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Public Health Service Financial Conflicts of Interest Policy

Introduction

Policy Statement

As noted in the Financial Conflicts of Interest in Research Policy, Washington and Lee University ("W&L" or "the University") encourages its faculty and staff to participate in research activities and to do so with the highest ethical standards.  While the potential for financial conflicts of interest is understandable, faculty and staff must prevent the introduction of bias into their research. 

This policy is intended to comply with the federal regulations issued by the Department of Health and Human Services entitled Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Serve Funding is Sought (42 CFR Part 50, Subpart F, and 45 CFR Part 94), which became effective August 24, 2012 ("the PHS regulations"). 

The purpose of this policy is to promote objectivity in research by establishing University standards that provide a reasonable expectation that the design, conduct, and reporting of research funded by the Public Health Service ("PHS") or any other sponsor that has adopted the PHS regulations will be free from bias resulting from Investigator Financial Conflicts of Interest.  This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid Financial Conflicts of Interest, and should respond appropriately when Financial Conflicts of Interest arise.  To that end, this policy informs faculty and staff about situations that generate Financial Conflicts of Interest related to research and provides mechanisms for Investigators and the University to manage those Financial Conflicts of Interest that arise.  Every Investigator must become familiar with, and abide by, the provisions of this policy.  If a situation arises raising questions of a Financial Conflict of Interest, an Investigator should discuss the situation with the Conflicts Coordinator.

Applicability

This policy applies to all Investigators (as defined in this policy) involved with research funded, or proposed for funding, by PHS or any other sponsor that has adopted the PHS regulations.  Investigators involved with research funded, or proposed for funding, by a sponsor other than PHS that has not adopted the PHS regulations are subject to the University's Financial Conflicts of Interest in Research Policy.  All employees are also subject to the Conflict of Interest Policy as stated in the University's employee handbook.

Definitions

Conflicts Coordinator2 means the individual within the University who has been designated to solicit and review disclosures from Investigators of Significant Financial Interests related to the Investigator's institutional responsibilities.  For the purposes of this policy, the Conflicts Coordinator shall be the Provost or his or her designee(s).

Financial Conflict of Interest means a Significant Financial Interest that the Conflicts Coordinator reasonably determines could directly and significantly affect the design, conduct or reporting of sponsored research.

Financial Interest means anything of monetary value received or held by an Investigator or his or her spouse and dependent children, whether or not the specific value is readily ascertainable.

Institutional responsibilities means the Investigator's responsibilities on behalf of the University, including, but not limited to research, research consultation, teaching, professional practice, University committee memberships, and service on University panels.

Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for any part of the design, conduct, or reporting of research that is either funded or proposed for funding by a sponsor.  The term Investigator may also include collaborators or consultants as appropriate.

Key personnel3 includes the research project director, principal investigator, and any other person identified as senior/key personnel by the University in the grant application, progress report, or any other report submitted to the sponsor by or on behalf of the University.

Public Health Service or PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of PHS to which the authority of PHS may be delegated.  The components of PHS include, but are not limited to, the National Institutes of Health ("NIH"). 

Research means a systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research.  The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).

Significant Financial Interest

i. A Significant Financial Interest means a Financial Interest consisting of one or more of the following interests of an Investigator and the Investigator's spouse and dependent children that reasonably appears to be related to the Investigator's institutional responsibilities:

  • With regard to any publicly traded entity, a Significant Financial Interest 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 the disclosure, when aggregated, exceeds $5,000.  Remuneration includes any salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship).  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, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or spouse, partner, dependent children) owns any equity interest, regardless of dollar value.  For purposes of this paragraph, the terms remuneration and equity interest shall have the same meanings as set forth above.
  • Intellectual property rights and interests (e.g. patents and copyrights) upon receipt of income related to such rights and interest.
  • Any occurrence of third-party reimbursed or sponsored travel related to the Investigator's institutional responsibilities, with the exception of any travel 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 center affiliated with an institution of higher education. 

ii. The term Significant Financial Interest does not include:

  • Salary, royalties, or other remuneration from the University;
  • Income from investment vehicles such as mutual funds or 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, an academic teaching hospitals, a medical center, or a research institute 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, an academic teaching hospitals, a medical center, or a research institute affiliated with an institution of higher education.

