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.
Recommendations for the Harmonization of Ancillary Reviews NEW!
Best practices for defining ancillary reviews and recommendations for centralizing certain reviews as well as for the timing of reviews and allocation of responsibilities in an sIRB context. Zip file includes guidance as well as an implementation checklist for centralizing ancillary reviews.
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Conflict of Interest Review Processes for sIRB Review
Guidance addresses the responsibilities of a Relying Institution and a Reviewing IRB/Reviewing IRB Institution in the COI review process, including specific guidance to assist in determining and managing COI, as well as answers to FAQs.
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Post-Approval Auditing for Studies Subject to Single IRB Review
Identifies best practices and provides tools to support for-cause and not-for-cause audits of studies under a single IRB arrangement. Zip file includes guidance as well as checklists and a template report.
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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 the continuing review process.
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Single IRB Review: Responsibilities Associated with the Review of Study Personnel
Recommendations for ensuring study personnel are appropriately trained and qualified to conduct the research under review.
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Reportable Events
- Recommendations for investigator-initiated multisite studies
- Reviewing noncompliance and unanticipated problems
- Ensuring prompt reporting
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Institutional Profile
- Captures institutional, local, and state requirements that apply to all protocols
- Documents information about an institution's IRB(s), if applicable
- Can also be created/updated in Joinder
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Protocol-specific Document
- Captures a Relying Institution's protocol-specific requirements
- Documents how the IRB reviewed/approved the protocol for the Relying Institution
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Fees and Costing Models under NIH sIRB Policy
- Charging fees for single IRB review
- Structuring and justifying fees
- Federal regulations on direct/indirect costs
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Institution v. IRB Responsibilities Guidance
- Regulatory purview of a Reviewing IRB
- Role and responsibilities for Relying Institutions
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Recommendations for the Harmonization of Local Considerations NEW!
The Working Group identified several challenges and inconsistencies related to local considerations (aka local context) and recommended harmonization in three key areas to improve the process for providing, collecting, and reviewing local considerations.
Comment period is closed; comments are under review.
The HSC is led by SMART IRB and NCATS and composed of representatives from the following institutions:
- Advarra
- Association for the Accreditation of Human Research Protection Programs
- Boston Children's Hospital
- Federal Demonstration Partnership
- Food and Drug Administration
- Harvard Catalyst
- Johns Hopkins Medicine
- Mass General Brigham
- Medical University of South Carolina
- National Cancer Institute Central IRB
- New York University Langone
- National Center for Advancing Translational Sciences
- NIH Intramural Research Program
- NIH Office of Science Policy
- Office of Human Research Protections
- PedsNet
- Trial Innovation Network
- Tufts University
- University of California, San Diego
- University of Cincinnati/StrokeNet
- University of Kentucky
- University of South Florida
- 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
- WIRB-Copernicus Group IRB
The HSC began meeting in February 2017 to advance harmonization in the implementation of single IRB review.
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Inventory Current Practices
Find common elements, identify differences, aggregate successful workflows, learn from current practices.
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Prioritize Topics
Currently addressing: continuing review, post-approval auditing, conflicts of interest, ancillary reviews.
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Convene Workgroups
HSC members (or others experts) are tasked with identifying and developing proposed solutions.
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Develop Resources
Iterative drafting and review incorporates feedback from HSC and other SMART IRB teams, the NCATS Trial Innovation Network, and external experts.
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Test and Review
Open for public review and comment to ensure broad utility.
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Disseminate
Resources may continue to be revised as needed to meet changing needs and/or regulations.