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JMU OSP

Financial Conflict of Interest

Frequently Asked Questions
Disclosure of Financial Interests Related to Research

 
1. Who do I contact about the Financial Conflict of Interest Disclosure Form or FCOI Training?

The Office of Research Compliance is a unit within Research and Public Service a Division of Academic Affairs and is responsible for receiving Financial Conflict of Interest Disclosure Forms and coordinating FCOI Training.
Contact: Pat Buennemeyer, Director of Research Compliance
Phone: 540.568.7025
Email: buennepd@jmu.edu
Website: http://www.jmu.edu/sponsprog/research_compliance/FCOI.html
Financial Conflict of Interest Disclosure Form (DF): FCOI Disclosure (.docx)

Forward all completed DF's to Pat Buennemeyer at MSC 4901. Refer all FCOI questions to her at 540.568.7025 or via e-mail at buennepd@jmu.edu.


2.
How does the University determine if there is a Financial Conflict of Interest related to my research?

When you submit a federal research funding proposal to the Office of Sponsored Programs, you will be asked to complete the Financial Conflict of Interest Disclosure Form: FCOI Disclosure (.docx) prior to submission of the proposal to the funding agency. Forward the completed signed document directly to the Office of Research Compliance at MSC 4901. The Office of Research Compliance will review your research proposal and Financial Disclosure Form to determine whether your financial interests meet the thresholds specified by federal regulation and University policy; or could directly and significantly affect the design, conduct, or reporting of the research. If your financial interests meet these requirements, a conflict of interest (or the appearance of a conflict) may exist.

A Significant Financial Interest does not include the following:


3. How do I know if I need to submit a Financial Conflict of Interest Disclosure Form (DF)?

The Principal Investigator (PI) and any other Investigator*** on the research project (regardless of title or position) who is responsible for the design, conduct or reporting of research, which may include collaborators or consultants, must submit a DF PRIOR to the submission of the federal research proposal. The DF must be updated annually for each investigator for as long as the project continues. Additionally, an updated DF must be submitted within 30 days of changes in the investigator's financial interests. If a new reportable Significant Financial Interest arises at any time during the period after the submission of the proposal through the entire period of any resulting award, the filing of a new DF is required.

Any Significant Financial Interest of the investigator that would reasonably appear to be affected by the research funded by the federal sponsor must be disclosed on the DF. Also to be disclosed are any significant interests of the investigator in an entity whose financial interests would reasonably appear to be directly and significantly affected by the research funded by the federal sponsor.

Each Investigator is required to submit a DF describing any financial interests held by the investigator, the investigator's spouse or any dependent child of the investigator that the investigator determines to be reasonably related to the investigator's institutional responsibilities.

*** If you are unsure whether you meet the criteria for an Investigator, please contact the Office of Research Compliance at buennepd@jmu.edu.


4.
When do I submit the Disclosure Form?

As required by federal regulation, all Significant Financial Interests by all investigators who are responsible for the design, conduct or reporting of research, including collaborators and consultants, must be disclosed with a DF PRIOR to submission of a federal research funding application.

The DF must be submitted annually during the project period if the research proposal is funded. Additionally, an updated DF must be submitted within 30 days of changes in the investigator's financial interests. Submit your DF to the Office Research Compliance, MSC4901 or by email to, buennepd@jmu.edu.


5. What if I need to update the Disclosure Form?


During the term of the federally-sponsored research project, the employee is required to annually update the DF. If any new Significant Financial Conflict of Interest arises during the term of the externally sponsored project, the employee must notify submit an new DF within 30 days so that any conflict resulting from the changed situation can be identified and reported, and appropriate measures taken to manage, reduce or eliminate the conflict of interest.


6. What are my FCOI training obligations?  


The PI and all investigators must complete appropriate FCOI training prior to engaging in any federally-funded research project. The training must be completed before an award will be accepted from the federal sponsor for a research project. The training must be repeated at least every four years. FCOI training must be completed immediately if the University FCOI policy is revised so as to affect the investigators' obligations, if an investigator is new to the University, or if the University finds an investigator to have violated this policy or any applicable FCOI Management Plan.

The Collaborative Institutional Training Initiative (CITI) Program provides the required FCOI training. The CITI Program is utilized by the University to ensure training is received by faculty, staff, and students engaged in federally-funded research activities. Individuals will receive an automatic notification upon completion of FCOI training. CITI retains a log of all training documentation. Please see the following URL to review the instructions for the required FCOI training and select the Conflict of Interest module: http://www.jmu.edu/sponsprog/research_compliance/conducttraining.html


7. Must I report travel?

Yes, you must disclose the occurrence of any reimbursed travel or expense-paid travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration). You are NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, and other Institutions of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The University will determine if any travel requires further investigation, including determination or disclosure of the monetary value.


8.
What counts as family for purposes of Financial Conflict of Interest Disclosure?

A financial conflict of interest exists under this policy when an investigator or member of his or her immediate family has a significant financial interest that could directly and significantly affect the design, conduct or reporting of research.


9. What should I expect if it is determined that I have a financial conflict of interest?

The Conflict of Interest (COI) Committee, with faculty representation from a broad range of research disciplines, will review the materials related to your financial interest(s) and the proposed research. The COI Committee will develop a recommended FCOI Management Plan and direct it to the Vice President for Academic Affairs.


10. How do I get a management plan?

Once the proposed FCOI Management Plan has been reviewed by the COI Committee and the Provost/Vice President for Academic Affairs, a written FCOI Management Plan will be sent to you for review and signature.  You may contact the Office of Research Compliance if you want to discuss your FCOI Management Plan. 


11. Will I be monitored after I receive an FCOI Management Plan?

The Office of Research Compliance will monitor whether you are following the terms of your management plan.  The approved management plan shall be incorporated into a memorandum that details the conditions or restrictions imposed upon the investigator in the conduct of the project or in the relationship with the business enterprise or entity. The memorandum shall be signed by the investigator and the investigator's supervisor (usually an academic unit head). The memorandum shall also be reviewed by the dean.


12. What are my continuing obligations concerning Financial Conflict of Interest?

You are responsible for updating your DF annually during the period of the federally-funded research project, and within 30 days of identifying or acquiring a new financial interest. Email updated DF's to buennepd@jmu.edu or drop in campus mail to MSC 4901.

 

Additional FCOI Resources

JMU Policy: http://www.jmu.edu/JMUpolicy/2203.shtml

JMU FCOI Disclosure Form: FCOI Disclosure (.docx)

Federal Guidelines

Publication of Revised Regulations in the Federal Register, 8/25/2011
(PDF)

NIH Overview of FCOI Regulation and Changes


NIH Frequently Asked Questions
(last revised October 18, 2012)

NIH FCOI tutorial

Note: THIS TUTORIAL IS SUPPLEMENTARY DOCUMENTATION AND DOES NOT TAKE THE PLACE OF REQUIRED CITI TRAINING

Summary of Major Changes
(.doc)

NIH Regulations: http://grants.nih.gov/grants/policy/coifaq.htm

NSF Policy: http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#510

FDA Regulation:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

 

 

 

 

 

 

 

 

 

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Last Modified May 16, 2013
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