STEP I

Annual Form

Sinai Central

All Mount Sinai principal investigators, co-investigators, mentors, and key personnel must complete an Annual Report of Outside Relationships (also called the Annual Form) disclosing all financial interests that they may have outside of employment at Mount Sinai.

Process

  • This is required to be completed within 45 days of hire, annually, and updated throughout the year (within 30 days) if there are changes to your financial interests.

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STEP II

Investigator Form (IF)

Sinai Central

Every time a project is submitted, the Investigator Form (known as the IF form) must be completed also in Sinai Central. Process

  • All study investigators and key research personnel must be listed on the IF form. Refer to the GCO Investigator and PPHS Investigator
  • Sinai Central generates the IF#, or Sinai Central Project ID#, used for the IRB/RUTH and GCO/InfoEd application.

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STEP III

Financial Interest in Research Disclosure Form

Sinai Central

Every person listed on the IF form will be prompted to complete a Financial Interest in Research Disclosure Form on Sinai Central through a notification email.

Process

  • Information from the Annual Form automatically imports into this form
  • On this form, researchers are asked whether a financial interest is related to the current research project. However, the determination whether any given financial interest represents a conflict of interest is made by the Financial Conflicts of Interest in Research Committee (FCOIRC), not the investigator. Not all financial interests represent a conflict of interest.
  • The Financial Interest in Research Disclosure Form also requires disclosure of related Institutional Financial Interests.
  • Please note: Studies using an external IRB are also required to complete an IF form in Sinai Central (exception – studies using BRANY for both IRB review and contracting). For detailed guidance on the Request to Rely (R2R) process, click here.

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STEP IV

Start GCO Application

InfoEd

The Grants and Contracts Office (GCO) reviews studies for accuracy of administrative information and budget, as well as for compliance with Federal, State, New York City, and Icahn School of Medicine regulations.

PROCESS
  • Start the InfoEd (GCO) application to obtain the PD# required to submit an IRB application.
    • Note: The InfoEd application DOES NOT need to be submitted to get the PD#.
  • Submit the GCO application AFTER the IRB application submission.

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STEP V

IRB Submission

RUTH

The ISMMS Institutional Review Board (IRB) is responsible for assessing and approving ALL research at the Mount Sinai Health System (MSHS) that is to be conducted on humans.

PROCESS
  • Submit request in the RUTH System.
  • The IRB submission should be concurrent with budget and contract negotiations. Final IRB approval is contingent on a fully-executed contract.
AVERAGE TURNAROUND TIME

Full Board projects: 27 business days from submission deadline to review at a meeting

Expedited projects: 25 business days from submission deadline to approval

2020 ISMMS IRB Review Deadlines & Board Meeting Dates

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Contracts & Budget Submission

MediTract

The Financial Administration of Clinical Trials Services (FACTS) office reviews, negotiates and executes all clinical research agreements funded or supported by For-Profit (Industry) Entities.

PROCESS
  • Submit Contacts & Budget to FACTS via the MediTract system
  • Contract negotiation should occur concurrently with budget negotiations and IRB review.

Avg Turnaround Time: 4 to 6 Weeks

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STEP VI

GCO Submission

InfoEd

The Grants and Contracts Office (GCO) evaluates the accuracy of administrative information and budget, as well as compliance with Federal, State, New York City, and Icahn School of Medicine regulations.

PROCESS
  • PI and the study personnel should review the application checklist.
  • PI must approve and submit the application in InfoEd.

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