Financial Conflict of Interest

National Institutes of Health (NIH) Revised Financial Conflict of Interest Regulations & New University of Manitoba Procedures

The NIH as part of the US Public Health Service has a revised  financial conflict of interest (FCOI) regulation that includes new disclosure, reporting and training requirements (42 CFR Part 50 Subpart F, Promoting Objectivity in Research).

The purpose of the FCOI regulation is to “promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator.”

Applicability

This regulation is applicable to each institution (including foreign institutions) that applies for or receives NIH grants or cooperative agreements for research and to each investigator planning to or participating in such research. This includes sub-grantees, contractors, consortium participants, collaborators and consultants.

For purposes of financial disclosure only, the regulation covers the investigator’s interests (and those of their spouse and dependent children) that reasonably appear to be related to the investigator’s institutional responsibilities (i.e., your professional responsibilities related to teaching, research and service on behalf of the University of Manitoba).

Investigators also must disclose the occurrence of any reimbursed or sponsored travel ( i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution 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.

Definition of FCOI

FCOI means “a significant financial interest that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.”

Significant Financial Interests include:

  • Compensation and other payment for services > $5,000 (e.g., consulting fees, paid authorship, and honoraria);
  • Equity interests (e.g. stocks, stock options, and other ownership interests); and
  • Intellectual property rights (e.g., patents, copyrights, and royalties).

Significant Financial Interests do not include:

  • Salary, royalties, or other remuneration paid by the University of Manitoba to the investigator if the investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;
    • Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution 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; or
  • Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution 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.

New University of Manitoba Procedures

All University of Manitoba faculty members who are planning to participate or who are participating in NIH-funded research must follow the steps below:

  • Complete and submit a Financial Interests Report form
The Form is required at the time of application or before a NIH sub-grant agreement is signed on behalf of the investigator. It is to be completed thereafter on an annual basis while holding a NIH grant or a NIH sub-grant agreement. The completed form must be submitted to the Office of Research Services for review by the University’s designated official. This form must also be completed immediately upon discovering or acquiring (e.g., through purchase, marriage or inheritance) a new significant financial interest.
Investigators are required to complete the NIH online tutorial and provide a copy of the Certificate of Completion to the Office of Research Services. Investigators are required to renew their training every four years while holding NIH funding.

University of Manitoba Responsibilities

If a significant financial interest has been declared, the University’s designated official will assess whether a FCOI exists and whether any significant financial interests relate to NIH-funded research. If the existence of a FCOI is confirmed, the designated official will implement a management plan to manage such FCOI.

In accordance with the revised regulation, if a significant financial interest is deemed to be a FCOI, is found to be related to NIH-funded research and has been disclosed and is still held by the investigator, the University of Manitoba is required to make this information publically accessible (e.g., on its website). Specifically, the University must make the following information available for at least three years:

  • Investigator’s name, title, and role with respect to the research project;
  • Name of the entity in which the investigator has an FCOI; and
  • The nature of the significant financial interest and its approximate dollar value.

For more information on international research grants, or if you are in the process of applying for a funding opportunity involving international research, contact:

Michelina Violi
Research Grants Officer (International)
Tel: (204) 789-3428


QUICK LINKs:

Financial Conflict of Interest Declaration Form

UM Conflict of Interest Policy

NIH Financial Conflict of Interest homepage

NIH Frequently Asked Questions

Subrecipient Commitment Form