submission deadline to request this letter. Your request should provide:

  • The name of the FIU PI
  • The name of the lead PI and the lead external site
  • The name of the sIRB, if already selected
  • The title of the study/grant
  • The grant deadline
  • A brief description of the study and a link to the NIH Request for Applications (RFA)
  • A brief description of the human research activities that will be performed by FIU
  • Confirmation that FIU will be following the same research protocol as all of the other sites
  • Any additional relevant information, such as whether the SMART IRB Master Reliance Agreement will be used

Important:  Please note that you will still be required to submit a formal IRB Reliance Request prior to actually commencing the research project.  The information requested above is just preliminary information that is needed to determine which site will serve as the sIRB, so that a letter of support can be included in the NIH application.  The IRB Reliance Request process is a separate process that is required to take place after the sIRB has been identified.

FIU is the lead site

You will need to:

  1. Contact ORI at ori@fiu.edu at least three (3) weeks before the grant submission deadline, to identify the independent IRB that will serve as the sIRB and to obtain a letter of support from ORI that describes the selected sIRB and the FIU’s willingness to rely on this IRB. Your request should provide:
    • The name of the FIU lead PI
    • The name of the sIRB, if already selected
    • The names of the external sites
    • The title of the study/grant
    • The grant deadline
    • A brief description of the study and a link to the NIH Request for Applications (RFA)
    • A brief description of the human research activities that will be performed by FIU
    • A brief description of the human research activities that will be performed by the external sites
    • Confirmation that all of the sites will be following the same exact research protocol
  2. Obtain letters of support from the IRB offices of all participating sites, indicating their agreement to rely upon the chosen sIRB. ORI has developed a template letter that may be used to facilitate this process. For sites that do not have their own IRBs: the letters should be signed by a compliance officer or other person with authority to act on behalf of the site.
  3. Provide relevant information about the sIRB plan in the grant application (including the budget) and include the letters of support. See the next section for complete information about grant information.

Important:  Please note that you will still be required to submit a formal IRB Reliance Request prior to actually commencing the research project.  The information requested above is just preliminary information that is needed to determine which site will serve as the sIRB, so that letters of support can be included in the NIH application.  The IRB Reliance Request process is a separate process that must take place after the sIRB has been identified.

6. What information should be included in grant applications?

NIH will expect the following new information in grant applications for multi-site research on and after January 25, 2018:

A plan describing the use of a sIRB. The plan should identify the IRB that will serve as the sIRB and should address any requests for exceptions from the policy. See the NIH sIRB plan instructions for further details on what needs to be included.

Letters of support from the FIU Office of Research Integrity and each of the sites that will rely on the sIRB. Each site participating in the study must document its agreement with the IRB review arrangement in a letter of support. This letter is not the same as the formal IRB reliance agreements that may need to be established after the grant is awarded. See the section above for more information about the letters of support.

IRB fees that will be charged as direct costs. Depending on the sIRB that is selected for your study, there could be fees involved.

A description of the resources (personnel, budget) you will need to manage IRB communications. ORI anticipates that studies with more than a handful of sites will require significant additional staffing resources to manage the complex communications and document management associated with the use of a sIRB and with IRB-related coordination across sites. This role is being called the “IRB Liaison” by HSD and at many other institutions nationwide. It is typically a staff member on the research team at the lead site.

7. What happens after the grant is funded?

The FIU lead PI should be prepared to:

  • Identify and hire an IRB liaison
    • If determined to be needed.
  • Submit a formal request to the FIU Office of Research Integrity for an IRB reliance agreement. 
  • Facilitate the establishment of reliance agreements between the sIRB and sites
    • Each participating site will need to establish a reliance agreement, also known as an IRB authorization agreement, with the sIRB. The reliance agreement documents the arrangement and also establishes expectations about communication, reporting, and procedures. Many peer institutions and many commercial IRBs have already signed a “generic” Master Reliance Agreement called the SMART IRB Agreement. The SMART IRB agreement eliminates the need to establish a study-specific agreement. Studies and institutions making use of this existing agreement will have a streamlined startup process.
  • Submit for IRB review, which will normally involve two steps.
    1. Submitting the generic protocol and consent materials for review by the sIRB.
    2. Submitting site-specific information such as investigator qualifications, site specific recruitment and consent information, and other local context information (e.g., state laws about the age of majority) for review by the sIRB.