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Single IRB (sIRB) Mandate

The single IRB (sIRB) mandate is a set of federal policies that require non-Exempt, federally-funded, cooperative research to rely on one IRB for study review and approval.  NIH funded studies approved on or after January 25, 2018, will continue to follow the NIH sIRB Policy  effective January 25, 2018

The single IRB mandate of the revised Common Rule, effective ​January 20, 2020*

The regulation applies to all sites in the United States participating in a federally funded cooperative research study (involves more than one site) approved on or after the effective date of January 20, 2020 with the exception of: 

  • Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or Research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.

  • Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

  • Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020. 

  • Cooperative research conducted or supported by NIH if either:

    • the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or  

    • NIH excepted the research from its single IRB policy before January 20, 2020.

* Originally effective for NIH-funded research beginning January 25, 2018. 

What is meant by cooperative research?

Cooperative research means that the same research protocol is being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. This typically involves a lead site that receives the grant or contract directly from NIH and then establishes a subaward or subcontract to each participating site. The research could be a clinical trial, an observational study, or a basic clinical research study.

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 or direct-charged 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.

  • If you are the lead site and will use an independent, commercial IRB as the sIRB, you must work with the HRPP to obtain that IRB’s fee structure. Brown has established a pre-negotiated Reliance Agreement with Advarra to facilitate this process.

  • If you are the lead site and will use the IRB of another institution (e.g., one of the participating sites) as the sIRB: IRB fees vary among institutions. You will need to work directly with the sIRB to get information about their fees.

What do I need to do before I submit my grant to OSP or BMRA?​

If Brown is the lead site (the sIRB of record)...

You will need to:

  1. Contact the HRPP at least three (3) weeks before the internal OSP grant submission deadline, to discuss the proposed use of Brown as the sIRB. In cases where your research involves >3 separate sites conducting the same research protocol (inclusive of Brown as a site), you may be directed to work with Advarra, a commercial IRB with which Brown has negotiated a Master Reliance Agreement.  You will need to obtain a letter of support from HRPP that describes Brown (or Advarra) as the selected sIRB and Brown’s willingness to rely on this IRB. Your request should provide:

    1. The name of the Brown lead PI

    2. The number of sites

    3. The title of the study/grant

    4. The grant deadline

    5. A brief description of the study or a link to the NIH Request for Applications (RFA)

  2. Obtain letters of support or affirmation of support from the IRB offices of all participating sites, indicating their agreement to rely upon Brown (or Advarra) as the chosen sIRB. The HRPP has developed a template letter that may be used to facilitate this process - please contact us for a copy. For sites that do not have their own IRBs but have an established FWA (Federalwide Assurance) with OHRP: 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 or otherwise affirm the agreement of all study sites to rely on Brown (or Advarra) as the sIRB. See the next section for complete information about grant information.

If Brown is a participating site (not the lead site)...

You will need to:

  1. The Brown HRPP can provide a letter of support from indicating that Brown will rely on the chosen sIRB. Contact HRPP at [email protected] at least one week before the internal OSP grant submission deadline to request this letter. Your request should provide:
    1. The name of the Brown PI

    2. The name of the lead PI and the lead site

    3. The name of the sIRB, if already selected

    4. The title of the study/grant

    5. The grant deadline

    6. A brief description of the study or a link to the NIH Request for Applications (RFA)

    7. Any additional relevant information, such as whether the SMART IRB Master Reliance Agreement will be used

 

What information should be included in grant applications?

  • 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. This information should be in the human subjects section of the grant proposal. HRPP has developed sample plan language that can be adapted for this use. Please contact [email protected] for the sample language.

  • Letters of support from the Brown HRPP and each of the sites that will rely on the sIRB. Each site participating in the study must agree to rely on Brown as the IRB of Record. This can be accomplished via a formal letter of support or other verbiage within the grant application.  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. HRPP will assist you in obtaining fee information as part of the process of identifying the most appropriate sIRB for your study.  Many institutions are charging for IRB services. Brown has opted not to charge fees for IRB services at this time.  If you will be using Advarra, we would be happy to connect you with Advarra for assistance in developing an appropriate budget for your study. The Advarra budget request form can be found here. Please contact Sheila Vandal for assistance.

  • A description of the resources (personnel, budget) you will need to manage IRB communications. HRPP 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 HRPP and at many other institutions nationwide. It is typically a staff member on the research team at the lead site. HRPP has developed a template that can be adapted for use in the Budget Justification sections of a NIH grant. HRPP is available to advise on individual study needs, including an IRB liaison FTE that may be appropriate for the study.

What happens after the grant is funded?

The Brown lead PI should be prepared to:

  • Train a member of the Brown research team to serve as the "IRB liaison."
    The HRPP plans to offer orientation, training and resources to IRB liaisons working with Brown PIs.  Contact Sheila Vandal for more information.

  • Contact the HRPP to request the use of an external IRB.
    Alert the HRPP that you have received funding and are ready to begin the process of establishing the sIRB review with an external site IRB or a commercial IRB (i.e., Advarra).  You will be asked to complete an IAA Application to provide the information we need to establish reliance agreements with other sites.

  • 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 (IAA), with the sIRB. The reliance agreement documents the arrangement and also establishes expectations about communication, reporting, and procedures. Brown University, many peer institutions, and many sIRBs 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.
    For specific information, visit our IRB Authorization Agreements (IAAs) website. In general, most sIRB review for cooperative research studies will involve the following steps:

    1. Submitting an IAA Application

    2. Submitting the generic protocol and consent materials for review by the sIRB.

    3. 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.

Frequently Asked Questions (FAQs)

1) The quote we received from a commercial IRB was very steep. Is there a designated portion of the costs that Brown will cover?

There is no institutional funding available to cover costs associated with using a commercial IRB (Advarra or otherwise). We strongly encourage the collaborating research sites to determine up-front which will serve as the IRB of Record. 

2) If a site is added in the middle of an ongoing project that already has 3 engaged sites, and the addition of this site results in 4 engaged sites, will a contract with Advarra (or another commercial IRB) need to be established?

In the rare instance that a fourth site is added mid-study and is engaged in human subjects research and Brown is already serving as the sIRB, we can evaluate that particular case to determine if Brown's IRB could continue to serve as the sIRB. 

3)  Do we have to use an external commercial IRB when we have >3 engaged sites?

There is no mandate that a cooperative research study use Advarra or any other external commercial IRB. Any site engaged in a cooperative research study can serve as the IRB of Record. Brown established a reliance agreement with Advarra to facilitate a more expeditious review in instances where an investigator elects to work with Advarra. In instances where all engaged research sites involved in collaborative research refuse to serve as the IRB of record, please notify us so we can keep track of how frequently this occurs and if it occurs in instances where there is a total cost cap mandated by the sponsor.

4) Is an external IRB only required with 4 or more research sites?

Yes, an external IRB is required for 4 or more non-Exempt sites engaged in human subjects research (including Brown in the total number of sites).

Sites that are not engaged in human subjects research or conducting Exempt research do not count toward the total number of research sites.