About Us

Overview

SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.

Streamlined

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Multisite

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Accelerated Resources

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Trials IRB Reliance Platform

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The Platform

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SMART IRB is not an IRB; rather, it’s a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB’s Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements.

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Investigators and their study teams, together with institutional and HRPP/IRB offices, use the SMART IRB platform to initiate single IRB review of a study. Institutions can join the SMART IRB Agreement and manage their institutional profile through the SMART IRB Joinder system.

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Through smartirb.org, investigators, study team members, and IRB/HRPP administrators and staff can access essential education as well as flexible tools and resources designed to support the adoption and implementation of single IRB review for a range of studies.

What We’re Working on

Growing a national IRB reliance network

• To date, more than 1100 Participating Institutions have joined the SMART IRB Agreement, a growing network that includes Clinical and Translational Science Awards (CTSA) hubs and affiliates, universities, academic medical centers, community hospitals, cancer centers, independent IRB organizations, NIH and more.,

• Proposed SMART IRB Reliance Agreement Version 3.0 was posted for review and comment from November 15, 2023 – February 15, 2024; comments are currently under review.

• SMART IRB ambassadors are available to answer questions about joining and implementing the SMART IRB Agreement.

Training and resources and education to support institutions and investigators

• A growing library of resources helps guide reviewing IRBs, relying institutions, and study teams, including standard operating procedures and FAQs, as well as checklists, templates, and guidance.

• The Learning Center for Investigators helps study teams successfully plan for and navigate sIRB review arrangements for their studies.

• The Learning Center for IRB and HRPP Administrators assists IRB and institution staff in managing and addressing challenges related to sIRB arrangements. Peer consultations, webinar recordings, and monthly SMART Talks are available to help IRBs and institutions implement single IRB review.

• SMART IRB’s Online Reliance System provides an easy way for investigators and institutions to track and document reliance arrangements on a study-by-study basis.

• Monthly online SMART Talks provide real-world perspectives, lessons learned, and first-hand advice around a range of sIRB issues.

• Annually, SMART Talks provides IRB and HRPP personnel new to sIRB arrangements with remote training on successful implementation of the sIRB model.

• The SMART IRB Symposium: Enhanced Training in Single IRB Review is a remote workshop for HRPP/IRB professionals who are experienced in the sIRB process, addressing challenges in managing sIRB oversight for a range of protocols.

• With NCATS Information Technology Resources Branch (ITRB), the SMART IRB team is developing a new, improved, and integrated system to request, track, and document reliance arrangements and manage institutional profiles, all in one place. This system will bring together the functionality of the Online Reliance System and the SMART IRB Joinder platform, while introducing exciting new features and workflow enhancements.

Harmonizing implementation of single IRB review across the nation

• The Harmonization Steering Committee and its working groups develop tools to support and encourage collaborative harmonization of best practices, policies, and procedures.

• Harmonized documents include: include: Fees and Costing Models under NIH sIRB Policy, Institution v. IRB Responsibilities Guidance, Institutional Profile, a Protocol-specific Document, Reportable Events Recommendations, Responsibilities Associated with the Review of Study Personnel, the Single IRB Continuing Review Process; Post-Approval Auditing for Studies Subject to Single IRB Review, Recommendations for the Harmonization of Ancillary Reviews, Conflicts of Interest Review Processes for sIRB Review; in process: Recommendations for the Harmonization of Local Considerations; Guidance on Reliance for Exemption Determinations.

Leadership

Barbara Bierer, MD

Principal Investigator and Program Director

Program Director, Regulatory Foundations, Ethics, and Law Program, Harvard Catalyst

Nichelle Cobb, PhD

Senior Advisor

Association for the Accreditation of Human Research Protection Programs

Aaron Kirby, MSc

Director, Regulatory Affairs Operations

Director, Regulatory Affairs Operations, Harvard Catalyst

Polly Goodman, CIP

Senior Associate Director, Regulatory Affairs Operations

Senior Associate Director, Regulatory Affairs Operations, SMART IRB, Harvard Catalyst

Jeremy Lavigne, MA, CIP

Senior Officer, Regulatory Affairs Operations

Senior Officer, SMART IRB, Harvard Catalyst

Jonathan M. Green, MD MBA

Program Director, Strategic Initiatives

Director, Office of Human Subjects Research Protections, National Institutes of Health

Michael Linke, PhD, CIP

Program Director, Education

Chair, University of Cincinnati IRB and StrokeNet Central IRB; Adjunct Professor of Internal Medicine, University of Cincinnati