Single IRBs and Other Research Sites

NIH Single IRB Policy

The NIH single IRB (sIRB) policy applies to domestic sites of new and competing renewal applications/proposals with due dates of January 25, 2018 and beyond for NIH-funded multi-site studies where each site will conduct the same protocol 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, you should contact the IRB office immediately at irbmail@nyspi.columbia.edu if your application proposes to:

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

If NYSPI is being proposed as one of the participating sites in an application to be submitted by another applicant organization, you must also contact the NYSPI IRB immediately. It is recommended that you contact us as soon as a decision is made to participate in a multi-site study affected by this NIH sIRB policy. Please contact us via IRBmail@nyspi.columbia.edu.

At a minimum we will need to see a draft of the protocol; the rationale for requesting the NYSPI-IRB either cede review to another IRB or assume the role of the sIRB; information about the funding mechanism (e.g., which business office, CU or RFMH? Is NYSPI the primary awardee or is there a subcontract?).

Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are consider to be the "same research protocol". Additionally, sites that are accruing research participants for studies that are identical except for variations due to local context considerations would be considered to be conducting the "same research protocol". IRB policies and procedures for sIRB are bring informed by current processes. If you have any questions, please contact IRBmail@nyspi.columbia.edu.

IRB of Record: Reliance Agreements

 Authorization Agreement

For sites that do not have an IRB, the NYSPI-IRB may serve as the IRB of record. The Authorization Agreement linked above is a necessary document to establish the site's reliance on the NSYPI IRB. The site 1) needs to be engaged in research (meaning it is not merely a recruitment site), 2) is NOT affiliated with an institution with an IRB, and 3) the NYSPI-IRB Director has been informed of the study's intention to seek an Authorization Agreement.

  • This process has four main components:
    • The NYSPI-IRB and RFMH will consider your request for us to serve as the IRB of record for another facility/site.
    • A formal agreement between NYSPI and the other site is executed (i.e., the authorization agreement).
    • The site obtains an FWA registering the agreement with OHRP (see below).
    • The NYSPI-RB issues an approval notice to begin the study at the site

To initiate a Reliance Agreement, proceed with the following these steps:

Tell us about the site and the role played by the site in this research
The request to have the NYSPI-IRB serve as the IRB of record for an outside facility begins with your submission of:

A completed Site Information Sheet.
A Protocol Summary Form (PSF) with the name(s) of the proposed site(s) added to the face page. We ask that you detail any site-specific procedures and personnel in the body of the PSF.
A cover memo explaining your request to facilitate review.

Our review of your request
The IRB Director, the IRB Chair, and the Deputy Managing Director of the Research Foundation for Mental Hygiene will review your request, the protocol, and the information about the site in order to decide whether to assume the role of responsible IRB. 
If agreed upon, you will be asked to complete the OHRP Authorization Agreement. 

Submit a completed Authorization Agreement
Please download and complete the  Authorization Agreement 
The agreement must be signed by the Institutional Signatory Official at the site.
Submit the signed original to the NYSPI-IRB. 
We will forward the agreement to the NYSPI IRB Director and the Managing Director of RFMH for their approval and signatures. 

File a federalwide assurance (FWA)
Once the Authorization Agreement is fully signed, we will give you the go-ahead to instruct the facility to file a domestic or international federalwide assurance with OHRP.
In filing an FWA, the facility registers its relationship to NYSPI with OHRP and agrees to adhere to federal regulations governing human subjects research and the principles of The Belmont Report.
Steps to File a Federalwide Assurance (FWA):
The NYSPI-IRB  registration number needed for the FWA application is: IRB00000488; IRB #1 NYS Psychiatric Institute.

You're almost done
Please submit evidence of the FWA to the NYSPI-IRB. A print-out directly from the online listing of the FWA including its name and number  will do the trick.
Once received, and the study is otherwise approved, an approval notice and stamped consent forms can be issued for the study site. 

OMH Sites Reliant Upon the NYPSI IRB

Buffalo Psychiatric Center

All research from the Buffalo Psychiatric Center must be reviewed by the PI-IRB. New studies must be created on PRISM, and should include the PSF, attachment of consent forms, recruitment materials, the grant application and any other relevant materials.

Administrative questions should be directed to IRBmail. For other inquiries you may call the IRB office at (646) 774-7155. Technical questions about the PRISM application process should be directed to IRBweb.

Institute for Basic Research

New York City Children's Center, Queens (NYCC)

Creedmoor Psychiatric Center (CPC)

New York State Office for People with Developmental Disabilities (NYSOPDD)