Please read the following before submitting to the PPHS office for human research review.
Starting new research at Mount Sinai click here
ISMMS allows any member of the study team to serve as Principal Investigator. (e.g. a student may be the PI for their own project); however, please note that ALL projects must have at least one ISMMS faculty member on the study team.
The submission process at Mount Sinai requires that you navigate three systems in this order:
1. eDisclosure Management System (eDMS) - Financial Conflict Of Interest - Create a new Triggering Event and complete the project-specific Research Trigger Form.
2. RUTH - This is the electronic submission system for human subjects research projects that are new requests or follow on submissions for projects approved in the RUTH system.
- Consent Templates are available in the RUTH library.
- All study personnel must complete the PPHS education requirements as a pre-requisite through the CITIProgram. To see the completed courses by the study team members, click on the Training tab in your RUTH submission. You are not required to upload copies of education certificates into RUTH.
- When using RUTH, each user must have a CV or Biosketch with the necessary information posted in their profile. The CV or Biosketch must be current and can be in any format, as long as its understandable and in a compatible file format. It is the individual’s responsibility to upload their own document into their profile – No one else can complete this task.
3. InfoEd - Used by the Grants and Contracts Office - a submission is required for all funded sponsored programs, research studies not submitted to the IRB/PPHS or IACUC and research studies that require a signed agreement from the Grants and Contracts Office.
If a principal investigator (PI) or study team member requires an official determination letter from the IRB, a submission to the RUTH application system is required for review. The PPHS/IRB cannot make retroactive determinations.
Average Turnaround Times
Our Service Pledge For Submission Turnaround
With the implementation of RUTH, the PPHS will be ending its deadline submission policy and will begin accepting applications on a rolling basis with a pledge to complete its review within a fixed period. Of course, to meet that pledge requires the cooperation of the research team and the ancillary offices. In general, studies will be reviewed in the order in which they are received. IRB submission review times vary, as they are based on the regulatory review categories, the complexity of the protocol and the completeness of the submission. Use the following submission guidelines when planning your IRB applications:
- Full Board Review: Greater than minimal risk projects will be presented at a board meeting within 6 weeks of a completed application.
- Expedited Reviews: Minimal risk projects will be approved within 6 weeks of a completed application.
- Request to Rely (R2R) Reviews: Projects will receive a Waiver of Jurisdiction within 2 weeks of receiving a completed application.