Program Procedures and Guidance
On this page:
- Applicability
- Introduction
- Investigator and University Responsibilities
- Conflict of Interest Certification
- Conflicts of Commitment
- COI Submission Review
- Confidentiality
- COI Management
- Non-compliance
- Sponsor Specific Requirements
- Regulatory and Legal References
Applicability
These procedures are adopted pursuant to authority granted to the Vice Provost for Research (“VPR”) under the authority of Policy No. 6110.
These procedures apply to all University faculty, staff, students, Agents, and external collaborators engaged in research (hereinafter referred to as “Investigators”) when:
- the funding sponsor requires disclosure of significant financial interests (e.g., federally funded projects) or financial conflicts of interest; or
- the research includes FDA-Regulated materials or activities; or
- a Wright State University ethics review committee (IRB or IACUC) requires COI certification; or
- the research involves collaboration with an institution outside of the U.S.; and
- if a University research compliance committee or OVPR determines the policy must apply to a project; and
- the Vice Provost for Research (VPR) maintains or assumes primary responsibility for Research Compliance.
* 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.
Introduction
The purpose of the Program is to promote objectivity and integrity in research. This includes a commitment to designing, conducting, and reporting research to eliminate or reduce bias and perceptions of bias resulting from conflicts of interest or commitment. An additional element of research integrity is transparency. Acknowledging and managing potential conflicts ultimately serves to support the validity of research. This Program addresses the commitments specified in University Policy 6110 (link)
This Program is not intended to eliminate or prohibit all situations involving potential conflicts of interest. Rather, the policy is intended to enable investigators to recognize situations that may pose a conflict of interest or commitment or the appearance of same, to provide a process for disclosing such interests to the University, and for working with the Office of the Vice Provost for Research (OVPR) to manage any such conflicts and minimize bias and the perceptions of bias.
Any individual described in the definition of an "Investigator" is required to disclose to the University any foreign and domestic Significant Financial Interests (SFI) (and those of their close family members) or conflicts of commitment if the activity reasonably appears to be related to their institutional responsibilities. The University will determine if the interest constitutes a Significant Financial Conflict of Interest (SFCI) or Commitment (SCC) requiring management.
Examples of reportable Significant Financial Interests include, but are not limited to, the following:
- An Investigator (and/or an Investigator's Close Family Member) entering into a paid consultancy with an outside entity doing work that is related to an Investigator’s University-based research;
- Using students or employees of the University to perform services for an outside entity in which an Investigator (and/or an Investigator's Close Family Member) has an ownership interest from which he/she receives any remuneration;
- An Investigator (and/or an Investigator's Close Family Member) receiving royalties or non-royalty payments related to ongoing research;
- An Investigator (and/or an Investigator's Close Family Member) having an equity interest (e.g., stocks, stock options, warrants) related to ongoing research; and
- Serving as an officer, director, or in any other fiduciary role for an outside entity that is, has been, or may financially benefit from the Investigator's University-based research, whether or not remuneration is received for such service.
Certification of the absence of conflicts or disclosing potential conflicts are accomplished through processes maintained by the Research and Sponsored Programs Office (RSP) for (i) each new project, (ii) as new conflicts develop are discovered, and (iii) annually to confirm that the documented status is currently correct. The timing of initial certification or disclosure may be dependent on the sponsor or nature of the research. Certification may be required at the proposal application or award stage and will be due upon notification from Cayuse or RSP. Information about the certification process, mediated through the utility “Cayuse,” can be found at: https://www.wright.edu/research/cayuse.
This Program addresses individual financial conflicts of interest or commitment; however, the University may also have conflicts of interest or commitment in research when 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 certification and disclosure procedure, they will be addressed in a manner consistent with this Program.
Responsibilities
Investigators are responsible for:
- Reading and understanding sponsor requirements, University and Unit Level Policies, and associated guidance;
- Completing any training in a timely manner as required by a sponsor or the University;
- Certifying absences of SFIs or reportable Conflicts of Commitment (SCC) in response to requests from the OVPR or disclosing SFIs and SCC to the University by completing appropriate forms upon request and before submission of grant/contract applications;
- Developing Management Plans in collaboration with OVPR to minimize or eliminate conflicts and the perceptions of conflict; and
- Complying with Management Plan provisions and monitoring requirements, as applicable.
