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1. What is a conflict of interest?
There are two personnel status classifications that conflict of interest has a direct application or impact on the conduct of their duties and responsibilities: employees and researchers.
For all employees at PVAMU, the basic definition of a conflict of interest refers to a situation in which outside financial interests or other personal considerations have the potential to compromise or have the appearance of compromising an employee's actions or judgments in the administration, management, or performance of their professional activities.
For researchers at PVAMU, the definition is more specific as it refers to a situation in which outside financial interests have the potential to compromise, or have the appearance of compromising, a researcher's professional actions or judgments in the designing, conducting, or reporting of their research results.
2. What is a financial interest?
A financial interest is anything of economic value, including a fiduciary relationship with an outside entity. Financial interests are the most important component or components of a conflict of interest for researchers. Some examples include, but are certainly not limited to:
Salaried or unsalaried positions with the sponsor or entity
Scientific advisory board memberships
Vested or non-vested stock or stock options
Income received through honoraria or consulting
Financial interests do not include monies derived from licensing fees or royalty income paid to TAMUS by the research sponsor. A sponsor's support for a research project, such as salary support paid by PVAMU from the grant or the reimbursement of study-specific travel costs, is not considered a financial interest.
3. Who must disclose? For Non-Federal Sponsored Research:
The principal investigator at PVAMU must disclose their financial interests; as well as the financial interests of their spouse, and/or their dependent children.
For Federal Sponsored Research:
The researcher at PVAMU is not the only individual who must disclose their significant financial interests. According to federal guideline, disclosure of financial interests extends to all other individuals who have responsibility for the: design, conduct, or reporting of research results for the sponsored project, as well. These individuals can include co-principal investigators, other investigators, and other individuals participating in the project.
4. When do I need to disclose? For Non-Federal Sponsored Research:
Disclosure is required with the initial proposal, renewal or additional funding and whenever there is a change in PI or if the PI has a change in reportable financial interests during the term of an award for which disclosure is required. The PI must disclose prior to final acceptance of a contract, grant, or gift.
For Federal Sponsored Research:
The researcher and all other individuals who have responsibility for the design, conduct, or reporting of research results for the sponsored project must disclose their financial interests at the time of the initial proposal submission, continuation, renewal or supplemental funding and whenever new personnel are added. Researchers must disclose if there is a change in reported financial interests occurring prior to or during the period of an award.
5. What financial interests must be disclosed? For Non-Federal Sponsored Research:
A financial interest refers to the direct financial relationship between the principal investigator and the non-federal sponsor, or indirectly through their spouse, their registered domestic partner, or their dependent child. Some examples of what must be disclosed includes:
Equity holdings in the sponsor
Management positions with the sponsor
Consulting income received from the sponsor
Honoraria received from the sponsor
Principal investigator's spouse or registered domestic partner being an employee of or having a financial interest in the non-federal sponsor
For Federal Sponsored Research:
A financial interest refers to the direct financial relationship between the researcher and an entity other than the federal sponsor. This is also referred to as a related financial interest and only applies to entities that could benefit from the results of the federal sponsored project. Some examples of what must be disclosed includes:
Equity holdings in the entity
Management position with the entity
Consulting income received from the entity
Honoraria received from the entity
6. When can a conflict of interest occur?
There are several instances when a conflict of interest can occur:
When an opportunity arises to influence PVAMU's business decisions, which produces personal financial gain for an employee, thus potentially compromising the integrity of decisions they may make as researchers, teachers, and providers of patient care in consideration of personal financial interests.
When an employee has a significant financial interest in a company that is providing funding for the employee's research or other PVAMU activity.
When research directly and significantly affects the financial interest of an employee who has the responsibility for the design, conduct, and reporting of their research results.
7. What do I need to submit? For Federal Sponsored Research:
Submit the Form 15.0103 - Disclosure of Financial Interests Related to Federal and Other Sponsored Projects Adopting the Federal Requirements for projects being sponsored by:
National Institutes of Health (NIH), as well as other DHHS sponsors
National Science Foundation (NSF)
American Cancer Society (ACS)
American Heart Association (AHA)
For more detailed information and requirements regarding the Form 15.0103, click here. For a Federal sponsor:
A financial interest refers to the direct financial relationship between the researcher and an entity other than the federal sponsor. This is also referred to as a related financial interest and only applies to entities that could benefit from the results of the federal sponsored project. Some examples of this include; equity holdings in the entity, a ]\management position with the entity, consulting income received from the entity, and/or honoraria received from the entity.
In addition to these relationships mentioned, and the various types of financial interests, the equity and dollar thresholds that must be disclosed also differ depending upon whether the researcher is requesting funding from a non-federal or a federal sponsor.
8. Is a financial interest automatically a conflict of interest?
Having an outside financial interest is not automatically a conflict of interest. A point of information is that some financial interests are of such low value and/or limited duration that they do not meet the definition or threshold of disclosable financial interests, or are so nominal or inconsequential that the research support from the sponsor can be accepted with no further action. Additionally, almost all disclosed financial interests and resulting conflicts of interest can be reduced, eliminated, or managed so that the research project can be accepted and funded by the proposed sponsor.
