Financial Conflict of Interest

Purpose: To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest. If you are submitting a proposal to a PHS agency, you must submit a Financial Conflict of Interest Disclosure even if there is no FCOI present. You must also complete required FCOI training once every four years.

We strongly recommend that you review the links listed below to understand the UMD policies and procedures addressing conflict of interest.

• FCOI Disclosure Quick Reference
• FCOI Annual Review Quick Reference
• Required Training
• Helpful Links
• Video Tutorials
• Definitions
• PHS FCOI Subcontractor Guidance
• University of Maryland Policy and Procedures on FCOI

 

---

FCOI Disclosure Quick Reference

FCOI Yearly Disclosure Quick Reference Guide - September 1, 2018

FCOI Disclosure Quick Reference Guide

1. Go to www.irbnet.org
2. Click "New User Registration" in the upper right hand corner OR log in if you already have an IRBNet account
3. Log in. Click "Forms and Templates" on the left side of the screen
4. Select "UMCP COI Committee • Documents for Researchers" from the "Select a Library" drop down box
5. Download "FCOI Submission Instructions" document
6. Follow FCOI Submission Instructions

This provides a FCOI workspace, with functionality similar to our existing IRB and IACUC Modules. It allows for FCOI forms to be directly submitted for review, and allows the creation and tracking of FCOI management plans. This module allows for submission of Initial, Interim, and Annual Disclosures. Once a Disclosure is acknowledged, reminders will be sent to the project owner 60, 45, 30, and 15 days prior to the due date of the Annual Disclosure submission.

Investigators/key personnel will submit their disclosure via a Smart Form in IRBNet and link it to their created project. This project can be shared with all key personnel on the project so that they may complete their Smart Form disclosure. Once all disclosures are linked to the project and all key personnel electronically sign the project, the project owner can submit to the COI Administrator. The COI Administrator, in conjunction with the COI Committee Chair and members, will determine if no FCOI is present or if a disclosure requires full COI Committee review.

 

---

FCOI Annual Review Quick Reference

FCOI Annual Review Quick Reference Guide

 

---

Required Training

Go to: www.citiprogram.org

Register and enroll in the "Conflict of Interest Mini-Course." This course and associated quizzes should take 30-60 minutes to complete. If you pass the quizzes, the training is good for four years. You will be sent an automatic reminder when your training is due to expire.

 

---

Helpful Links

• FCOI Flowchart
• PHS FCOI Frequently Asked Questions

 

---

Video Tutorials

• Initial FCOI disclosure

 

---

Definitions

PHS is the Public Health Service which comprises the following agencies:

• Office of Global Affairs(OG)
• Office of the Assistant Secretary for Health(OASH)
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centre for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Services (IHS)
• National Institutes of Health (NIH)
• Substance Abuse and Mental Health Services Administration (SAMHSA)

Non-PHS Agencies:

• Administration for Children and Families (ACF)
• Alliance for Lupus Research (ALR)
• American Cancer Society (ACS)
• American Heart Association(AHA)
• American Lung Association (ALA)
• Arthritis Foundation (AF)
• Juvenile Diabetes Research Foundation (JDRF)
• Susan G. Komen for the Cure
• Cure PSP

Investigator means anyone with responsibility for the design, conduct, or reporting of the research.

Financial Interest means anything of value whether or not the value is readily ascertainable.

Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS funded research.

Significant FCOI means the value of any remuneration (salary, payment for services, consulting fees, honorarium, paid authorship, stock) exceeding $5000 in the prior 12 months. The UMD threshold is $0.
 

---

PHS FCOI Subcontractor Guidance

The Investigator discloses any Significant Financial Interests to the institution's internal COI Committee. Before a Sub-award is issued, ORA will be asking those Sub-recipients to certify whether a) they have a policy, and b) if there are any FCOI's to report.

If an FCOI is reported, or if a • new" FCOI arises after the Sub-award is initiated, that FCOI has to be reported by the Sub-recipient to us and UMD has to report it to the government within 60 days.

For more information, please visit our PHS FCOI Subcontractor Guidance page.

 

---

University of Maryland Policies and Procedures on FCOI

Policy on Financial Conflicts of Interest in PHS Funded Research, Section II-3.10(C)