Conflict of Interest (COI)

The term “conflict of interest (COI) in research” refers to situations where reasonable observers would believe that an investigator’s outside financial interest/s or obligation/s have the potential to inappropriately influence his/her judgment or actions in designing or conducting or reporting research or cause harm to human subjects participating in a research project. Such situations could also affect how staff are hired and how materials are procured. Similarly, “conflict of commitment in research” refers to situations where the external activities, either paid or unpaid, interfere with an investigator's primary research obligation and commitment to the university. Both occur when university members are in a position to derive personal benefit from actions or decisions made in their official capacity. Conflict of interest/commitment situations are inevitable because NJIT community members often interact in their private consulting/public service capacities with industry, government, community groups, and professional organizations. Being in this situation is not unethical, but not recognizing and not reporting them is, and this could tarnish the reputation of the researcher, his/her department, the institution, and also result in fines and loss of funding/employment. To protect against actual conflicts of interest and commitment and to guard against any perceived conflicts, every NJIT researcher must disclose his/her external professional activities and any financial interests in entities that he/she and his/her immediate family members may have that are related to his/her institutional responsibilities.

Federal regulations require any investigator applying for or receiving funding from the Public Health Service (PHS) (including the National Institutes of Health and the Centers for Disease Control and Prevention), sponsors adopting the PHS regulations, or the National Science Foundation (NSF) must submit a financial conflict of interest (COI) disclosure form at least once annually. NJIT also requires the completion of this information each time a research proposal is submitted for external funding. Additionally, NJIT researchers who are responsible for the design, conduct, or reporting of NIH funded research are required to take COI training at least every four years.

All researchers have an obligation to become familiar with, and abide by, the provisions of NJIT Financial Conflicts of Commitment and Interest (FCOI) on Sponsored Research Projects policy.

Reporting Conflict of Interest

The Office of Research is committed to ensuring that the personal interest/s of all NJIT researchers do not unduly influence his/her primary obligations to science, sponsors, university, colleagues or students. The purpose of the project specific and annual disclosure and certification processes are to confirm that the Office of Research has a complete, accurate, and up-to-date account of all NJIT researcher’s reportable outside activities and/or financial interests. As part of the disclosure process, researchers must certify that they are in compliance with all applicable NJIT policies and procedures. All NJIT researchers must complete an Annual Disclosure and Certification, and are also required to disclose, within 30 days of any change to their outside professional activities and interests.

The following activities are examples of potential conflict of interest situations:

Accepting gratuities or favors (including equipment gifts or loans) from companies sponsoring your research or doing business with the University or that makes product/s that you are researching or developing;
Accepting excessive honoraria for lectures at companies/entities that have an interest in your scientific or scholarly expertise and that also have the potential to benefit financially from your research;
Working for or conducting any kind of research (including assigning your students) for a company/entity in which you have equity ownership or that has an interest in your research or that seeks to patent and license your invention;
Assigning a textbook or text for which you receive royalties as “required reading” for a course;
Representing the University for the purchase of materials/equipments from a company/entity in which you and your immediate family members have a financial interest or influencing NJIT business dealing with such company/entity in any way;
Providing privileged information developed at NJIT to a company/entity in which you and your immediate family members have a financial interest;
Accepting gifts from students/fellows who work on your research project and whom you must evaluate;
Providing or receiving financial bonuses for recruiting a targeted number of research subjects;
Holding any official or membership position on a board or committee of an company/entity that supports your research at NJIT or having any equity interests and/or stock options in that company/entity;
Receiving royalties or other licensing proceeds from intellectual property that you invented at NJIT;
Entering into a Materials Transfer Agreement or Human Tissue Agreement (MTA/HTA) to provide materials used in your research to an external company/entity; and
Accepting a publication restriction condition in a research contract or imposing restrictions on disclosure of research findings and the actions of students/trainees at the request of a sponsor or a company/entity that has the potential to benefit from your research.

If a situation raising questions of conflict of interest arises, a researcher should discuss the situation with his or her department Chair or lab/division head or with the assistant director for research compliance and integrity or the executive director of sponsored research at the Office of Research.

All COI disclosures must be submitted via Streamlyne. For Streamlyne COI training and access information, go here.

While most disclosures of conflict of financial interests and conflict of commitment will be deemed de minimus or not significant in terms of potential effects on the individual’s ability to perform his or her NJIT duties without any undue influence, financial interests and commitments above thresholds will automatically be deemed significant and will require closer scrutiny and possible management, mitigation, and/or elimination.

Significant Financial Interests

Financial interest means anything of monetary value, including but not limited to compensation, equity, gifts, and intellectual property of an investigator or the immediate family member of an investigator, whether or not the value is readily ascertainable. It refers to financial interests related to the institutional responsibilities of an investigator and 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.

If NJIT determines that a conflict of interest situation could unduly influence the research, the conflict will either be managed or mitigated or eliminated according to a management plan provided to the researcher by the Office of Research. Other administrative actions, such as embedding a financial interest disclosure in the publication and public talks to allow the audience to form their own opinions may be required. Some common strategies for managing, mitigating, or eliminating conflicts also include:

Training on conflicts of interest and commitment for all involved researchers
Monitoring and oversight of the research activity by an impartial third-party
Modifying research design to either remove the conflicted researcher from participation in all or a portion of the research
Divestiture of significant financial interests
Prohibiting unacceptable levels of commitment/private interests
Creating, implementing, and enforcing effective conflict of interest management plans
Instituting a process to review the outcome or product produced by the researcher/s and the research by non-conflicted experts

US Public Health Service (PHS)

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).

If NJIT makes a determination that PHS agency funded investigators have a Financial Conflict of Interest, it will implement a management plan and report it (along with the management plan) to the PHS funding agency within 60 days.

NJIT is also required to make information regarding Financial Conflict of Interest reported to PHS accessible to the public upon PHS request.

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.