Why does The College of New Jersey have a new policy on Financial Conflicts of Interest?
The new policy on Financial Conflicts of Interest was implemented to ensure compliance with federal regulations. All institutions that apply for and/or receive funding from agencies of the U.S. Public Health Service (at TCNJ this mostly refers to NIH and DHHS funding) are required to have in place a publicly posted Financial Conflict of Interest Policy.
This policy promotes objectivity in Research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of Investigator’s Research performed under Public Health Service (PHS) and National Science Foundation (NSF) sponsored grants or cooperative agreements will be free from bias resulting from Investigator Financial Conflict of Interest.
In accordance with 1) Public Health Service (PHS) Policy 42 CFR Part 50 Subpart F, and 2) National Science Foundation (NSF) policy “Notice No. 117,” an Investigator’s Significant Financial Interests (SFI) must be disclosed to the College.
What is a 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 12 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.
- A SFI exists if you receive income related to the Intellectual Property Rights and Interests (e.g., patents, copyrights) by the Investigator, and/or Investigator’s spouse, and/or Investigator’s dependent children.
- 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/or Investigator’s spouse, and/or Investigator’s dependent children.
Do I have a significant financial interest?
Financial Conflict of Interest exists when the College, through its designated official(s), reasonably determines that an Investigator’s significant financial interest is related to a PHS and/or NSF-funded Research project and could directly and significantly affect the design, conduct or reporting of the Research.
Who is required to disclose?
Under the regulation, Investigators who are planning to participate in, or are participating in, PHS or NSF funded Research, are required to disclose their Significant Financial Interests (and/or those of Investigator’s spouse, and/or Investigator’s 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 funded by PHS and/or NSF, or proposed for such funding, which may include collaborators or consultants.
When do I need to report?
As is required under PHS and NSF 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 Significant Financial Interest Disclosure Form.
In addition, all PHS or NSF-funded Investigators will be required to update their financial conflict of interest status in an Annual Significant Financial Interest Disclosure Form. This form must be completed and returned to the Compliance Officer on or before October 1st, annually, or within 60 days of appointment or within 30 days if a new Significant Financial Interest is obtained.
Does the new Policy require Investigator training?
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:
- TCNJ Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements.
- An Investigator is new to the TCNJ.
- TCNJ finds that an individual is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.
The training requirement was effective August 24, 2012 for any individual awarded a new PHS award.
How is this different from the Outside Activity Questionnaire, Scholarly Capacity Disclosure Form, or Personal and Business Disclosure Form?
The Outside Activity Questionnaire, Scholarly Capacity Disclosure, and Personal and Business Disclosure forms collect information that must be submitted pursuant to New Jersey Statue (NJAC 19:61-6.10(a)). Although addressing some similar information, the information collected on these forms is not sufficient to evaluate potential significant financial interest as it relates to PHS or NSF funded Research and the corresponding federal regulations.