PHS Financial Conflict of Interest Procedures

The NSF and PHS (Public Health Service) have different definitions and requirements.  Be sure to use the appropriate procedures.  In addition, other agencies and grant funders have adopted the PHS regulations.  If you are unsure about what regulations apply, contact grants@cofc.edu.

Applicability

These procedures governing Financial Conflict of Interest apply to all Investigators as defined in this document who are submitting applications for PHS sponsored programs or research or who have received funding from PHS and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.  These procedures further apply to other funding organizations or agencies which have adopted the PHS policy.

Regulatory Authority

The College of Charleston  (Institution) shall assure that conflicts of interest by its researchers are identified and managed in adherence with Public Health Service (PHS) requirements of 42 CFR 50 and 45 CFR 94 and PHS Policy Clarification Concerning Disclosure Requirements for Reimbursed and Sponsored Travel - 42 CFR Part 50 Subpart F.

Where there are substantive differences between these procedures and the regulations, the regulations take precedence.

Definitions

Designated Official (DO) means the individual(s) within the Institution who is(are) responsible for the solicitation and review of disclosures of Significant Financial Interests (SFI).

Research Conflict of Interest Panel (RCIP) means the Institution’s Panel that reviews investigator disclosures upon recommendation by the DO and determines whether a conflict of interest exists.   If a conflict of interest exists, a management plan is developed for handling the identified conflict.  RCIP members are appointed by the Provost.  The RCIP shall include, at a minimum, three tenured faculty members representing a cross section of academic disciplines, the Assistant Vice President for Research, and a representative from Legal Affairs.  The DO shall serve as an ex officio, non-voting member of the committee.

Institutional Responsibilities means the Investigator’s teaching/education, research, outreach, professional practice, and public service on behalf of the Institution which are in the course and scope of the Investigator’s appointment/employment.

Investigator means any individual, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS and NSF sponsored research, or proposals for such funding – and the Investigator’s spouse and dependent children.   This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students.  The definition may also include collaborators or consultants as appropriate.

Subrecipient means collaborators, subawardees, subcontractors, or consortium members.

Financial Conflict of Interest (FCOI) means a Significant Financial Interest that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of funded research or sponsored programs.

PHS Significant Financial Interest (PHS SFI) means a financial interest consisting of one or more of the following interests of the Investigator (as defined above) that reasonably appears to be related to the Investigator's Institutional Responsibilities (as defined above).

Determining PHS Significant Financial Interest (PHS-SFI)

  • With regard to any publicly traded entity, PHS-SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated per entity, exceeds $5,000. For purposes of this definition, remuneration includes:
    • salary; or
    • any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); or
    • equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
  • With regard to any non-publicly traded entity, PHS-SFI exists:
    • if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated per entity, exceeds $5,000; or
    • when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
    • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • The occurrence of any reimbursed or sponsored travel, the value of which per entity exceeds $5,000*, related to their institutional responsibilities.  This disclosure requirement does not apply to 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.

* NIH Provides Policy Clarification Concerning Disclosure Requirements for Reimbursed and Sponsored Travel - 42 CFR Part 50 Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought" Notice Number: NOT-OD-13-004 Key Dates Release Date: October 18, 2012 “Institutions may, within the discretion afforded by the Final Rule, impose the $5,000 de minimis threshold to reimbursed or sponsored travel disclosure in their institutional policies which specify the disclosure details.  For example, consistent with the requirement for other types of financial interests within the regulatory definition of SFI, Institutions could apply the de minimis threshold when aggregated per entity.  Disclosure of reimbursed or sponsored travel is also subject to the exclusions described in 50.603(3).”

  • PHS-SFI does not include:
    • Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including:
      • intellectual property rights assigned to the Institution and
      • agreements to share in royalties related to such rights;
    • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
    • Income from seminars, lectures, or teaching engagements 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; or
    • Income from service on advisory committees or review panels for 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.

Disclosure Procedures

Each Investigator shall submit disclosures on the Investigator Financial Interests Report eform system of the Office of Research and Grants Administration.

  • Initial Disclosure
    • An Investigator Financial Interests Report form must be on file at the time of submission of a proposal to the NSF for research funding.
    • This disclosure shall cover the 12 months prior to submission.
    • Investigators new to the Institution who are transferring a funded project or research shall submit a disclosure at the time of the transfer.
  • Award Disclosure
    • Each Investigator shall submit an Investigator Financial Interests Report form addendum at the time of acceptance of an award from the PHS.
  • Annual Disclosure
    • An Investigator Financial Interests Report form addendum shall be submitted annually within 30 days of the anniversary date of the award.
  • Ad Hoc Disclosure
    • An Investigator Financial Interests Report form addendum shall be submitted by each Investigator during the course the funded activity within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) the PHS-SFI.
  • Travel
    • Disclosure of travel must include, at a minimum, the
      • purpose of the trip,
      • identity of the sponsor/organizer,
      • destination, the duration, and,
      • monetary value (if known).  The Designated Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s PHS-funded research.

