FCOI

Yes

Your CoI disclosure is maintained as confidential information. Only ORSP staff and the CoI Committee will have access to your information.

A Significant Financial Interest (SFI) is defined as one of the following:

• A financial or other personal interests of the investigator, his or her spouse, domestic partner, children, parent or siblings that reasonably appears to be related to the Investigator’s institutional responsibilities:
• Service as an officer, director or in any other fiduciary role for a financially interested company, whether or not remuneration is received for such service;
• Intellectual property rights (e.g., pending patent applications, patents, licenses, material transfer agreements, copyrights and royalties of any amount from such rights, including those royalties distributed by the University);
• With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes compensation, royalties, consulting fees, honoraria, gifts or other emoluments, bonuses, enrollment incentives or milestone payments, and “in kind” compensation or entitlement to same made directly or indirectly to the investigator by a financially interested company (or entitlement to the same), whether for consulting, lecturing, travel (including reimbursed travel or sponsored travel), service on an advisory board, or for any purpose not directly related to the reasonable costs of conducting the research (as specified in the research agreement between the sponsor and the University), as determined through reference to public prices or other reasonable measures of fair market value, either in the year prior to the grant application or initiation of unsponsored research and submission of the accompanying Disclosure Form, or in the twelve months following the grant application or initiation of unsponsored research;
• Greater than 1% of the ownership of stock, assets or profits of a company which has, or seeks to have an agreement with the University, where the agreement is for the development of scientific or technological discoveries or innovations in which the University has or will have a property right.
• Equity interests, including stock options, of any amount in a non-publicly traded financially interested company (or entitlement to the same);
• Equity interests (or entitlement to the same) that in aggregate exceed $5,000 in a publicly-traded financially interested company

Yes. If the investigator can influence the decision as to which company sells reagents to her lab, she must disclose the financial interest because it relates to her institutional responsibilities. This kind of financial interest is unlikely to be determined to affect or potentially affect research. It is, however, likely to be an issue under the State ethics rules.

Generally speaking this includes teaching, research, administration, and professional practice; as well as other activities that involve the same expertise for which UNC Asheville employs the Investigator. For example: a geneticist who writes a textbook on genetics would disclose it; a geneticist who wrote a science fiction book that requires an understanding of genetics would disclose that also; but if a geneticist wrote a book on baseball, that would not be disclosed.

No

No, that type of manufacturing is unrelated to the Investigator’s institutional responsibilities.

Yes, if both the stock value combined with the consulting fees exceeded $5,000 in the last 12 months.

Yes

Yes

Yes, there is no threshold for disclosing equity, since no specific value can be attributed to equity in a privately-held firm. The existence of an interest would be disclosed but not quantified.

Because the value of the stocks are not readily available.

Reimbursed or sponsored travel is related to the investigator’s institutional responsibilities (and includes the purpose of the trip, the name of sponsor/organizer, the destination, the duration of the trip).

PHS grant-funded travel does NOT need to be disclosed.

“Sponsored” in this case means paid directly to vendors (i.e., the investigator may not even know the costs involved).

The federal regulations require all PHS funded investigators to “disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities…” 42 CFR §50.603.

Any principal investigator or any member of the key personnel on any project funded by the U.S. Public Health Service, (for example NIH). Key personnel means the PD/PI and any other person identified as key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this regulation.

Includes but not limited to:

• Reimbursed or sponsored travel related to Institutional responsibilities (including the purpose of trip, sponsor/organizer, destination, duration). Exceptions for travel are listed in the next section.
• Travel that is reimbursed or paid directly for consulting.
• Travel that is reimbursed or paid directly by a for-profit or non-profit organization for a conference, or to participate in a meeting.
• Travel that is reimbursed or paid directly when the investigator has a financial interest in that entity, ie a start-up

The types of Sponsored Travel that do not need to be disclosed include:

• Travel that is reimbursed or paid directly by a federal, state, or local government agency
• Travel that is reimbursed or paid directly by an institution of higher education as defined at 20 U.S.C. 1001(a) (or in plain English, a university)
• Travel that is reimbursed or paid directly by an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education

Travel reimbursed or paid directly by non-profit organizations in which UNC Asheville is a member institution and for which the investigator serves as a member of its governing board, a panel or a task force where such service has been approved by the UNC Asheville.