Requests to Rely (R2R) on an External IRB
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 at that external site and our investigators are involved in the analysis of data or performing assays, we have entered into an agreements to rely on the other institution’s IRB for the review of the research. As the research and regulatory communities have moved in the direction of utilizing a single IRB to serve as the Reviewing IRB for multi-site projects, the ISMMS PPHS Office has worked to establish a more systematic process for submission, tracking, and monitoring of these projects. Please note that all projects relying on an external IRB are still subject to all ISMMS policies and procedures for the conduct of research. Research activities may not begin until an initial acknowledgement that all requirements are met has been issued by the PPHS.
NIH Single IRB Policy for Multi-site Research (effective 1/25/18): The PPHS has issued a statement confirming our understanding of the policy and agreeing to rely on external institutions serving as the sIRB using the SMART IRB Reliance agreement. The full statement is available for download here and may be included in grant applications meeting this criteria: ISMMS PPHS Statement on NIH sIRB Policy
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.
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).
HRP-232: HRP-232 is a tool for study teams to assist in the development of a complete and accurate R2R submission. On January 21, 2020, it will be required for all R2R submissions.
Reliance Forms: 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:
Consent Forms: All consent documents used to enroll participants in research at ISMMS are required to include site specific template language: Please click here for the site specific consent language required for ISMMS consent forms When uploading consent documents that will be reviewed and approved by an external IRB, select type Other-Other IRB Correspondence to avoid an ISMMS IRB stamp being added in Ideate.
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.
R2R continuations still require that regular ISMMS GCO and IF submissions be made prior to the submission of the continuation registration to the PPHS.
Financial Conflict of Interest Review:
For R2R continuations submitted after July 19, 2019, study teams will be responsible for initiating the FCOI Review for continuation submissions when relying on an external IRB. It is recommended that the FCOI Review is complete prior to submission of the continuation to the external IRB. An incomplete continuation submitted to PPHS will be returned to the study team to complete the FCOI process. Please refer to this guidance document for specific steps for initiating the review for R2R project where:
- Any personnel have a conflict disclosed on the new IF;
- The study has a COI Management Plan from the previous year and no personnel have a conflict disclosed on the new IF;
Once the Reviewing IRB has issued a continuing approval, that approval must also be registered in Ideate so that the PPHS can track ongoing research. Continuation registrations submissions should not be made prior to obtaining continuing review approval from the Reviewing IRB.
For R2Rs initially submitted 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.
For R2Rs initially submitted 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*
*These items are not required for BRANY protocols where BRANY is also negotiating the contract.
Continuing Research Activities:
It is noted that continuation approval from external IRBs are often received by the study team very close to the expiration date. As such, once the approval from the external IRB has been submitted to the PPHS, and accepted (i.e. not rejected), research activities may continue. However, it is possible that modifications may be required based on local requirements/conditional office review. A formal acknowledgement will be issued once local requirements have been confirmed as complete.
Once all local ISMMS requirements have been satisfied, the IRB approval dates will be set to match those issued by the external IRB. Please note that automated expiration notices cannot be turned off in Ideate, and it is possible that an expiration notice will be sent while the continuation registration is being processed. If the registration submission has made it past the intake process and is under the review of an analyst, this automated notice can be disregarded.
Modifications under the purview of an external IRB do not need to be submitted to the ISMMS PPHS unless they also affect local requirements (e.g. change in PI, change in recruitment procedures, change in a conditional office review – RSC, IDS, FACTS, etc.). While the PI should track the qualifications of new study personnel, individual personnel changes do not need to be submitted to the local ISMMS IRB unless there is a change in PI or conflict of interest disclosures. The most recent versions of all study materials should be included at the time of Continuation registration.
Launched in 2016, SMART IRB is currently funded by the NIH Clinical and Translational Science Awards (CTSA) Program, grant number UL1TR002541-01S1. For more information, please visit www.smartirb.org.
We are a participating institution in the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (SMART IRB Agreement), which provides a standard agreement and agreed upon standard operating procedures in support of the NIH single IRB mandate. The PPHS has experience conducting the necessary local context reviews and working with other institutions as a Relying institution. Please note that the SMART IRB Agreement is an agreement, and not an actual IRB that will conduct review of the project. Each reviewing and relying institution is responsible for ensuring that the protocol-specific details of the agreement are clear for each project, as necessary. All projects utilizing the SMART IRB agreement must be submitted via Ideate as per the R2R process outlined above.
An AAHRPP-accredited Commercial IRB with which ISMMS has an existing Master Agreement, including BRANY and the NCI CIRB, when the use of the commercial IRB is mandated, or when all of the following criteria are met:
- Multi-site, industry sponsored, study, where ISMMS is involved as a site with no additional responsibilities beyond those of other sites,
- Industry holds the IND/IDE and initiated the protocol, and
- Research is not a Phase I first-in-human study.
- Research is not a registry
When using BRANY:
- Permission to use the BRANY IRB must be obtained via a submission in Ideate prior to submission to BRANY for review. Permission will be provided via return correspondence after the initial review by the PPHS and conditional offices.
- At the time of your Ideate submission, please ensure that the Setup section, under the Summary tab, accurately indicates whether BRANY is serving as the Reviewing IRB AND negotiating the contract, or only serving as the Reviewing IRB. If BRANY is not negotiating the contract, a regular GCO submission and IF are required through the usual ISMMS process.
Please complete and upload the waiver form corresponding to the Commercial IRB you are requesting to use, under the Attachments tab in Ideate:
- Quorum Coversheet
- WIRB Waiver of Jurisdiction
- Advarra Waiver of IRB Oversight
- Note: Advarra was formed through a merger of Schulman Associates and Chesapeake IRBs.
- Sterling IRB
- Note: a consent template with the ISMMS required language already inserted must also be submitted at the time of your initial submission. The bottom of the waiver will be completed once the language has been deemed appropriate.
- Alpha IRB
- Note: a consent template with the ISMMS required language already inserted must also be submitted at the time of your initial submission. The waiver will be signed once the language has been deemed appropriate.
- Jaeb - if you are using the Jaeb IRB - an Attachment A, specific to your protocol, and a consent template with the ISMMS required language already inserted must also be submitted at the time of your initial submission.
Please contact the PPHS Office at 212-824-8200 or firstname.lastname@example.org with questions about the Request to Rely (R2R) requirements or whether your protocol qualifies to use the R2R process.