PHS Financial Conflict of Interest Procedures

Sponsor:

Office of Sponsored Programs

Contact:

Director, Office of Sponsored Programs

Category:

Research and Sponsored Programs

Number:

900.007

Effective Date:

2012/08/25

Review Date:

2016/01/01

Implementation History:

Revised on 08/25/2012

Keywords:

Public Health Service (PHS), National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ) financial conflict of interest

Background Information:

Purpose

The Public Health Service (PHS), which includes funding agencies such as the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ), implemented expanded regulations for financial conflict of interest on grants.  On August 23, 2012 the State University of New York (SUNY) and the Research Foundation of SUNY (RF) approved a policy which complies with the PHS Financial Conflict of Interest (FCOI) regulations.

Definitions

Investigator – A SUNY or RF employee who is the project director or principal Investigator and any other person, including a student or post-doctoral fellow, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Institutional Responsibilities – Investigator’s professional responsibilities on behalf of SUNY and/or RF, which may include activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards or data and safety monitoring boards.

Related Party – An investigator’s spouse and dependent children.

Significant Financial Interests (SFI) – A financial interest of the Investigator (or a Related Party) that reasonably appears to be related to the Investigator’s institutional responsibilities and that consists of one or more of the following:

1. With regard to any publicly traded entity, a SFI exists if:

  1. The value of the remuneration (salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship) received from the entity in the twelve months preceding the disclosure; and
  2. The value of any equity interest (any stock, stock option, or otherwise ownership interest, as determined through reference to public prices or other reasonable measures of fair market value) in the equity as of the date of the disclosure, when aggregated, exceeds $5,000.

2. With regard to any non-publicly traded entity, a SFI exists if:

  1. The value of the remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or
  2. The Investigator (or a Related Party) holds any equity interest (e.g., stock, stock option, or other ownership interest;

3. Intellectual property rights and interests (e.g., patents, copyrights), and royalties from such rights, upon receipt of income related to such rights and interests; or

4. Reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator, and not reimbursed to the Investigator so that the exact monetary value may not be known by the Investigator), related to the Investigator’s Institutional Responsibilities, in an amount or estimated amount in excess of $500.  Excluded from this requirement is travel that is reimbursed or sponsored by a federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001 (a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

Financial Conflict of Interest (FCOI) – A Financial Conflict of Interest exists when a SFI could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Senior/Key Personnel – Project Director/Principal Investigator and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to PHS by SUNY or RF, per PHS regulations.

Statements

To comply with the PHS regulations and the SUNY/RF policy, Empire State College commits to the following:

1. The appointment of the Vice Provost of Research, Innovation and Open Education as the Designated Official (DIO).  The Vice Provost will review and manage all actual and potential financial conflicts of interests.

2. Responsibilities of the DIO include:

  1. Review of FCOI disclosures to determine if a financial conflict of interest or potential conflict exists.
  2. Where there is a determination that a FCOI or a potential FCOI does exist, to develop and monitor a management plan to reduce or eliminate the FCOI.
  3. Submit to PHS a notification of any FCOI and the management plan either prior to the expenditure of award funds or within 60 days of identifying a new FCOI during the award period or of a new Investigator on the funded project.
  4. Submit an annual report to PHS of all FCOIs and the status of the management plans.
  5. Respond within five business days to any request for information concerning Senior or Key personnel regarding a FCOI.  Such response will include at a minimum the name of the Investigator, the Investigator’s title and role on the research project, the name of the entity in which the Investigator has a SFI, the nature of the SFI and the approximate dollar value.  The New York Freedom of Information Law will govern the response if other than Senior or Key personnel are involved.
  6. If a FCOI is not identified, managed in a timely manner, or when an Investigator fails to comply with a management plan, the DOI will complete a retrospective review within 120 days of determination of non-compliance.  The review will cover the Investigator’s activities on the funded project and determine if there is a bias in the design, conduct, or reporting of the research.  If a bias is found, the DIO must inform the PHS awarding component promptly.

3. Financial Disclosures

  1. All Investigators applying for a PHS funded grant will complete the college’s PHS Financial Conflict of Interest disclosure form prior to the submission of the proposal.  The disclosure will be submitted to the Director of Sponsored Programs for initial review.  If there is an actual or potential FCOI, the disclosure will be forwarded to the DIO for development of a management plan to mitigate the FCOI.  The management plan will be agreed to by the Investigator and other Senior or Key personnel in writing.
  2. Notification of any FCOI and the management will be submitted to PHS either prior to the expenditure of funds or within 60 days of identifying a new FCOI during the award period or of a new Investigator on the funded project.
  3. If the grant is awarded, prior to an account being established, all Investigators on the project will complete and pass a FCOI training which is available through CITI.
  4. Prior to the establishment of the account, all Investigators will sign a statement which outlines their responsibility to inform the Office of Sponsored Programs of any travel or conferences that are paid for by entities other than the college or other higher education institution/organizations.

4. Documentation

Records of all Investigator disclosures of financial interests, DIO’s review of, and response to, such disclosures, and all actions under this PHS FCOI policy, including any retrospective reviews, will be maintained for at least three years from the date of the submission of the final fiscal expenditures report or, if there are special conditions, as specified under 45 CFR clauses.

Applicable Legislation and Regulations

Public Health Service regulation on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.

Related References, Policies, Procedures, Forms and Appendices

State University of New York and Research Foundation of SUNY policy titled Policy on the Conflicts of Interest in Public Health Service Sponsored Programs