# SMART IRB GOVERNANCE, ADMINISTRATION, AND OPERATIONS SUPPORT

> **NIH NIH N02** · HARVARD MEDICAL SCHOOL · 2024 · $1,000,000

## Abstract

45 C.F.R. Part 46, Protection of Human Subjects, also known as the Common Rule, requires review by an institutional review board (IRB) of any research involving human subjects that is conducted, supported, or regulated by any Federal department or agency. Historically, institutions establish their own IRBs, which for multi-site research could result in multiple IRBs reviewing the same research. However, multi-site research is required by NIH to designate a single IRB (sIRB). See NOT OD-16-094. In addition, the Common Rule requires single IRB review of multi-site research for research supported or conducted by any of the Common Rule signatory agencies.
NCATS established the SMART IRB program in 2016 to harmonize and streamline the IRB review process for multi-site studies. SMART IRB is currently administered by a third party and funded by the NIH Clinical and Translational Science Awards (CTSA) Program. See https://smartirb.org/.

## Key facts

- **NIH application ID:** 11128308
- **Project number:** 75N95023C00008-P00005-9999-1
- **Recipient organization:** HARVARD MEDICAL SCHOOL
- **Principal Investigator:** MATTHEW BARSTOW
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,000,000
- **Award type:** —
- **Project period:** 2023-07-01 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11128308

## Citation

> US National Institutes of Health, RePORTER application 11128308, SMART IRB GOVERNANCE, ADMINISTRATION, AND OPERATIONS SUPPORT (75N95023C00008-P00005-9999-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11128308. Licensed CC0.

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