Office of Responsible Research Practices
The Ohio State University

Single IRB (sIRB) for Multi-Site Research

sIRB Purpose

In the past, each site on a multi-site study had its own Institutional Review Board (IRB) conduct an independent review of the research.  This was a time-consuming process and made it difficult to coordinate site start-up.  On January 25, 2018, the National Institute of Health (NIH) policy for use of single IRBs (sIRB) went into effect with the goal of eliminating the unnecessary repetition of IRB reviews across all sites.  The new sIRB policy goal is to streamline the IRB review process for multi-site research conducting the same protocol so that research can proceed as quickly as possible without compromising ethical principles and protections for human subjects.

sIRB in NIH Grant Applications

For grant applications with due dates on or after January 25, 2018, the NIH expects all sites participating in non-exempt multi-site human subject research to use a single IRB to conduct the ethical review.  The policy applies to locations within the United States where each site will conduct the same protocol.  It does not apply to career development, research training or fellowship awards.  NIH applicants are expected to include a plan for the use of a sIRB in grant applications and contract proposals.

sIRB Multi-Site Study Challenges

Although the sIRB mandate streamlines IRB review, it does not eliminate the participating institutions’ many other responsibilities for oversight of human subjects research.  Each institution remains responsible for researcher training, conflict of interest disclosures, HIPAA, conducting ancillary reviews such as IBC or radiation safety, compliant research conduct, and maintaining oversight with respect to state and local laws and other institutional policies.  The NIH sIRB policy increases and most likely complicates a lead investigator’s management responsibilities and it increases the reviewing IRB’s responsibilities for ethical oversight.  Although the IRB review is streamlined, oversight and conduct of the study may be more complicated in light of the new sIRB structure.  The burden of notifying multiple locations and keeping track of reportable events falls to the lead investigator and is no longer spread among multiple IRBs.

Consistent communication between the lead site and all participating sites is the key to successfully conducting a multi-site study.  The NIH policy allows awardee institutions to decide who will be responsible for managing communications to the participating sites.  Whoever is responsible for communication will require processes to manage and document the exchanges.  Some institutions have IRB systems that automatically send notices of approval and updates to all sites.  Most academic institutions do not have IRB systems capable of this level of communication.  Ohio State’s Buck-IRB system is not structured to enable external sites to submit event notices or receive approval notifications.  Instead, the responsibility lies with the principal investigator to have in place a communication plan and designated people to manage it.  For communication plan guidance, see the Communication Plan for SMART IRB (SMART IRB template).

Buck-IRB was updated January 12, 2018 to enable better management and review of multi-site research.  The system patch included new features such as an upload box for local context worksheets and site-specific documents.  The local context worksheet was implemented to enable the IRB to obtain additional information about participating relying sites in multi-site research studies.  The worksheet collects information to create an institutional profile about collaborating sites, and study specific considerations such as local laws that may affect the conduct of research.  This form should be submitted when the participating site will be recruiting or obtaining consent from research subjects or if any research interventions or subject interactions will occur at the site. In conjunction with the system changes, the ORRP Operations staff received training on the changes and the office has been implementing new procedures to manage the expected increase in collaborative research submissions.

sIRB Forms and Resources

Below are resources and forms for investigators using an Ohio State University IRB as the IRB of record or as a sIRB for multi-site human subjects research.

  • IRB Authorization Agreement – FWA Holding Institutions (IAA OHRP template)
    This type of IRB Authorization Agreement (IAA) authorizes a FWA holding institution who is not a SMART IRB participating institution to rely on an Ohio State IRB for review responsibilities.  The IAA document describes the division of responsibilities between the relying institution and the Ohio State IRB.
  • IRB Authorization Agreement – SMART IRB Participating Institutions
    Ohio State prefers to use the SMART IRB Online Reliance System or a SMART IRB Letter of Acknowledgement (Ohio State template) for SMART IRB participating institutions who rely on an Ohio State IRB.
  • Institutional Profile and Study Specific Local Context for Relying Sites (Ohio State form)
    New non-Ohio State research site – use this form to identify and report the local context considerations for a non-Ohio State research site which will be engaged in research and rely on an Ohio State IRB.  This form provides an institutional profile and study specific considerations.  This form should be submitted when the participating site will be recruiting or obtaining consent from research subjects or if any research interventions or subject interactions will occur at the site.
  • Study Specific Local Context Worksheet for Relying Sites (Ohio State form)
    Existing non-Ohio State research site – use this form to identify and report the local context considerations for a non-Ohio State research site which already has an institutional profile registered in Buck-IRB.  This form should be submitted for each study when the participating site will be recruiting or obtaining consent from research subjects or if any research interventions or subject interactions will occur at the site.

Additional Forms and Tools

Letter of Support for Relying Institutions (Ohio State template)
Single IRB Communication Plan (Ohio State template)
Communication Plan for SMART IRB (SMART IRB template)
Description of SMART IRB for Grant Applications (SMART IRB template)
Principal Investigator/Lead Study Team Guidance and Checklist (SMART IRB)
Initiating a request in the Online Reliance System (SMART IRB)
SMART IRB Resources Page

SMART IRB Participating Institution

Ohio State is a participating institution in SMART IRB, a platform designed to ease common challenges and burdens associated with initiating multi-site research. SMART IRB allows institutions to minimize duplicative IRB reviews while maintaining appropriate oversight and navigate the National Institutes of Health (NIH) Policy on the Use of Single Institutional Review Board for Multi-Site Research.

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Questions or Assistance

Jessica Evans
614-292-9832
IRBAgreements@osu.edu