Financial Conflict of Interest


Investigator Financial Disclosure Policy

 

(Applicable to all Sponsored Project Proposals)


What is required?

Federal regulations require institutions to have policies and procedures in place that ensure that investigators disclose any significant financial interest that may present an actual or potential conflict of interest in relationship to externally sponsored projects. Such disclosures must be made prior to the submission of a proposal for funding, (if a new reportable significant conflict of interest arises at any time during the period after the submission of the proposal through the period of the award, the filing of a disclosure is also required) and institutions must develop specific mechanisms by which conflicts of interest will be satisfactorily managed, reduced, or eliminated prior to the expenditure of any funds on an award.

Who is covered?

"Investigator" means the principal investigator/project director, co-principal investigators, and any other person at the University who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding by an external sponsor. In this context, the term "Investigator" includes the investigator's spouse and dependent children.

What must be disclosed?

Each Investigator shall disclose all significant financial interests:

(I) that would reasonably appear to be affected by the research, educational, or service activities or proposed for funding, by an external sponsor; or

(II) in entities whose financial interests would reasonably appear to be affected by such activities.

What is covered?

"Significant Financial Interests" mean anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

(1) Salary, royalties, or other remuneration from Central Connecticut State University;

(2) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

(3) Income from service on advisory committees or review panels for public or nonprofit entities;

(4) An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value determined through reference to public prices or other reasonable measures of fair market value, or constitute more that a 5 percent ownership interest in any single entity; or

(5) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

Disclosure Procedures:

(1) All Investigators must disclose their significant financial interests utilizing this form and attaching all required supporting documentation. The completed form and packet must be submitted with the proposal and the CCSU Internal Administrative Routing Sheet to the Grants & Funded Research Office. Supporting documentation should be submitted in a sealed envelope marked "confidential."

(2) In accordance with Federal regulations, a complete disclosure must be made by Investigators prior to the submission of the proposal.

(3) Resolutions to conflicts of interest will be incorporated into a Memorandum of Agreement (MOA) between the Investigator(s) and the University [signed by Investigator(s) and the authorized University Certifying Official] prior to expenditure of any award funds.

 

CENTRAL CONNECTICUT STATE UNIVERSITY

Investigator Significant Financial Interest Disclosure Policy for Sponsored Projects

In order to protect the credibility and integrity of CCSU's faculty and staff and to ensure public trust and confidence in the University's sponsored activities, it is the policy of Central Connecticut State University that investigators disclose any significant financial interest that would reasonably appear to be affected by sponsored research. In response to Federal regulations requiring universities to formulate a policy regarding investigator financial conflict of interest, CCSU has assumed the responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator

DEFINITIONS

POTENTIAL CONFLICT OF INTEREST - exists when there is a divergence between an individual's private interests and his or her professional obligations to CCSU such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise.

ACTUAL CONFLICT OF INTEREST - exists when the University, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of sponsored projects.

INVESTIGATOR - the principal investigator/project director, co-principal investigator, and any other person who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by an external sponsor. In this context, the term "Investigator" includes the investigator's spouse and dependent children.

SIGNIFICANT FINANCIAL INTEREST - anything of monetary value, including, but not limited to:

* salary or other payments for services (e.g., consulting fees or honoraria)

* equity interests (e.g., stocks, stock options, or other ownership interests)

* intellectual property rights (e.g., patents, copyrights, and royalties from such rights)

The term does not include:

1. Salary, royalties, or other remuneration from CCSU;

2. Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;

3. Income from service on advisory committees or review panels for public or nonprofit entities;

4. An equity interest that, when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity;

5. Salary, royalties or other payments that, when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

PROCEDURES

  1. Each Investigator is required to disclose the following Significant Financial Interests:

(I) Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or

(II) Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.

Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interests, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

  1. Each Investigator who has Significant Financial Interest requiring disclosure shall complete a Significant Financial Interests Disclosure Form and attach all required supporting documentation. The completed Disclosure Form must be submitted with the proposal and the CCSU Internal Administrative Approval Form to the Grants & Funded Research Office. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked "confidential" and accompany the Disclosure Form.
  2. As required by Federal regulation, all Significant Financial Interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by Investigators during the period of the award as new reportable Significant Financial Interests are obtained.
  3. The Director of Grants & Funded Research will forward the Disclosure Form to the Dean of Graduate Studies and Research who shall conduct an initial review of all financial disclosures. If the initial determination is made that there may be a potential for conflict of interest covered by this policy, then the Disclosure packet will be referred to the University Conflict of Interest Review Committee (CIRC). Committee members are appointed by the Dean of Graduate Studies and Research and will be comprised of a minimum of three faculty members representing a cross section of academic disciplines. A conflict of interest exists when the CIRC reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. The CIRC shall than determine what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflicts of interest arising from disclosed Significant Financial Interests.
  4. Upon receipt of the CIRC recommendations, the Investigator will propose a Conflict of Interest Resolution Plan that details steps that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a Significant Financial Interest. At a minimum, the Resolution Plan shall address such issues as:

(1) Public disclosure of significant financial interests;

(2) Review of research protocol by independent reviewers; and

(3) Monitoring of research by independent reviewers.

