What

The Financial Interest in Research Disclosure Form is used to determine whether any financial interests pose actual or perceived conflicts with a proposed research project. This form is required for every grant and research project/study.

When

The Financial Interest in Research Disclosure Form is required to be completed prior to IRB and GCO submission. The Financial Conflicts of Interest in Research Committee (FCOIRC) reviews this disclosure form once the IRB application is submitted. Study personnel with financial interests relevant to the research during the course of the study must disclose such interests immediately and are required to comply with any subsequently imposed Management Plan.

Failure to complete the Financial Interest in Research Disclosure Forms in a timely manner will DELAY research projects. The IRB and GCO will not accept applications until ALL forms are completed.

How

Investigators and key personnel who are listed on the Investigator Form (IF) will receive an automatic email notification to complete the Financial Interest in Research Disclosure Form. Note: Steps 1 & 2 must be completed prior to Step 3.

Step 1: 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. Federal Conflict of Interest (COI) regulations require that all investigators submit annual conflict disclosures.

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.

Annual Form Instructions

Step 2: 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 definitions.
  • Sinai Central generates the IF#, or Sinai Central Project ID#, used for the IRB/Ideate and GCO/InfoEd application.

Investigator Form Instructions

Step 3: 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.

Financial Interest in Research Disclosure Form Instructions

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Form Status Tracking

It is highly recommended that the PI or assigned study personnel track the Financial Interest in Research Disclosure Form status in Sinai Central or Ideate to ensure key personnel complete the form in a timely manner.

To learn how to track Financial Interest in Research Disclosure Form status, refer to Ideate Module 3 training in PEAK.

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