Conflicts of Interest (COI)
Financial Conflicts of Interest in RSCA (COIR)
Faculty who participate in RSCA may have to disclose additional information on Conflicts of Interest. The type of disclosure that you must complete and the information that must be disclosed depends on the source of funding.
Regardless of the funding source, the information disclosed is reviewed by the Associate Vice President for Research (AVP) or their designee. As it would be difficult (if not impossible) to determine whether or not any particular financial relationship has caused bias in a project, this review seeks to identify the faculty member’s financial interest could directly and significantly affect the design, conduct, or reporting of the research, or that the outcome of the research could potentially impact the faculty member’s financial interest.
If the AVP determines that the potential for a Financial Conflict of Interest exists, they will recommend a plan to manage this potential and ensure that the RSCA activities can proceed unimpeded. The AVP will ask the faculty member to agree to the management plan, along with their department chair and dean.
SJSU will keep all disclosures confidential to the extent possible. However, it is important to remember that FCOI disclosure documents may be considered a public record and information from some federal disclosures may be requested under the Freedom of Information Act.
Resources
Academic Senate Policy S99-11 [pdf]
Privately Funded RSCA
The State of California requires the Principal Investigator (the person with principal responsibility for the research) to complete the 700-U form if:
- The research is funded or supported, in whole or in part by a contract or grant from
a nongovernmental entity; or
- The research funds from a nongovernmental entity have been earmarked by the donor
for a specific research project or a specific researcher.
Please note that some non-profit entities are exempt from these regulations. To find out if your non-profit sponsor is exempt, please contact Research Compliance.
Some examples of RSCA projects that would require a 700-U disclosure are:
- Gift funds from a private company to a single researcher;
- A grant from a non-exempt nonprofit foundation;
- Research funds form a pharmaceutical company to carry out a clinical trial.
Resources
Government Funded RSCA
Each federal and state agency has different rules regarding what information needs to be disclosed. All investigators (anyone responsible for the design, conduct, or reporting of the research) must complete the SJSU Disclosure Form for Government Funded Research if your research is funded by any federal, state, or municipal agency.
Frequently Asked Questions - Conflicts of Interest in RSCA
Training
Q: I was told that I must take the CITI COI training before my proposal can be submitted, but I’ve already taken COI training through CSU Learn. Why isn’t my CSU Learn COI certificate sufficient?
A: The COI training through CSU Learn focuses on California Regulations related to conflicts of interest that apply to all state employees. The CITI COI training, on the other hand, covers federal regulations that are specific to conflicts of interest in research activities. The scope of the two courses is very different, and therefore, we cannot accept the CSU Learn training certificate in place of the CITI COI certificate.
Q: Why do I have to take both the COI training through CSU Learn and the CITI COI training?
A: Any Principal Investigator who conducts privately-funded research will be required by University Personnel to complete the COI training through CSU Learn. If you are an investigator (responsible for the design, conduct, or reporting) of government-funded research, you will be required to take the CITI COI training. If you have awards from both private and public sources, you will have to take both.
Q: I completed Responsible Conduct of Research (RCR) training through CITI, and that included a COI module. Why isn’t my RCR certificate sufficient?
A: While the RCR program contains important information on how to identify and mitigate conflicts of interest, the CITI “Conflicts of Interest” course is more rigorous and covers the federal regulations that apply to research activities in more detail. To obtain the CITI COI certificate, you must complete both modules of the course: “Overview, Investigator Responsibilities, and COI Rules” and “Institutional Responsibilities as They Affect Investigators.” You must also pass the quiz at the end of each module with a score of at least 80%.
Q: My proposal will be submitted to a government agency, but it only includes training activities, not RSCA. Why do I still have to take the CITI COI training?
A: Anyone who submits a proposal to a government agency through the Research Foundation must take the CITI COI training. We currently do not differentiate the training requirement based on the content of the proposal.
Disclosure
Q: I am submitting a proposal to a public agency. Who has to disclose their financial interests?
A: All key personnel must complete the “Financial Conflict of Interest (FCOI) Disclosure Form for All Government Agencies” on behalf of themselves and their spouse/domestic partner and/or dependent children.
Q: How do I know what financial information I should disclose?
A: You should disclose any financial information that is related to your institutional responsibilities, that is, your professional actions on behalf of SJSU, which can include research, research consultation, professional practice, institutional committee memberships, and service on panels, boards, or committees.
There are some exceptions. The following financial interests do not need to be disclosed:
- Salary, royalties, or other remuneration paid to the investigator by their institution;
- royalties or licensing income from their institution;
- income from investment vehicles such as mutual funds and retirement accounts as long as the investigator does not directly control the investment decisions made in these vehicles;
- income from seminars, lectures or teaching engagement sponsored by a federal, state, or local government agency or a U.S. institution of higher education as defined at 20 U.S.C. 100(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an U.S. institution of higher education.
Q: How do I know if I need to disclose my reimbursed or sponsored travel?
A: Reimbursed or sponsored travel will need to be disclosed if it meets three criteria:
- The travel was related to your institutional responsibilities, that is, any related to any activity that you undertake in your professional capacity;
- The travel was sponsored or reimbursed by a single entity that was not a U.S. Federal state or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, U.S. medical center, or a research institute that is affiliated with a U.S. institution of higher education;
- The cost of the travel, when aggregated over 12 months, exceeds $5,000 (for example, a single trip per year costing $2,000 would not require disclosure but three trips in the course of a year that cost $2,000 each would need to be disclosed).
Q: What if the travel expenses were paid on my behalf and I don’t know the actual amount?
A: Please estimate the cost of the trip based on the current market value.
Q: What happens to the information that I disclose?
A: Your disclosure is reviewed by the Associate Vice President for Research (AVP) or their Designee. If the information you reported is determined to be a Significant Financial Interest (based on the sponsor’s thresholds and SJSU policy), the AVP will determine whether the potential for a Financial Conflict of Interest exists. The AVP will recommend a plan to manage this potential for conflict and ensure that the research can proceed. This plan will also be approved by your college chair and dean.
Q: Is this information kept confidential?
A: SJSU will keep all disclosures confidential to the extent possible. However, it is important to remember that FCOI disclosure documents may be considered a public record under California Code, Government Code Section 81008(a). Information from your disclosure may also be requested by members of the public under the California Public Records Act or the Freedom of Information Act.
Resources
2 CFR Part 200.112 Conflict of Interest
42 CFR Part 50, 45 CFR Part 94 (NIH) [pdf]
NIH Policy & Compliance: Financial Conflicts of Interest
NSF Awards and Administration Guide Chapter IV.A
NASA Grant and Cooperative Agreement Manual (GCAM) [pdf]
NASA Guidelines for Promoting Scientific and Research Integrity [pdf]
CIRM Grants Administration Policy for Discovery, Translation, and Education Projects [pdf]
CIRM Grants Administration Policy for Clinical Stage Projects [pdf]
