Based upon the following definitions, University Committees/Boards responsible for the review and approval of research are obligated to complete a Financial Disclosure Report and complete Conflict of Interest training at least annually.
Institutional responsibilities -
We proposed this definition in the NPRM to mean an Investigator’s professional responsibilities on behalf of the Institution including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Consistent with our proposal in the NPRM, we have revised the definition of ‘‘Investigator’’ to clarify that it means the Project Director/Principal Investigator (PD/PI) as well as any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Member Conflict of Interest (COI) and Financial Conflict of Interest (FCOI)
Conflict of Interest – This refers to situations in which a committee/board member and or his/her immediate family has personal interests (COI) or financial interests (FCOI) that may compromise, or have the appearance of compromising, the person’s professional judgment in reviewing research. Institutional Conflict of Interest (ICOI) may occur when the institution, any of its senior management or trustees, or a department, school, or other sub-unit, has an external relationship, or financial interest in a company that itself has a financial interest in a research project. A member, and or his/her immediate family, may have a COI that relates to the company that is providing support for a proposed study.
- If you have a financial or non-financial conflict of interest, you cannot be present for the discussion or vote. You should recuse yourself and announce to staff that you are doing so in order for the minutes to reflect your recusal. Recusals cannot be counted toward quorum.
- The committee may ask a recused member with a FCOI or COI to return to the meeting to answer specific questions about the protocol in question. After the questions are answered, the member with the COI or FCOI should again leave the meeting during further discussion and voting.
- Members are required to file a FCOI disclosure regarding all potential sponsors with the FCOI Committee within one month of their appointment to the board/committee. The disclosure must be updated on an annual basis and more frequently when significant changes have occurred.
- Members and administrative staff are required to leave the room during the discussion of research protocols involving sponsors with whom they have a potential ICOI. Members with a conflict of interest are not counted towards quorum.
- Consultants are required to file a FCOI disclosure regarding all potential sponsors with the FCOI Committee as soon as they agree to assist with the review of a research protocol. This disclosure should include any relevant ICOI and must be updated on an annual basis and more frequently when significant changes have occurred.
UMKC IRB Conflict of Interest Disclosure Form