Propose a Single IRB

Propose a Single IRB

Policies regarding accepting oversight for other institutions vary widely.  Study teams must identify an IRB of record and ensure that the chosen IRB is willing and able to serve as the reviewing IRB for the research (i.e., obtain an acknowledgment/letter of support from the IRB identified as the reviewing IRB for the cooperative research project).

Alternative options include relying on an external IRB from one of the participating institutions.

Budget Accordingly: Assess any costs associated with using the single IRB, such as fees for the TTUHSC El Paso IRB to serve as the single IRB, commercial IRB fees, monitoring fees, translation fees for consent forms and other materials, etc. Include these costs in the budget accordingly.

Budget Justification: Provide adequate budget justification for the costs associated with the use of a single IRB.

sIRB plan in NIH Grant Proposals

The sIRB plan must be uploaded as an attachment in the grant submission, as applicable.  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 researchers should be cognizant of the need for IRB review and approval 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
  • 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.

The TTUHSC El Paso IRB has limited capacity at this time, both in staffing and infrastructure, to serve as a sIRB. The TTUHSC El Paso 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 TTUHSC El Paso 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 TTUHSC El Paso 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.

sIRB options

To rely on another institution’s IRB or to serve as an IRB of record for another institution, TTUHSC El Paso must have a written reliance/reciprocity agreement with the other institution. TTUHSC El Paso is party to a number of reliance/reciprocity agreements including:

  • TTUHSC El Paso is a participant in the SMART IRB initiative, which includes over 1000 organizations. There are several commercial IRBs included.
  • TTUHSC El Paso is a participant in the State of Texas IRB Reciprocity Agreement which includes UT System components and several other institutions of higher education within Texas including Rice University, Baylor, Texas A&M University System, etc.

We recommend that you initiate the process early by submitting the Single IRB (sIRB) Reliance Intake Form. 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 TTUHSC El Paso site is not the lead site, please contact the IRB office to ensure TTUHSC El Paso 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 the TTUHSC El Paso IRB will be the reviewing IRB, the fee structure for each relying site will be:

 

Single IRB Fees

Per External Site

Initial Review Fee

$1500.00/site

Continuing Review Fee

$1000.00/site

Study-wide Amendment

$500.00/site

Compliance Monitoring Fee

$250.00/site

 

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.

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

Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research: NOT-OD-16-094

NIH Guidance on Implementation of the Single IRB Policy

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

NIH Single IRB Policy FAQs for Extramural Community on Implementation of sIRB Policy

We thank UTHealth Houston Human Subjects Division for giving us permission to use much of their content on sIRBs.