sIRB for NIH Research

ISU Implementation of NIH Policy on Single IRB of Record (sIRB)
for Multi-site Research

Applicability
FAQs
Steps to Complete Prior to Submission of an NIH Proposal or Application
Steps after you receive notice of an NIH Award
Resources

Applicability

Beginning January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research must utilize a single IRB-of-record (sIRB) for IRB review.  The NIH policy is effective for all:

  • NIH competing grant applications (new, renewal, revisions, resubmissions) received on or after January 25, 2018; and
     
  • NIH contract solicitations issued on or after January 25, 2018

The NIH Policy applies to all non-exempt studies that:

  • Are supported in whole or part by NIH through grants, cooperative agreements, contracts, or the NIH Intramural Research Program; and

  • Involve multiple (two or more) domestic sites (in the US), all of which are conducting the same protocol (see NIH FAQ’s for NIH meaning of “same protocol”).

The NIH Policy does NOT require single IRB review for:

  • Foreign sites

  • Sites for which federal, state, or tribal laws, regulations, or policies require local IRB review

  • Sites that are conducting a different protocol

  • Research that is funded by career development (K), research training (T), or fellowship (F) awards

Additionally, exceptions may be granted by NIH in very limited circumstances with compelling justification.  See NIH Guidance on Exceptions to the NIH Single IRB Policy for more information. 

Frequently Asked Questions

1.  When must the single IRB (sIRB) be selected for an NIH Award and who is responsible for selection?

In the NIH application/proposal for research funding, the applicant/offeror is expected to submit a plan describing the use of a sIRB that would be selected to serve as the IRB of record for all study sites.  The NIH Guidance on Implementation of the NIH Policy on Use of a sIRB  and PHS Human Subjects and Clinical Trials Form Application Guide include more information. 

When possible, the plan must identify the IRB that will serve as the sIRB. For delayed-onset research, where the IRB cannot be identified, applications/proposals should include a statement indicating that award recipients will follow the NIH single IRB policy and will provide a single IRB plan to the funding NIH Institute or Center prior to initiating a multi-site protocol.

All participating sites must agree to a single IRB arrangement prior to the submission of the grant application or proposal; the proposal must indicate the participating sites’ willingness to rely on the sIRB.  See below for information on obtaining a letter documenting ISU’s agreement to rely on an external sIRB.

Currently, the Iowa State University IRB will not serve as sIRB for multi-site studies subject to the NIH policy.  When ISU is the lead site on an NIH proposal or application, the principal investigator may:

  • Identify an IRB at a participating site that is willing to serve as sIRB; OR
     
  • sIRB responsibilities may be handled by an independent IRB.  ISU has established an agreement with a pre-selected independent IRB—Advarra IRB—to serve in the capacity.  Costs associated with independent IRB review must be included in the NIH budget.

2.  Does NIH expect that the IRB at the lead institution serve as the single IRB?

No.  A qualified IRB at any of the participating sites may serve as the single IRB, or participating sites may rely on an independent IRB.  If ISU is the lead site, the principal investigator may identify an IRB at a participating site to serve as sIRB; OR sIRB responsibilities may be handled by an independent IRB, such as ISU’s pre-selected independent IRB—Advarra IRB

3.  Must all participating sites agree prior to grant proposal submission to rely on the single IRB identified in the NIH application?

Yes—participating sites should agree to the sIRB arrangements prior to submission of the NIH application or proposal.  The application must indicate the participating sites’ willingness to rely on the selected IRB.  However, the formal reliance or authorization agreement (the agreement that is signed by officials at each institution documenting review arrangements) need not be obtained until the time of award. 

At this time, the Iowa State University IRB will not serve as the sIRB for multi-site studies subject to the NIH policy.  But, the ISU IRB must be consulted to ascertain its willingness to rely on the selected sIRB. 

NOTE:  ISU cannot guarantee its willingness to support use of an sIRB that has been selected without prior consultation with and agreement from ISU IRB staff. 

Researchers who need a letter of support from the ISU IRB indicating willingness to rely on the sIRB must contact the IRB staff (IRB@iastate.edu) very early in the planning stages, at least three weeks prior to the grant submission deadline.  A request to rely on the pre-selected independent IRB (Advarra IRB) can be processed fairly quickly; requests to rely on an IRB at another institution may take more time as there are additional necessary verification steps. 

4.  How will sIRB review be paid for?

NIH has provided guidance on which IRB fees should be charged as direct vs indirect costs.  In general, fees charged by an independent (commercial) IRB which are NOT affiliated with a research institution (like Advarra IRB) may be charged as a direct cost when they are serving as the single IRB.  NIH FAQ’s provide additional guidance on cost allocation.

Researchers must work with the selected sIRB to determine costs.  Advarra IRB has a budget worksheet researchers submit to request an estimate from Advarra.  If another institution’s IRB will be used, consult with the PI or IRB staff at that institution for information about their fees.  Be aware that IRB fees vary among institutions.

