Sites Without IRBs

If you are conducting research at another site or facility, and that facility is engaged in research but does not have an IRB (and is not affiliated with an institution that does), the NYSPI-IRB may agree to serve as the site's IRB under certain circumstances.

This process has four main components:

  • The PI-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.

  • The site obtains an FWA registering the agreement with OHRP.

  • The PI-RB issues an approval notice to begin the study at the site

How to arrange for the NYSPI-IRB to serve as the IRB of record for a site without its own IRB

To proceed with a request, please follow the steps below.

1. Tell us about the site and the role played by the site in this research

The request to have the PI-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.

2. Our review of your request

The IRB Administrative 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 (IAA).

3. Submit a completed OHRP Authorization Agreement

  • Please download and complete the OHRP 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 Executive Director of PI and the Managing Director of RFMH for their approval and signatures. 

4. 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.

5. 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.