FORMS, POLICIES, & PROCEDURES
Conflict of Interest
|I. Application of Policy
This policy is intended to supplement, but not replace, federal and state laws governing conflicts of interest applicable to nonprofit corporations. It applies to board members and staff. Persons covered under this policy, as well as their relatives and associates, are hereinafter referred to as “interested parties.”
II. Conflict of Interest
A conflict of interest (actual or perceived) may exist when any financial or other arrangement, situation, or action affects or could be perceived to exert inappropriate influence on the design, review, conduct, results, or reporting of research activities or findings. Conflicts may be related to financial gain, reputation, promotion, or to the role of research investigator vs. health care provider, among others.
A interested party is required to disclose a significant financial interest when he or she, any of his or her family, or any associated entity possesses a significant financial interest in a research activity that is related to his or her responsibilities as a member of PVARF conducting research at VA Portland Health Care System (VAPORHCS).
PVARF members are also subject to the conflict of interest policies of the federal government and institutions such as VAPORHCS and the Oregon Health and Science University (OHSU) with whom they may have an affiliation or appointment, and have a responsibility to disclose financial interests in research according to the policies of those institutions.
This policy covers all PVARF administered research projects or programs and closely adheres to the policy as promulgated in the 2011 revised Department of Health and Human Services (DHHS) Financial Conflict of Interest (FCOI) regulation. Research supported by U.S. Public Health Service (PHS) funding has additional requirements addressed in the section for Additional Requirements for PHS Awards and in definitions noted below.
Investigator means the principal investigator, co-investigators, and other individuals who are responsible for the design, conduct, or reporting of research. It is not intended to apply to individuals who provide primarily technical support or who are purely advisory and without direct access to the data (e.g., control over its collection or analysis), unless they are in a position to influence the study’s design, reporting, or results or have privileged information as to the outcome. Senior or key personnel identified on a grant application or progress report, consultants and post-doctoral fellows may or may not be included as Investigators.
Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development
Significant Financial Interest means a financial interest consisting of one or more of the following interests of the Investigator (or those of the Investigator’s spouse or 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 disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes 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 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.
A significant financial interest 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 by 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 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
IV. Disclosure of Potential Conflicts of Interest
For all research projects, Investigators must disclose financial interests prior to review and approval by the Research & Development (R&D) Committee.
For PVARF Board members, each member must complete a financial discloser annually for Board review.
For Investigators under the PHS policy, disclosure is additionally required at the time of application and at least annually thereafter as delineated in the Financial Conflict of Interest Guidelines for PHS Awards. Disclosure should include the relationship of the financial interest to their institutional duties.
Interested parties are under a continuing obligation to disclose any potential conflict of interest within 30 days of being known or when it reasonably should be known.
Retrospective reviews will be required for significant financial interests not disclosed in a timely manner.
An interested party shall complete the Questionnaire attached as Appendix A to fully and completely disclose the material facts about any potential conflicts of interest. The disclosure statement and Affirmation of Compliance (Appendix B) shall be submitted upon his/her association with PVARF and shall be reviewed annually thereafter. An additional disclosure statement shall be filed whenever a potential conflict arises.
Disclosure statements will be submitted as follows. For board members, the disclosure statements shall be provided to the Chair of the board. The Chair’s disclosure statement shall be provided to the Secretary of the board or its equivalent. Copies also shall be provided to the Executive Director of PVARF.
In the case of investigators, the disclosure statements shall be provided to the Executive Director of PVARF. In the case of the Executive Director, the disclosure statement shall be provided to the Chair of the Board.
In all cases, the recipient is the designated reviewing official responsible for bringing potential conflicts to the attention of the appropriate authorities. The Secretary of the Board of Directors shall file copies of all disclosure statements with the official corporate records of PVARF.
V. Procedures for Review of Potential Conflicts
Whenever there is reason to believe that a potential conflict of interest exists between PVARF and a Board member or the Executive Director, the Board of Directors shall determine the appropriate response. This shall include, but not necessarily be limited to, invoking the procedures described below with respect to a specific proposed action, policy or transaction. The designated reviewing official has a responsibility to bring a potential conflict of interest to the attention of the board promptly for action at the next regular meeting of the board or during a special meeting called specifically to review the potential conflict of interest.
