Skip to main content
  1. Research Offices
  2. OHSP
  3. Human Research Review
  4. Single IRB (or "sIRB") Reviews

Single IRB Review

  • What it is . . .

  • Why it is . . .

  • How FSU gets it done!

A single IRB ("sIRB") is an IRB generally designated by agreement and on a study-by-study basis for providing human research ethical and regulatory review, on-going oversight and related central IRB administrative coordination for a multi-site study or cooperative research. An sIRB may be a part of a research organization(s), or may be independent from any research organization. Single IRB review may substantially reduce collaborating institutions' and researchers' human research review regulatory burden as well as cost. At the panels below you may access more detailed information and related instructions, including when sIRB review is required, applicable sIRB mandates, documenting sIRB review and requesting sIRB review (by the FSU sIRB or non-FSU sIRB) for your study.

sIRB review is generally required under the federal Common Rule* for research that is approved by an IRB on or after January 20, 2020, conducted in the U.S., involves collaboration among multiple institutions, and is funded by a federal department or agency that is a signatory to the Common Rule. Exceptions to the sIRB requirement include:

  • research for which more than sIRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe);
  • research for which a federal department or agency supporting the research determines that sIRB review is not appropriate; or,
  • research that is determined to be exempt or not involve human subjects (these determinations are made by the OHSP/IRB).

*The "Common Rule" is the Federal Policy for the Protection of Human Subjects, which policy is incorporated in the separate regulations of the federal departments and agencies that have adopted the Common Rule via regulation. Many federal departments and agencies, including those that fund the preponderance of human research, such as the National Science Foundation, NIH and other U.S. Department of Health and Human Services agencies, as well as the departments of Education and Defense, follow the federal Common Rule. For research for which sIRB may not be required, participating institutions or sites may nonetheless elect sIRB review.

Additionally, for research that is specifically funded by the National Institutes of Health (NIH) (i.e., a subordinate NIH Center or Institute), NIH policy provides that sIRB review is, as of January 25, 2018, generally required for the domestic (U.S.) sites of multi-site studies where each site will conduct the same research protocol involving non-exempt human subjects research. The policy applies whether the study is supported through grants, cooperative agreements, or contracts. Some exceptions were provided, but these must now be consistent with the federal Common Rule. See this NIH FAQs page.

A “multi-site” study is a study in which the same research protocol will be carried out at more than one U.S. site, with a local collaborating investigator responsible for a participating site. A multi-site study generally includes a lead site as the grantee institution or contractor, with the lead site issuing a subaward or subcontract to each participating site.

The "same research protocol" is a protocol that, at each U.S. site in a multi-site study, will address the same research questions, involve the same methodologies, and evaluate the same outcomes. Sites that accrue participants for studies that are identical except for variations due to local context consideration are still considered to be conducting the “same research protocol.”

See the following panel for links to the mandates and related guidance. 

Federal Common Rule. The following federal regulations and policies mandate sIRB review of research that is subject to the federal Common Rule:

  • Federal Policy for the Protection of Human Subjects (Federal Policy) [link] (see §__.114) (various federal departments and agencies are signatories to this policy, compliance with which was January 21, 2019; see "Agency" for a list of original signatories, or this link for a current list, scroll down to "Common Rule Departments and Agencies")
  • Basic HHS Policy for Protection of Human Research Subjects [DHHS link] (see §46.114) (this is the unofficial U.S. Department of Health and Human Services version of the Federal Policy; see this DHHS sIRB exceptions page)
  • To locate a specific federal department or agency's (e.g., National Science Foundation; Department of Defense; Department of Education) electronic version of the Federal Policy, find the agency and its "CFR Citation" from this link, then visit https://www.ecfr.gov/ and search for the referenced CFR Title and §s. The eCFR is not an official edition of the CFR (click here for the official legal version) but is more readily accessible and may be more current.

