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 proceed with a request, follow 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.