COLLABORATOR Certification

Financial Conflict of Interest (FCOI)

Office of Sponsored Programs (OSP)

The United States Public Health Service (PHS) Financial Conflict of Interest (FCOI) regulations (effective August 24, 2012) mandate that James Madison University (JMU) determine if a collaborator has a PHS-compliant FCOI policy and also requires the collaboratorto disclose certain information should a FCOI be present. JMU will collect this information prior to submission of all federally funded research projects and all PHS funded projects. JMU will also recheck FCOI status of collaborators prior to issuing a subaward or a consulting agreement and throughout the project period.

1. Collaborator Information

Collaborating Entity:

Collaborating Entity’sInvestigator(s):List the principal investigator or project director and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of federally funded research and PHS funded projects (may include, for example, collaborators/consultants.)

Name / Phone # / Email

2. Certification. JMU requires FCOI disclosure from its subcontractors, award subrecipients, and collaborators.By signing this certification,Collaborator hereby certifies that (check all that apply):

Option A

Collaborator entity is registered in the FDP Institutional Clearinghouse, certified as compliant with PHS Financial Conflict of Interest requirements.

AND

Investigator(s) participating in this project will comply with the Collaborator’s Conflict of Interest policy, which:

a)Is publicly accessible;

b)Is in compliance with Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94);

c)Will ensure that investigator(s) have disclosed their financial interests;

d)Will ensure that Collaborator has made any FCOI information publicly accessible;

e)Will ensure that investigator(s) have a current record of completed mandatory FCOI training; and

f)Will ensure that Collaborator will report identified FCOIs for its investigator(s) in a manner to allow JMU to report the FCOI as required by regulation.

OR

Option B

Investigator(s), who are employed by Collaborator, who will participate in the proposed project will comply with the Conflict of Interest Policies of James Madison University (#2203), and

a)Will complete a JMU Conflict of Interest Disclosure Form, prior to application submission, and

b)Will complete mandatory training for Financial Conflict of Interest (FCOI) in compliance with Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94) or federal research funding prior to release of subaward or consulting agreement.

3. Reporting:

Entity agrees to submit the following reports to JMU’s Office of Research Integrity (ORI) in accordance with the due date:

Report Type / Description / Due / CFR Reference
Initial Report: Any Investigator FCOI and management plan / Prior to proposal submission / 42 CFR Part 50.605(b)(1)
42 CFR Part 94.5(b)(1)
Subsequent Report: Any FCOI subsequently identified after initial report and management plan / Within 45 days of identification / 42 CFR Part 50.605(b)(2)
42 CFR Part 94.5(b)(2)
Annual Report: addressing status of FCOI and any changes to management plan / At request of JMU / 42 CFR Part 50.605(b)(1)
42 CFR Part 94.5(b)(1)

Initial and subsequent reports shall include the information required in 42 CFR Part 50.605(b)(3) or 42 CFR Part 94.5(b)(3)

FCOI questions? Contact the Office of Research Integrity at or (540) 568-2318.

4. Collaborator Signature (Authorized Official Only)

Signature of Authorized Official
Name of Authorized Official / Title / Date

Return the completed form(s) to .

If you have questions, please contact Sponsored Programs at (540) 568-6872.

For Office Use Only

JMU PI: JMU Proposal #:

Prime Sponsor:

Proposal Title:

Page 1 of 2