Virginia Polytechnic Institute & State University (Virginia Tech)
Office of Research – Sponsored Programs (OSP)
EXTERNAL ENTITY FINANCIAL CONFLICT OF INTEREST (FCOI) CERTIFICATION
Instructions
Section 1: Entity-List the entity that is involved in the research. If this is a consultant acting in their individual capacity outside of their institution, list the individual’s name not their affiliated institution. Entity PI-List the lead PI of the subcontract institution. If a consultant, list the name of the person conducting the work. Project Title/VT PI-Please provide a project title and name of lead VT PI.
Section 2: Certification of Compliance with PHS regulations-You must select A or B. Select A if you are following your institution’s PHS compliant policy. Select B, if you are following Virginia Tech’s PHS compliant policy.
******Consultants acting in an individual capacity outside of their institution or entities without a PHS compliant policy MUST follow Virginia Tech’s policy, complete the Virginia Tech Conflict of Interest training and complete a 3rd party travel disclosure prior to conducting work on this project. Upon award, the Virginia Tech COI Office will request the above actions be completed.
Section 3: Initial FCOI Report-select one of the options. If there is an identified FCOI, please attach a disclosure that describes in detail the conflict of interest. Any new FCOIs identified hereafter must be disclosed to VT within 45 days.
Section 4: Signature of External Entity’s Authorized Official-If you are following an institution’s PHS compliant policy the institution’s AOR must sign this form. If you do not have a PHS compliant policy, the individual should sign this form.
All investigators involved in this project must comply with the PHS policy that includes disclosure of significant financial interests. Investigator is defined in 42 CFR Part 50.603 or 45 CFR Part 94.3 as anyone regardless of position or title that is responsible for the design, conduct, or reporting of research.
In Accordance with 42 CFR Part 50 or 45 CFR Part 94 all External Entities responsible for design, conduct or reporting of research must complete this form when submitting a proposal to Virginia Tech to receive funding
from the United States Public Health Service (PHS).
This form will be incorporated as an attachment into any subaward resulting from this proposal.
1. / External Entity:Entity PI:
Proposal Title/VT PI:
2. / Certification of Compliance with PHS regulations
Check ONE of the following options (MANDATORY):
- ☐ Entity’s Investigators* will comply with the Subrecipient’s Financial Conflict of Interest Policy as follows
- Entity certifies that its policy complies with the requirements of 42 CFR Part 50 and 45 CFR Part 94
- Entity agrees to submit the following reports to Virginia Tech OSP in accordance with the due date:
Report Type / Description / Due / CFR Reference
1. / Initial Report: Any Investigator FCOI and management plan / In Section 3 Below / 42 CFR Part 50.605(b)(1)
45 CFR Part 94.5(b)(1)
2. / Subsequent Report: Any FCOI subsequently identified after initial report / Within 45 days of identification / 42 CFR Part 50.605(b)(2)
45 CFR Part 94.5(b)(2)
3 / Annual Report: addressing status of FCOI and any changes to management plan / As designated in the NIH Prime Award Document / 42 CFR Part 50.605(b)(1)
45 CFR Part 94.5(b)(1)
Initial and Subsequent reports shall include the information required in 42 CFR Part 50.605(b)(3) or 45 CFR Part 94.5(b)(3)
- ☐ Entity’s Investigators* will comply with Virginia Tech Financial Conflict of Interest Policy found at
- Entity agrees to submit all Investigator disclosures of significant financial interests to Virginia Tech in accordance with the timelines specified in the Virginia Tech FCOI policy section 3.2
- Entity agrees all Entity Investigators will complete the Virginia Tech FCOI training prior to engaging in research related to this PHS funding and at least every four years and other circumstances as described in 42 CFR
3. / Initial FCOI Report
Check ONE of the following options (MANDATORY):
☐Entity certifies that there is currently no FCOI for any entity Investigators on this proposal and agrees to notify Virginia Tech OSP of any subsequently identified FCOI within 45 days of identification
☐Entity certifies that the attached disclosure of FCOI for all entity Investigators on this proposal and is a complete, current list and agrees to notify Virginia Tech OSP of any subsequently identified FCOI within 45 days of identification
4. / Signature of External Entity’s Authorized Official
Printed Name / Signature / Date
*Investigator is defined in 42 CFR Part 50.603 or 45 CFR Part 94.3 as anyone regardless of position or title that is responsible for the design, conduct, or reporting of research.
Revised: 10/15/2018