Single IRB (sIRB)

There are two federal policies mandating sIRB review.

The NIH Policy, effective for submissions after January 25, 2018

• Applies to:NIH funded studies in which the sites are all using the same protocol. These will typically be clinical trials, but can include observational studies.
• Exceptions:VA sites; international sites; sites involving tribal nations.

The Common Rule regulation, effective January 20, 2020

• Applies to :Federally funded cooperative research – that is, studies that involve more than one institution.
• Exceptions: VA sites; international sites; sites involving tribal nations.

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.

What happens on January 25, 2018?

All competing NIH grant applications (new, renewal, revision, or re-submission) with receipt dates on or after January 25, 2018 must include a plan describing the use of a sIRB for the study.

• Our investigator guideline on ceded review has information about ceding for investigators.
• Per institutional policy, only federally funded (or sponsor required), non-exempt, collaborative, domestic studies are eligible.
• Studies not eligible for ceding include:
  • Exempt studies (including chart reviews and non-human studies)
  • Industry or other non-federally funded studies where sponsor does not require sIRB review.
  • Research on UF student athletes
  • Research involving the Alachua County School System
  • Research involving fetal tissue and embryonic stem cells
  • Research studies proposing to cede regulatory oversight to an IRB that is not sufficiently qualified (AAHRPP accredited or having equivalent standards to accredited organizations)
  • Review of proposed community consultation plan for studies involving exception from informed consent (EFIC)

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 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 UF IRBs can serve as the sIRB for multisite research. Serving as the sIRB means additional work not only for UF IRB, but also for the UF PI serving as the lead PI on the project. Researchers who wish to have a UF IRB serve as the sIRB must (a) consult with UF’s sIRB Team as early in the process as possible and (b) receive written approval from the UF IRB to serve as the sIRB before committing to this with other institutions or in any grants.

UF can cede IRB review to an outside sIRB. UF must assess the qualifications of the sIRB to ensure regulatory compliance and subject protection. In addition, other factors will be assessed including our investigator’s experience, compliance history, resources, type of research, etc. NOTE: when UF cedes IRB review to an outside sIRB, researchers must still complete all other related UF compliance requirements (e.g. Conflict of Interest, billing compliance with the Office of Clinical Research (OCR, formerly RAC), HURRC or IBC review if applicable, etc).

1. Is the protocol already approved at the outside IRB?

• No: UF IRB cannot conduct its local review until after the protocol is approved by the sIRB.
• Yes: submit the study in myIRB as a new ceded study. Helpful hint: The IRB’s Research Manual has step by step instructions on how to navigate this process.
  • sIRBs usually require UF IRB to verify (a) study staff required training and qualifications, (b) approve “local context” in informed consent forms, and (c) verify other study-specific local human research related issues like Conflict of Interest, injury coverage, etc. have been appropriately addressed.
  • Note: you must still comply with all research related compliance requirements.
  • You will receive correspondence that acknowledges that the IRB has given permission to cede the study

2. Once the study is approved by the reviewing sIRB

• In myIRB execute the ‘Submit Site Materials’ activity in myIRB to attach (a) sIRB approval letter adding UF as a site and (b) the sIRB approved consent. Once this is received via myIRB the ceding of the study will be completed/approved in myIRB.
• After approval, submit all changes in PI, study staff, or local context in ICF as a revision in myIRB
• After approval, submit CRs in the myIRB system prior to study expiration. This must include the sIRB continuing review approval letters, the current protocol and consent.
• Know and comply with any additional requirements the sIRB may have.

3. Resources:

• Ceded sIRB Flowchart (https://irb.ufl.edu/wp-content/uploads/sIRB-workflow.pdf)
• Researcher Manual https://irb.ufl.edu/wp-content/uploads/Researcher-Manual_FINAL.pdf)

1. Email the UF sIRB team to request UF IRB to serve as sIRB for other institutions via email

• UF’s sIRB team may ask to meet with the PI and study staff to discuss the different requirements, PI responsibilities, and logistics with ceding review.

2. Is the protocol already approved by UF IRB?

• If “No”, submit study in myIRB, state it is a sIRB study but only list UF as site.

3. Does UF already have an IAA in place with the proposed relying institutions ?

• UF uses SMART IRB Master reliance agreement. Relying institutions are expected to either use SMART IAA  or if not a signatory of SMART IAA, UF will offer a UF Master IAA.

4. Once study is approved for UF, submit a p-Site revision to add other sites.

• Attach copy of fully executed reliance implementation documents and participating sites’ local informed consent addendums. .

5. UF PI is responsible for communicating all approvals and approved study documents to site investigators.

• Site investigators are responsible for forwarding any documentation to their local IRB that it requires.

6. UF PI is responsible for submitting all revisions, adverse events, continuing reviews and other items to UF IRB.

• Site investigators are responsible for giving UF PI all pertinent local information like adverse events, enrollment numbers/status for continuing review, etc.

7. UF PI is responsible for ensuring the continuing review is submitted in a timely fashion to secure re-approval prior to study expiration

• If re-approval is not obtained prior to expiration, research activities must discontinue at ALL sites.

8. Resources:

• UF sIRB Flowchart
• SMART IAA (Version 1)
• SMART IAA Implementation Documents
• UF Master Agreement
• Exhibit B
• Exhibit C (UF Master IAA)
• Researcher Manual

• The SMART IRB Master Reliance Agreement is a national master agreement that allows institutions to avoid having to negotiate individual agreement per study or group of studies. More information about SMART IRB can be found at https://smartirb.org. A list of institutions that have joined SMART IRB by signing onto the agreement can be found at https://smartirb.org/participatinginstitutions/.
  • University of Florida is a signatory of the SMART IRB Master Reliance Agreement.
• Some institutions use the SMART IRB online tracking system to document reliance.
  • However, like many institutions, the University of Florida IRB does not use the SMART IRB online tracking system to document reliance (although we’ll indicate reliance for study teams when the IRB of record uses the system for documenting reliance). UF documents reliance in myIRB