VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

Conflict of Interest Committee: Committee appointed by the President and Provost that shall have the authority to review and manage conflicts of interests.

Disclosure : Full recording or spe cification of the I nvestigator’s relationship with an external organization or involvement in external activities.

Family : Family of an I nvestigator that includes his/her spouse or domestic partner and dependent children as determined by the definitions of the Internal Revenue Service, Commonwealth of Virginia and State law of South Carolina and Alabama.

Financial Conflict of Interest : A significant financial interest that could directly and significantly affect the des ign, conduct or reporting of research at the College, regardless of sponsor.

Financial Interest : Anything of monetary value, whether or not the value is readily ascertainable.

Financially Interested Company: A commercial entity with financial interests that would reasonably appear to be affected by the conduct or outcome of the research. This term includes companies that compete with the sponsor of the research or the manufacturer of the investigational prod uct. If the I nvestigator actually knows that the financial interests of such a company would reasonably appear to be affected by the research. This term also includes any entity acting as the agent of a Financially Interested Company (for example, a contra ct research organization). Financially Interested Individual: An I nvestigator who holds significant financial interests in research as described below that would reasonably appear to be related to the individual’s institutional responsibilities and could directly or significantly affect the design, conduct or reporting of research. Investigator : Includes the principal investigator/project director and any other person, regardless of title or position, who is responsible for the design, conduct or report ing of research, whether externally or internally funded. This includes the principal investigator, co - investigators, lab technicians, collaborators or consultants. College full and part - time faculty, post - doctoral fellows, students, trainees and staff and all contracted facul ty and staff can be considered I nvestigators. Investigator’s Institutional Responsibilities: The I nvestigator’s professional responsibilities on behalf of the College which may include activities such as research, research consultati on, teaching, professional practice, and committee memberships and service. Institutional Integrity Officer: The institutional official responsible for reviewing disclosures of significant financial interests from each Investigator who is planning to par ticipate in, or who is participating in, research. PHS: Public Health Service of the U.S. Department of Health and Human Services, and any components to which the auth ority involved may be delegated. This agencies are: National Institutes of Health (NIH), Health Resources and Services Administration (HRSA), Fo od and Drug Administration (FDA), Agency for Healthcare Research & Quality (AHRQ) , Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Substance Abuse and Mental Health Services Administration (SAMHSA) and Agency for Toxic Substances and Disease Registry (ATSDR). Research : A systematic investigation designed to develop or contribute to generalizable knowledge. Research includes basic an d applied research, research development, testing and evaluation (i.e., pilot studies). It also includes all research meeting the definition of human subjects research as defined in the

Financial Conflicts of Interest in Research Policy

Page 3 of 13