Significant Financial Interest Review

  • Initial Review
    • The Investigator Financial Interests Report shall be initially reviewed within 10 working days by the Designated Official.
    • If the Designated Official concludes that a PHS-SFI could directly and significantly affect the design, conduct, or reporting of sponsored projects or research, the RCIP shall be convened to determine that an FCOI exists and if so, require that an approved FCOI Management Plan shall be required before any related research goes forward.
  • Retrospective Review
    • Whenever an FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by the Institution to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Institution shall, within 120 days of the Institution's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
    • The Institution is required to document the retrospective review; such documentation shall include, at least the following key elements:
      • Project number;
      • Project title;
      • PD/PI or contact PD/PI if a multiple PD/PI model is used;
      • Name of the Investigator with the FCOI;
      • Name of the entity with which the Investigator has a financial conflict of interest;
      • Reason(s) for the retrospective review;
      • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
      • Findings of the review; and
      • Conclusions of the review.
    • Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward.
    • If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).
    • Depending on the nature of the financial conflict of interest, the Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the FCOI or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review.
    • Thereafter, the Institution will submit FCOI reports annually as required.

Training

Each Investigator shall complete training regarding FCOI and PHS regulations related to FCOI prior to engaging in research related to any PHS-funded grant and at least every four years thereafter, and immediately when any of the following circumstances apply:

  • The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
  • An Investigator is new to the Institution; or
  • The Institution finds that an Investigator is not in compliance with the Institution's FCOI policy or management plan.

Reporting

Should any reported conflict or non-compliance require reporting to the funding agency, the Assistant Vice President for Research will submit reports as required.  If the funding is made available from a prime PHS awardee, such reporting shall be made available to the prime awardee such that they may fulfill their reporting obligations.

  • Prior to the Institution's expenditure of any funds under a PHS-funded research project, the Institution shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's SFI found by the Institution to be conflicting and ensure that the Institution has implemented a management plan.
  • In cases in which the Institution identifies an FCOI and eliminates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit an FCOI report to the PHS Awarding Component.
  • For any SFI that the Institution identifies as conflicting subsequent to the Institution's initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project),
    • The Institution shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that the Institution has implemented a management plan.
    • Where such FCOI report involves an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by the Institution (e.g., was not timely reviewed or reported by a subrecipient), the Institution also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research.
    • Additionally, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
  • Any FCOI report shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:
    • Project number;
    • PD/PI or Contact PD/PI if a multiple PD/PI model is used;
    • Name of the Investigator with the financial conflict of interest;
    • Name of the entity with which the Investigator has a financial conflict of interest;
    • 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 PHS-funded research and the basis for the Institution's determination that the financial interest conflicts with such research; and
    • 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.
  • For any financial conflict of interest previously reported by the Institution with regard to an ongoing PHS-funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists.
  • The Institution shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

Record Retention

The Office of Research and Grants Administration shall maintain records relating to:

  • All Investigator disclosures of financial interests and
  • The Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of a financial conflict of interest,  and
  • All actions under the Institution's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations.

Investigator Non-Compliance

  • Disciplinary Action
    • In the event of an Investigator’s failure to comply with this Policy, the Provost may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Provost is implemented.
    • The Provost’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Provost, will be described in a written explanation of the decision to the investigator, RCIP, and, where applicable, the IRB, and will notify the individual of the right to appeal the decision.

Public Accessibility

  • The Institution will make available upon written response to any requestor within five business days of a request, information concerning any SFI that meets the following criteria:
    • The SFI was disclosed and is still held by the Investigator;
    • A determination has been made that the SFI is related to the funded research; and
    • A determination has been made that the SFI is an FCOI.
  • Information that the Institution makes available upon written response to any requestor within five business days of a request shall include, at a minimum, the
    • Investigator's name;
    • Investigator's title and role with respect to the research project;
    • name of the entity in which the significant financial interest is held;
    • nature of the significant financial interest; and
    • approximate dollar value of the significant 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.
  • Information concerning the SFI of an Investigator shall remain available for responses to written requests at least three years from the date that the information was most recently updated.

Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential.  However, the Institution may make such information available to an agency funding the research, to a requestor of information concerning FCOI related to PHS or NSF funding or to the primary entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

Subrecipient

  • When the Institution carries out the PHS-funded research through a Subrecipient, it shall incorporate as part of a written agreement with the subrecipient terms that establish whether the FCOI policy of the Institution or that of the Subrecipient will apply to the Subrecipient's Investigators;
  • If the Subrecipient's Investigators must comply with the subrecipient's FCOI policy, the Subrecipient shall certify as part of the agreement referenced above that its policy complies with the PHS regulations. If the Subrecipient cannot provide such certification, the agreement shall state that Subrecipient Investigators are subject to the FCOI policy of the Institution for disclosing SFI that are directly related to the Subrecipient's work for the Institution;
  • Further, if the Subrecipient's Investigators are permitted to comply with the Subrecipient's FCOI policy, the agreement referenced above shall specify time period(s) for the Subrecipient to report all identified FCOI to the Institution.  Such time period(s) shall be sufficient to enable the Institution to provide timely FCOI reports as required by the PHS;
  • Alternatively, if the Subrecipient's Investigators must comply with the Institution's FCOI policy, the agreement referenced above shall specify time period(s) for the Subrecipient to submit all Investigator disclosures of SFI to the Institution.  Such time period(s) shall be sufficient to enable the Institution to comply timely with its review, management, and reporting obligations under the PHS regulations.