Definitions

As used in Policy No. 6110 and related University procedures, the following terms shall have the meanings ascribed to them in this Section:

Certification means a process through which an Investigator submits a formal declaration that either (i) they (or close family members) have no significant financial interests (SFCI) related to the research they are or will be conducting or (ii) the Investigator (or close family members) does have an SFCI reasonably related to their research and this SFCI will be disclosed to the University.

• Certification is managed through an online utility (Cayuse) integrated with the Research and Sponsored Programs application and post-award processes: https://www.wright.edu/research/cayuse.

Close Family Member means spouse, domestic partner, parents, siblings, children or parents.

Conflicts of Commitment (CoC) means relationships, responsibilities or obligations that place or appear to place competing demands on an Investigator’s time, resources, loyalties or legal rights.

Disclosure means submitting information about an SFCI to the University using established procedures for evaluation and Management Plan development.

Engagement means when the participation of an investigator or institution is responsible for the design, conduct, or reporting of research or proposed for such funding. Such activities include but are not limited to: influencing study design, obtaining subject consent, collecting data, analyzing data, and reporting of results.

Ethics Oversight Committee means a committee at the University formed to review the aspects of research related to the responsible conduct of research (e.g. Institutional Review for Human Subjects Protection, Institutional Animal Care and Use Committee, Institutional Biosafety Committee, Outside Interests Committee)

External Personnel means any Investigator working on a project who is not (i) employed by the University, or (ii) a student of the University, or (iii) formally appointed as a University affiliate.

Financial Interest means anything of monetary value or potential monetary value, foreign or domestic, held by the Investigator or a close member of the Investigator’s family (spouse, domestic partner, children, parents or siblings), whether or not the value is readily ascertainable, held or received.

Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the University including research, consultation, teaching, professional practice, University committee memberships, and service.

Institutional Conflicts occur whenever the financial interests of the University, or of a University official acting within his or her authority on behalf of the University, might affect, or reasonably appear to affect, University processes for the conduct, review, or oversight of research. If institutional conflicts of interest are identified via the disclosure process described below, they will normally be addressed in a manner that is consistent with this Program.

Investigator means any person, internal or external to the University, who is:

• developing proposals for funding; or
• involved with the design, conduct, or reporting of research; and
• associated with research administered by or affiliated with the University.

Management means to act to eliminate or reduce to an acceptable level real or perceived perceptions of bias in the design, conduct or reporting of research.

Management Plan means a documented, University-approved plan developed to describe and require research practices that eliminate or reduce real or perceived Investigator conflicts.

Need to Know means access to confidential information by persons only to the extent required to evaluate and manage potential conflicts to meet University, and research sponsor, or regulatory, or legal requirements, typically to evaluate or manage potential conflicts.  The “Need to Know” of an individual or entity is determined by the delegated reviewing official in consultation with the General Counsel’s Office and/or the Vice President for Compliance and Risk Management. 

Outside Interest Committee (OIC) is an ad hoc committee that works with Investigators and the OVPR to resolve potential or apparent financial conflicts of interest and conflicts of commitment by implementing reasonable controls as needed. Members are appointed to the OIC by the VPR or Provost based on expertise and institutional need given the nature of the individual case.

Related Financial Interest means an interest that is reasonably related to the research or other institutional responsibilities of an Investigator or a Close Family Member.

Research means a systematic investigation designed to develop or contribute to generalizable knowledge. It includes basic and applied research and product development.

Significant Conflicts of Commitment (SCC) means when an Investigator is working on one or more funded projects; preparing to submit a request for a new project; serving as a peer reviewer; sitting on advisory boards; or working as a paid consultant, officer, or employee in a private company or more than one funding source is used to support the research activities and the activity could interfere with or affect research.

Significant Financial Interest (SFI) means when the character of the interest exceeds thresholds specified by a funding entity or is of a nature otherwise described in sponsor policies and regulations and can reasonably be related to institutional responsibilities.

Significant Financial Conflict of Interest (SFCI) means when an SFI could reasonably be perceived to be a conflict that could impact the conduct of research.

Threshold means the minimum value of an interest type that qualifies the interest as a Significant Financial Interest. Some interest types have no minimum threshold thus all must be disclosed.

Unit Level Policies and Guidance means methods and procedures maintained at the unit level to address individual funder and oversight program requirements.

University means Wright State University.