Single IRBs and NYS OMH Sites Reliant Upon the NYSPI IRB
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 firstname.lastname@example.org if your application proposes to:
- Conduct non-exempt human subject research; AND
- The same research protocol will be conducted at multiple domestic sites.
Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered 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 conducting the "same research protocol".
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 an overview of the protocol; the rationale for requesting the NYSPI-IRB either to cede review to another IRB or to 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?).
If the NYSPI IRB has agreed, in principle, to be the sIRB for a multi-site study (please note, the NYSPI IRB will only serve as the sIRB for a total of 3 sites, including NYSPI), please submit the protocol in PRISM with a cover memo attached requesting that we serve as the sIRB. A NYSPI Relying Site Information Sheet needs to be completed for each site and uploaded with the protocol and other study attachments. You will be notified by email when the study has been scheduled for review.
If the NYSPI IRB has agreed, in principle, to cede review to another sIRB, the protocol will need to be submitted in PRISM (once the protocol has been approved by the sIRB) with a cover memo attached requesting that we cede review to another IRB. A Reliance Request Form needs to be completed and uploaded with the protocol and other study attachments. You will be notified by email when the study has been scheduled for review.
If you have any questions, please contact IRBmail@nyspi.columbia.edu.
OMH Sites Reliant Upon the NYPSI IRB
All research from these institutions must be reviewed by the NYSPI-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.