9. Who reviews financial disclosures to determine if a conflict of interest exists?
The Independent Review Committee (IRC) on Conflict of Interest is a panel of faculty members from disciplines across the campus that functions as the principal advisory committee to the vice president for research and graduate studies for conflict of interest related to research. The IRC meet on a bimonthly basis, or as needed, to review disclosures of financial interests to determine whether these interests constitute significant conflicts of interest that must be eliminated, reduced, or managed before research support can be accepted. If the IRC determines that the research support may be accepted, they then also recommend to the vice president for research and graduate studies appropriate strategies for the management of any significant conflict.
10. Are there set rules or general guidelines as to what may or may not be acceptable financial interests?
The Independent Review Committee (IRC) reviews each financial disclosure in accordance with the federal guideline, system regulations and policies, and local university rules and procedures. In general, the IRC asks:
Are the research interests and the private interests kept separate?
Is the research appropriate to the University?
Is the teaching and research environment open?
Is there freedom to publish?
Have licensing agreements been appropriately reviewed?
Are PVAMU facilities used appropriately?
The IRC then determines whether the financial interest represents a real or perceived conflict of interest, and if so, whether any action should be undertaken to eliminate, reduce, or manage the conflict of interest. The IRC applies standards that have evolved over time, based on their prior experience, the appearance of new types of conflicts, and input from the local and national research community. 11. What happens if the IRC determines that a conflict of interest exists?
If the Independent Review Committee (IRC) determines that the disclosed financial interests constitute a real or perceived conflict of interest, they will recommend actions designed to eliminate, reduce, or manage the conflict of interest. In some instances, the IRC may simply recommend disclosing the interest in all presentations, abstracts and publications.
Depending on the facts, the IRC may also recommend other measures such as divestiture of all equity interest in the sponsor or elimination of any consulting arrangement with the sponsor or other entity. In some cases, the IRC may attempt to mediate the conflict of interest situation by recommending changes in financial arrangements to protect the interests of PVAMU, or implementing some form of faculty accountability for research by monitoring and oversight.
12. Can I start a company or serve on a board of directors?
Yes, the PVAMU's conflict of interest policy does not prohibit investigators from starting their own company or serving on a board of directors. However, where such outside activities are related to the investigator's research, the investigator must report his or her interests to the IRC. If the IRC determines that these interests may conflict with the research, the Committee will require the investigator to take steps to manage, reduce or eliminate the conflict before the research can proceed. Investigators who are contemplating starting a new company or serving on a board can contact the Conflict of Interest Office to discuss possible conflict of interest issues.
13. I have a financial interest in an outside company; can they sponsor my research project at PVAMU?
Yes, but financial interest(s) must be disclosed using the proper form(s), and the Independent Review Committee (IRC) must review the disclosure to determine whether the interest(s) constitute significant conflicts of interest that must be eliminated, reduced, or managed before research support can be accepted.
14. I have a financial interest in a company that wants to apply for an SBIR or STTR grant; can I participate?
Yes, but generally not in both the research being conducted by the company and research to be conducted at PVAMU, as the academic collaborator.
The Principal Investigator for the small business and the Principal Investigator for the subcontracted work to PVAMU must be different individuals. If a PVAMU Principal Investigator has significant financial interest in a small business entity, that individual may not bring research into his/her own laboratory under a SBIR or STTR subcontract from that same small business.
15. What if my project involves human subjects?
Special concerns arise when human subjects are involved, as the research subjects may be placed at additional risk because of an investigator's financial interests. Situations that warrant additional consideration by the IRC include those where an investigator has a financial interest in the sponsor or manufacturer of a product being tested in human subjects, or in which the investigator is the inventor of the product.
In such situations, the IRC maintains that any research involving human subjects must be free of conflict of interest and recommends that individuals who have independent roles in projects and who are responsible for the design, analysis, conduct, or reporting of the research performed (or to be performed) under a human subjects protocol shall not concurrently receive any compensation from the sponsor or other entity supplying materials, drugs or devices for the project, including honoraria and consulting fees, during the course of the study.
However, the IRC will also consider:
The investigator's role in the project.
Whether the investigator is involved in subject selection, including prescreening for inclusion/exclusion criteria.
Participation of the investigator in the consent process.
Investigator participation in clinical treatment of subjects, separate from the research interventions or procedures.
The design of the clinical study; whether it is a single-site, investigator-initiated study or a multicenter study with oversight provided by a sponsor or other third party.
16. Are there special considerations for involving students in research if I have a financial interest?
Yes, PVAMU graduate students and post docs may not be involved in a company in which their dissertation adviser or faculty mentor has a significant financial interest. Involvement means they may not be employed in the company, undertake training in the company, or do their dissertation research in the company. Students and postdocs may undertake educationally-related research activities at companies as long as the following conditions are met:
The faculty adviser does not have a significant financial interest in the company.
The company places no confidentiality or non-disclosure restrictions on the student and permits the student to freely discuss and publish the results of his work without delays.
Any company patent agreement the student is required to sign be reviewed and approved by the University.
The Office of Graduate Studiescan provide additional information on the responsibilities of faculty members to students as teachers, mentors, or supervisors of research.
17. Are my financial disclosures treated confidentially?
Yes, the details of personal financial interests reported to the campus are treated sensitively and confidentially and are shared only on a need to know basis within PVAMU. The decision of the IRC may be shared with PVAMU officials as deemed necessary. In cases relating to projects involving human subjects, the recommendation will be shared with the IRB. It may also be shared with the research sponsor if requested. Other than these mandated disclosures or limited internal disclosures, the information is treated as confidential. However, under Texas law, information disclosed to the University must be made available to the public, upon request.
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