NIH SINGLE IRB MANDATE
Effective January 25, 2018, NIH-funded multi-site studies, where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program must use a single Institutional Review Board (sIRB). This requirement applies to all competing NIH grant applications (new, renewal, revision or re-submission) with submission date on or after Jan 25, 2018. On this page, you will find information that will guide you in making decisions regarding single IRB review for NIH human subjects studies.
Studies covered by NIH sIRB mandate
NIH-funded multi-site studies mean that the same protocol involving non-exempt human subjects research is being conducted at more than one site and is being wholly or partially funded by NIH. Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.”
Additionally, sites that are accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the “same research protocol.” If a study involves a separate site for study coordination or coordination of data and statistical analyses and the site is conducting the same protocol as the other participating sites, then all sites would be expected to rely on the designated single IRB.
Collaborative projects where different sites are conducting different parts of the research is not considered to be multi-site research and does not have to use sIRB. The sIRB requirement does not apply to studies that are:
- Conducted at foreign sites.
- Funded through career development (K), institutional training (T), or fellowship awards (F).
- Where sIRB review is prohibited by federal, tribal, or state law, regulation or policy.
The NIH sIRB Exceptions Review Committee (ERC) will review and consider requests for exceptions with compelling justification, however, they expect this to be rare.
sIRB plan in NIH Grant Proposals
The sIRB plan must be uploaded as an attachment in section 3.2 in the Study Record: PHS Human Subjects and Clinical Trials information form (part of SF424 (R&R) FORMS-E). Follow any specific sIRB instructions in the Request for Proposal (RFP). The sIRB plan should include the following elements:
- Describe how you will comply with the NIH Policy on the Use of sIRB for Multi-Site Research.
- Provide the name of the IRB that will serve as the sIRB of record.
- Indicate that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.
- Briefly describe how communication between sites and the sIRB will be handled.
- Indicate that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.
- Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.
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
A letter of support from the sIRB is not required at proposal stage, but a certification of IRB approval will be required as part of the Just-in-Time process. Any award made without certification of IRB approval will include terms and conditions restricting all human subject activities until Reliance Agreements are in place and IRB approval is obtained. NIH has clarified that the sIRB Plan will not be evaluated in proposal peer review.
Selecting the sIRB
If not already specified in the RFP, in most situations, the overall Principal Investigator, in collaboration with the IRB office at the overall 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. Some of the options for a sIRB are listed below:
- The IRB at the overall PI’s site
- The IRB at a participating site
- The IRB at a non-participating site
- Commercial IRBs (WIRB, Quorum, Schulman, Chesapeake, BRANY)
- A NIH IRB - This option is available only if NIH has specified its use in the FOA or RFP.
- An IRB specifically set up for an already-established-and-funded research network or consortium —This option is available only if the study you are proposing will be conducted under the auspices of the network/consortium that has an IRB.
- A Trial Innovation Network (TIN) IRB — There are three TIN Central IRBs (Utah, Hopkins, Vanderbilt) that may be available free of charge.
The UTHealth IRB has limited capacity at this time, both in staffing and infrastructure, to serve as a sIRB. The UTHealth IRB will make determinations on a case-by-case basis, whether to accept the role of the sIRB for a research proposal based on type of research study, risks to human subjects in proposed research, number of sites involved, experience of the UTHealth PI and study team with coordinating multi-site research, etc.
If you are the overall PI for the proposed research and/or the main applicant of the grant, the UTHealth IRB staff will be glad to assist you in choosing an appropriate sIRB for the proposed research. We strongly encourage you to contact the IRB office well in advance of the grant submission deadline.
To rely on another institution’s IRB or to serve as an IRB of record for another institution, UTHealth must have a written reliance/reciprocity agreement with the other institution. UTHealth is party to a number of reliance/reciprocity agreements including:
- UTHealth is a participant in the SMART IRB initiative, which includes over 350 organizations.
- UTHealth also has standing agreements with several commercial IRBs (WCG IRBs, Schulman IRB, Sterling IRB, Chesapeake IRB, Quorum IRB, Advarra IRB and BRANY IRB).
- UTHealth is a participant in the State of Texas IRB Reciprocity Agreement which includes all UT System components and several other institutions of higher education within Texas including Rice University, Texas Tech University, Texas A&M University System etc. List of participating institutions
We recommend that you contact the IRB office early in the process. The IRB staff will be happy to help you navigate all the available options for sIRB to help you make an informed decision. Even if the UTHealth site is not the lead site, please contact the IRB office to ensure UTHealth has an agreement with which ever IRB is designated as the sIRB for a research proposal. Negotiating IRB reliance agreements takes time, so the earlier you contact the IRB office, the better.
Budgeting for sIRB Review
Costs for IRB review of federally funded research are usually considered an indirect cost that is covered under an institution’s Facilities and Administration (F&A rate) and may not be included in the budget. However, this does not include the cost of review of other sites by the institution’s IRB. This is a new task for the IRB and the cost of this task must be included in the grant budget. The fees charged by independent IRBs (also called commercial IRBs) may be charged as a direct cost when they are serving as the single IRB.
When UTHealth IRB will be the reviewing IRB, the fee structure for each relying site will be:
Full Board Initial Review - $1500
Full Board Continuing Review - $650
Expedited and Exempt Initial Review - $750
Expedited and Exempt Continuing Review – None
NIH encourages applicant and recipient institutions to consult any available resources as needed, including commercial IRBs, in order to obtain needed costing information. Contact the commercial IRBs directly for current fee structure. Goes to Section 5 which has contact information.
For more information on budgeting for sIRB review, please review the NIH notice Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research – NOT-OD-16-109
If you have questions, contact:
Resources on NIH Policy
We thank University of Washington Human Subjects Division for giving us permission to use much of their content on sIRBs.