# SMART IRB, A NATIONAL SINGLE IRB RELIANCE PLATFORM TO SUPPORT MULTI-SITE HUMAN RESEARCH STUDIES

> **NIH NIH UL1** · HARVARD MEDICAL SCHOOL · 2021 · $1,836,848

## Abstract

PROJECT SUMMARY/ABSTRACT
The SMART IRB platform has transformed the process of conducting multi-site studies and fostering
collaboration on a national scale. The deployment of a common reliance agreement, supported by a
centralized IT platform, has led to improved efficiencies in conducting single IRB oversight and review.
However, several obstacles remain, including delays in research, compliance issues, and challenges
experienced by investigators regarding familiarity with reliance review and execution of multisite studies.
Furthermore, additional changes to the agreement are required in order to accommodate the onboarding of
additional federal agencies. To overcome these and other barriers, SMART IRB plans to (AIM 1: JOIN)
Extend the reach and capacity of SMART IRB by developing a SMART IRB MRA 3.0, necessary for the VA,
DoD, DOE, and other federal agencies, health centers and research institutions to sign onto SMART IRB.
SMART IRB will re-sign current signatories when SMART IRB 3.0 is finalized, through the engagement of the
trusted Ambassador network; (AIM 2: ENABLE) Educate, communicate and improve the currency, depth, and
range of SMART IRB competencies by advancing educational and training resources to transfer knowledge to
IRBs, Ambassadors, institutional Points of Contact, and regulatory and network teams both within and beyond
the CTSAs. SMART IRB will continue to develop additional education and training resources for these
constituencies, as well as develop a toolkit and training opportunities targeted to PIs and research teams who
work with a single IRB; (AIM 3: HARMONIZE) Reconcile, unify, and simplify workflow and policies by
identifying policies, procedures, and processes of Reviewing IRBs, Relying Institutions, and investigators and
their study teams that differ in order to identify common elements and differences, learn from current
practices, and propose successful workflows. This is an essential predicate to the design of a future
comprehensive solution for managing human research protections across the nation.

## Key facts

- **NIH application ID:** 10370538
- **Project number:** 3UL1TR002541-04S2
- **Recipient organization:** HARVARD MEDICAL SCHOOL
- **Principal Investigator:** Lee Marshall Nadler
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,836,848
- **Award type:** 3
- **Project period:** 2018-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10370538

## Citation

> US National Institutes of Health, RePORTER application 10370538, SMART IRB, A NATIONAL SINGLE IRB RELIANCE PLATFORM TO SUPPORT MULTI-SITE HUMAN RESEARCH STUDIES (3UL1TR002541-04S2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10370538. Licensed CC0.

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