National Institutes of Health (NIH). Policies that mandate sIRB review of research that is funded by any NIH Center, Institute or Office include or may be accessed at the following:

  • The initial NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research [link] (this was applicable for NIH grant applications submitted on or after January 25, 2018, and is still in effect, with some subsequent revisions)
  • Related NIH policies [link] (scroll down this NIH web page to Notices and Statements; some of these policies provide additional guidance, such as for implementation, direct and indirect costs, and exceptions, and some may be superseded or outdated so plan accordingly)
  • Important Note! Unless otherwise required in the applicable FOA pertaining to a central IRB, NIH funding applicants no longer need submit a plan describing their planned use of a single IRB at the time of application submission. However, applicants that are required to use an sIRB must provide the name of the sIRB during Just-in-time submission before an award will be issued. Providing the name of the sIRB will satisfy the sIRB policy requirement for an sIRB plan for NIH grant applicants.

Other sIRB Policies: In additional to the above regulations and policies, contact the Program Officer for the funding opportunity announcement of the federal department or agency or other sponsor from which you may apply for funding to obtain up-to-date sIRB requirements and related information or instructions.

See the following panel to find out how sIRB review must be documented.

Federal law provides that for research conducted at an institution and for which research IRB review and oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution’s reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy. Such documentation may include a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol (Federal Policy at §__.103(e)).

Generally, documenting an sIRB reliance arrangement requires that the participating institutions or organizations execute a reliance agreement to document the arrangement. This reliance agreement may also be referred to as an IRB Authorization Agreement, or IAA. Reliance arrangements are often executed on a study-by-study basis, but in some instances institutions may execute omnibus agreements with an external IRB to cover all of an institution's studies, all studies carried out by certain investigators or institutional components, or studies for which an institution's IRB lacks the requisite review background or expertise. Omnibus agreements may apply as well to multi-site studies. Reliance agreements must be signed by an institutional official who is authorized to do so as such agreements are between institutions and not between investigators.

The OHSP/IRB provides FSU researchers with flexibility in the manner of documenting sIRB review. See the following panel to find out how to request sIRB review for your study.

All requests for sIRB review merit careful planning, including setting aside sufficient time for such requests to be submitted and reviewed. Below for planning purposes are some of the key general considerations:

1. Chose the sIRB.

  • The institutions involved in conducting a cooperative or multi-site study should agree on which IRB will serve as the sIRB to perform IRB review on behalf of all of the involved institutions. The study team at the institution whose IRB will serve as the sIRB must unequivocally be willing and able to coordinate the sIRB review for all of the involved institutions.
  • For some cooperative or multi-site studies, one institution may serve as the lead study site that directs and coordinates the activities of the other participating institutions. The IRB of an institution that serves as the lead study site may be suitable sIRB.
  • Importantly, the selected IRB must be registered by the federal Office for Human Research Protections and be suitably qualifed to perform review. Other than the IRB of a lead study site, participating site or awardee, an independent IRB or central IRB may also serve as the sIRB. 
  • Even when there may not be a clearly defined or designated lead study site, the responsibility for coordination of sIRB review must still be carefully delegated and discharged, so for this purpose the collective study team must confer and agree that one of the study sites and its Principal Investigator (PI) must be charged with the sIRB responsibility.
  • For reference, the OHSP provides a template of language about FSU's human research protections and related regulatory compliance that may be shared with other institutions (as well as study sponsors); sIRB language begins on page 2.