- Disclosing SFIs that are reasonably related to their institutional responsibilities at the time of application, within 14 days of acquiring or discovering a new SFI, and on an annual basis as prescribed by the institution.
The University is responsible for:
- Providing training and a confidential certification program to satisfy conflicts reporting requirements;
- Providing mechanisms to facilitate reporting and investigator compliance with contractual obligations;
- Reviewing interests reasonably related to an investigators institutional research responsibilities to determine SFCI status and the degree of management required;
- Assisting investigators in developing their Management Plans to manage Significant Conflicts of Interest; and
- Provide post approval monitoring of SFCI plans as required by sponsor or a Management Plan.
Conflict of Interest Certification
Certification typically occurs at three possible stages during the life of a research project: (1) during funding proposal and/or protocol development; (2) as SFIs or SCCs develop and Significant Financial Conflicts of Interests are identified; and (3) during the annual certification process.:
A. Initial: Certification or disclosure requirements are linked to both sponsor and University policies.
For federally funded research or any research involving FDA regulated materials, certification and/or disclosure is required:
- at the proposal stage for research involving FDA regulated materials or activities;
- at the award stage for all other federally funded research; and
- as may be requested by an Ethics Review Committee as part of the protocol review process.
As required by the project sponsor or a University Ethics Review Committee.
B. Ongoing: Research certification and/or disclosure is required within 14 days if:
- a conflict having developed or been discovered for any project for which a certification has been required at the initial stage (A above); and
- a person being added to the project in an Investigator role for federally funded, FDA regulated research, or a sponsor or ethics committee has previously required COI certification.
- a previously determined FCOI under management is eliminated as a conflict, this must be disclosed to the University within 14 days.
- or at any time requested by the OVPR, the Investigator will complete or update their certification or disclosure with current SFIs or SCCs.
C. Annual: Confirmation of the current SFIs or SCCs and review by the University for FCOI status and/or as requested by University administration.
The Certification process is documented through the Cayuse system. The screening and disclosure instruments incorporated into Cayuse have been developed to address federal sponsor and FDA requirements and guidelines. They are updated as regulations and knowledge of potential issues change. Guidance and instructions are found here: (https://www.wright.edu/research/cayuse).
Conflicts of Commitment
Conflicts of commitment relate to affiliations foreign and domestic that may be related to the Investigator's institutional responsibilities. Investigators, including subrecipient investigators, must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, reimbursed expenses, or sponsored travel) received from any foreign entity, including foreign institutions of higher education or foreign governments (including local, state, provincial, or equivalent governments of another country).
Investigators are required to disclose to the University, in conjunction with disclosure of significant financial interests, all affiliations with entities external to the University regardless of funding that:
- have not been disclosed and described as part of the associated grant or funding application; and
- the entity has a reasonable connection to the research that could be perceived to impart a bias to the conduct of the research; or
- are with foreign entities whether private, public, or government, or located within the U.S. but funded and controlled by foreign entities.
COI Submission Review
The OVPR conducts an initial review of all SFIs with regard to FCOIs and any SCCs with regard to any Investigator activities reported on certification forms. If necessary, the OVPR will request additional information from the Investigator and other individuals to help determine whether the SFI or SCC disclosed is related to a proposed or existing sponsored project or program. The OVPR may refer the case to an ad hoc University Outside Interest Committee (OIC) for COI and Commitment review and management.
An Investigator's SFI is related to research when the University, through the OVPR or designee or OIC, reasonably determines that the SFI: (i) could affect, or be affected by, the research, or (ii); involves an entity whose financial interest could affect or be affected by the research.
A Financial Conflict of Interest requiring management exists when the University, through the OVPR or designee and/or OIC, determines that an investigators SFI could directly and significantly affect the design, conduct, or reporting of research SFI’s determined to be Financial Conflicts of Interest must be managed or eliminated prior to an Investigators involvement in research activities.
Considerations as to whether an SFCI or SCC exists include:
- potential impact on the integrity of research data;
- potential for significant outside influence on research processes and/or conclusions; and
- appearance of conflicting interests or commitments.
