Prior to submitting a proposal or beginning work on a grant-funded project, all key personnel must comply with Middlebury’s Financial Conflict of Interest Policy.

Policy Summary

Federal regulations require institutions have policies and procedures that ensure investigators disclose any significant financial interest that may present an actual or potential conflict of interest in relationship to externally sponsored projects. Investigators must fully disclose any significant financial interest before the proposal is submitted.

As of August 2012, new Public Health Service (PHS) regulations require that all PHS-funded investigators (including those funded through the NIH, the CDC, and subawards from the Vermont Genetics Network) file a disclosure—even if it’s a negative report—with each grant proposal and annually for the life of the grant.

All conflicts of interest or potential conflicts of interest must be resolved before any award funds can be spent. The Director of Grants and Contract Administration may require a written plan for resolving conflicts.

If a new reportable significant financial interest arises at any time during the period after the submission of the proposal through the period of the award, that interest must also be disclosed.

Who Is Covered

Investigator means the principal investigator/project director, co-principal investigators, and any other person at Middlebury 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.

What Must Be Disclosed

  • Any significant financial interest that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor
  • Any significant financial interest in an entity whose financial interests would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor

What Is Covered

Significant financial interest means anything of monetary value, including (but not limited to) the following:

  • 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)

Significant financial interest does not include the following:

  • Salary, royalties, or other remuneration from Middlebury
  • 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
    • does not represent more than a five percent ownership interest in any single entity
  • 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
  • Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities
  • Income from service on advisory committees or review panels for public or nonprofit entities

The exclusions in the first three items do not apply if the compensation or transfer of an equity interest is conditional upon a particular outcome in a sponsored research project.

Full Text of Middlebury Policy

These guidelines define general Middlebury policy and procedures regarding conflicts of interest in relationship to sponsored projects involving research, education, and service. Their purpose is to protect the credibility and integrity of Middlebury’s faculty and staff so that public trust and confidence in Middlebury’s sponsored activities is ensured.

For purposes of this policy, “Middlebury” means all entities formally governed by the President and Fellows of Middlebury College, including Middlebury College, Middlebury Language Schools, Middlebury C.V. Starr Schools Abroad, Middlebury Bread Loaf School of English, Middlebury Bread Loaf Writers’ Conference, Middlebury School of the Environment, and the Middlebury Institute of International Studies at Monterey.

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 Middlebury 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 Middlebury, 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:

  • Salary, royalties, or other remuneration from Middlebury
  • 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
  • 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
  • Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities
  • 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.

Applicability

When a sponsor requires grantee institutions to maintain and enforce a written policy on conflict of interest, this policy will apply. For research funded by the U.S. Public Health Service (PHS), Middlebury’s PHS/NIH Financial Conflict of Interest will apply.

In accordance with Federal regulations, Middlebury has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator. Thus, Middlebury requires that investigators disclose any significant financial interest that may reasonably appear to be affected by sponsored projects.

Disclosure

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

  • 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
  • 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.

  • 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 Grant Proposal Endorsement Form (blue sheet) to the Comptroller’s office following normal Middlebury 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.
  • 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

  • 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.
  • Prior to submitting a proposal that involves disclosure of Significant Financial Interests the Investigator should discuss with appropriate Middlebury 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 might include:
    • Public disclosure of significant financial interests
    • Review of research protocol by independent reviewer
    • Monitoring of research by independent reviewers

Following review of the disclosure materials, the Comptroller may impose additional conditions or restrictions, including the following:

  • Modification of the research plan
  • Disqualification from participation in all or a portion of the research funded
  • Divestiture of significant financial interests
  • 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 Middlebury and the Investigator.

  • 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 Middlebury 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 Middlebury and assure that the interest has been managed, reduced or eliminated. NSF only requires Middlebury 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 Middlebury policies regarding misconduct in science, then the VPAA will defer decision on sanctions until the misconduct in science process is completed.

In addition, Middlebury 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 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 records.

Collaborative Projects/Sub-agreements

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.