2. Identify and budget for sIRB-related expenses.

  • Coordinating sIRB review for multi-site or cooperative research may be an extraordinary study activity that is atypical of single-site studies. Therefore, be certain to take into account the added expense, time and effort that will be required to plan, undertake, document and communicate sIRB reviews and continuing oversight. This added expense may include initial review and ongoing oversight-related fees charged by an sIRB or independent IRB.
  • Although sIRB review may reduce the collective IRB burden among the participating institutions, sIRB review fees and related expenses or personnel costs incurred by the lead site or institution selected to provide sIRB for the lead and participating sites should be identified and where appropriate, included in the study's budget and budget justification (see., e.g., Section F Other Direct Costs, in the R&R Budget Form).
  • Note that sponsors may under certain conditions allow for direct costs associated with sIRB IRB review [See, e.g., this NIH link and these FAQs]. Contact your department or Institutional grants coordinator or office to see how sIRB-related expenses should be budgeted in any funding application. Note the following:
    • If FSU is the prime awardee and the FSU IRB serves as the sIRB, then generally the primary expenses associated with sIRB review are included in the FSU's indirect costs and should not be separately budgeted in a funding application. Secondary expenses (e.g., review of participating site-specific materials) may be separately budgeted as Other Direct Costs.
    • If FSU is the prime awardee and the another IRB will serve as the sIRB, then generally the primary and secondary expenses associated with sIRB review must be included as a direct cost and separately budgeted in a funding application. As the expense of a non-FSU IRB as the sIRB is not covered as an FSU indirect cost, it is the responsibility of the PI to ensure that a funding application includes these sIRB expenses in the budget as Other Direct Costs so that such expenses may be paid out from grant funds. 

3. Confirm sIRB Designation.

  • PIs of participating institutions must contact their institution's IRB office to confirm their willingness to rely on the selected sIRB and convey this confirmation to the lead study site's PI.
  • The FSU OHSP/IRB makes available templated language [link] about FSU's conformance with applicable human subjects protection regulations and sIRB requirements; this may be shared with participating study sites and sponsors to assist with obtaining confirmation about their willingness to rely upon the FSU IRB as the sIRB.

See the following panels to find out how to request that the FSU IRB serve as sIRB review for your study, or request that FSU rely upon a non-FSU sIRB.

In accordance with FSU Policy 7-IRB-0, the FSU IRB may serve as the sIRB for other institutions provided that the FSU IRB has the requisite qualifications to provide such review and the OHSP has the requisite resources to support the FSU IRB as the sIRB.

Currently, the FSU IRB has extremely limited capacity to serve as an sIRB, and decisions to serve as the sIRB are reserved for the OHSP and evaluated on a case-by-case basis. Some factors taken into consideration include whether FSU is the grantee institution with an FSU PI; the number of relying study sites; study scope and risks; adequacy of the communication plan; and qualifications of the FSU study team. Any request that the FSU IRB serve as the sIRB may be declined based upon these and other considerations.

To request that the FSU IRB serve as the reviewing IRB (sIRB), follow the steps below:

  • Email OHSP at humansubjects@fsu.edu (do not call, since doing so does not permit ease of internal coordination or time for thorough consideration) and provide the following details:
    • the name of the overall multi-site or cooperative study PI;
    • the name of the lead institution for the study;
    • the names of all the participating institutions;
    • the name of the FSU PI;
    • the name of the study's sponsor and awardee institution;
    • if funded by a federal department or agency, a copy of the funding application and notice of award;
    • documentation or a statement to the effect that the FSU has been identified as the sIRB by the federal department or agency; and,
    • a statement about whether the study is a clinical trial, involves any FDA-regulated product (drug, device, biologic, nutritional supplement or combination product, or involves any classified information.
  • Upon review of the above information and materials, you will within a few days be contacted, including need for clarification, declining the request that the FSU IRB serve as the sIRB, or instructions for next steps.
    • Promptly and carefully respond to any request for clarification or additional information.
    • If FSU IRB as sIRB is declined, you will need to coordinate with your study collaborators to arrange and confirm some other IRB as the sIRB.
  • When you are are instructed or ready to submit your study for FSU IRB review, the following multi-site study-related general steps and any specific instructions provided to you by OHSP should be followed: 
    • In RAMP IRB, under the IRB and Help Center tabs, review the RAMP IRB "Multi-Site Study Guide" and review the sections for sIRB Researchers and pSite Coordinators (participating Site) (this guide provides instructions for submitting a multi-site study).
      • Submit your study as usual, following the "Multi-Site Study Guide" instructions. Visit our related video tutorial "Multisite or Cooperative Studies" on our tutorials page (scroll down to Specific Video Tutorials for Using RAMP IRB). 
      • In the Basic Study Information section of your RAMP IRB workspace, you will indicate the study is a "Multi-site or Collaborative study"; answer "No" to the question "Will an external IRB act as the IRB of record for this study?"; and answer "Yes" to the question "Will your IRB act as the single IRB of record for other participating sites?"
      • Among other study-related materials, the overall protocol, FSU-site specific documents, and templates of local relying site documents (e.g., site consent forms, recruitment materials) must be uploaded.
      • After FSU IRB approval, participating site (pSite) submissions, to include final relying site documents, must be intiated by the FSU PI for each relying site.
    • In RAMP Agreements, under the Agreements and Help Center tabs, review the "RAMP AGM PI Quick Reference" and "RAMP AGM How to Guide REL" (for reliance agreements) (this guide provides instructions for submitting a reliance agreement for a multi-site study).
      • Prepare your agreement submission following the "RAMP AGM How to Guide REL" instructions, completing each section as may be applicable.
      • Note that on the Agreement upload page, section 3, instead of uploading a reliance agreement, check the box "Institution to generate first draft?" In section 5, use the pull down menu to select Reliance Agreements.
      • On the Agreement Information page, check "Yes" to the question "For this Agreement, is FSU the IRB of Record?"
      • Non-FSU sites are expected to provide the FSU PI with site-specific documentation, including local context and communication forms; documentation of local study team CVs and human subjects training; and conflicts of interest disclosures.
  • The FSU and relying site study team must comply with the FSU IRB's conditions of approval, the FSU IRB-approved protocol, and the policies and other requirements of the FSU IRB. FSU PIs must provide the study team with copies of the above.

