Investigator Responsibilities

Each Investigator must disclose all Significant Financial Interests:

1. that would reasonably appear to be affected by the research, educational, or service activities funded or proposed for funding, by an external sponsor; or
2. in entities whose interests would reasonably appear to be affected by such activities.

The Institution's Responsibilities Regarding Conflicting Interest of Invest

Fisk University must:

• Maintain an appropriate written, enforced policy on conflict of interest and inform each Investigator of that policy, the Investigator’s reporting responsibilities, and of the federal regulations. If Fisk University carries out the federally funded research through subgrantees, contractors, or collaborators, the University must take reasonable steps to ensure that Investigators working for such entities comply with the federal regulations, by requiring those Investigators to comply with Fisk University’s policy as described in this manual.
• Designate an institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in federally funded research. This person for Fisk University is the Director of the OSP.
• Require, by the time an application is submitted to a federal agency, each Investigator who is planning to participate in the research to submit to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children):
  1. that would reasonably appear to be affected by the research, educational, or service activities funded or proposed for funding, by an external sponsor; and
  2. in entities whose interests would reasonably appear to be affected by such activities.
• Require all financial disclosures to be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.
• Provide guidelines to identify conflicting interests and take such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated
• Maintain records of all financial disclosures and all actions taken by Fisk University with respect to each conflicting interest for at least three years from the date of submission of the final expenditures report
• Establish adequate enforcement mechanisms and provide for sanctions where appropriate.
• Certify, in each application for funding to which the regulations apply, that:
  1. There is in effect at Fisk University a written and enforced administrative process to eliminate conflicting interests with respect to all research projects for which funding is sought from the federal agency.
  2. Prior to Fisk’s expenditure of any funds under the award, the University will report to the federal agency Awarding Component the existence of a conflicting interest (but not the nature of the interest or other details) and assure that the interest has been managed, reduced, or eliminated.
  3. For any interest that Fisk University identifies as conflicting subsequent to Fisk’s initial report under the award, the report will be made and conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of the identification.
  4. Fisk University agrees to make information available, upon request, to the federal government of all conflicting interests identified by the university and how those interests have been managed, reduced, or eliminated to protect the research from bias.
  5. Fisk University will otherwise comply with the applicable federal regulations.

Management of Conflicting Interests

Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to:

1. Public disclosure of significant financial interests;
2. Monitoring of research by independent reviewers;
3. Modification of the research plan;
4. Disqualification from participation in all or a portion of the research funded by the federal agency;
5. Divestiture of significant financial interests; or
6. Severance of relationships that create actual or potential conflicts

Remedies for Conflict of Interests

If the failure of an Investigator to comply with the conflict of interest policy of Fisk University has biased the design, conduct, or reporting of funded research, the university will promptly notify the funding agency of the corrective action taken or to be taken. The agencies may at any time inquire into Fisk’s procedures and actions regarding conflicting financial interests in federally funded research, including a requirement for submission of, or review on site, all pertinent records. To the extent permitted by law, the federal government will maintain the confidentiality of all records of financial interests.
In any case in which the federal agency determines that a federally funded project has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed, Fisk University requires the Investigators involved to disclose the conflicting interest in each public presentation of the results of the research.