Source: https://www.pvamu.edu/research/osp/maestro-help-2/conflict-of-interest/frequently-asked-questions/
Timestamp: 2019-05-19 20:51:07
Document Index: 206348249

Matched Legal Cases: ['§1001', '§1001', '§1001', '§1001', '§1001', '§1001', '§1001']

Home / Research / Office of Sponsored Programs / MAESTRO Help / Financial Conflict of Interest (FCOI) / Frequently Asked Questions
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Frequently Asked Questionsrehernandez2017-08-07T15:00:34-05:00
Q: Who must disclose?
A. Any individual acting as a “project director, principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research” is an investigator and must satisfy the disclosure requirements.
Q: Who is an investigator?
A. Any University employee, regardless of title or position, who has the ability to make independent decisions related to the design, conduct, or reporting of University research. This does not include individuals who perform only incidental or isolated tasks related to a University research project. Since title and position are not indications of who is an “investigator,” it is possible for students and post-docs to meet this definition. Please note, in nearly all situations when an individual is listed as senior or key personnel on a proposal or award they are considered an investigator for purposes of submitting a financial disclosure statement.
Q: Do post-docs and graduate students need to disclose?
A. Yes, if they meet the definition of investigator above.
Q: What needs to be disclosed?
A. Investigators are required to disclose any Significant Financial Interest (SFI) to the University.
Q: What is a Significant Financial Interest (SFI)?
A. A financial interest, including but not limited to one or more of the following interests of the investigator (and those of the investigator’s covered family members) that reasonably appears to be related to the investigator’s institutional responsibilities:
(a) With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated for the investigator and members of his/her immediate family, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(b) With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated for the investigator and members of his/her immediate family, exceeds $5,000, or when the investigator (or the investigator’s immediate family member) holds any equity interest (e.g., stock, stock option, or other ownership interest);
(c) Intellectual property and royalty interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests;
(d) The occurrence of any reimbursed or sponsored travel related to their institutional responsibilities (including that which is paid on behalf of the investigator but not reimbursed to the investigator so that the exact monetary value may not be readily available); provided, however, that this does not include travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;.
(e) Gifts, when the value of a single gift received by the investigator or a covered family member in the preceding 12 months exceeds $250, or when the aggregated value of multiple gifts received from a single entity within the preceding 12 months exceeds $250, excluding gifts received from a covered family member; or
(f) Any fiduciary position held by an investigator or a covered family member in a for-profit or nonprofit entity in the preceding 12 months, including a position as a member of the board of directors, an officer, or other executive or management position, for which the investigator or covered family member received any form of remuneration or reimbursement for expenses.
SFI does NOT include:
(a) Salary, royalties, or other remuneration paid by a member to the investigator if the investigator is currently employed or otherwise appointed by the member;
(b) Intellectual property rights assigned to the system or its member and agreements to share in royalties related to such rights;
(c) 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;
(d) Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
(e) Income from service on advisory committees or review panels for a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
(f) Travel reimbursed or sponsored by a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Q: How do I know if my SFI is related to my institutional responsibilities?
A. Investigators must disclose those SFIs that “reasonably appear to be related” to the investigator’s institutional responsibilities. Each Investigator can make a reasonable, good-faith determination about whether or not any given SFI is related to their institutional responsibilities, rather than simply disclosing everything. They need to ask whether, to the best of their knowledge, the research or other institutional responsibilities that they have could affect the value of the financial interest or could have a financial impact on the entity in which they hold the financial interest (even if only in the future). Generally, however, income received from consulting or speaking on behalf of an entity is always related because the investigator has been retained as a consultant based on their overall expertise in the field. In addition, if an entity in which an SFI is held is involved in the same research project (e.g. , via a subcontract), then it is always related to the investigator’s institutional responsibilities.
Q: What are some examples of research projects that would be related to an SFI?
You are a paid consultant to COI, Inc., which also subcontracts a portion of a research project to your lab at the University.
You are a paid consultant to COI, Inc., and you subcontract a portion of your research project back to COI, Inc.
You are a paid speaker for COI, Inc., and also the PI of a research project funded by COI, Inc.
COI, Inc. has paid for your travel. You also conduct research at the University that is likely to develop intellectual property that you know would be of interest to COI, Inc.
You own stock in COI, Inc. and COI, Inc. provides cost-sharing on an award in your lab at Texas A&M University.
Q: If I do not have any SFI, do I still need to submit anything?
A. Yes. Even if you do not have an SFI to disclose, you must still complete the Financial Disclosure Statement and return to the Conflict of Interest Official at mcshelton@pvamu.edu or by campus mail to: COI Official, Marcia C. Shelton Mail Stop 2800 P.O. Box 519 Delco Building, Room 163, Prairie View, TX 77446
Q: If I receive an honorarium or other payment from another university, does that need to be disclosed?
A. No. Income from a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, is not included in SFI and does not need to be disclosed. However, honoraria or payments from foreign institutions MUST be disclosed.
Q: Does income from a government agency need to be disclosed?
