Supplemental Significant Financial Interest Disclosure Form CONFIDENTIAL (Form 2)

Revised 03/16/15

Who should complete this form?

If you answered “Yes” to the question on the Significant Financial Interest Review form (Form 1), you must complete a form for each entity in which you and/or your family member(s) have a significant financial interest and for each occurrence of sponsored travel (for PHS funded projects). “Family member” is defined as your spouse and/or dependent children.

When do I complete this form?

The Significant Financial Interest Disclosure form is due:

Prior to the submission of a research proposal and annually during the award period if funded.
If there are any changes in the status of a significant financial interest (new disclosure then required within thirty days)
When research involves human subjects, the Investigator must disclose significant financial interests to the Institutional Review Board (IRB) with every submission of protocols
If research is ongoing and an Investigator is newly participating in the project.

Definitions can be found at the end of this document.

Attach a copy of Form 1(that was previously submitted with the project proposal) to this form.

FCOI # (to be completed by SPS)

Investigator Name / Date
Proposal Title
Sponsor/Funding Agency*

*If PHS funding (and those who follow PHS standards), please complete Section 1 and Section 3.

If non-PHSfunding, please complete Section 2 and Section 3.

SECTION 1: PHSfunding (and those who follow PHS standards)

CATEGORY 1: Interest in a Publicly Traded Entity:Do you (meaning you, your spouse, or dependent children) have an equity interestin any publicly traded entity, or have you received remuneration from any publicly traded entity in the past 12 months, where the combined value of the equity interest and remuneration exceeds $5,000?

Yes No (if no, go to next category)

Name of publicly traded entity:
Address of publicly traded entity:
Holder(s) of interest: You Your spouse Your dependent child
Nature of interest: Describe the interest you hold in this entity, such as the type of remuneration (e.g., salary, consulting fees, honoraria, etc.) or the nature or conditions of the equity interest.
Relationship to research: Explain how this interest is related to this research, sponsors of this research, or to your institutional responsibilities.
Value of remuneration in the past 12 months:
Value of equity interest:
Aggregated value of remuneration and equity interest:

CATEGORY 2: Interest in a Non-Publicly Traded Entity:Do you(meaning you, your spouse, or dependent children) have an equity interest(e.g., stock, stock options, etc.) of any amount in a non-publicly traded entity, or have you received remuneration in the past 12 months from a non-publicly traded entity that,when aggregated, exceeds $5,000?

Yes No (if no, go to next category)

Name of non-publicly traded entity:
Address of non-publicly traded entity:
Holder(s) of interest: You Your spouse Your dependent child
Nature of interest: Describe the interest you hold in this entity, such as the type of remuneration (e.g., salary, consulting fees, honoraria, etc.) or the nature or conditions of the equity interest.
Relationship to research: Explain how this interest is related to this research, sponsors of this research, or to your institutional responsibilities.
Value of remuneration in the past 12 months:
Value of equity interest:

CATEGORY 3: Intellectual Property Rights and Interest:Do you have anyintellectual property (IP) rights or interests (e.g., patents, copyrights) that reasonably appear to be related to your institutional responsibilities, for which you have received income related to such rights and interests?

Yes No (if no, go to next category)

Intellectual Property: Describe the IP, such as the patented device, copyrighted work, trade secret, or other.
Holder(s) of interest: You Your spouse Your dependent child
Nature ofinterest: Describe the interest you hold in this IP, such as the rights assigned to you under the terms of intellectual property agreements or the nature or conditions of royalties received from the interest.
Relationship to research: Explain how this interest is related to this research, sponsors of this research, or to your institutional responsibilities.
Name of sponsor: Name the sponsor, research institution, or other entity to which this IP right or interest reasonably appears to be related.
Income from IP Interest: What is the value of the income you have received from this IP interest as of the date of this disclosure?

CATEGORY 4: Reimbursed or Sponsored Travel:In the past 12 months, have you had any occurrence of reimbursed or sponsored travel (e.g., that which is paid on your behalf and not reimbursed to you) related to your institutional responsibilities? This DOES NOT apply to travel 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.

Yes No (if no, go to Section 3)

Name of Travel Sponsor/Organizer:
Traveler(s): You Your spouse Your dependent child
Purpose of travel:
Destination:
Duration of travel:
Relationship to research: Explain how this travel is related to your institutional responsibilities.

