Regardless of which IRB will officially review your project, your application to PPHS will be made through Ideate.
All Faculty of ISMMS are required to use the ISMMS IRB regardless of where they are conducting human subjects research, unless other arrangements have been allowed by the PPHS. All human subjects research being conducted at ISMMS requires a Faculty member as a member of the research team.
Board A (effective 6.5.18)
Board B (effective 9.5.18)
Board C (effective 4.16.18)
Board D (effective 7.24.18)
Board E (effective 6.5.18)
NFL Board (effective 1.2.18)
Translational Oncology Board (effective 1.2.18)
Complete IORG Registration (all Boards - last updated 9.5.18)
ISMMS Federalwide Assurance: FWA00005656
In rare instances, non-faculty research may be covered under the Federalwide Assurance of the Mount Sinai Hospitals Group: FWA00005651. If you believe your research may fall under this category, please contact the PPHS at email@example.com
It has been our long-standing practice to work collaboratively with other academic institutions. Traditionally, we have worked with other institution’s IRB offices to determine appropriate arrangements when one institution is involved in a small aspect of the overall project, for example, if a study is recruiting elsewhere and all research interventions/interactions are occurring elsewhere and our investigators are involved in the analysis of data or performing assays, we have entered into agreements to rely on the other institutions IRB for the review of the research.
We are a participating institution in the SMART IRB initiative, which provides a standard agreement and agreed upon standard operating procedures in support of the NIH single IRB mandate, and have experience conducting the necessary local context reviews and working with other institutions as a Relying institution.
As an AAHRPP-accredited program, our policy is to only rely on Institutions who demonstrate that they have comparably robust Human Subjects Research Protection Programs. We will enter into agreements to rely on another IRB only if they are accredited.
For multi-site sponsored clinical trials where ISMMS is involved as a site with no additional responsibilities than other sites, industry holds the IND/IDE and initiated the protocol, and the research is not a Phase I first-in-human study or a registry study, an investigator can request to rely on an AAHRPP-accredited Commercial IRB.
If you are unsure if your study qualifies, please contact the PPHS office.
A Researchers Guide to Request to Rely on a Commercial IRB and Waiver of jurisdiction forms for the frequently used commercial IRBs are on the Forms and Documents page.
For multi-site sponsored clinical trials where ISMMS is involved as a site with no additional responsibilities than other sites, industry holds the IND/IDE and initiated the protocol, and the research is not a Phase I first-in-human study or a registry study, an investigator can request to use BRANY IRB. All BRANY projects must be registered with the PPHS.
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 R2R submission process.
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 submittedto 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 firstname.lastname@example.org with questions about the Request to Rely (R2R) requirements.