VCOM Conflict of Interest Policy Overview of Financial Conflict of Interest Related to Research December 4, 2013

Purpose of Regulation & Policy The VCOM policy follows the federal regulation, Responsibility of Applicants for Promoting Objectivity in Research, 42.CFR.50, Subpart F and 45.CFR CFR.50, Subpart F 45.CFR.94 This regulation establishes standards that provide a reasonable expectation that the design, conduct and reporting of research funded under PHS-agencies will be free from bias resulting from investigator financial conflict of interest. VOM policy dictates that all externally sponsored research shall follow this regulation, not just those projects funded by PHS agencies. December 4, 2013

Applicability This policy is applicable to investigators who plan to participate or who are participating in any extramurally funded research at VCOM. Additional regulations as described in 42.CFR.50 and 45.CFR.94 are applicable to any PHS-funded research at VCOM. Investigator includes the principal investigator/project director and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research. This includes the principal investigator, co- investigators, lab technicians, collaborators or consultants. December 4, 2013

Definitions A conflict of interest arises in a situation in which an actual, potential or perceived conflict exists that cause undue influence over judgment associated with VCOM responsibilities such as performing research, reporting research results or mentoring students. Conflicts of interest in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of an investigator when designing, conducting or reporting research. December 4, 2013

Definitions A significant financial interest consists of one or more of the following interests of the investigator (and those of the investigators spouse and dependent children) that reasonably appear to be related to the investigators institutional responsibilities: Any financial interest in a publicly traded entity where the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest as of the date of disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary. 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. December 4, 2013

Definitions Any financial interest in a non-publically traded entity where 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 holds any equity interest. Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests. Travel related to an Investigators institutional responsibilities that is either paid on behalf of the Investigator or not directly reimbursed to the Investigator. This does not apply to travel reimbursed or sponsored by a government agency, institution of higher education, academic teaching hospital, medical center or a research institute affiliated with an institution of higher education. Disclosure is required only by the Investigator and not the Investigators spouse or dependent children. December 4, 2013

Disclosure All individuals listed on the grant or protocol, regardless of title or position, who may be responsible for the design, conduct or reporting of the research must complete a Research Financial Conflict of Interest Disclosure Form in order to disclose all financial interests that would reasonably appear to be related to their institutional responsibilities. December 4, 2013

Disclosure It is important to disclosure and manage financial conflicts of interest in order to: Protect the integrity of all research conducted at VCOM, Comply with federal regulations, Support and not impede research and Ensure the safety of community and human subjects research volunteers. December 4, 2013

Disclosure Investigators need to disclose: Consulting income, honoraria or salary (excluding that from VCOM) from a commercial entity, Equity (such as stock or stock options) held directly in publicly traded or privately held companies, Royalties received from technology licensed for a commercial entity, Fiduciary role (such as officer, director or trustee) for a commercial entity and Externally reimbursed or sponsored travel from professional associations, societies, foundations, commercial entities or foreign governments. December 4, 2013

Disclosure Investigators must complete the Research Financial Conflict of Interest Disclosure Form each time they are involved with an extramurally- funded research project. This form must be submitted at the time of the proposal submission to the ORA. Disclosure forms must be updated within 30 days of any new activity or change in the status of the existing disclosure. Disclosure must pertain to all institutional responsibilities. December 4, 2013

Determining FCOI The Institutional Integrity Officer will review all disclosure forms for actual, potential or perceived significant financial interest: Is financial disclosure related to the research? Is financial disclosure significant? Could the financial disclosure be perceived to directly and significantly affect the research, technology or commercial entity? December 4, 2013

Determining FCOI The Conflict of Interest Committee will review any significant financial interests so identified by the Institutional Integrity Officer. The Committee will determine if the significant financial interest is related to the research. If related, the Committee will determine whether the significant financial interest is a financial conflict of interest. December 4, 2013

Management Management strategies include: Public disclosure such as when presenting or publishing research results or directly to participants in the informed consent form. Modifications and changes to the research plan including a change of responsibilities or disqualification from participation in some or all portions of the research. Reduction or elimination of interests, such as selling all equity interests or severance of relationships that create interests. December 4, 2013

Monitoring When a management plan is implemented, VCOM shall monitor investigator compliance with the management plan: This shall occur on an ongoing basis until the completion of the research project, Shall be done by an independent monitor or committee, Oversight includes audits of the research and consent/enrollment process, May require interests be escrowed. December 4, 2013

Reporting to Public For any financial conflicts of interest in PHS-funded research, the following must be reported within five days in response to a written request: Investigator name, title and role on the project Project title and number Name of entity in which a significant financial interest has been disclosed Nature of the interest Approximate dollar amount December 4, 2013

Subrecipient Requirements For all subrecipient entities involved in applications to PHS agencies or who have a written agreement with VCOM that falls under PHS-funded research: Subrecipient entities must certify whether they will follow their own COI policy consistent with the federal regulations or whether they will follow VCOMs policy. If subrecipient entity will follow VCOMs COI policy, VCOM must collect disclosure forms from subrecipient investigators, ensure they receive training and manage and monitor any financial conflicts of interest. These activities must occur prior to funds being expended. December 4, 2013

Questions For any questions related to the Financial Conflicts of Interest in Research Policy, please contact: Research Division: / Office of Research Administration home page: December 4, 2013