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Office of Research

PHS Conflict of Interest

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Policy

The U.S. Public Health Service (PHS) amended its Financial Conflict of Interest (FCOI) Regulation effective August 24, 2012.

Accordingly, Clemson University has adopted a new PHS Financial Conflict of Interest (FCOI) Policy effective August 24, 2012 (policy attached). In order to fully comply with PHS’s new regulation, Clemson University has created a new PHS Financial Conflict of Interest (COI) Disclosure Form and Supplement Form. If you plan to apply for funding from a PHS (directly or flowing thru another agency) or have current PHS funding or plan to ask for no cost extension of an existing PHS award, you must comply with the new FCOI Regulations. PHS Agencies include:

  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)
  • National Institutes of Health (NIH)
  • Office of the Inspector General (IG)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Before a PI can submit a proposal to any of the PHS agencies, all investigators must have a completed Disclosure Form on file and have completed the Conflict of Interest training.  Relevant links are listed at the bottom of the page.

PHS defines "Investigator" as the project director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research.

  • Investigator is broadly defined so that it may include any CU personnel, post-doctoral associates, and students.

Changes to PHS FCOI Policy

The FCOI regulation, effective August 24, 2012, requires that all persons applying for, receiving or being supported on PHS funds must be compliant with PHS rules on training, disclosure, and establishment of conflict of interest management plans prior to the awarding of funds. The rules apply to current interests and interests in the 12 months preceding the disclosure, rather than interests that are anticipated in the future.

The major changes to the PHS Financial Conflict of Interest Policy include:

  • Lower financial disclosure thresholds
  • Increased transparency for travel reimbursement
  • New conflict of interest training
  • New public accessibility requirements

Lower Financial Thresholds

Investigators must disclose the following as a significant financial interest if applicable to the Investigator, the Investigator’s spouse (or domestic partner), or dependent children:

  • The value of any remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $5,000.
    • Please note that assets in or income from investment vehicles such as mutual funds and retirement accounts are not considered significant financial interests and do not need to be disclosed as long as you do not directly control the investment decisions made in these vehicles.
  • The value of any remuneration received from any non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000, or any equity interest in non-publicly traded entities. Intellectual property rights and interests count toward the $5,000 received from the entity upon receipt of income related to such rights and interests.

Increased Transparency for Travel Reimbursement

Any reimbursed travel or sponsored travel related to Institutional responsibilities if paid directly on behalf of the Investigator (including purpose of trip, sponsor/organizer, destination, and duration) must be disclosed as a Significant Financial Interest.

Please note that you are not required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. For example, if travel is reimbursed or paid by Clemson University as part of a gift or sponsored project, it is not considered a significant financial interest and does not need to be disclosed.

Financial Conflict of Interest Training for PHS Investigators

Please note that effective August 24, 2012, each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the following circumstances:

  • Institutional FCOI policies change in a manner that affects Investigator requirements; An Investigator is new to Clemson University; or
  • Clemson University finds an Investigator noncompliant with CU’s COI policy or management plan.

Public Accessibility Requirements

Clemson University must make certain information available concerning identified FCOIs held by senior/key personnel via a publicly accessible website or by a written response to any requestor within five business days of a request. PHS defines “senior/key personnel” as the project director or Principal Investigator and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution. At a minimum, Clemson University must provide the following information:

  • Investigator’s name;
  • Investigator’s title and role on the PHS research project;
  • Name of the entity in which the significant financial interest is held; and
  • Approximate dollar value of the significant financial interest.
    • These can be reported in a dollar range: $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.

Forms

PHS/NIH Investigator Disclosure Form

Policy

Clemson University Financial Conflict of Interest Policy for PHS/NIH Supported Research

Things You Need to Know (informational flyer)

CITI COI Training

Contact for further information or assistance: phscoiadmin@clemson.edu

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