For Researchers

Please read the following before submitting to the PPHS office for human research review. 

If you are new to research at Mount Sinai click here

The submission process at Mount Sinai requires that you navigate three systems in this order:

  • Sinai Central - FCOI (Create a new Investigator Form and complete Financial Conflict of Interest Disclosures) 
  • Ideate - This is the electronic submission system for human subjects research projects that are new requests or subsequent submissions for projects approved in the Ideate system.
  • InfoEd - Used by the Grants and Contracts Office - a submission is required regardless of the type of funding, including no external funding.  

All non-Ideate submissions (only accepted for ongoing research that was approved outside of the Ideate system) must be sent to the IRB Inbox at IRB@mssm.edu.

IDEATE is the new electronic submission system that is being implemented for human research project applications to the PPHS/IRB. For more information on when to submit in Ideate, click here.

Consent Templates are available on the PPHS Forms and Documents page.

Pre-Requisite for submission to the PPHS:

All study personnel must complete the PPHS education requirements (please see PPHS Ed Reqs for more information on the requirements) through the CITIProgram. To see the completed courses, review the Investigators Form for the project in Sinai Central. You are not required to upload copies of education certificates into Ideate.

2017 ISMMS IRB Review Deadlines & Board Meeting Dates

2018 ISMMS IRB Review Deadlines & Board Meeting Dates

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.

 

 

Current rate for IRB reviews at Mount Sinai (all system sites):

  • Initial Review:  $2,500 (one-time)
  • Continuation Reviews:  $1,200/each
  • Modification Reviews:  $500/each
  • External IRB Review Administrative Fee:  $575 (one-time)

Existing studies with executed contracts prior to December 31, 2015, and without a modified budget since January 01, 2016, are subject to the rate schedule previously negotiated by that system site.

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, or who inadvertently receive payments for IRB review fees, should contact the PPHS office at 212-824-8200 and ask to speak with the financial analyst.

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:

1. 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;

2. As the DCC, the 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

3. 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;

4. 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;

5. 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

6. 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.

Regardless of which IRB will officially review your project, your application to PPHS will be made through Ideate. 

Our IRB

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.

Commercial IRBs

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.

BRANY

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.

Other IRBs

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.

Please use the Grant/Protocol 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.

 

Please review HRP-317- Worksheet:  Emergency Use of a Test Article and contact the Investigational Drug Services (IDS) at 212-241-2437 to discuss your situation.

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.