Middlebury

 

Full Text of Middlebury Policy

Definitions

A potential Conflict of Interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the College 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. An actual conflict of interest depends on the situation and not on the character or actions of the individual. For the purposes of this policy, a conflict of interest exists when the College, 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 means the principal investigator/project director, co-principal investigators, 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 or domestic partner and dependent children.

Significant Financial Interest means 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 the College;

(2) An equity interest that when aggregated for the Investigator and the Investigator's spouse or domestic partner 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; or

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

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

(5) Income from service on advisory committees or review panels for public or nonprofit entities.

Provided, however, that the exclusions in the first three items shall not apply if the compensation or transfer of an equity interest is conditioned upon a particular outcome in a sponsored research project.

Disclosure

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 interest, 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.

2. Each Investigator who has a 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 College Grant Proposal Endorsement Form ("blue sheet") to the Comptroller's office following normal College procedures. 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.

3. 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, either on an annual basis or as new reportable Significant Financial Interests are obtained.

Review Process

1. The Comptroller or official designee shall review all financial disclosures to determine whether a conflict of interest exists. A conflict of interest exists when the review reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. If the Comptroller determines that there is a potential for conflict of interest covered by this policy, then the Comptroller will determine what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflicts of interest arising from the disclosed Significant Financial Interests.

2. Prior to submitting a proposal that involves disclosure of Significant Financial Interests the Investigator should discuss with appropriate College officials proposed measures that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a Significant Financial Interest. Such measures could include:
(1) Public disclosure of significant financial interests;
(2) Review of research protocol by independent reviewers; and
(3) Monitoring of research by independent reviewers.

Following review of the Disclosure materials the Comptroller may impose additional 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.

The Comptroller may require that a plan for reducing or eliminating conflicts of interest be incorporated into a Memo of Understanding between the College and the Investigator.

3. The Comptroller will notify the VPAA of the conditions or restrictions to be imposed. If the VPAA determines that imposing the above referenced conditions or restrictions would be ineffective or inequitable, or 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 VPAA may recommend that, to the extent permitted by Federal regulations [PHS policy, for example, does not permit such an action], the research go forward without imposing such conditions or restrictions. In these cases, the VPAA shall make the final decision regarding resolution.

Managing Conflicts of Interest

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, the PHS requires the College 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 College and assure that the interest has been managed, reduced or eliminated. NSF only requires the College to report conflicts that cannot be satisfactorily managed, reduced, or eliminated.]

Violations of Conflict of Interest Policy

Whenever an Investigator has violated this policy or the terms of any resolution plan required by the Comptroller (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms) the Comptroller shall notify the VPAA who will impose sanctions or institute disciplinary proceedings against the violating individual.

If the violation results in a collateral proceeding under College policies regarding misconduct in science, then the VPAA will defer decision on sanctions until the misconduct in science process is completed.

In addition, the College 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.

Record Maintenance

Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Comptroller's Office until 3 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 records.

Collaborative Projects/Subagreements

Collaborators/subrecipients/subcontractors from other organizations must either comply with this policy or provide a certification that their organizations 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.

Adopted by the Middlebury College Academic Administration 9/19/95.