Harmonization
Strategic, efficient, and cooperative approaches
Inconsistent approaches to implementing single IRB review introduce new burdens and inefficiencies for investigators, collaborating institutions, and IRBs. SMART IRB seeks to harmonize approaches by promoting the alignment of policies and processes and the adoption of common forms, practices, and workflows.
Guidance, Tools & Templates
Recommendations for the Harmonization of Ancillary Reviews
Best practices for defining ancillary reviews and recommendations for centralizing reviews, timing, and allocating responsibilities in an sIRB context. Includes guidance and an implementation checklist.
Conflict of Interest Review Processes
Addresses responsibilities of a Relying Institution and a Reviewing IRB/Reviewing IRB Institution in the COI review process, including FAQs and guidance for determining and managing COI.
Post-Approval Auditing
Identifies best practices and provides tools to support for-cause and not-for-cause audits in an sIRB context. Includes guidance, checklists, and a template report.
Single IRB Continuing Review Process
Recommendations for the roles and responsibilities of Reviewing IRBs, Relying Institutions, Overall PIs, and Relying Site Investigators as they relate to continuing review.
Responsibilities Associated with Review of Study Personnel
Recommendations for ensuring study personnel are appropriately trained and qualified to conduct the research under review.
Reportable Events
Recommendations for investigator-initiated multisite studies, reviewing noncompliance and unanticipated problems, and ensuring prompt reporting.
Institutional Profile
Captures institutional, local, and state requirements that apply to all protocols. Documents information about an institution’s IRB(s), if applicable. Institutions can create and manage their profile in the Reliance System.
Protocol-specific Document
Captures a Relying Institution’s protocol-specific requirements and documents how the IRB reviewed/approved the protocol for the Relying Institution.
Fees and Costing Models under NIH sIRB Policy
Addresses charging fees for single IRB review, as well as structuring and justifying fees and federal regulations on direct/indirect costs.
Institution v. IRB Responsibilities Guidance
Delineates the regulatory purview of a Reviewing IRB and the role and responsibilities for Relying Institutions.
For Review and Comment
Documents are posted as they become available. Your feedback helps ensure these resources reflect and can be used by diverse research institutions and practices.
Recommendations for the Harmonization of Local Considerations
Identifies challenges related to local considerations (“local context”) and recommends harmonization in three key areas to improve the process for providing, collecting, and reviewing local considerations.
Comment period is closed; comments are under review.
Steering Committee
The Harmonization Steering Committee (HSC) is led by SMART IRB and NCATS and is composed of representatives from the following institutions:
Advarra
Association for the Accreditation of Human Research Protection Programs
Boston Children’s Hospital
Food and Drug Administration
GSC Advising
Harvard Catalyst
Johns Hopkins University School of Medicine
Mass General Brigham
National Center for Advancing Translational Sciences
New York University Langone
NIH Intramural Research Program
NIH Office of Science Policy
North Star Review Board
Office of Human Research Protections
University of California, San Diego
University of Cincinnati/StrokeNet
University of Kentucky
University of Texas Health Science Center at San Antonio
US Department of Defense
US Department of Veteran Affairs
Washington University in St. Louis
WCG IRB
How We Work
Since 2017 the HSC has come together 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
- Addresses those topics with the greatest need for alignment and strongest likelihood of achieving consensus for best practice across the nations.
- Convene Workgroups
- HSC members and experts across the US are tasked with identifying and developing proposed solutions.
- Develop Resources
- Iterative drafting and review incorporates feedback from the HSC and other SMART IRB teams and external experts.
- Test and Review
- Draft resources are opened for public review and comment and revised accordingly to ensure broad utility.
- Disseminate
- Resources may continue to be revised as needed to meet changing needs and/or regulations.