5.  How will the sIRB policy affect submission of grant proposals?

Researchers are encouraged to review NIH FAQs for more complete information about NIH expectations regarding this policy and how the policy affects grant submissions.  NIH has developed separate FAQ’s covering implementation issues and costs

The NIH website includes information about the New Human Subjects and Clinical Trial Information Form and Tips for Describing Human Subjects Studies in Multi-Project Applications.

Steps to Complete Prior to Submission of an NIH Proposal or Application

Step 1:  Work with participating sites to identify the sIRB.  The selected sIRB must be willing to serve in this capacity.  The ISU IRB will NOT serve as sIRB, but has pre-selected an independent IRB (Advarra IRB) on which it will rely.  Alternatively, you may select a qualified IRB at another participating site or another independent IRB. 

Step 2:  Work with the selected sIRB to obtain information about review fees for inclusion in the NIH budget.

Working with Advarra IRB

For budget quote requests, fee schedules, and instructions on how to submit to Advarra, please contact: ISLteam@advarra.com.

Step 3:  Develop a communication plan outlining roles and responsibilities and processes for communication and notifications between researchers at participating sites and the sIRB.  A communication plan is required in the NIH proposal submission.

Step 4:  Ascertain the willingness of all participating sites to rely on the selected sIRB. 

To obtain a letter of support from the ISU IRB, send the following information along with a very brief description of your project to IRB@iastate.edu:

  1. ISU PI Name
  2. Whether ISU is the lead/prime or is a participating site
  3. Name of the lead PI and lead site (if not ISU)
  4. Name of the sIRB
  5. The exact title of the grant proposal/application
  6. The grant submission deadline (or deadline for providing information to the lead site)
  7. The name(s) of the participating sites and Site PIs, if known
  8. Any additional relevant information (such as any prior contact with the sIRB, sIRB contact person information, etc.)
  9. A brief description of your project.

Steps After You Receive Notice of an NIH Award

Step 1:  Send a formal request for ISU to rely on an external IRB by completing an IRB Application xForm in IRBManager.  This is the same form used to obtain IRB approval for a new study, however the xForm is conditioned to ask questions only pertinent to the reliance arrangements when you indicate that researchers at other institutions will be involved and you wish for the ISU IRB to rely on another institution’s IRB for oversight.   

NOTE:  Each participating site will need to establish a reliance agreement (also called an IRB Authorization Agreement (IAA) or Deferral Agreement) with the sIRB.  Reliance agreements are carefully reviewed and must be signed by institutional officials at each participating site and at the site of the sIRB.  Investigators DO NOT have the authority to sign reliance agreements on behalf of ISU.

Step 2:  Work with the sIRB, following their established processes, to seek IRB approval.

  Working with Advarra IRB
         
          Submit a Study to Advarra IRB
          Investigator FAQ’s
        

NOTE:  Local Context Information:  The SIRB may require ISU-specific local context information, such as contact information for the ISU IRB, ISU-specific policies such as child-abuse reporting, etc.  

Child-abuse reporting:   ISU policy requires reporting by employees who in the course of employment receive information related to suspected physical or sexual abuse of children.  Participants should be informed of your reporting obligations when applicable.

Contact information for the ISU IRB that may be included in consent forms:  If you have any questions about the rights of research subjects or research-related injury, please contact the IRB Administrator, (515) 294-4566, IRB@iastate.edu, or the Director, Office of Research Ethics, Iowa State University at (515) 294-3115.

Records related to payment to research subjects:  Research subjects that receive compensation must complete ISU’s Research Participant Receipt Form to meet ISU recordkeeping requirements.  Participants should be informed if they must complete the Research Participant Receipt Form, especially if the form requires disclosure of their social security number.

Step 3:  Communicate the outcome of initial and subsequent sIRB review with the ISU IRB office (IRB@iastate.edu).  If Advarra IRB is the selected sIRB, Advarra will handle this process.  

Step 4:  Conduct the study in a manner that ensures compliance with the sIRB approved protocol and all policies and procedures of the sIRB. 

NOTE:  sIRB review addresses only one aspect of responsible research —the ISU PI is also responsible for ensuring compliance with all applicable federal, state, and local regulations and laws as well as with ISU institutional requirements and policies related to research.  See the Office of the Vice President for Research website for guidance regarding a variety of aspects of responsible research. 


Resources

NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for
  Multi-Site Research

NIH FAQ’s – Implementation of the sIRB Policy
Guidance on Exceptions to the NIH Single IRB Policy
NIH FAQ’s – Use of sIRB for Multi-Site Research Costs
NIH -- Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review
PHS Human Subjects and Clinical Trials Information Form Application Guide
R&R Budget Form – Application Guide
Tips for Describing Human Subjects Studies in Multi-project Applications