Policy

I. Disclosure of Significant Financial Interests

Prior to the submission of a proposal for funding, each Investigator shall complete a Public Health Service Significant Financial Interest Disclosure Form ("disclosure form") (available at: http://go.wlu.edu/OGC/PHS-SignificantFinancialInterestDisclosureForm) and attach all required supporting documentation, if any. 4  An Investigator must submit a disclosure form prior to the time a proposal is submitted even if he or she does not have any Significant Financial Interests.  Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential and accompany the disclosure form. 

All financial disclosures must be updated by Investigators during the period of the award on an annual basis and on an ad hoc basis, as described below. Each Investigator must also disclose any reimbursed or sponsored travel related to his or her research.

All disclosure forms and supporting documentation shall be submitted to the Conflicts Coordinator.  Additional information may be requested by the Conflicts Coordinator and shall be furnished upon request.  The Conflicts Coordinator is responsible for the receipt, processing, review, and retention of all disclosure forms.  

Regardless of the minimum disclosure requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual Financial Conflict of Interest or be perceived to present a Financial Conflict of Interest.  Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

Collaborators from other institutions who share responsibility for the design, conduct or reporting of research results, and who will be conducting research under a sub-grant or subcontract from the University are expected to comply with the policies and procedures for disclosure and review of a Significant Financial Interests at the institution at which they are employed.  If their institution does not have a conflict of interest policy that complies with the applicable regulations, they shall comply with this policy for disclosure and review of a Significant Financial Interests.  Sub-awards issued by the University shall ask the sub-recipient institution to certify that its policy is in compliance with applicable regulations, and unless the sub-recipient does not have a compliant policy, shall indicate that the recipient organization is responsible for reviewing the disclosures submitted by its Investigators and, if a Financial Conflict of Interest is identified, for sending the University notification of the Financial Conflict of Interest, and of the sub-recipient institution's plan to manage, reduce, or eliminate the identified Financial Conflict of Interest, in accordance with applicable reporting requirements.6 

A. New Proposal

Before submitting a proposal for funding, each Investigator shall disclose his or her Significant Financial Interests to the Conflicts Coordinator.  The University will not submit a research proposal unless each Investigator has submitted the required Significant Financial Interest disclosures.7

B. Annual Disclosures

During the grant period, all Investigators shall disclose their Significant Financial Interests to the Conflicts Coordinator at least annually.8

C. Ad Hoc Disclosures

An Investigator shall make an ad hoc disclosure in the following situations:

  1. New Investigators
    Before joining an ongoing research project, a new Investigator shall submit a disclosure of his or her Significant Financial Interests to the Conflicts Coordinator.9
  2. New Significant Financial Interest
    Each Investigator shall disclose to the Conflicts Coordinator any Significant Financial Interest that he or she acquires during the course of the year within 30 days of discovering or acquiring the Significant Financial Interest.10

D. Travel

Each Investigator shall disclose third-party reimbursed or sponsored travel related to his or her institutional responsibilities within 30 days of the travel.  Disclosures relating to Investigator travel shall include, at a minimum, the purpose of the trip, the identity of the sponsor and organizer, the destination, and the duration of the trip.  Additional information, including the estimated cost of travel, may be requested by the Conflicts Coordinator and shall be furnished upon request.11

II. Review and Decision of the Conflicts Coordinator

The Conflicts Coordinator shall promptly review each disclosure of a Significant Financial Interest to determine whether it constitutes a Financial Conflict of Interest.  A Financial Conflict of Interest exists when the Conflicts Coordinator determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting research funded by a sponsor covered by this policy, or is in an entity whose financial interest could be affected by the research.12  If the Conflicts Coordinator determines that a Financial Conflict of Interest exists, the Conflicts Coordinator shall take action to eliminate, reduce, or manage the Financial Conflict of Interest, as appropriate.  The Conflicts Coordinator may consult with other University officials, as appropriate.  Notwithstanding the foregoing, the Conflicts Coordinator shall review all Significant Financial Interest disclosures, determine whether a Financial Conflict of Interest exists, and, if so, take action to eliminate, reduce, or manage the Financial Conflict of Interest, prior to the expenditure of any funds received from the sponsor.13  Further notwithstanding, during the course of research, whenever a new Investigator discloses a Significant Financial Interest or an existing Investigator discloses a new Significant Financial Interest, the Conflicts Coordinator shall review the disclosed Significant Financial Interests, determine whether a Financial Conflict of Interest exists, and, if so, at least on an interim basis, take action to eliminate, reduce, or manage the Financial Conflict of Interest, within 60 days of the disclosure.14 

