For Researchers

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. Sinai Central - Financial Conflict Of Interest - Create a new Investigator Form and complete Financial Conflict of Interest Disclosures.

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, review the IF for the project in Sinai Central or by clicking the Training tab in the 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.

2021 ISMMS IRB Meeting Dates

Faculty, fellows, residents, staff, students or agents* 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 study team.

*See Human Research Protection Program Plan for the definition of an agent.

Board Rosters

IRB Membership Roster (All Board rosters listed- complete IORG Registration last updated 6.9.2021)

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 irb@mssm.edu  

*If you would like the ISMMS IRB to serve as the Reviewing IRB for external sites, please review the information on the Request to Serve (R2S) page.

*For information related to use of an External IRB, please visit the Request to Rely (R2R) page.

The IRB must ensure, to the extent possible, the safety of research subjects including that subjects do not incur undue risk and that the risks versus benefits are continually reassessed throughout the study period.  In order to make this evaluation, the IRB must consider the Data Safety Monitoring Plan proposed for the study. The types of monitoring are anticipated based on the nature, size, and complexity of the study.

Data and safety monitoring is required for all types of studies and there are minimum standards for all human research conducted and/or overseen by ISMMS.

1. Minimum Standards for Data Safety Monitoring Plans (for projects that entail minimal risk to subjects)

The following minimum requirements apply to all projects, including retrospective reviews of medical records, use of tissue samples, and many minimal risk studies, such as observational and survey research. Because these minimum requirements apply to all studies within a project, a specific written Data Safety Monitoring Plan (DSMP) will not usually be required for projects that do not pose greater than minimal risk to subjects. PPHS may alter the required level of monitoring if appropriate.

For all projects, the principal investigator must have a plan to assure that data integrity will be maintained during data collection, storage, and analysis. All research projects must adhere to ISMMS’ recommendations on the storage of research data. Loss of data containing identifiable information is reportable to the IRB within five business days.

Any problems concerning the consent process, and any subject complaints should be monitored by the investigator who should file reports of such problems at least annually. The discretion of the protocol director will guide the need to report these problems immediately or more frequently in accordance with the Requirements for the submission of Reportable New Information.

Typically, the principal investigator is the monitoring entity for the minimum DSMP. When a principal investigator is not a faculty member, the supervising faculty member must be responsible for the data and safety monitoring aspect of the protocol.

2. Data Safety Monitoring Plans for projects that entail potential greater than minimal risk to subjects

We follow NIH Policy and FDA Guidance on Data and Safety Monitoring, including when a Data Safety Monitoring Board (DSMB) is required.

Please refer to the following information when proposing a Data and Safety Monitoring Plan. In addition, when a Data Safety Monitoring Board (DSMB) is required the IRB requires the submission of the Charter for review.

Fee Schedule effective February 1, 2019

Submission Type Fee
Initial review $3,000
Continuing review $1,500
Modification review* $900
External IRB - Initial review administrative fee $750
External IRB - Continuing review administrative fee $425
External IRB - Modification review administrative fee $100
Reactivation of a study with a lapsed IRB approval $500
Expired projects with no activation/no final report $200

*Regardless of whether the modification accompanies another kind of submission (i.e. a continuation)

NOTE: The fee schedule does not apply to R2S fees for NIH-funded projects where Mount Sinai is serving as the IRB of record for external sites.  Requests for the Mount Sinai IRB to serve as the sIRB must be included in the budget of the grant.  Please refer to the instructions under “Grant Submissions” on the PPHS R2S page.

The PPHS office generates IRB review invoices. Industry sponsored payments should be made payable to the Icahn School of Medicine at Mount Sinai, and include a memo indicating the invoice number. Payments are to be mailed to the following address:

Mount Sinai Health System
PPHS/IRB Office
One Gustave L. Levy Place; Box 1081
New York, NY 10029

Study teams with questions about invoices, who prefer to pay via ACH/EFT/Wire, or who inadvertently receive payments for IRB review fees, should contact the PPHS office at 212-824-8200 or by email at IRB@mssm,edu and ask to speak with the financial analyst.

Existing studies with executed contracts prior to February 1, 2019 are not affected by the new fee schedule. For the fee schedule prior to February 1, 2019 contact the PPHS office at IRB@mssm.edu.

Statements to be provided to Sponsors regarding PPHS/IRB practices:

The last FDA audit of the PPHS occurred in March 2018 and there were no significant findings. No 483 was issued.

If you are the coordinating center for a multi-centered study, there are specific requirements related to your role as the coordinating center. Please provide the IRB with information regarding the following:

  • The management, data analysis, and data safety and monitoring plan are adequate for the research provided. Please explain the plan for reporting of adverse events, in which all events will be reported to the data safety monitoring board. The DSMB will be convened under the regulations of the National Institute of Health (NIH) and will compile statistics relative to the adverse events, analyze them for trends, and report on a regular basis. In addition, specify that all adverse events will be appropriately forwarded to the FDA and promptly reported to individual enrollment sites for their submission to their designated IRB's;

  • As the DCC, the Principal Investigator (PI) is responsible for the development of a sample protocol and consent document and for ensuring that adequate provisions are in place for their distribution to each collaborating institution.

  • The PI must submit evidence that they will assure that each collaborating institution holds an applicable OHRP-approved Assurance and will maintain documentation of such;

  • The PI must submit evidence that the coordinating center will assure that the protocol will be reviewed and approved by the IRBs at the collaborating institutions prior to the enrollment of subjects at each site;

  • The PI must detail what mechanisms are in place to determine if substantive modifications by the collaborating institutions of the sample consent information are appropriately justified and documented, as well as communicated to the DSMB, particularly with regard to risks or alternative procedures; and

  • The PI must demonstrate that there are appropriate procedures in place to assure that informed consent is obtained from each subject in compliance with HHS regulations.  If MSSM is also serving as a site, or the PI is the lead PI on the study, or the PI is the Sponsor-Investigator of an IND or IDE, sufficient information must be presented to the IRB to allow the appropriate determinations to be made for each set of regulatory considerations and requirements that apply.

Please use the Protocol Review Wizard to see which institutional research administration offices will need to be involved and for additional information.

 

For information on what requires Information Security Risk Assessments, and the process of obtaining a Risk Assessment, click here.

If the study requires Information Security Risk Assessment, download and complete the Risk Assessment Intake Form.

If you are looking for Institutional requirements regarding security levels for different types of data, please review the Data Classification Reference Guide.

 

Emergency use of a test article requires a special consent form–the standard hospital clinical consent for treatment does not cover treatments that are experimental and are not FDA approved. For additional information and to obtain the template consent and forms required, contact the IDS.

Please review HRP-322 - Emergency Use and contact the Investigational Drug Services (IDS) at 212-241-2437 to discuss your situation.