Single IRB Review for Multi-Site Research
Office of Research
Policy 4.2.4
Effective Date: Spring 2026
Last Updated: Spring 2026
I. Policy Summary
NJIT is committed to complying with the National Institutes of Health (NIH) policy on the use of a single Institutional Review Board (sIRB) of Record for Multi-Site Research. NJIT’s single IRB policy facilitates an arrangement where one IRB provides review services for multiple sites participating in a study.
II. Policy Purpose
The purpose of this policy is to establish the administrative foundation of NJIT to facilitate compliance with NIH’s single IRB requirement, provide instructions to investigators considering ceding oversight to another IRB or requesting the NJIT IRB to serve as the IRB of record for multi-site collaborative projects, and enhance and streamline the IRB review process for multi-site research studies.
III. Policy Scope and Applicability
As of January 20th, 2020, all non-exempt cooperative research that is funded by a Common Rule agency are required to rely on a single IRB [45 CFR 46.114(b)]. The Single IRB mandate requires a single IRB to be designated for NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. Under this policy, a single IRB is designated to review and approve the research protocol for all participating sites, rather than requiring each site to obtain separate IRB approvals. The sIRB policy was established to streamline the IRB review process and reduce administrative burden for researchers, institutions, and IRBs. It applies to domestic awardees and participating domestic sites, and does not apply to exempt human subjects research or research that is not funded by the NIH.
IV. Definitions
Authorization Agreement (Reliance Agreement)
The agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on the designated IRB.
Cooperative Research
Cooperative research projects are those projects that involve more than one institution.
Multi-site Study
A study that uses the same protocol to conduct non-exempt human subjects research at more than one site.
Participating Site
A domestic entity in a multi-site study that will rely on the sIRB to carry out the site’s IRB review of human subjects research for the multi-site study.
Same Protocol
Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same protocol.”
Single IRB (sIRB)
The selected IRB of record that conducts the ethical review for participating sites of the multi-site study.
SMART IRB
An online system designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is an integrated, comprehensive platform that facilitates the creation of reliance agreements for single protocols involving multisite studies and is freely available for institutions and investigators. SMART IRB is not an IRB, but a system that efficiently completes the reliance process for a study being conducted with another SMART IRB participating institution. SMART IRB is funded by the National Center for Advancing Translational Sciences and intended to serve as a roadmap for institutions to implement the NIH Policy on the Use of a Single IRB for Multisite Research. It has about 1200 participating institutions.
V. Policy Statement
NJIT complies with the NIH policy on the use of a single Institutional Review Board of Record for Multi-Site Research and expects all faculty, staff, and students involved in NIH funded multi-site research to comply fully with all applicable conditions set forth in the reliance agreements.
VI. Reliance Process
NJIT has joined SMART IRB and uses its online system to create and enter into reliance agreements with other institutions participating in multisite studies. Investigators are encouraged to reach out to the NJIT IRB if they intend to rely on an external IRB, or have NJIT IRB serve as the IRB of record. The single IRB process involves designating a single IRB to review and approve the research protocol for all participating sites in a multi-site research study. The process typically involves the following steps:
1. Determining if the study is subject to the single IRB policy: The single IRB policy applies to certain types of federally-funded research studies that involve multiple sites conducting the same protocol. The study team is responsible for determining if the single IRB policy applies to their proposed study.
2. Identifying the Lead Study Team: The research team is responsible for identifying the Lead Study Team. The Lead Study Team is responsible for initiating the single IRB review process and assuming additional responsibilities. Specifically, it is responsible for providing the IRB of Record with details about the study (studywide protocol, template consent document/s, instruments, recruitment), and information on all sites that will be engaged in human subjects research. The Lead Study Team is also responsible for communicating any required information about the sIRB to any funding agencies as part of the grant or contract application.
3. Selecting the single IRB and obtaining approval: The study team should identify a single IRB to review and approve the research protocol for all participating sites. The selection of the IRB should be based on factors such as expertise, capacity, and cost. The Lead Study Team should submit the research protocol to the designated single IRB for review (usually the IRB of their institution) and approval. The IRB will evaluate the protocol to ensure that it meets the ethical and regulatory requirements for the protection of human research participants.
VII. Roles & Responsibilities
Principal Investigators are ultimately responsible for determining the need for a single IRB review for their research projects involving human subjects. The Office of Research serves as the campus signatory for single IRB reliance agreements, is responsible for reviewing requests for single IRB review, and facilitating the process if NJIT IRB is either selected as the IRB of Record or will be ceding review to an IRB of another institution. The reliance agreement documents the arrangement and establishes expectations about communication, reporting, and procedures. If an NJIT PI will lead the study team and NJIT IRB is selected to be the IRB of record, s/he must follow the processes listed at
https://smartirb.org/wp-content/uploads/Implementation-Checklist-and-Documentation-Tool-F.pdf
If an NJIT investigator elects to rely on another IRB to review, approve, and oversee a research study, the reviewing IRB takes on all IRB oversight responsibilities. The NJIT investigator is responsible for providing key local context information about state law, study team member training and qualifications, and any applicable conflict of interest situations to the reviewing IRB. NJIT and its investigators are responsible for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms as set forth in our Federal Wide Assurance.
VIII. Authority and Responsibility
The Office of Research holds institutional authority for the issues covered in this policy. Any questions regarding this policy should be directed to the director of research compliance and services in the Office of Research.
Related Policies and Regulations
Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html
Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-004.html
Single IRB Policy for Multi-site Research Frequently Asked Questions (FAQs)
https://grants.nih.gov/faqs#/hs-single-IRB-policy-for-multi-site-research.htm
Related Resources
https://smartirb.org/
For IRBs and Institutions
For Investigators
https://smartirb.org/investigators/