91����Ƶ

Financial conflicts of interest in sponsored research occur when the financial interests of Investigators (or those of the Investigator’s spouse/domestic partner and dependent children) could directly and significantly affect the design, conduct or reporting of ODU research, or present the appearance of doing so. Conflicts of interest have the potential to inappropriately influence many aspects of research – from how a study is designed, how data is collected, analyzed and reported, to what individuals/suppliers are involved in the work. In a university setting, especially one that promotes technology transfer and entrepreneurial activity, conflicts of interest naturally arise and they must be addressed appropriately.

Federal regulations and guidance regarding financial conflicts of interest in research (e.g., PHS regulations entitled “Promoting Objectivity in Research,” 42 CFR Part 50 and 45 CFR Part 94) also promote objectivity in research and require that the design, conduct, and reporting of research funded under federal grants, cooperative agreements, or contracts will be free from bias resulting from conflicts. Many nongovernmental funding organizations also have conflict of interest requirements.

Conflicts may also arise in other 91����Ƶ activities unrelated to sponsored research (e.g., unfunded research or educational or service activities) when a 91����Ƶ member’s personal/external interests may influence how they conduct their 91����Ƶ activities.

This web page provides a summary of relevant information. Additional detail can be found in the information below:

To complete a disclosure in the ODU COI Management System, it is critical to understand the terms used in the regulations and ODU requirements.

���Ա�����پ������ٴǰ�” includes the Principal Investigator (PI), Co-Principal Investigator (Co-PI), Co-Investigator (Co-I), and any other key personnel, regardless of title or position, who has the responsible charge or oversight for the design, conduct, or reporting of research. The PI for any research activity conducted at a 91����Ƶ facility must be a 91����Ƶ employee or Old Dominion 91����Ƶ Research Foundation (RF) employee, or, under appropriate circumstances (e.g., NSF Graduate Fellowship), graduate student, post-doc, research assistants. Co-PIs are key personnel who have responsibilities like that of a PI on research projects. While the PI has ultimate responsibility for the conduct of a research project, the Co-PI is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research. Note: The PI determines who is an Investigator on a project.

Immediate Family Member is a spouse and any other person residing in the same household as the investigator who is a dependent of the investigator or of whom the investigator is a dependent.

Significant Financial Interest is a significant financial interest means the receipt by an Investigator or an Investigator’s Immediate Family Member of anything of monetary value, including but not limited to the following, provided they appear to be reasonably related to the Investigator’s Institutional Responsibilities:

• Non-publicly traded entity: if the value of any remuneration received from any foreign or domestic, non-publicly-traded entity over a 12-month period, when aggregated, exceeds $5,000, or when the Investigator or the Investigator’s Immediate Family Members holds any equity interest.
• Publicly traded entity: Any equity interest, including stock options in any foreign or domestic publicly-traded entity held by an Investigator and the Investigator’s immediate family members, that, when aggregated, exceeds 5% ownership interest in any single entity or a current value of $5,000, as determined through reference to public prices, recent financing events, or other reasonable measures of fair market value.
• Salary, consulting fees, honoraria, royalties, and other payments received directly from a single outside entity that, when aggregated for the Investigator and the Investigator’s Immediate Family Members, exceeds $5,000 over a 12-month period.
• Any sponsored or reimbursed travel related to Institutional Responsibilities, regardless of dollar amount.
• Any income received from rights in Intellectual Property (e.g., patents, copyrights), as measured over a 12-month basis.
• Any venture or other capital financing.

Exclusions from the Significant Financial Interest Definition:

• Salary or supplementary payments paid by ODU or its affiliates.
• Income from mutual funds and/or retirement accounts so long as you do not have direct control over investment decisions.
• Income from seminars, lectures, teaching, service on advisory committees or review panels, for federal, state or local government agency, institution of higher education (as defined by 20 USC 1001(a)), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;
• Reimbursed or sponsored travel by a Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic medical center, or a research institute that is affiliated with an Institution of higher education.
• Royalties, milestone payments, licensing fees, or other remuneration paid by the 91����Ƶ, or its affiliates to the Investigator if the Investigator is currently employed or otherwise appointed by the 91����Ƶ or the Old Dominion 91����Ƶ Research Foundation.

Exceptions and examples are listed in the FCOI Guidelines.

Disclosures are filed via the �ܲԻ�����My Menu Options�����Ի���My COI.

Image

Disclosures must be filed at the following times:

• Before engaging in research proposed to or funded by sponsors subject to ODU’s COI requirements
  • A disclosure must be on file in ODU’s Research Portal COI Module for each Investigator on a proposal before the proposal can be submitted to the sponsor by the institution, and/or for each PI, Co-Investigator, or Key Personnel on an IRB protocol before a protocol can be approved by ODU’s Institutional Review Board (IRB).
• Within 30 days of receiving or becoming aware of a new SFI
  • SFIs must be disclosed in the ODU Research Portal COI Module within 30 days of acquisition, receipt of payment, etc.
  • Do NOT wait until annual disclosure time to update your disclosure with new SFIs.
• At least annually by February 28th each year.
  • If you have no new SFIs to disclose between annual COI disclosure cycle, the annual COI disclosure is sufficient. You must complete a COI disclosure annually, even if acknowledging no change, by carrying over your prior annual disclosure to the new reporting year.
  • The annual COI cycle runs between January and February of every year.
  • The information collected is for the previous calendar year (January – December), to align with the receipt of income forms/statements and preparation of taxes.