If the Conflicts Coordinator determines that there is a Financial Conflict of Interest that can be managed, he or she shall require and approve a written management plan before any related research goes forward.15  The affected Investigator, in consultation with the Conflicts Coordinator, is responsible for developing and submitting a proposed management plan.

Examples of conditions or restrictions that the Conflicts Coordinator may impose to manage a Financial Conflict of Interest include, but are not limited to:

  • Public disclosure of Significant Financial Interests;
  • For research projects involving human subjects, disclosure of Financial Conflicts of Interest to participants;
  • 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;
  • Modification of the research plan;
  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
  • Reduction or elimination of the Financial Interest; or
  • Severance of the relationships that create Financial Conflicts of Interest.16

The Conflicts Coordinator shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the research project.17

To address complex situations, the Conflicts Coordinator may establish an oversight committee to periodically review the ongoing research, to monitor how the research is conducted, to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.

III. Reporting to Sponsors

The Conflicts Coordinator shall provide initial and ongoing reports relating to an Investigator's Financial Conflicts of Interest to the sponsor in accordance with applicable federal regulations and the sponsor's policies.18  If the funding for the research is a sub-award from a prime awardee, reports shall be made to the prime awardee to permit the prime awardee to fulfill his or her reporting obligations to the sponsor.

IV. Investigator Non-Compliance

A. Disciplinary Action

In the event of an Investigator's failure to comply with this policy, the Conflicts Coordinator may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Conflicts Coordinator is implemented.19

A Conflicts Coordinator'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 Conflicts Coordinator shall be described in a written explanation of the decision to the Investigator and, where applicable, to other University bodies, including, but not limited to, the Institutional Review Board for Research With Human Participants and the Institutional Animal Care and Use Committee.20

B. Retrospective Review

If the Conflicts Coordinator determines that a Significant Financial Interest was not properly disclosed or reviewed, the Conflicts Coordinator shall review the Significant Financial Interest and determine whether a Financial Conflict of Interest exists within 60 days.21  If the Conflicts Coordinator determines that a Financial Conflict of Interest exists, the Conflicts Coordinator shall implement, at least on an interim basis, a management plan that specifies the actions that have been or will be taken to manage the Financial Conflict of Interest going forward.22  In addition, whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including but not limited to an Investigator's failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, the Conflicts Coordinator shall complete a retrospective review of the Investigator's activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.23

Documentation of the retrospective review shall include the project number, project title, the name of the project director or principal investigator (or equivalent) or the contact project director or principal investigator (or equivalent), name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reasons for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.24

If required, the Conflicts Coordinator shall update any report previously submitted to the sponsor or the prime awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.25  If bias is found, the report shall include a mitigation report in accordance with the applicable regulations or policies, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.26

V. Training

Each Investigator shall complete training on this policy prior to engaging in sponsored research, and at least every four years thereafter.  Investigators shall also complete training within a reasonable period of time as determined by the Conflicts Coordinator in the following situations:

  • If this policy is substantively amended in a manner that affects the requirements of Investigators;
  • If the Investigator is new to the University; or
  • If it is determined that the Investigator has not complied with this policy or with a management plan related to his or her activities.27

VI. Record Retention

The Conflicts Coordinator shall retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the sponsor or to the prime awardee or from such other date specified in the applicable regulations.28

VII. Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information shall be confidential.  However, the University may make such information available to a sponsor of an Investigator's research, to a requestor of information concerning the Financial Conflict of Interest, or to the primary entity that made the funding available to the University, if required.29  If the University provides disclosure forms, conflict management plans, or related information to an outside entity, the Investigator shall be informed of this disclosure.

