Request for ISMMS to Serve (R2S) as the Reviewing IRB
All requests for the ISMMS IRB to serve as the single Institutional Review Board (sIRB) (i.e., Reviewing IRB) must be discussed with and approved by the PPHS at least two weeks in advance of the grant submission. The IRB fees associated with the sIRB need to be included in the grant budget. Please refer to “Grant Submissions” below for instructions to request that ISMMS IRB serve as the sIRB for a study. Last minute requests may not be accommodated and may be referred to an external IRB.
The revised Common Rule (i.e., the 2018 Requirements) requires at 45 CFR 46.114(b) that all institutions located in the United States that are engaged in cooperative, multi-site and/or collaborative research conducted or supported by a Federal department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States.
*This policy applies to the domestic sites of federally-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research.
- Click here for more information about the single IRB requirement
- Click here for more information from the NIH, including the full policy.
The ISMMS IRB is willing to serve as the Reviewing IRB for all sites, at the discretion of the PPHS Executive Director, after consideration of the protocol complexity, the role of ISMMS in the research, and the PPHS resources required to facilitate this review. At a minimum, the following criteria must be met:
- In addition to the ISMMS site, there are 5 or fewer external sites.
- The external sites have joined, or are willing to join, the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (SMART IRB Agreement).**
**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.
Requests for the ISMMS IRB to serve as the Reviewing IRB for all domestic sites under the NIH sIRB mandate must be made well in advance of your grant submission.
Prior to your grant submission deadline, you must submit a Request to Serve (R2S) inquiry to the IRB inbox (firstname.lastname@example.org) by providing the HRP-230 form. The following information must be clearly included in the request or the form will be sent back for revisions:
- The name of each domestic site requesting to rely on the ISMMS review, and
- Whether each site is a current member of the SMART IRB Agreement (membership can be confirmed at https://smartirb.org/participating-institutions/). If not, their willingness to join the SMART IRB Agreement must be confirmed.
- An explanation of the research activities that will be conducted at each site
- The role of the ISMMS site in the research, including
- Coordinating center responsibilities,
- Research activities that will be conducted, and
- Whether ISMMS will be the prime awardee of the grant.
If the ISMMS IRB agrees to serve as the Reviewing IRB, PPHS staff will provide budget information and a letter of support from the PPHS Executive Director. Researchers are encouraged to use the Grant Applications, Template Description of SMART IRB in their application.
Once there is an indication from the federal agency that a project will be funded, please notify the PPHS at email@example.com as soon as possible for further guidance on the review process. A full IRB application must be completed via RUTH and all sites, including the ISMMS site, must be reviewed separately.
Of note, these projects will be reviewed following the regular ISMMS Board meeting timelines. Once the overall project is approved, further details for submitting to activate individual sites will be provided by the PPHS.
Please note that most sites will likely still require a submission to their local IRB for the review of their local documents and completion of the forms associated with the SMART agreement. Each site should be in touch with their local institutions to ensure they are aware of the requirements as early as possible.
Sites will be granted approval once all components of the review are complete, and expiration dates will be set to match those of the overall protocol. A member of the Lead Site or Coordinating Center will be required to ensure that all sites have provided:
- HRP-821 - FORM - Local Context for External Sites*
- HRP-822 - ADDENDUM - SMART IRB Agreement*
- Site-specific study material (consent forms and recruitment materials) that have been revised to meet all local site requirements
External study teams are not permitted to submit directly to the ISMMS IRB, and a member of the ISMMS team is required to manage each sites paperwork for completeness prior to submission through RUTH. The paperwork for each individual site activation should be submitted via the IRB inbox (firstname.lastname@example.org) for review, prior to submission in RUTH, to avoid an individual sites from delaying the activation of other sites. Once a site is deemed ready for activation, the team will receive an email from PPHS with instructions for submisison.
No individual site may begin the conduct of research locally until a specific modification adding the site has been approved by the ISMMS IRB, and all local requirements and approvals have been fulfilled following the investigator’s home institutions policies and/or guidance for relying on an external IRB.
* These forms will be provided to the Mount Sinai Study Team after IRB review is complete and must be provided by each site in addition to their site-specific study materials.