Significant Financial Interest Disclosure Pocket guide for Faculty and Investigators
Who is covered by the regulation?
The regulation is applicable to each Institution that applies for NIH grants or cooperative agreements for research, NSF grants or contracts, or
submits a proposal for a research contract whether in response to a solicitation or otherwise and, through implementation of the regulation by
each Institution, to any Investigator participating in that research (see regulatory definition of Investigator, discussed in separate questions,
below). An Institution is defined as any domestic or foreign, public or private, entity or organization (excluding a Federal agency).
Does the regulation apply to all grants/research contracts awarded by NIH?
No. This regulation does not apply to Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) program
applications or awards. The regulation also does not apply to training and fellowship awards funded under the “T” and “F” award mechanisms and
to Research Construction Programs funded under C06 and UC6 award mechanisms.
Who is considered an “Investigator” for this purpose?
An “Investigator” is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research
funded by the NIH, or proposed for such funding, including subgrantees, contractors, or collaborators. The definition of Investigator includes the
Investigator’s spouse and dependent children.
Process at Rowan University
1)
2)
For all PHS and PHS operational agencies and NSF of which funding is sought and the purpose is research, need to disclose significant
financial interests
Self-report any Significant Financial Interests (SFI) via Significant Financial Disclosure Form to the Office of Research and/or Office of
Sponsored Programs
Significant Financial interest Criteria
Publicly traded companies:
I. Any remuneration received within the 12 months preceding disclosure and in aggregate or alone exceeds $5,000
a. Remuneration includes salary, consulting fees, honoraria, paid authorship
II. Any equity interest at the time of disclosure and in aggregate or alone exceeds $5,000
a. Equity interest includes stock options or other ownership interest
Non-publicly (Private) traded companies:
I. Any remuneration received within the 12 months preceding disclosure and in aggregate or alone exceeds $5,000
a. Remuneration includes salary, consulting fees, honoraria, paid authorship
II. Any equity interest at the time of disclosure
a. Equity interest includes stock options or other ownership interest
Travel:
I. Purchased and made on behalf of the Investigator, amount is not readily available and unknown
a. Amount of travel is not required on disclosure form
b. Additional information may be required to determine if the significant financial interest is a financial conflict of interest
Consulting Agreements and Engagements:
Were/are in effect for the 12 months preceding the disclosure
Significant Financial Interest Examples
 IP developed by the Investigator that is being used, tested, or further developed in the research
 IP owned by the institution and optioned/licensed to an entity in which the investigator has an SFI that is being used, tested, or further
developed in the research
 Products / services being provided or purchased from a company in which the Investigator has an SFI
 The Investigator has an SFI in a company which manufactures or sells a concomitant or comparator drug or device, or procedure
 The Investigator has an SFI in an entity to which research space will be leased or from which research space will be rented
 Entity in which the Investigator has an SFI is a sub-recipient under the proposed research
 The Investigator will be involved in research under a subaward from an entity in which she/he has an SFI
 The Investigator has an SFI in an entity that is part of a consortium or will otherwise participate in the research
 The Investigator is a founder, holds a management or executive position, serves on a board, is a consultant (with or without compensation),
and / or he/she has received travel income/reimbursement from an entity whose products or services will be used in, are the subject of
and/or are closely aligned with the research
3)
4)
5)
6)
7)
Disclosure Review Committee or designee will make a determination whether or not an SFI is a Financial Conflict of Interest
a. If an FCOI exists, the FCOI needs to be reported
b. Mandatory Conflict of Interest training will be required after award notice but prior to fund creation and use of funds
Investigator has a right to appeal the decision made by the Disclosure Review Committee or designee
Disclosure Review Committee or designee will recommend and implement a management plan to effectively minimize, reduce, or
eliminate the conflict
a. Investigator can take part in the development of the management plan
Investigator has a right to appeal the management plan
Upon successful agreement and creation of management plan, research can begin
Investigator SFI Disclosure and Institutional FCOI Reporting Requirements
Investigator Discloses known
SFI(s) to the Institution
Institution Reports identified FCOI(s) to the NIH and NSF
(Designated official(s) review the disclosures to make determinations of FCOIs and report any FCOIs to NIH.)
At time of Application
Prior to the Expenditure of Funds
Within 30 days of acquiring or
discovering SFI
Within 60 days of identification
Annually at the time period
prescribed by the Institution
during the award period
Annually: At the same time as when the grantee submits the annual progress report or the extension of project.
Annual FCOI report is submitted through eRA Commons FCOI Module.
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Version Date: 03/22/2016