The CIRC shall review the Resolution Plan and approve it, add conditions or restrictions, including the following:

(1) Modification of the research plan;

(2) Disqualification from participation in all or a portion of the research funded;

(3) Divestiture of significant financial interests; or

(4) Severance of relationships that create actual or potential conflicts of interest

If the CIRC determines that imposing the above referenced conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the CIRC may recommend that, to the extent permitted by Federal regulations (PHS policy does not permit such an action), the research go forward without imposing such conditions or restrictions. In these cases, the Dean of Graduate Studies and Research shall make the final decision regarding resolution.

  1. The approved Resolution Plan shall be incorporated into a Memorandum of Agreement (MOA) between CCSU and the Investigator that details the conditions or restrictions imposed upon the Investigator in the conduct of the project. The MOA shall be signed by the Investigator and the authorized University Certifying Official (President, Vice President for Finance and Administration, or Vice President for Academic Affairs). Actual or potential conflicts of interest will be satisfactorily managed, reduced, or eliminated in accordance with these Guidelines and all required reports regarding the conflict of interest submitted to the sponsor prior to expenditure of any funds under an award. (For example, PHS requires the University to report to the PHS Awarding Component the existence of a conflicting interest [but not the nature of the interest or other details] found by the University and assure that the interest has been managed, reduced or eliminated. NSF only requires the University to report conflicts which cannot be satisfactorily managed, reduced or eliminated).
  2. Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Grants & Funded Research Office until three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those awards.
  3. Whenever an Investigator has violated this policy or the terms of the MOA, the CIRC shall recommend to the Vice President for Academic Affairs that disciplinary actions be taken in accordance with the provisions of Article 16 of the CSU-AAUP Collective Bargaining Agreement. In addition, the University shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved. |
  4. Collaborators/subrecipients/subcontractors from other academic or not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies. Subcontractors from commercial firms need not make a certification, except when the prime award is from PHS. The PHS requires a certification from any subcontractor, including commercial firms, stating that it is in compliance with Federal policies regarding investigator significant financial interest disclosure and that its portion of the project is in compliance with company policies.
  5. Nothing in this policy shall be taken to contradict Article 10.14 of the CSU-AAUP Collective Bargaining Agreement which references members' responsibility for complying with conflict of interest provisions as defined by Connecticut General Statutes 1-84-85.

 

 

CCSU Significant Financial Interest Disclosure Form

Faculty/Staff Name: _________________________________________________

Department: _____________________________________________________________

School: _______________________________________________________________

Proposal Title: ______________________________________________________

Sponsoring Agency: _____________________________________________________

I am disclosing the following financial interests (check one) and attaching supporting documentation (marked confidential") that identifies the business enterprise or entity involved and the nature and amount of interest.

("Significant Financial Interests" are defined as interests or projected annual income valued at greater that $10,000 or an equity or ownership interest of more that five percent held by an investigator and/or the investigator's spouse or dependent children. See Significant Financial Interest Disclosure Policy for exempt interests).

____ Salary or other payment for services (e.g., consulting fees or honoraria)

____ Equity interests (e.g., stocks, stock options, or other ownership interests)

____ Intellectual property rights (e.g., patents, copyrights, and royalties from such rights)

____ Other significant financial interest of the investigator that possibly could affect or be perceived to affect the results of the research, educational, or service activities funded or proposed for funding

Further I Agree:

* To update this disclosure during the period of the award as new reportable significant financial interests are obtained.

* To cooperate in the development of a Memorandum of Agreement (MOA) that constitutes a conflict of interest "resolution plan."

* To comply with any conditions or restrictions imposed by the University to manage, reduce, or eliminate actual or potential conflicts of interest or forfeit the award.

* To have a fully executed MOA in place prior to making any expenditures of sponsored project funds.

Signed: ____________________________________ Date: ________________

(Original signature only)

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