Financial Conflict of Interest FAQ

The policy on Financial Conflicts of Interest was first implemented to ensure compliance with federal regulations. All institutions that applied for and/or receive funding from agencies of the U.S. Public Health Service are required to have in place a publicly posted Financial Conflict of Interest Policy.
In accordance with the Federal Office of Management and Budget (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 2 CFR 200.112 and a) Public Health Service (PHS) Policy 42 CFR Part 50 Subpart F, and b) National Science Foundation (NSF) policy “Notice No. 117, an investigator’s  actual and potential Significant Financial Interests (SFI) must be disclosed to the University.
This policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under a federally sponsored grant or cooperative agreement will be free from bias resulting from investigator Financial Conflict of Interest.

The term significant financial interest (SFI) means remuneration; equity interests; intellectual property rights and interests (e.g., patents, copyrights and royalties from such rights) reasonably related to the Investigator’s institutional responsibilities, e.g., Research and/or scholarly activities, teaching and advising.
For example:

• An SFI exists if the value of any remuneration received from the publicly traded company in the last twelve months and the value of any equity interest in the company as of the date of disclosure exceeds $5,000.
• An SFI exists if the value of any remuneration received from a non-publicly traded company in the last twelve months before the disclosure exceeds $5,000.
• An SFI exists when the individual holds any equity interest (e.g., stock, stock option, or other ownership interest) in a non-publicly traded company.
• Intellectual Property Rights and Interests (e.g., patents, copyrights)-An SFI exists if you receive income related to the rights and interests by the individual and/or their spouse and dependents.
• An SFI exists in an occurrence of any reimbursed or sponsored travel related to their institutional responsibilities; however, does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, or an institution of higher education.

* The financial interests that must be disclosed by the Investigator include the aggregated amounts or values of financial interests held by the Investigator and his/her spouse and dependent children.
Financial Conflict of Interest exists when the University, through its designated official(s), reasonably determines that an Investigator’s significant financial interest is related to a federally-funded Research project and could directly and significantly affect the design, conduct or reporting of the Research.
The term SFI does not include:

• salary, royalties or other remuneration from the University;
• nominal income from service on advisory committees or review panels for public or nonprofit entities;
• royalties or other payments from publicly traded entities, when aggregated for the investigator, and the investigator’s spouse, partner and immediate family, are not expected to exceed $5,000 during the previous twelve-month period;
• income from self-authored textbooks, software, etc. that are used for the investigator’s teaching purposes;
• travel related or sponsored travel related to institutional responsibilities that is reimbursed by a federal, state, or local government agency, or an institution of higher education as defined at 20 U.S.C. 1001(a);
• income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control decisions made on the investment vehicles;
• income from seminars, lectures or teaching engagements sponsored by and service on an advisory or review panel for federal, state, or local government agency, or other institution of higher education
• unsolicited gifts or items that are of nominal value

Under the regulation, Investigators who are planning to participate in, or are participating in, federally-funded Research, are required to disclose their Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.
Investigator means the Project Director, Principal Investigator, or any other person regardless of title or position who is responsible for the design, conduct or reporting of Research federally-funded or proposed for such funding, which may include collaborators or consultants.

As is required under the policy, all Investigators involved in the design, conduct and reporting of the Research must disclose at the time of submission if they have any SFIs on the Routing Form and if necessary utilize the Proposal Significant Financial Interest Disclosure Form to provide further details. If the conflict or SFI arises between proposal and award, the investigator is responsible for utilizing the Proposal Significant Financial Interest Disclosure Form to provide further details.
In addition, all federally-funded Investigators will be required to update their financial conflict of interest status in an Annual Significant Financial Interest Disclosure Form. A request for these forms will be sent out to investigators in the first quarter of the fiscal year. The form should be completed within 1 week of the receipt of the initial request. If a new Significant Financial Interest is obtained, the investigator should contact the Office of Research Compliance at ric@montclair.edu within 30 days.

At present, only PHS investigators are required to take COI training through the Collaborative Institutional Training Initiative (CITI) Program, although NSF investigators are encouraged to complete training since the NSF’s requirements are very similar to PHS.  Each PHS Investigator must complete training prior to engaging in PHS funded Research and at least every four years, and immediately under the designated circumstances:

• Montclair State University Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements.
• An Investigator is new to the University.
• The University finds that an individual is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.

The training requirement will begin August 24, 2012 with any individual awarded a new PHS award.

The Outside Activity Questionnaire and Annual College & University Disclosure collect information that must be submitted pursuant to New Jersey Statue (NJAC 19:61-6.10(a)). Although similar, the information collected is not sufficient in evaluating potential significant financial interest as it relates to federally-funded Research and the corresponding federal regulations.

The Outside Activity Questionnaire will collect information about international collaboration related to research activities.

You will receive an email from Research Compliance with an attached Microsoft Word fillable form. You may download, complete, sign and email the form back to ric@montclair.edu. Copy your Chair or Supervisor on the return email so they may sign and return the form to ric@montclair.edu, as well. Alternatively, you may print, complete, have both parties sign and then scan/email or send via interoffice mail to the Office of Research Compliance at The School of Nursing and The Graduate School Building, Room 333.

After you sign the form, either copy your Department Chair/Dean on the return email or send it as a separate email for their signature, asking them to return it to us. Alternatively, you may print it out and have your supervisor provide a physical signature. That document can be scanned or sent via interoffice mail to the Office of Research Compliance at The School of Nursing and The Graduate School Building, Room 333.

You as an investigator should only fill out one form and list every funded project that you are working on on the same form. Such projects are not limited to ones in which you are the PI; if you are a member of the research team or Co-PI on other projects, you should list those as well.

Yes, it is an annual requirement.

Noncompliance will be reported to the Office of Sponsored Programs. Should the form be more than 60 days past due, Grants Accounting will be notified and current award spending may be paused or suspended at the discretion of the Grants Accounting Director.

You can contact the Office of Research Compliance at ric@montclair.edu.