Strategic, efficient, and cooperative approaches to single IRB review.

As institutions apply diverse approaches to implementing single IRB review, new burdens and challenges emerge for investigators, collaborating institutions, and IRBs. One of the goals of SMART IRB is to harmonize these diverse approaches by promoting not only the alignment of policies and processes, but also the adoption of common forms and identification of common practices and workflows.

Harmonized Documents

These documents were developed and approved by the leaders and topic experts who comprise the Harmonization Steering Committee (HSC) and its working groups following consideration of public review and comment.

Institutional Profile

  • Captures institutional, local, and state requirements that apply to all protocols
  • Documents information about an institution's IRB(s), if applicable

Protocol-specific Document

  • Captures a Relying Institution's protocol-specific requirements
  • Documents how the IRB reviewed/approved the protocol for the Relying Institution

Fees and Costing Models under NIH sIRB Policy

  • Charging fees for single IRB review
  • Structuring and justifying fees
  • Federal regulations on direct/indirect costs

Institution v. IRB Responsibilities Guidance

  • Regulatory purview of a Reviewing IRB
  • Role and responsibilities for Relying Institutions

Documents for Review and Comment

Documents are posted for review and comment as they become available. Your feedback will help us ensure they reflect – and can be adopted to – the diversity in research institutions and practices.

Summary Requirement for Informed Consent Documents (draft - not official guidance)

  • Draft points to consider to assist in meeting new requirements in the revised Common Rule
  • Provides overall principles and options for implementation
  • Will be modified to conform to official guidance or regulatory clarifications as they become available

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Review Document Submit Comments

Open for comments until OHRP guidance is published

The comment period for the following documents is now closed; comments are under review.

Reportable Events

  • Recommendations for investigator-initiated multisite studies
  • Reviewing noncompliance and unanticipated problems
  • Ensuring prompt reporting

Comment period is now closed.

Harmonization Steering Committee

The HSC is led by SMART IRB and NCATS and composed of representatives from the following institutions:

  • Association for the Accreditation of Human Research Protection Programs
  • Federal Demonstration Partnership
  • Food and Drug Administration
  • Harvard Catalyst
  • National Cancer Institute Central IRB
  • National Center for Advancing Translational Sciences
  • NeuroNext IRB
  • NIH Division of Intramural Research
  • NIH Office of Extramural Research
  • NIH Office of Science Policy
  • Office of Human Research Protections
  • Patient-Centered Outcomes Research Institute
  • PedsNet
  • Quorum IRB
  • Rare Diseases Clinical Research Network
  • Schulman IRB
  • TransCelerate BioPharma Inc.
  • Trial Innovation Network
  • UC BRAID: University of California Biomedical Research Acceleration, Integration, & Development
  • University of California, San Diego
  • University of Cincinnati/StrokeNet
  • University of Kansas Medical Center
  • University of Kentucky
  • University of Texas Health Science Center at San Antonio
  • University of Wisconsin-Madison
  • US Department of Defense
  • US Department of Veteran Affairs
  • Washington University in St. Louis/Council on Governmental Relations
  • WIRB-Copernicus Group IRB

Harmonizing Practices, Policies, and Procedures

The HSC began meeting in February 2017 to advance harmonization in the implementation of single IRB review.
Inventory Current Practices
Find common elements, identify differences, aggregate successful workflows, learn from current practices.
Prioritize Topics
Phase 1: fees & charging models, institution v. IRB responsibilities, local requirements, reportable events, and standard templates
Convene Workgroups
HSC members (or others experts) are tasked with identifying and developing proposed solutions.
Develop Resources
Iterative drafting and review incorporates feedback from HSC and other SMART IRB teams, the NCATS Trial Innovation Network, and external experts.
Test and Review
Open for public review and comment to ensure broad utility.
Resources may continue to be revised as needed to meet changing needs and/or regulations.

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