All human subjects research being reviewed by an external IRB, through either a master reliance agreement with a commercial IRB, the SMART IRB Reliance Agreement, or through study-specific reliance agreements with other institutions, must submit a Request to Rely (R2R) to the PPHS office through Ideate for registration and review of local requirements (e.g. conflict of interest, education requirements, state law, institutional policy, auxiliary office review).
Forms required by the external IRB (e.g. agreements, waiver of jurisdiction forms, local context forms) will not be completed prior to a submission in Ideate. While each external IRB may have specific requirements, the use of any external IRB by Mount Sinai researchers should follow the general process outlined below.
Please note that research activities cannot begin at any Mount Sinai location until acknowledgment of this registration has been provided, even if the external IRB has provided their review/approval of the protocol.
Continuations: All ongoing research must renew the R2R, prior to the expiration date issued by the reviewing IRB, by making a Continuation submission once continuing review approval from the IRB of record has been obtained. Once the approval from the external IRB has been submitted to the PPHS, it is not required that research activities stop until an acknowledgement is processed; however, it is possible that modifications may be required based on local requirements.
- For requests made through Ideate, create a continuing review application and upload the current IRB approval documents and copies of the most recent protocol and/or consent forms if any changes have been made
- If the initial request was made outside of Ideate, a copy of IRB approval must be submitted to IRB@mssm.edu with HSM# – External IRB Continuation in the subject line. The body of the email should include the following:
- Current study status (e.g. open to enrollment, open for data analysis only)
- The new IF# for all financial conflict of interest disclosures in Sinai Central
- A statement regarding whether there have been any changes in research personnel over the past year.
- A statement regarding whether there have been any changes to the protocol that would require additional local review (e.g. addition of radiation exposure, changes to required consent form language, changes in PI)
- Copies of the most recent protocol and/or consent forms if any changes have been made (regardless of whether the changes affect local review)
- GCO# and confirmation that an annual submission to GCO has been made in InfoEd
Please contact the PPHS Office at 212-824-8200 or IRB@mssm.edu with questions about the Request to Rely (R2R) requirements.