VIII. Public Accessibility

Prior to the expenditure of funds received from a sponsor, the University shall ensure public accessibility, via written response to a requestor within five business days of the request, of information concerning any Significant Financial Interest that meets the following criteria:

  • The Significant Financial Interest was disclosed and is still held by Key Personnel;
  • A determination has been made that the Significant Financial Interest is related to the research funded by a sponsor covered by this policy; and
  • A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.30

The information to be made available shall be consistent with the requirements of the applicable federal regulations and sponsor policies, if any.31

IX. Regulatory Authority

This policy is intended to comply with the requirements of the PHS regulations.  Where there are substantive differences between this policy and the regulations, the regulations shall take precedence.

Endnotes

[1] Generally from 42 CFR §50.603 and/or 45 CFR §94.3, unless otherwise expressly provided.

[2] Used for convenience of reference, and to satisfy the requirement of 42 CFR §50.604(d) and 45 CFR §94.4(d) to "designate an institutional official to solicit and review disclosures of Significant Financial Interests," but not expressly defined in the federal regulations.

[3] Slightly different definition in 45 CFR §94.3

[4] 42 CFR §50.604(e)(1); 45 CFR §94.4(e)(1) (NOTE: The regulations do not require a submission if the Investigator does not have a Significant Financial Interest.  However, in order to ensure that W&L has the appropriate documentation, we decided to require a submission regardless of whether the Investigator has a Significant Financial Interest.)

[5] 42 CFR §50.604(e)(2)-(3), 45 CFR §94.4(e)(2)-(3)

[6] 42 CFR §50.604(c); 45 CFR §94.4(c)

[7] 42 CFR §50.604(e)(1); 45 CFR §94.4(e)(1)

[8] 42 CFR §50.604(e)(2); 45 CFR §94.4(e)(2)

[9] Common provision in other policies.

[10] 42 CFR §50.604(e)(3); 45 CFR §94.4(e)(3)

[11] 42 CFR §50.603; 45 CFR §94.3 (definition of Significant Financial Interest, subparagraph 2)

[12] 42 CFR §50.604(f)

[13] 42 CFR §50.605(a)(1); 45 CFR §94.5(a)(1)

[14] 42 CFR §50.605(a)(2); 45 CFR §94.5(a)(2)

[15] 42 CFR §50.605(a)(1); 45 CFR §94.5(a)(1)

[16] 42 CFR §50.605(a)(1); 45 CFR §94.5(a)(1)

[17] 42 CFR §50.605(a)(4); 45 CFR §94.5(a)(1)

[18] 42 CFR §50.604(h); 42 CFR §50.605(b); 45 CFR §94.4(h); 45 CFR §94.5(b)

[19] 42 CFR §50.604(j); 45 CFR §94.4(j)

[20] Modeled after Middlebury's policy.

[21] 42 CFR §50.605(a)(3); 45 CFR §94.5(a)(3)

[22] 42 CFR §50.605(a)(3)(i); 45 CFR §94.5(a)(3)(i)

[23] 42 CFR §50.605(a)(3)(ii)(A); 45 CFR §94.5(a)(3)(ii)(A)

[24] 42 CFR §50.605(a)(3)(ii)(B); 45 CFR §94.5(a)(3)(ii)(B)

[25] 42 CFR §50.605(a)(3)(iii); 45 CFR §94.5(a)(3)(iii)

[26] 42 CFR §50.605(a)(3)(iii); 45 CFR §94.5(a)(3)(iii)

[27] 42 CFR §50.604(b)(1)-(3); 45 CFR §94.4(b)

[28] 42 CFR §50.604(i); 45 CFR §94.4(i)

[29] 42 CFR §50.604(k)(4); 42 CFR §50.605(a)(5)(i); 45 CFR §94.4(k)(4)(i); 45 CFR §94.5(a)(5)(i)

[30] 42 CFR §50.605(a)(5)(i); 45 CFR §94.5(a)(5)(i)

[31] 42 CFR §50.605(a)(5)(ii); 45 CFR §94.5(a)(5)(ii)