A. No. Income from a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, is not included in SFI and does not need to be disclosed.
Q: What about a foreign government agency?
A. Yes. Honoraria or payments from foreign institutions MUST be disclosed.
Q: Does income from a foreign institution of higher education or a foreign government need to be disclosed?
A. Yes. Foreign institutions and governments are not excluded from SFI, and any income OR travel from one must be disclosed.
Q: Does income from a non-profit organization need to be disclosed?
A. Yes. Federal regulations require the disclosure of income and travel from non-profit organizations.
Q: Do honoraria or travel from a professional society need to be disclosed?
A. Yes. Professional societies are non-profit organizations, and travel and income from them is required to be disclosed.
Q: I sit on an editorial board for a journal. Does my income from that need to be disclosed?
A. This depends on whether the journal is a private organization or if it is published by a U.S. government agency or a U.S. institution of higher education. Follow the same guidelines as for other income.
Q: I receive royalties or licensing income from a patent that is owned by The Texas A&M University System. Do I need to disclose that?
A. No. Royalties or other remuneration received from the A&M System is excluded from the definition of SFI and does not need to be disclosed.
Q: What about mutual funds or other investments?
A. Investments such as mutual funds, in which an investigator does not have control over the individual securities held, are excluded from SFI and do not need to be disclosed. If you own other investments, such as stock in an individual corporation, even if held in a retirement account, and those investments can be bought or sold at your discretion, you will need to evaluate each such investment in order to determine whether it is reasonably related to your institutional responsibilities.
Q: What if someone from a business comes to campus and takes me to lunch to discuss my research? Must I disclose that?
A. The lunch would be considered a gift and could be disclosed if, in aggregate with other compensation or any equity in the company, you exceed the $5,000 threshold for the past 12 months. However, if the lunch (gift) is the only financial interest you have in the company, then it would not need to be disclosed. Please note that this is not a travel expense as the lunch occurred locally. Also, if you receive meals while travelling, you would not be required to disclose them specifically, but could be included in the total expense of the trip if you know the expense.
Q: Does income from service as an expert witness need to be disclosed?
A. Income from service as an expert witness should be disclosed if it relates to your institutional responsibilities. If the work you perform as an expert witness is based on your general expertise but does not relate directly to specific work that you perform at the University, the compensation does not need to be disclosed. However, if the work you perform as an expert witness does directly relate to a specific research project(s) or to other activities you are involved in, such as purchasing decisions, then you should disclose your expert witness compensation.
Q: When do I need to disclose or update my disclosure?
A. Investigators are required to disclose their SFI:
(a) within 30 days of the investigator’s initial employment date;
(b) annually, not later than August 31;
(c) within 30 days after acquiring a new SFI requiring disclosure; and
(d) for those Investigators participating in Public Health Service (PHS)-funded research, not later than the application date for PHS-funded research, except that an investigator who will be participating in an ongoing PHS-funded research project must submit a Financial Disclosure Statement within 30 days of the investigator’s initial employment date.
Q: What if I inadvertently fail to disclose my significant financial interest (SFI)?
A. You must disclose the SFI immediately. The disclosure will be reviewed to determine if a financial conflict of interest exists, and if so, an interim management plan will be implemented to ensure the objectivity of the research going forward.
Q: Will the COI review process delay my research project(s)?
A. It is important to submit your disclosure and any updates in a timely manner. If your disclosure requires review by the COI Committee, it can take one or more months due to the committee’s docket and depending on the complexity of information, as well as any follow-up meetings or information collection required. In addition, if you will be using human participants in your research, please note that the Institutional Review Board (IRB) will not complete its review of your application until the COI review has been completed. Finally, the Sponsored Research Services (SRS) will not release funds for a project until all compliance reviews have been completed.
Q: Does travel need to be disclosed?
A. Yes. The revised federal regulation does not provide a minimum threshold for the disclosure of reimbursed or sponsored travel. The occurrence of any reimbursed or sponsored travel related to the investigator’s institutional responsibilities must be disclosed, UNLESS the reimbursed or sponsored travel is by a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Q: When do I need to update my reimbursed or sponsored travel – before the trip or after?
A. All investigators must update their disclosure with information regarding travel within 30 days of the end of the trip.
Q: What types of sponsored or reimbursed travel do NOT need to be disclosed?
A. You do not need to disclose travel that is sponsored or reimbursed by a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Q: What if I do not know the cost of my travel?
A. The actual cost of a trip is not required information in your disclosure of sponsored or reimbursed travel. The only required information is the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Cost is an optional entry if you have the information available. Many investigators receive travel that is paid directly on their behalf (sponsored) and are never aware of the actual cost.
Q: What exactly needs to be disclosed regarding travel?
A. You should disclose the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
Q: Do I need to disclose meals received while travelling?
A. If you receive meals while traveling, it is not required to be disclosed specifically, but can be included in the total expense of the trip if you know the expense.
Q: Does travel paid by a professional society need to be disclosed?
A. Yes. Professional societies are non-profit organizations and travel and income from them is required to be disclosed.