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Office of Research Compliance


Disclosure Guidance

All Investigators are required to adhere to the university's policy on the Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects [pdf] which requires that a financial disclosure form must be completed at least annually and be reviewed in connections with certain proposals submitted to the Office of Sponsored Awards Management (SAM). Currently, this requirement applies to all proposals submitted to the Public Health Service (PHS), including the National Institutes of Health (NIH), and the National Science Foundation (NSF). It also applies to any investigator who discloses a financial interest connected with the work to be performed on a sponsored project.  

When must a disclosure form be submitted or amended?

  • Annually. Or, at the time a proposal is submitted to SAM there must be a disclosure on file.

  • When there is a change in previously reported financial interests, including while a proposal is pending and during the period of an award.

Who must submit a disclosure of financial interests form?

Any individual named on a sponsored project who is responsible for the design, conduct, or reporting of the results of work performed must complete a Disclosure Form. This includes the principal investigator, co-investigator(s), and other individuals, including consultants, who have independent responsibility for accomplishing project objectives.

What must be disclosed?

Anything of monetary value received by the investigator (including the Investigator's spouse or dependent children) that reasonably appears to be related to his/her institutional responsibilities* must be reported. Financial interests that are deemed to be significant will be reviewed to determine if there is a financial conflict of interest (FCOI).

*Institutional responsibilities include teaching/education, research, outreach, clinical service and public service, which are carried out on behalf of the University of South Carolina within the scope of the investigator's USC appointment/employment.

What constitutes a Significant Financial Interest (SFI)?

  • For a publicly traded entity: Income or other payment for services including, but not limited to salary, consulting payments, honoraria, paid authorship, payments made to a health sciences compensation (practice) plan, or other consideration of value, received during the prior twelve months and the value of any equity interest (including stock, stock options or other ownership interests, as determined by public prices or other reasonable measure of fair market value) in the entity as of the date of disclosure, which when aggregated, exceeds $5,000.

Investigators are not required to disclose (a) payments made by USC, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration from USC; (b) income for seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with an institution of higher education; or (c) SFI in mutual funds or other investment vehicles such as retirement funds as long as the investigator does not directly control the investment decisions made for these investment vehicles.

  • Intellectual property rights and interests: Income received from each organization that exceeds $5,000 during the prior twelve months; however, SFI does not include royalties or payments related to patents and copyrights that are owned by USC (i.e. payments from USC are excluded from the reporting requirement).

  • For a non-publicly traded entity: Income or other payment for services including, but not limited to salary, consulting payments, honoraria, paid authorship, payments made to a health sciences compensation (practice) plan or other consideration of value, received during the prior twelve months that exceeds $5,000, or ANY equity interest, including, but not limited to stock, stock options, or ownership interest in the entity. 

  • Travel: Reimbursements or payments of any amount for travel received by the Investigator during the prior twelve months, or the value of travel paid on behalf of the Investigator. Whether or not the value of the travel is known, the following must be reported for each trip:

      • Purpose

      • Source of funding

      • Destination; and

      • Duration of trip

This does not include travel paid by USC grants, sponsored projects, or other USC institutional funds. Nor does it include travel paid by a non-foreign government agency, an institution of higher education, academic teaching hospital/medical center, or a research institute affiliated with an institution of higher education.

What happens after the proposal is submitted?

The USC 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.

When is a financical interest considered related to a sponsored project?

When the work to be performed under the sponsored project and/or the results of the undertaking reasonably could be expected to have an impact on a financial interest, the financial interest is "related" to the sponsored project and must be reviewed by the university's RO to determine if the relationship constitutes a FCOI.The following are examples of "related" financial interest(s):

  • 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.

What constitutes a FCOI?

A FCOI exists when it is determined reasonably by the RO and COIC that the related financial interest could affect directly and significantly the design, conduct, or reporting of the sponsored research/project.

How is a FCOI managed? 

If it is determined that a FCOI exists, the RO and CoIC will advise the investigator and the university on how the project must be managed and other actions that must be taken to eliminate the conflict or reduce it to an acceptable level. This will be communicated to the Investigator in the form of a Conflicts Management Plan.Options for managing financial conflicts include, but are not limited to:

  • Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to Institutional Review Board(s);

  • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to subjects;

  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;

  • Modification of the research plan;

  • Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;

  • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

  • Severance of relationships that create financial conflicts

What will be reported to sponsoring agencies?

In the case of PHS supported projects, the University 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 university's management plan. The report will include, but not be limited to, the following elements.

  • Project number;

  • PD/PI or Contact PD/PI if a multiple PD/PI model is used;

  • Name of the investigator with the FCOI;

  • Name(s) of the entity(ies) with which the investigator has a FCOI;

  • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);

  • Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000- $9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;

  • A description of how the financial interest relates to the NIH-funded research and why the institution determined that the financial interest conflicts with such research;

  • A description of the key elements of the institution's management plan, including:

    • Role and principal duties of the conflicted investigator in the research project;

    • Conditions of the management plan

    • How the management plan is designed to safeguard objectivity in the research project;

    • Confirmation of the investigator's agreement to the management plan;

    • How the management plan will be monitored to ensure investigator compliance; and

    • Other information as needed.

Additional reports must be submitted to PHS throughout the life of the award as follows; 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.)

What will happen in the case of non-compliance? 

Failure to file a complete Disclosure of Financial Interest Form, update the disclosure, or to comply with any conditions or restrictions imposed on the conduct of the project under USC Policy RSCH 1.06 will be grounds for disciplinary action pursuant to the relevant university policies related to faculty conduct or other applicable employee disciplinary policies. In addition, federal regulations may require reports to the federal sponsor of any information which may show a violation of university policy. Sponsors may suspend or terminate the award and/or debar an Investigator from receiving future awards in the event of failure to comply with applicable federal regulations on disclosure, review, and management of significant financial interests related to federally sponsored projects.

Will the disclosure form be available to the public? 

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.
  • The SFI was disclosed and is still held by the senior/key personnel for the PHS-funded research project
  • The university determines that the SFI is related to the PHS-funded research; and
  • It is determined that the SFI is a Financial Conflict of Interest.
Information subject to public disclosure includes at a minimum:
  • investigator's name;
  • investigator's title and role with respect to the research project;
  • name of the entity in which the SFI is held;
  • nature of the SFI; and
  • 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.

 

 

 

 

 

 

 

 

Office of Research Compliance