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Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

IRB Reliance

SMART IRB

SMART IRB is a national platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy. The SMART IRB Agreement supports IRB reliance among a growing number of SMART IRB Participating Institutions across the nation, including all CTSA hubs as well as numerous CTSA affiliates, and a variety of other institutions and organizations.

SMART IRB is supported by a variety of resources, including the SMART IRB Online Reliance System, which provides a central, web-based mechanism for participating institutions and their investigators to request, track, and document reliance arrangements under the SMART IRB Agreement. Learn more about how to use the Online Reliance System to submit a request for your study. We also recommend you contact your institution's designated SMART IRB Point of Contact to discuss using SMART IRB for your study.

SMART IRB is led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy.

Learn more or email SMART IRB with any questions.

Harvard Catalyst's Master Reciprocal Common IRB Reliance Agreement (MRA)

Please note: Most institutions that are signatory to the MRA have joined and started using SMART IRB to enable IRB reliance. The Harvard Catalyst IRB Cede Review Request System has been decommissioned; this means there is no longer an online system for requesting and tracking reliance arrangements under the Master Reciprocal Common IRB Reliance Agreement (MRA). Contact your institution's designated representative (below) to discuss the best mechanism to enable IRB reliance for your study.

History

The Master Reciprocal Common IRB Reliance Agreement (MRA) was developed to support institutions and investigators conducting multicenter studies. The goal of the MRA was to reduce duplicative IRB review and in that way, promote and accelerate collaborative research efforts among investigators at the signatory institutions. The MRA accomplished this goal by providing a legal framework to support single or consolidated IRB review for multisite studies. It also served as a model for other regional reliance networks as well as the national SMART IRB Agreement, which has been adopted across the CTSA consortium.

Watch a video about how the MRA and IRB Cede Review facilitated a three-year hearing study on Boston Marathon bombing victims.

Read more about the development of the IRB Reliance Agreement in Clinical and Translational Science.

Signatories

Originally developed and executed among Harvard Catalyst participating institutions, the MRA is now composed of over 30 signatory institutions across the United States including institutions affiliated with Harvard Catalyst, Boston University Clinical and Translational Science Institute, Dartmouth Synergy | The Dartmouth Clinical and Translational Science Institute, Tufts Clinical and Translational Science Institute (Tufts CTSI), the Southern California Clinical and Translational Science Institute (SC CTSI), and the University of Rhode Island.

MRA signatory institutions and their designated representatives for reliance-related questions:

* Harvard University's 12 degree-granting schools in addition to the Radcliffe Institute for Advanced Study all receive regulatory coverage from the Harvard University FAS IRB.

Elements of the Agreement

When signatories join the MRA they must agree to the following three key elements:

Common language and regulatory interpretation:
  • "Uncheck the Box"
    Institutions must uncheck the box on their FWA, meaning they will not apply each subpart of 45 CFR 46 to all human subject research, regardless of funding.
  • Harmonization of Subject Injury Language
    Institutions agree to one set of common subject injury language or to "substantially equivalency" review.
  • Insurance Coverage
    The MRA includes an insurance provision that requires all participating institutions to have appropriate and sufficient coverage.
  • Privacy Compliance Requirements
    All participating sites must be able to comply with HIPAA, HITECH, and related privacy laws when reviewing research on behalf of a covered entity.
Common processes and consistent approach:
  • Identifying the reviewing IRB
    The principal investigator's (PI) institution is presumed to be the reviewing IRB, though another IRB may be determined to be more appropriate for a particular study.
  • Defining Chain of Responsibility and Communication
    The overall PI is ultimately responsible for the conduct of the research; local site investigators report to the PI, who reports to the reviewing IRB.
  • Quality Assurance Mechanisms
    Participating institutions that are not accredited by AAHRPP must engage OHRP's Quality Assessment Program.
  • Aligning Certification and Continuing Education Requirements
    Institutions agree to a three-year continuing education (CE) schedule and accept one another's trainings when feasible. The CITI Program is the preferred program.
  • Controlling Study Activation
    Each IRB must to be able to delay the activation and initiation of a study until institutional processes are complete (i.e. completion of clinical trial negotiations).
  • Unanticipated Problems, (Serious) Adverse Events, and Deviations
    Institutions report relevant issues to each other: the reviewing IRB is responsible for reporting; relying institution(s) can also make, review, and comment on reports.

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Common standard operating procedures (SOPs):
  • Reliance Agreement Policy
    Institutions create or amend a policy stipulating the use of reliance agreements (including the MRA), or other arrangements for reducing duplicate review.
  • Audit SOP
    Sites may conduct not-for-cause and for-cause audits.
  • SOP for Reporting Serious Adverse Events (SAEs) and Unanticipated Problems
    For non-federally funded research, institutions must report SAEs and unanticipated problems to a high-level institutional official, reserving the right to report to OHRP.
  • SOP for Data Protection and Incident Responses
    Institutions must have a set of procedures that delineates duties when managing a data breach when there is IRB reliance.
  • SOP for Managing Conflicts of Interest (COI)
    The reviewing IRB will return a COI ("zero dollar" threshold) to the relying institution to reduce, eliminate, or manage, subject to the reviewing IRB's approval.
  • SOP for Training
    A policy or process is recommended to agree to accept one another's trainings, when appropriate and possible.

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Contact

For more information please email us.

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