Financial Conflict of Interest FAQ
- Why does Montclair State University have a new policy on Financial Conflicts of Interest?
- Do I have a significant financial interest? And when is it a financial conflict of interest?
- Who is required to disclose?
- When do I need to report?
- Does the new Policy require Investigator training?
- How is this different from the Outside Activity Questionnaire or Annual College & University Disclosure Form?
- How do I find the form I need to fill out?
- How should I obtain my supervisor's signature? Should I print out the form and have them sign a copy?
- Can I fill out the form on my phone?
- How do I submit the form? Should I email it as an attachment or print it out?
- I have multiple funded studies, but I only received one link to fill out the form. How do I fill out a form for every project?
- I have already filled out this form before, do I need to fill it out again?
- What happens if I don't fill out the form?
- I'm not sure if I have a significant financial interest to disclose. Who can I contact with any additional questions?
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.
- A 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.
- A 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.
- A 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)-A 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.
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.
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 Signiciant Financial Interest is obtained, the investigator should contact Research Compliance and Regulatory Programs at email@example.com within 30 days.
At present, only PHS investigators are required to take training, 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:
- MSU Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
- An Investigator is new to the MSU
- MSU 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.
How is this different from the Outside Activity Questionnaire or Annual College & University Disclosure Form?
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 federally-funded Research and the corresponding federal regulations.
You will receive an email from Research Compliance from the address firstname.lastname@example.org with a link to fill out the form via Adobe Sign.
How should I obtain my supervisor’s signature? Should I print out the form and have them sign a copy?
After you sign and submit the form, it will automatically be sent to your supervisor. You will receive a final PDF copy of the form once it has been signed by all parties.
Adobe Sign is mobile-friendly, and you should be able to sign it from your mobile device.
When you sign and submit the form with Adobe Sign, it will automatically move forward in the workflow. You do not need to email us a copy of the form or print it out unless you wish to keep a hard copy for your own records.
I have multiple funded studies, but I only received one link to fill out the form. How do I fill out a form for every project?
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 Research and Sponsored Programs.
I’m not sure if I have a signifciant finacial interest to disclose. Who can I contact with any additional questions?
You can contact the Research Compliance and Regulatory Programs at email@example.com.