Institutional Review Board

Single IRB Request/Review Process

*If you are requesting that Einstein serve as the Lead IRB for more than one external site, please contact us prior to submitting your study in iRIS.* 

Decisions about whether Albert Einstein College of Medicine, Inc. & Montefiore Medical Center will enter into a Reliance Agreement for IRB review, whereby Einstein will rely on the IRB at another institution or will review for other institutions, are handled on a protocol-specific, case-by-case basis, once those requests have been submitted in iRIS.  We encourage researchers to review the Einstein sIRB Request/Submission Process Guidance and to contact the Einstein IRB as soon as possible (and prior to submitting grants) to discuss the feasibility and process for ceding arrangements between institutions. We also remind researchers to familiarize themselves with the reporting requirements of both Einstein/Montefiore and the external IRB, since PIs will usually need to provide information and ongoing reports to both institutions.

Questions about the use of a single IRB (sIRB), SMART IRB, or collaboration with individual investigators outside of Einstein/Montefiore? 

Email us at SingleIRB@einstein.yu.edu or call us at 718-430-2237 and ask to speak with the IRB Reliance Specialist about reliance agreements or the use of single IRBs.

sIRB Resources

Document  Revised 

Einstein sIRB Request/Submission Process Guidance (as a Relying Site) 

4/19/18 

Reliance Request Information Sheet 

3/20/18 


NIH Single IRB policy

The NIH Single IRB (sIRB) Policy is only applicable to new and competing renewal applications/proposals for NIH funding that are due on or after January 25, 2018, and contract solicitations issued on or after January 25, 2018.  The policy is applicable to NIH-funded multi-site domestic studies involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

If you are preparing an NIH application due after January 25, 2018, you should contact the Einstein IRB immediately at SingleIRB@einstein.yu.edu if your application proposes to: 

  • Conduct non-exempt human subjects research; AND
  • The same research protocol will be conducted at multiple domestic sites.

PIs and/or departments can reach out to SingleIRB@einstein.yu.edu to inform the Einstein IRB about these applications. As part of your email, please include a complete Reliance Request Information Sheet.


NIH SINGLE IRB FAQs

What is the "same research protocol?" Protocols that address the same research questions, involve the same methodologies and procedures at each site, and evaluate the same outcomes are considered to be the “same research protocol.”

What is the difference between a central IRB and a single IRB? Both are designed to help streamline IRB review, and the terms are sometimes used interchangeably. In general:

  • A Central IRB is the IRB of record that provides the ethical review for all sites participating in more than one multi-site study. The sites are usually in a network, consortium or particular program.
  • A Single IRB is the IRB of record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site study.

Note: At Einstein the same request form and process is used for requesting either a central IRB or a single IRB.

Additional NIH single IRB FAQ’s can be found here.


NIH Single IRB Resources

Document  Revised 

Reliance Request Information Sheet 

3/20/18 

SMART IRB Communication Plan Form 

4/9/18 

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