Learn more about SmartIRB

FSU is member of the SMART IRB, a national organization sponsored by the NIH. SMARTIRB provides a streamlined process sIRB review among collaborating institutions. The FSU IRB prefers the SMART IRB process for restablishing reliance arrangements with other SMARTIRB institutions. The FSU IRB will generate a formal SMART IRB "Letter of Acknowledgment" once the FSU PI has submitted a request for reliance in RAMP Agreements as instructed above. 

In accordance with FSU Policy 7-IRB-0, the FSU IRB may rely upon an external (non-FSU) IRB to serve as the sIRB for a multi-site or cooperative study, provided that the OHSP concurs to such reliance through a written agreement; if otherwise then the request to rely upon an external IRB will be declined.

To request that the FSU IRB rely upon an external IRB as the sIRB, follow the steps below:

  • Email OHSP at humansubjects@fsu.edu (do not call, since doing so does not permit ease of internal coordination or time for thorough consideration) and provide the following details:
    • the name of the overall multi-site or cooperative study PI;
    • the name of the lead institution for the study;
    • the names of all the participating institutions;
    • the name of the FSU PI;
    • the name of the study's sponsor and awardee institution;
    • if funded by a federal department or agency, a copy of the funding application and notice of award;
    • documentation or a statement to the effect that an external IRB has been identified as the sIRB by the federal department or agency; and,
    • a statement about whether the study is a clinical trial, involves any FDA-regulated product (drug, device, biologic, nutritional supplement or combination product, or involves any classified information.
  • Upon review of the above information and materials, you will within a few days be contacted, including need for clarification, declining the request for reliance upon a non-FSU IRB as the sIRB (with rationale*), or instructions for next steps.
    • Promptly and carefully respond to any request for clarification or additional information.
    • If reliance upon a non-FSU IRB as the sIRB is declined, you will need to share the OHSP/FSU IRB rationale and coordinate with your study collaborators to arrange and confirm some other non-FSU IRB or the FSU IRB as the sIRB.
  • When you are instructed or ready to submit your study for local and non-FSU sIRB review, the following general steps and any specific instructions provided to you by OHSP should be followed: 
    • In RAMP IRB, under the IRB and Help Center tabs, review the RAMP IRB "Multi-Site Study Guide" and review the sections for sIRB Researchers and pSite Coordinators (participating Site) (this guide provides instructions for submitting a multi-site study).
      • You will submit your study in abbreviated form, following the "Multi-Site Study Guide" instructions.
      • In the Basic Study Information section of your RAMP IRB workspace, you will indicate the study is a "Multi-site or Collaborative study"; answer "Yes" to the question "Will an external IRB act as the IRB of record for this study?"; and skip selecting the Lead PI for the overall study. Visit our related video tutorial "Multisite or Cooperative Studies" on our tutorials page (scroll down to Specific Video Tutorials for Using RAMP IRB). 
      • Abbreviated requirements: the usual requirements may be substituted as follows:
        • provide the protocol or IRB application approved by or under review by the reviewing sIRB.
        • provide any study documents that have been customized for the FSU study site (e.g., local consent form and recruitment materials); documentation of FSU study team members' human subjects training and conflicts of interest disclosures; and a communication plan (these will after FSU review be required by the non-FSU sIRB).