END OF SECTION 1 – GO TO SECTION 3

SECTION 2: Non-PHSfunding

CATEGORY 1: Other Income:Have you (meaning you, your spouse, or dependent children) received salary, royalties or other paymentsnot from the University for services (e.g., consulting fees or honoraria) that when aggregated over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months?

Yes No (if no, go to next category)

Name of business/entity:
Address of business/entity:
Holder(s) of income: You Your spouse Your dependent child
Nature of income: Describe the nature of income from this entity (e.g., consulting fees, honoraria).
What services, related to this income, did you perform for this business/entity?
Value of income in the past 12 months:
Expected value of income in the next 12 months:

CATEGORY 2: Equity Interest:Do you have an equity interest (e.g., partnership, ownership, stock, stock options, etc.) that when aggregated over the last 12 months exceeded $5,000 or is expected to exceed $5,000 over the next 12 months (as determined through reference to public prices or other reasonable measures of fair market value), or do you hold a 5% or greater equity interest in a single publicly traded entity or hold any equity interest in a non-publicly traded entity?

Yes No (if no, go to Section 3)

Name of business/entity:
Address of business/entity:
Holder(s) of interest: You Your spouse Your dependent child
Nature of interest: Describe the nature or conditions of the equity interest.
Value of equity interest in the past 12 months:
Expected value of equity interest in the next 12 months:

END OF SECTION 2 – GO TO SECTION 3

SECTION 3: Investigator Affirmation and Signature

The Investigator affirms that:

The previous information is true to the best of his/her knowledge.
The Investigator has read the University’s policy on Financial Conflicts of Interest in Research (
If the disclosed relationship with the external entity is determined by the Financial Conflict of Interest in Research Committee to be a significant financial interest related to the sponsored research, then the relationship will be determined to be a Financial Conflict of Interest (FCOI) and the Investigator will be given a University approved management plan to follow prior to expenditure of funds related to the research project.

If the research is funded by PHS:

Prior to receiving PHS funds, the Investigator must complete mandatory FCOI training and update training as required by the University (42 CFR 50.605).
If the financial relationship changes during the funding period, the Investigator agrees to update this form within 30 days of acquiring or discovering a new or a change in the Investigator’s financial relationship.
The Investigator must disclose all sponsored or reimbursed travel (42 CFR 50.605) within 30 days if not previously reported on this form.
An updated version of this form must be submitted to SPS annually during the funding period.
The University is required to report all FCOIs to the PHS funding agency, or primary award institution when UConn is a subcontract (42 CFR 50.605).
All PHS Investigator disclosures are subject to the public disclosure requirements of the PHS regulation (42 CFR 50.605). The University must provide written response to written requests within 5 business days of receipt of request.
The Investigator will comply with any further requests for information or clarification from the University.

This is:

New disclosure of a significant financial interest related to research

Updated disclosure of a previously disclosed significant financial interest related to research

Annual disclosure of a previously disclosed significant financial interest related to research

(1) Sign your name on the signature below.

(2) Save a copy of this form for your records.

(3) Submit the signed form to Research Compliance Services.

Discloser Signature: ______Date: ______

Signature of Chair / Division Head ______Date: ______

SUBMIT THIS FORM:

Via Campus Mail/U.S. Mail:

CONFIDENTIAL – FCOIRC

Unit 1246

Research Compliance Services

438 Whitney Road Ext.

Storrs, CT 06269-1246

Via Email:

Send to

If you choose to submit via email: please be advised that email is not a secure or confidential communication medium. By submitting your Supplemental SFI Disclosure form by email, you acknowledge that the University cannot guarantee the security or confidentiality of the email, and that you assume all risk of loss.

DEFINITIONS

Significant Financial Interest (SFI) - PHS funding:

With regard to any publicly traded entity, an SFI 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; or
With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s Immediate Family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
Investigators also must disclose the occurrence of any reimbursed or sponsored travel (e.g., 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.

Significant Financial Interest (SFI) - Non-PHS funding:

An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; or
Salary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months.

Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:

Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators' institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.

*Remuneration:

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

The term Significant Financial Interestdoes not include the following types of financial interests:

Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
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 engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 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; or
Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 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.
Travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 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.