Research Conflicts of Interest: Identifying and Minimizing COI from the Perspectives of Sponsors, Faculty and the IRB Research Conflicts of Interest: Identifying and Minimizing COI from the Perspectives of Sponsors, Faculty and the IRB 5 th Thursday for Human Research Protections July 30, 2009

Research Conflicts of Interest: Research Conflicts of Interest: Perspectives of the Sponsor Susan Robb, CRA Assistant VP for Research Administration Vice President’s Office for Research

Significant Financial Conflict of Interest NIH - 42 CFR 50 Subpart F – Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought NSF – Chapter V, Part 510 of Grant Policy Manual Commonwealth of Virginia - Section of the Code of VirginiaSection of the Code of Virginia Institutional Policies - No reporting or dollar threshold for human subjects research

Conflict of Interest Requirements Purpose - to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under federal grants will be biased by any conflicting financial interest of an investigator

Definitions Institution refers to any domestic or foreign, public or private, entity or organization that is the direct and primary recipient of NIH grant funds or that submits an application/proposal for a research grant/contract and is accountable for the performance of the research grant/contract, the appropriate expenditure of grant/contract funds by all parties, and all other obligations of the grantee/awardee, such as compliance with terms and conditions. Investigator -– the principal investigator and any other person who is responsible for the design, conduct, or reporting of research. For purposes relating to financial interests, “investigator” includes the Investigator’s spouse and dependent children Financial Conflict of Interest (FCOI) – an FCOI exists when the Institution’s designated official(s) reasonably determines that a Significant Financial Interest (defined below) could directly and significantly affect the design, conduct, or reporting of funded research Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights)

Definitions Significant Financial Interest Does NOT include: – Salary, royalties, or other remuneration from the applicant institution; any ownership interest in the SBIR applicant; income from seminars, lectures, or other teaching engagements sponsored by public or nonprofit entities; income from service on advisory committees or review panels for public or non-profit entities – An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures and does not represent more than a five percent ownership interest in a single entity – Salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

Institution Responsibility Maintain a written, enforced policy on conflict of interest Designate an institutional official(s) to solicit and review financial disclosure statements Require that by the time an application is submitted all investigators have submitted a list of known Significant Financial Interests Provide guidelines to official to identify conflicting interests and take necessary actions Maintain records of all disclosures and all actions taken Establish adequate enforcement mechanisms and provide for sanctions Certify in each application to all of the above Prior to the Institution’s expenditure of any funds under the award, the Institution must report to the NIH the existence of an FCOI (but not the natre of the interest or other details) and ensure that the conflict interest has been managed, reduced, or eliminated. For any FCOI that the Institution identifies subsequent to the Institution’s initial report, the Institution must report the FCOI and manage, reduce, or eliminate it, at least on an interim basis, within 60 days of that identification.

Management of Conflicts Public disclosure of significant financial interests Monitoring of research by independent reviewers Modification of the research plan Disqualification from participation in all or a portion of the research Divestiture of significant financial interest Severance of relationships

Virginia State Conflict of Interests Act

Virginia State Conflicts of Interest Act

VCU Researcher Conflict Of Interests Policy Definition – Conflict of Interest Situations in which financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting, a researcher’s professional judgment in exercising any University duty or responsibility, including the design, conduct or reporting of research.

State Levels for COI Reporting Dollar values the same as federal $10,000 in a 12 month period Equity interests less than federal 3% equity interest (federal is 5%)

Forms One form for all investigators to answer two (2) questions (or one (1) if unfunded) and sign PI is responsible for determining who needs to complete, i.e. who qualifies as an “investigator.” “Investigator” is anyone on the project with the responsibility for the design, conduct, or reporting of research No other forms UNLESS they have an interest to disclose

Questions A and B must be answered by each investigator unless the project is unfunded (one check in item C).

If either Question A or B is answered yes, the individual answering yes must complete the Disclosure Supplement Form.

VCU Management of Conflicts Most often, conflicts identified by our faculty members can be managed through disclosure, i.e. faculty members are required to disclose in the presentations, publications, and to their students the identified conflict of interest. Occasionally, conflicts are managed through disclosure AND oversight. Another faculty member oversees the research progress and data and reports to COI Review Committee.

VCU Reporting of Conflicts to Federal Agencies Research funded by NIH – Through the NIH eRA Commons, submit a report indicating that a Financial Conflict of Interest has been identified and either managed, reduced or eliminated. Continuing responsibility for the life of the award Research funded by NSF – Report only if the institution is unable to satisfactorily manage a conflict of interest All agencies – Maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any agency action involving those records, whichever is longer.