        • provide the sIRB approval letter if already issued.
        • upload any local context form (including any institutional approvals) required by the sIRB.
    • In RAMP Agreements, under the Agreements and Help Center tabs, review the "RAMP AGM PI Quick Reference" and "RAMP AGM How to Guide REL" (for reliance agreements) (this guide provides instructions for submitting a reliance agreement for a multi-site study)
      • Prepare your agreement submission following the "RAMP AGM How to Guide REL" instructions, completing each section as may be applicable.
      • Note that on the Agreement upload page, section 3, either the agreement draft provided by the sIRB may be uploaded or check the box "Institution to generate first draft?" In section 5, use the pull down menu to select Reliance Agreements.
      • On the General Information page, select or enter the sIRB institution's information.
      • On the Agreement Information page, check "No" to the question "For this Agreement, is FSU the IRB of Record?"
  • When FSU is a relying site in a multicenter study, the FSU IRB will review the study, including any local requirements (e.g., FSU study team's human subjects training, conflicts of interest disclosures, communication plan), convey acceptance of a reliance arrangement with the sIRB, after which the FSU IRB will await the non-FSU sIRB approval.
  • The OHSP/FSU IRB will communicate or assist the FSU to communicate with the sIRB to prepare and execute the reliance agreement
  • The FSU study team must comply with the sIRB conditions of approval, the sIRB-approved protocol, and the policies and other requirements of the sIRB. Request and maintain copies of the above
  • The FSU study team must also comply with FSU IRB requirements, including submitting study modifications applicable to local study activities or the FSU study team; reports of new information (e.g., unanticipated problems at FSU involving risks to subjects or others; non-compliance; external audits and data safety and monitoring outcomes); continuing reviews; study close out involving the FSU study site

*Some reasons for declining reliance upon a non-FSU IRB as the sIRB include, for example, the following: the designated sIRB is not registered with OHRP; the sIRB institution does not have a Federalwide Assurance (FWA); the sponsor's documentation indicates a different IRB (including the FSU IRB) as the sIRB; or the designated sIRB does not agree to serve as the sIRB for the study or for the FSU study activities.

Learn more about SmartIRB

FSU is member of the SMART IRB, a national organization sponsored by the NIH. SMARTIRB provides a streamlined process sIRB review among collaborating institutions. If the sIRB uses the SMART IRB process for a reliance arrangement with FSU, then the sIRB will generate a formal SMART IRB Letter of Acknowledgment; the PI should upload this letter in RAMP Agreements.

Coming soon! See transition information below.

Florida State University (FSU) may designate WCG IRB as an IRB of record for some selected studies, subject to FSU authorization. The WCG IRB is a commercial IRB that is not part of FSU. Selected FSU studies that may be reviewed by WCG include:

  • Industry-funded, designed, and sponsored clinical trials (all phases).
  • Cooperative or multi-site collaborative research that requires Single IRB review (sIRB) per federal agency or department policy.

For WCG studies, the FSU study team completes the submission for IRB review to WCG IRB through the WCG Connexus online system; WCG IRB will conduct the requisite regulatory and ethical review on behalf of FSU.