Confidentiality
Refer to section 6110.10 in the CONFLICTS OF INTEREST AND COMMITMENT IN RESEARCH policy 6110 for a statement on Confidentiality. The university will maintain records related to all financial disclosures and all responses to or actions taken by the University with respect to each significant financial conflict of interest for at least three years after the termination or completion of an award, and in the case of federally funded research, at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations.
COI Management
COI management means acting to address a financial conflict of interest, including mitigating or eliminating the potential financial conflict of interest effects to ensure that the design, conduct or reporting of research is free from bias or the appearance of bias. Typically, written Management Plans are developed according to the nature of the conflict of interest and the research. The OVPR, the Investigator, and the Investigator's supervisor will collaborate in an attempt to resolve potential or apparent financial conflicts of interest and finalize an appropriate COI Management Plan.
Examples of conditions or restrictions that may be employed to manage conflicts include but are not limited to:
- Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to the Institution’s Institutional Review Board(s), Institutional Animal Care and Use Committee(s), etc;
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest); or severance of relationships that create financial conflicts; or severance of relationships that create financial conflicts.
If it proves impossible to reach an acceptable COI Management Plan, the University in its sole discretion may decide how to resolve the situation including but not limited to: having the Provost make a final determination on the COI Management Plan, removal of the Investigator from the project, transfer of funds to another investigator, or returning funds to the sponsor.
An Investigator may submit a formal request to modify a Management Plan within 10 days of the receipt of the final COI Management Plan. Details may be found in University Policy 6110.
Monitoring
The Investigator is responsible to monitor and ensure any requirements of the COI Management Plan(s) are being met. Additionally, the University will monitor, and may require periodic reports regarding Investigator compliance with COI Management Plans to assure compliance and demonstrate appropriate institutional oversight. The frequency of monitoring may be dictated by sponsor requirements and as specified in the Management Plan.
Non-Compliance
The University shall, in its sole discretion, take appropriate disciplinary action in response to non-compliance with this Program, up to and including termination of employment or referral and reporting of violations to the home institution of external personnel and/or appropriate government or law enforcement agencies. Violations of this Program include, without limitation:
- Intentionally or recklessly, by act or omission, providing incomplete, false, or misleading information on conflicts certification or disclosure forms; or
- Failing to timely make all required disclosures; or
- Failing to timely provide information requested by the University to adequately review a Significant Financial Interest and/or manage an identified SFCI; or
- Failing to abide by the terms of a Management Plan
If the failure of an Investigator to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.
Sponsor Specific Requirements
The Research Conflicts of Interest and Commitment Program and Procedures, the University Policy (6110), and the certification, disclosure and management program described above are designed to address federal regulations and sponsor requirements. Agency and sponsor requirements may differ but the University policies are designed to cover the most common requirements. Requirements of external sponsors may require additional steps to meet contractual requirements. Examples of explicit common requirements can be found here: Link
It is the Investigator’s responsibility to identify, understand, educate and inform themselves and their team, and comply with sponsor-specific requirements, if any. Should requirements be identified that are not yet included in this document, Investigators should notify RSP of those requirements so updates, if necessary, can be made to this or other appropriate documents.
Regulatory and Legal References
In addition to this Program and the University Policy (6110), Investigators must be aware that as a result of their financial interest or fiduciary role in an outside institution/entity/company they may have additional obligations under state and federal laws and local policies. Investigators should also be aware that research sponsors may have additional requirements regarding financial interests that would be defined in the grant or contract. The University is not responsible for ensuring Investigators meet the requirements of any external roles. Questions concerning the applicability of outside legal or regulatory authorities should be promptly referred to the Office of General Counsel (generalcounsel@wright.edu). The following outside legal or regulatory authorities may apply:
State
- Ohio Revised Code (Sections 102.03, 2921.42, and 2921.43)
- Ohio Ethics Commission
Federal
- Public Health Service (PHS) 42 CFR, part 50, subpart F and 45 CFR part 94
- National Science Foundation (NSF) Grantee Conflict of Interest Policies
- Department of Energy Interim Conflict of Interest Policy Requirements for Financial Interest, FAL 2022-02
- U.S. Food and Drug Administration (FDA) 21 CFR 54
- Federal Office of Management & Budget publication 2 CFR Chapter I, Chapter II, Part 200, et al., "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards."
- Securities and Exchange Commission (SEC)
Revised December 1, 2023
