Important Update
On April 14, the NIH sent Harvard University a Stop Work Order of the SMART IRB federal funding contract.
From the beginning, SMART IRB has been a collaborative, grassroots effort: SMART IRB was built by and for the community. It is not owned by Harvard, NIH, HHS, or any other entity.  At this time, Harvard is supporting the core team to maintain the Agreement and assist Participating Institutions to the best of our abilities. It is our intention to continue to provide this vital support to advance collaborative research. Please contact us for assistance.
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SMART IRB

Supporting single IRB review and advancing collaborative research

SMART IRB eases challenges associated with multisite research by providing free, comprehensive support for single IRB (sIRB) arrangements. 

From small collaborations to large research networks, SMART IRB is designed to make multisite research work better for both IRB/HRPP personnel and research teams. Our educational resources, tools, templates, and guidance help Participating Institutions across the country improve efficiency, reduce burden, and advance research.

News and Events

Important Update on SMART IRB

Harvard University receives Stop Work Order of SMART IRB federal funding contract; our work to support the Agreement and Participating Institutions continues.

SMART IRB Reliance Agreement V3.0 is here!

Hot off the presses: review and join the *new* SMART IRB Agreement

NEW: Office Hours

Weekly on Wednesdays

Practical tips and technical support to help you get started with Version 3.0 and the Reliance System.

A roadmap to single IRB review

Reliance Agreement

Streamlines IRB review and oversight for multisite studies and eliminates the time and effort of negotiating IRB authorization agreements for each study. Once your institution has joined, you may use the Agreement to support collaborations with Participating Institutions.

Reliance System

Allows institutions to join the Reliance Agreement and maintain their Institutional Profile. Provides a centralized system for investigators and institutions to request, track, and document reliance arrangements for their studies.

Resource Library

Browse, search, and sort SOPs, templates, checklists, tools, guidance, and more. These flexible resources are ready to use, easy to adapt, and designed to support IRB/HRPP staff, investigators, and study teams.

Learning Center

Education, on-demand training, and packaged resources to help investigators, study teams, and IRB/HRPP staff and institutions successfully plan for and navigate single IRB arrangements.

Investigators & Study Teams

Learn about your responsibilities related to single IRB and download start-up packages to help you plan your study and navigate IRB reliance arrangements.

IRB/HRPP Staff & Institutions

Learn about the roles and responsibilities of Reviewing IRBs and Relying Institutions and download start-up packages to help you implement the SMART IRB Agreement.

Featured Resource

Communication Plan

This form is helpful to guide conversations among the Reviewing IRB, Relying Institutions, and the Lead and Relying Site Study Teams.

SMART Talk

A monthly community forum

For IRB/HRPP Professionals & Study Teams

Watch past SMART Talks tackling emerging issues, persistent challenges, lessons learned, and best practices related to single IRB review.

Harmonization

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 for sIRB Review

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 for Studies Subject to Single IRB Review 

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.

Support

Support Center

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SMART IRB Ambassadors