Federal regulations require institutions to have policies and procedures in place to ensure that 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.
1. If you are funded by or applying to a PHS sponsor, use the PHS/NIH FCOI Disclosure Form.
If you are funded by any other sponsor, fill out a Conflicting Financial Interest Disclosure form.
2. Attach all required supporting documentation in a sealed envelope marked confidential.
3. Submit the form to the SRO with the proposal and blue sheet, following normal College procedures.
All conflicts of interest or potential conflicts of interest must be resolved before any award funds can be spent. The Director of Grants & 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 the College 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):
- 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:
- Salary, royalties, or other remuneration from the College
- 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.