FCOIR – Research Trigger Form (project-specific form)

What

The Research Trigger 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 Research Trigger 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 Research Trigger 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 a Triggering Event (TE) will receive an automatic email notification to complete the Research Trigger Form. Note: Steps 1 & 2 must be completed prior to Step 3.

Step 1: eDMS Disclosure Profile - eDisclosure Management System (eDMS)

All Mount Sinai principal investigators, co-investigators, mentors, and key personnel must complete the eDMS Disclosure Profile 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.

eDMS Disclosure Profile Instructions

Step 2: Triggering Event (TE) - eDisclosure Management System (eDMS)

Every time a project is submitted, the Triggering Event (TE) Form must be completed also in eDisclosure Management System (eDMS).

Process:

• All study investigators and key research personnel must be listed on the Triggering Event (TE) form. Refer to the GCO Investigator and PPHS Investigator definitions.
• eDisclosure Management System (eDMS) generates the TE# used for the IRB/RUTH and GCO/InfoEd application.

Triggering Event Instructions

Step 3: Research Trigger Form - eDisclosure Management System (eDMS)

Every person listed on the Triggering Event (TE) form will be prompted to complete a Research Trigger Form on eDisclosure Management System (eDMS) through a notification email.

Process:

• Information from the eDMS Disclosure Profile 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 Research Trigger Form also requires disclosure of related Institutional Financial Interests.
• Please note: Studies using an external IRB are also required to complete a Triggering Event (TE) form in eDisclosure Management System (eDMS) (exception – studies using BRANY for both IRB review and contracting). For detailed guidance on the Request to Rely (R2R) process, click here.

Research Trigger Form Instructions