Where the potential conflict involves an employee of PVARF other than the Executive Director, the Executive Director shall be responsible for reviewing the matter and may take appropriate action as necessary to protect the interests of PVARF. The Executive Director shall report to the Chair the results of any review and the action taken. The Chair shall determine whether any further board review or action is required.
VI. Procedures for Addressing Conflicts of Interest
Where a potential conflict exists between the interests of PVARF and an interested party with respect to a specific proposed action, policy or transaction, the Board of Directors shall consider the matter during a meeting of the board. PVARF shall refrain from acting until such time as the proposed action, policy or transaction has been approved by the disinterested members of the Board of Directors of PVARF. The following procedures shall apply:
An interested party who has a potential conflict of interest with respect to a proposed action, policy or transaction of the corporation shall not participate in any way in, or be present during, the deliberations and decision-making vote of PVARF with respect to such action, policy or transaction. However, the interested party shall have an opportunity to provide factual information about the proposed conflict and/or action, policy or transaction. Also, the board may request that the interested party be available to answer questions.
VII. Violations of Conflict of Interest Policy
If the Board of Directors has reason to believe that an interested party has failed to disclose a potential conflict of interest, it shall inform the person of the basis for such belief and allow the person an opportunity to explain the alleged failure to disclose.
If the board decides that the interested party has in fact failed to disclose a possible conflict of interest, the board shall take such disciplinary and corrective action as the board shall determine to include but not limited to:
· Disclosure of significant financial interests to the public, human subjects, researchers and other participants, publishers, and/or conference organizers
· Requiring additional disclosures or actions with respect to IRB or IACUC applications or materials
· Monitoring of research by disinterested co-researchers or independent reviewers or committees capable of taking measures to protect research from bias
· Disqualification from participation in activity affecting or affected by a technology transfer transaction
· Requiring that investigator participation in the recruitment or consent of subjects be prohibited or restricted
· Requiring that the significant financial interest be divested, restructured, or placed in a blind trust
· Modification or severance of relationships that create potential conflicts of interest
· Changing terms of the grant agreement or CRADA relating to the research
· Requiring non-participation in any business transactions between the parties to agreements involving the research in question.
Conditions imposed by PVARF or the VAPORHCS R&D Committee must be met by the Investigator in order to receive approval to conduct a proposed research project. PVARF will not expend funds in support of a research project until any significant financial interest has been reviewed and any conflict of interest has been satisfactorily managed or eliminated.
PVARF will comply with sponsor requirements for ongoing reporting of FCOIs including management plans, retrospective reviews, and mitigation reports. Any violation of this policy may require reporting to a sponsoring entity and affiliated institutions as appropriate.
VIII. Record Retention
All records relating to the disclosure of conflicts of interest and any action taken with respect thereto will be maintained for at least three years or as required by applicable government regulations, whichever is longer.
IX. Additional Requirements for PHS Awards
Additional requirements for PHS awards are promulgated by the 2011 revised DHHS Financial Conflict of Interest (FCOI) regulation, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). Compliance with these regulations is delineated under the Financial Conflict of Interest Guidelines for PHS Awards found on the PVARF website.
Investigators entering consortium arrangements should be aware that PVARF will include a requirement that subrecipient institutions comply with the PHS policy on Financial Conflict of Interest.
The PHS policy requires travel disclosure and training as defined below.
Travel and training requirements do not extend to Investigators’ immediate family members (spouses and dependent children).
Disclosure Under PHS Awards
Investigators must disclose all significant financial interests as defined above and in addition include 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 readily available) related to their institutional responsibilities. However, 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; an academic teaching hospital; a medical center; or a research institute that is affiliated with an Institution of higher education.
Disclosures are required: (1) at the time of application for PHS-funding; (2) at least annually during the period of award; (3) within 30 days of acquiring or learning of a newly acquired significant financial interest; (4) within 30 days of an Investigator newly participating in the project; and (5) within 30 days of travel.
All Investigators involved in the design, conduct, or reporting of research will complete training at least once every four years.
In accordance with PHS policy, PVARF makes identified FCOIs held by Investigators available to requestors within five calendar days of the receipt date of a written request.