Financial Conflict of Interest

• NSF Investigators* must:
  1. Be familiar with the College's National Science Foundation (NSF) Financial Conflict of Interest Procedures.
  2. Submit a Financial Interests Report eForm at the time of submission of the grant proposal and, if funded, at intervals specified by the grant.
• PHS (NIH) Investigators* must:
  1. Be familiar with the College's Public Health Service ** (PHS) Financial Conflict of Interest Procedures.
  2. Complete the NIH Financial Conflict of Interest Training.
  3. Submit a Financial Interests Report eForm at the time of submission of the grant proposal and, if funded, at intervals specified by the grant.
• Non-College of Charleston Co-Investigators must contact our office to determine next steps.

• The organization in which an Investigator has a financial interest will manufacture or commercialize the drug, device, procedure, or any other product which will predictably result from the project.
• The results of the project would be relevant to the development, manufacturing, or improvement of the product or services of the organization in which an Investigator has a financial interest.
• The sponsored project will subcontract a portion of the work, lease property, or make purchases from an entity in which an investigator has a financial interest.
• The sponsored project will involve referral of participants to an organization in which an investigator has a financial interest, or includes collaboration or participation in a consortium of organizations in which an investigator has a financial interest.

The College Reviewing Official (RO) will review the disclosure form and reasonably determine whether any reported financial interest is related to the sponsored project, and if related, whether the financial interest constitutes a financial conflict of interest.  If the RO determines that there is a potential FCOI, the Conflict of Interest Review Committee  will be convened.

The CIRC is College’s committee that advises the Reviewing Officer on conflict of interest matters.  CIRC members are appointed by the Provost.  The CIRC shall include, at a minimum, two faculty members representing a cross section of academic disciplines and the Assistant Vice President for Research.

An FCOI will exist when the RO or designee determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS and NSF supported sponsored projects or research.

The affected investigator, in cooperation with his or her academic department/unit director and dean/cognizant vice president, shall develop and present to the CIRC a Conflict of Interest Management Plan that details proposed 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 financial interests (e.g., when presenting or publishing the research);
2. For Research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
3. Appointment of an independent Monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest.

Where it deems appropriate, the CIRC shall review the resolution plan, modify it or add conditions or restrictions as necessary, and approve or disapprove it.  Modifications, conditions, and restrictions that the CIRC may consider include, but are not limited to, the following:

1. Modification of the research/project plan;
2. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or part of the research;
3. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
4. Severance of relationships that create financial conflicts.

The approved resolution plan shall be signed by the investigator and, on behalf of the College, the Executive Vice President for Business Affairs.

In the case of PHS supported projects, the College must report the existence of a FCOI prior to expending any grant funds. The report must include sufficient information to enable the sponsoring agency to understand the nature and extent of the FCOI and to assess the appropriateness of the College's management plan.   Additional reports must be submitted to PHS throughout the life of the award; 1) when progress reports are submitted, 2) within 60 days of determining that a newly acquired SFI constitutes a FCOI, or 3) within 60 days of determining that a FCOI exists for an investigator who joins the project. Reports to other sponsoring agencies will be submitted in accordance with agency requirements. (e.g., NSF requires that the University report only the existence of a FCOI which cannot be managed, reduced or eliminated.)

The disclosure form(s) will be retained as part of the project file, and upon receipt of a written request, disclosures that meet the following criteria may be disclosed publicly.

1. The SFI was disclosed and is still held by the senior/key personnel for the PHS-funded research project.
2. The University determines that the SFI is related to the PHS-funded research; and
3. It is determined that the SFI is a Financial Conflict of Interest.

Information subject to public disclosure includes at a minimum:

1. Investigator's name;
2. Investigator's title and role with respect to the research project;
3. Name of the entity in which the SFI is held;
4. Nature of the SFI; and
5. Approximate dollar value of the SFI.

The information included on disclosure forms must be retained for three (3) years after termination of the sponsored project or until resolution of any action by the sponsor, whichever is longer.

• PHS - NIH Grants Policy
• NSF Grant Policy Manual