What

The Financial Conflict of Interest in Research (FCOIR) Disclosure Form is used to determine whether any financial interests pose actual or perceived conflicts with a proposed research project. A FCOIR form is required for every grant and industry sponsored research study. Federal Conflict of Interest (COI) regulations require that all investigators submit annual conflict disclosures.

When

The FCOIR Form is required to be completed prior to IRB and GCO submission. The Financial Conflicts of Interest Committee reviews the FCOIR 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 FCOIR Forms in a timely manner will DELAY research projects. The IRB and GCO will not accept applications until ALL FCOIR Forms are completed.

How

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

Step 1 – Financial Conflict of Interest in Research (FCOIR) Training – REQUIRED

The mandatory FCOIR education module must be completed prior to submitting the FCOIR Form. FCOIR Training is valid for 4 years.

FCOIR Training Instructions

Step 2 – Complete the Annual Disclosure Form – REQUIRED

All Mount Sinai principal investigators, co-investigators, and mentors must complete an Annual Report of Outside Relationships or Annual Form, disclosing all financial interests that they may have outside of employment at Mount Sinai. This Annual Form is required to be completed annually, and updated throughout the year if there is a change to your financial interests.

Annual Disclosure Form Instructions

Step 3 – Complete or Amend Financial Conflict of Interest in Research (FCOIR) Form

FCOIR Form Instructions

Z

FCOIR Status Tracking

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

To learn how to track FCOIR status, refer to Ideate Module 3 training in PEAK.

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