Single IRB Review

Single IRB for Federally Funded Research

Institutional Review Board

All research involving human subjects that is funded or sponsored by a federal department or agency, and the research involves two or more U.S. sites requires review by a single IRB for all collaborating sites. The federal Policy for Human Subjects (i.e., Common Rule) was revised and this provision for single IRB review became effective January 2020. Researchers applying for federal funding, or seeking to collaborate with another institution on federally funded research, should contact the IRB office for a consultation. The consultation is necessary prior to submitting an application for funding as the proposal budget may need to include the cost of additional staff, and/or IRB fees depending on the outcome of the consultation. 

  • Applicability

    Effective January 20, 2020, reliance on a single IRB (sIRB) is required for non-exempt cooperative research projects that:

    • involve more than one institution conducted in the United States; and are
    • funded or supported by a federal agency that has adopted the Common Rule regulations

    Reliance on a single IRB (sIRB) is not required when:

    • more than single IRB review is required by law (including tribal law); or
    • the Federal agency supporting the research determines and documents that use of a single IRB is not appropriate for the particular context. 
  • Federal departments/agencies

    This policy applies to all federal departments and agencies that have adopted the Common Rule regulations. Of the common rule signatories the following are the most common sponsors for ETSU human research:

    • Department of Health and Human Services
      • NIH
      • SAMSHA
      • HRSA
      • CDC
      • AHRQ
    • National Science Foundation
    • Department of Defense
    • Department of Education
    • Environmental Protection Agency
    • Department of Veterans Affairs
  • Regulatory citation

    2020 Common Rule Single IRB (sIRB) requirement [45 CFR 46.114(b)]:

    §46.114 Cooperative Research.

    (a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

    (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

    (2) The following research is not subject to this provision:

    (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
    (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

    (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.

Single IRB Plan for Grant Application:

Each federal department or agency that provides research awards has their own application processes and requirements. Researchers should work with the Office of Research and Sponsored Programs Administration (ORSPA) and the extramural sponsor to determine the appropriate information to include in the grant submission. Some proposals may need to include a single IRB plan, name the single IRB, certify that sites have agreed to the single IRB plan, and/or a communication plan among the various research sites and the designated single IRB. Additionally, complying with single IRB requirements creates more administrative work for the single IRB and lead research team, so the budget may need to include funds for additional personnel and/or review fees as applicable.

  • Prior to Funding Proposal Submission:

    Step 1:  Work with collaborators across all sites to identify the IRB that will serve as the sIRB.  Contact the chosen IRB office to verify they are willing to assume responsibility as sIRB.

    IMPORTANT:  East Tennessee State University IRB will not serve as sIRB for multi-site, clinical trials subject to the sIRB mandate.  When ETSU is the lead site on a funding proposal or award, the principal investigator may:  (a)  Identify a qualified IRB at a collaborating site that is willing to serve as sIRB; or (b)  sIRB responsibilities may be handled by an independent IRB.  Costs associated with independent IRB review are the responsibility of the PI and may be included in the funding proposal budget.

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

    Step 3:  Ascertain the willingness of all participating sites to rely on the sIRB.  To obtain a letter of support from the ETSU IRB, email the following information to IRB@etsu.edu:

    • ETSU PI Name
    • Whether ETSU is the lead/prime or a participating site
    • Name of the lead PI and lead site
    • Name of the proposed sIRB
    • Title of the grant proposal/application
    • Grant submission deadline (or deadline for providing information to the lead site)
    • Name(s) of the participating sites and Site PIs, if known
    • Any additional relevant information (such as any prior contact with the sIRB, sIRB contact person information, etc.)
    • A brief description of your project
       

    Step 4:  Develop a communication plan outlining the following:

    1. roles and responsibilities associated with IRB review 
    2. processes for communication and notifications between researchers at collaborating sites and the
    3. sIRB
    4. reporting policies among participating sites and sIRB
    5. which institution is responsible for any associated clinical trial posting requirements
    6. which institution is responsible for NIH Genomic Data Sharing Policy, if applicable

    Note:  Some funding agencies may require submission of a communication plan with the proposal.

    Does my proposed study require a single IRB?

Upon Notification of an Award:

If the Human Research Protection Program has provided a consultation during the funding proposal stage, you may proceed with the plan established during that initial consultation. If plans for the single IRB changed since proposal development or you have not talked with the HRPP about the plan, please contact our office to discuss the project. Regardless of which organization will serve as the single IRB, every human research study at ETSU needs to be submitted in IRBManager. Learn more about IRB approval for single IRB projects.

NOTE:  The IRBs at each collaborating site will need to establish a reliance agreement (also called an IRB Authorization Agreement (IAA) with the sIRB.  Reliance agreements are reviewed and 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 ETSU.

Resources:

SMART IRBETSU is a member of the SMART IRB, a national organization sponsored by the NIH, which provides a streamlined process for relying or accepting IRB oversight among its collaborating institutions.