Federal regulations require that all persons who are involved in the design, conduct, or reporting of research must complete an annual COI disclosure. Federal regulations requirements also mandate that faculty, staff and students who are key personnel on research protocols involving the use of human subjects, animals, or biohazardous materials in research also be screened for potential COIs, NJIT requires the completion of this information each time a research proposal is submitted for external funding.
You must report all personal financial interests from external sources, including travel. This would include any interest in a company, business, foundation or other organization that:
- Provides products or services in your academic, clinical, or research discipline or area of study. An example would be a manufacturer that has products in your professional discipline, clinical practice area, or area of research;
- Will likely make use of your scholarly work or research – either directly or indirectly. For example, could the company, foundation or organization use your scholarly work or research in its own product line, or could it be used by a competitor?
- Is a member of an industry, trade, advocacy group or professional association that funds scholarly work, research or is an advocate for funding in your professional discipline or area of study or expertise;
- Has some other relationship not described above that could reasonably appear to impact your research or other obligations to the University;
- You receive royalties directly from intellectual property that you have licensed to an external entity.
A "financial interest" is any monetary value that belongs to you, your spouse or partner, or your dependent children. The financial interest becomes "significant" if it meets ANY of the following conditions:
- All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, when combined, exceeds $10,000 or represents more than 5% ownership interest in any single entity. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
- ANY equity interest held in a non-publicly traded entity, or more than $10,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
- Income from intellectual property rights and interests received from an entity other than NJIT that exceeds $10,000 during the 12 months prior to disclosure.
Please note that the U.S. Public Health Service (PHS) and its agencies define a "significant" financial interest (SFI) at a lower level than do other federal agencies, such as the National Science Foundation, and the university’s longstanding level of $10,000 described above.
Specifically, if you have worked on PHS funded research in the past year, or expect to work on PHS-funded projects this year, a financial interest becomes “significant” if it meets ANY of the following conditions:
- All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, when combined, exceeds $5,000. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
- ANY equity interest held in a non-publicly traded entity, or more than $5,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
- Income from intellectual property rights and interests received from an entity other than NJIT that exceeded $5,000 during the 12 months prior to disclosure.
PHS agencies include the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families (ACF), or Administration on Aging (AOA).
Federal regulations and university policy do not require you to disclose the following types of financial interests:
- Reimbursement or payment of travel paid by NJIT, or covered by a sponsored program agreement managed through the Office of Research;
- Royalties received from NJIT for intellectual property owned by the university;
- Royalties resulting from traditional academic publishing activities such as the publication of text books or other educational materials;
- Any salary or other remuneration paid to you by NJIT.
Faculty, staff, and students are required to disclose the occurrence of any reimbursed or sponsored travel paid for directly or reimbursed by an external entity.
However, this disclosure requirement does not apply to:
- Any travel reimbursed, sponsored or paid for by a U.S. government agency, a U.S. higher education institution, a U.S. academic teaching hospital, medical center, or a U.S. research institute affiliated with a U.S. higher education institution; and
- Any travel reimbursement or payment of travel made by NJIT, a university college, department or unit, or travel covered by a sponsored program agreement managed through the Office of Research.
For research purposes, if you disclose a “significant” financial interest with an outside entity, your e-COI disclosure is reviewed by your department chair or college dean, who determines if the significant financial interest may be related to your institutional responsibilities
For research purposes, if it is determined that a significant financial conflict of interest exists that may directly and significantly affect the design, conduct or reporting of a specific research project, then the case will be reviewed by the Vice Provost for Research.