ODU now uses the to electronically to collect and store disclosures and certifications.

Disclosures/Significant Financial Interests (SFIs) are reviewed in comparison to each open research project subject to ODU’s COI requirements. ODU’s Office of Research AVP for Compliance performs an initial review; if a potential or actual COI is identified, the review is referred to the COI Committee (COIC).

A COI exists when the Conflict of Interest Committee (COIC) reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the Investigator’s research activity.

SIGNIFICANT FINANCIAL INTERESTS vs. CONFLICTS OF INTEREST
A SFI is any financial interest meeting the definition that is related to your Institutional Responsibilities. These must be disclosed.

Institutions then review SFIs relative to research projects to identify any potential overlap or relationship. Not every disclosed SFI is a COI.

A Financial Conflict of Interest (FCOI or COI) is an SFI that could directly and significantly affect the design conduct or report of specific research activity. These must be managed, reduce or eliminated.

If the COIC identifies a COI, they will provide suggested management strategies to the AVP for Compliance. The the AVP for Compliance will then work with the Investigator to reduce, manage, or eliminate the COI through the implementation of a Conflict Management Plan (CMP).

Examples of management strategies include:

• Public disclosure of financial interests (e.g., when presenting or publishing research);
• Written disclosure to colleagues and collaborators;
• Disclosure to IRB and to research participants;
• Reduced role in project;
• Independent data review and/or monitoring;
• Modification of the research plan;
• Change of personnel or personnel responsibilities;
• Divestment of the financial interest;
• Severance of relationships that create the conflict (e.g., consulting);

The AVP for Compliance will communicate the COIC’s determination regarding a management plan to the Investigator. The Investigator may not commence or participate in the research until the Investigator agrees to and complies with a management plan imposed to manage a COI. Once agreed to, the AVP for Compliance works with departments to monitor compliance with the management plan. Management plans are sometimes updated to reflect changes in research personnel, financial interests or other factors.

Some sponsors require that certain information relative to COIs be reported prior to expenditure of funds, which is done by the ODU Research Foundation. The ODU Research Foundation will notify Investigators prior to such reporting.

Certain COI information relative to PHS-funded research must be made available to the public upon request. ODU Research Foundation will notify Investigators prior to provision of such information.

ODU is required to notify certain research sponsors about COIs and management plans to address the COI. Investigators will cooperate with ODU’s AVP for Compliance to fulfill all reporting requirements to research sponsors, including those relating to organizational conflicts of interest and other conflicts.

In the event it is determined that a researcher has a financial conflict of interest as it relates to PHS or DOE funded research, the regulation requires that certain information be made available to the public about the Investigator’s significant financial interest (SFI). The information that ODU is required to release includes:

• Investigator’s name;
• Investigator’s title, and role with respect to the research;
• Name of the entity in which the SFI is held;
• Nature of the SFI (stock, income, etc.);
• Approximate dollar value of the SFI in dollar ranges ($0 – $4,999, $5,000 – $9,999, $10,000 – $19,999, amounts between $20,000 – $100,00 by increments of $20,000, amounts above $100,000 by increments of $50,000), or if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect.

In these cases, the PHS and DOE regulations provide the university with a choice between posting information about financial conflicts of interest on the internet and making the information available within five (5) days of a written request. ODU has chosen to make information available upon written request to the ODU Office of Research AVP for Compliance. Requests can be made by submitting the  Financial COI Request form���ڱʶٹ��.

The Public Health Service includes the following agencies:

• Administration for Children and Families (ACF)
• Agency for Health Care Research & Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Office of Global Affairs (OG)
• Office of the Assistant Secretary for Health (OASH)
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Office of Public Health and Science (OPHS)
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• A number of other sponsors have adopted the PHS COI standards

PHS and DOE-funded Investigators are required to disclose sponsored or reimbursed travel that is related to their institutional responsibilities. Reimbursed travel involves instances where the Investigator is directly reimbursed by a non-ODU entity for the Investigator’s travel expenses. Sponsored travel involves situations where an Investigator’s travel is paid directly by the external sponsoring entity and is not reimbursed to the Investigator.

There are a number of exceptions to the travel disclosure requirement. Please note, the following exceptions do not apply to foreign travel . You are not required to disclose travel that is reimbursed or sponsored by a domestic:

• Federal, state, or local government agency;
• institution of higher education as defined at 20 U.S.C. 1001 (a);
• academic or teaching hospital;
• medical center; or
• research institution that is affiliated with an institution of higher education.