FSU study teams must also register the study in the FSU RAMP IRB system so that FSU may (1) conduct any required local reviews (e.g., conflicts of interest, human subjects/good clinical practice training, environmental/radiation safety, kany other ancillary review, etc.) and (2) document and track the research conducted at FSU in accordance with applicable federal law.

FSU IRB's role in WCG IRB-reviewed studies: As with other FSU studies that may be reviewed by an external IRB, the FSU IRB coordinator assigned to the study will verify that all FSU local institutional requirements are met via the local FSU RAMP IRB submission.

STUDIES THAT MAY BE SENT TO THE WCG IRB:

  • All Phase I-through-IV drug or device studies that are industry-designed, initiated, and sponsored may be sent to WCG IRB for review (with a few exceptions listed below). Note, the FSU IRB reserves the right to withhold any new research study from being sent to WCG IRB.
  • Federally-funded (e.g., NIH) studies where use of a single IRB (sIRB) is required and the federal funding agency or department or lead study team has selected WCG IRB to serve as the IRB of record.

STUDIES THAT MAY NOT BE SENT TO WCG IRB (UNLESS USED TO COMPLY WITH NIH'S SIRB OR OTHER FEDERAL AGENCY OR DEPARTMENT MANDATES):

  • Investigator-initiated
  • Cooperative Group-led/coordinated
  • Industry-funded studies for which an Emory PI holds the IND/IDE

Note: If an industry sponsor is using an IRB other than WCG IRB, you will need to use the IRB chosen by the sponsor.

Please contact clientservices@wirb.com for current WCG IRB fees.

For any federal agency or department grant-funded studies that will be sent to WCG IRB, it is very important to calculate the cost of single IRB review into the budget that is submitted with the grant application. Follow the instructions at the top of this Single IRB Quote Request Form (PDF) to obtain a quote.

  • Who should we list as "contacts" on the initial submission form?

    • You should add the Principal Investigator and one other contact, usually the Study Coordinator, as contact people in the initial form. You may ask Client Services if you want to add more staff members to the list, but no more than 15 people.

  • What if I forgot a document in my initial submission?

    • If you submitted your study documents and later realized you forgot an important document, email Chris Gennai (information below) and he will add the information to their internal documents.

  • How do I fill out the "billing" section of my application?

    • You are required to complete the billing section of the application. At this time, ALL studies should state that WCG IRB will either (1) for sponsored studies bill the study sponsor or (2) for NIH-funded studies requiring sIRB review and designating the FSU IRB as the sIRB bill FSU.

  • How can I tell if my submission is completed correctly?

    • At the very end of the initial review form there is a button to validate the document and it will highlight the missing items.

  • How do I identify FSU as the local institution when submitting a study via Connexus?

    • When submitting through Connexus, the study team can ensure that WCG IRB links the study to FSU's research program by naming "Florida State University" as the institution which has a contract to use WCG IRB for IRB services. The FSU IRB institution number is *****.

  • How can I check the status of my submission once the study has been submitted to WCG IRB, including when the study seems to be delayed?

    • WCG IRB timeline for the review of a study starts with the assignment of the study to a WCG IRB staff member within the first 24 hours. Within 48 hours, the WCG IRB analyst will send the study staff a list of issues that need to be reconciled, including the institutional sign-off required by Emory. Once all the issues have been reconciled, the study is sent to review. Contact Chris Gennai (cgennai@wirb.com) for a breakdown on the timeline of your specific study. For all inquiries, please contact our WCG IRB contact Christopher Gennai (information below) or email clientservices@wirb.com.

FSU WCG IRB CONTACTS

  • The FSU IRB coordinator assigned to your RAMP IRB submission (check here for contact information)
  • Julie Haltiwanger (OHSP Assistant Director) at jhaltiwanger@fsu.edu

WIRB CONTACT

Christopher Gennai, CIP (Senior Account Manager, Institutions)

Jonathan Gellert (Institutions Partnership Manager)

Questions? Click for FAQs!