Research Conflict of Interest and Financial Disclosure Policy

It is the policy of Wright State University to operate in compliance with all applicable legal and regulatory requirements and University policies, including as it relates to the management of conflicts of interest and/or commitments, including, but not limited to, 42 CFR Part 50 Subpart F Section 50.604. It is the intent of this policy to identify and manage, not eliminate or prohibit, all situations involving potential conflicts of interest.

As used in this Policy and any related procedures, the capitalized terms shall have the meaning ascribed to them by OVPR in its procedures. (URL)

The OVPR is authorized to develop, implement, and require the use of procedures and forms to facilitate its oversight and enforcement of this Policy. Such procedures and forms shall be reviewed and approved by the Office of General Counsel (a) before initial adoption and (b) before adopting any revision. The procedures and forms shall be posted on or available through the OVPR website.

This Policy is subordinate to applicable laws and regulations, which shall prevail over the Policy in the event of a conflict. This Policy is superior to any procedures adopted by OVPR pursuant to this Policy, and the Policy shall prevail over the procedures in the event of a conflict.

This policy applies to all University faculty, staff, students, agents, and external collaborators engaged*(as defined below) 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
• the research involves collaboration with an institution outside of the U.S.; or
• if a University research compliance committee or OVPR determines the policy must apply to a project; and
• OVPR maintains 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.

Investigators are responsible for:

1. Reading and understanding sponsor requirements, University and Unit Level Policies, and associated guidance;
2. Completing any training in a timely manner as required by a sponsor or the University;
3. 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;
4. Developing Management Plans in collaboration with OVPR to minimize or eliminate conflicts and the perceptions of conflict; and
5. Complying with Management Plan provisions and monitoring requirements, as applicable.
6. 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:

1. Providing training and a confidential certification program to satisfy conflicts reporting requirements;
2. Providing mechanisms to facilitate reporting and investigator compliance with contractual obligations;
3. Reviewing interests reasonably related to an investigators institutional research responsibilities to determine SFCI status and the degree of management required;
4. Assisting investigators in developing their Management Plans to manage Significant Conflicts of Interest; and
5. Provide post approval monitoring of SFCI plans as required by sponsor or Management Plan requirements.

Investigators are required:

• when applying for external funding to complete an initial Project Specific COI Certification form that indicates an absence of reasonable SFIs or provides information about any SFI for review by the VPR-designated official (this Certification must be completed before a grant is submitted to a funding agency); or
• to complete an initial Project Specific COI Certification when directed to do so by an Ethics Oversight Committee as part of a protocol review and approval process;
• to complete and submit modifications or amendments to the Project Based Certification form for any project within 14 days of when an SFI develops or is discovered;
• to complete all appropriate sections of the Certification forms including but not limited to those relating to international collaborations;
• to complete and submit an Annual COI Certification Update assuring that all Project Based SFI’s have been updated and provide additional required information; and
• to abide by the provisions of any COI Management Plan developed and approved for the project.

Investigators are required to disclose to the University all affiliations with entities external to the University regardless of funding that:

1. have not been disclosed and described as part of the associated grant or funding application; and
2. the entity has a reasonable connection to the research that could be perceived to impart a bias to the conduct of the research; or
3. are with foreign entities whether private, public, or government, or located within the U.S. but funded and controlled by foreign entities.

Specific procedures and details regarding sponsor requirements are found in the COI Procedures and Guidance. (URL)

The OVPR conducts an initial review of all SFIs with regard to FCOI regulations and any SCCs with regard to any Investigator activities reported on certification forms. If necessary, in its discretion, the OVPR will request additional information from the Investigator and/or other individuals appropriate to the case 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 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, 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.

An Investigator may challenge an SFCI or SCC determination or Management Plan. A challenge must be filed in writing, and received by the OVPR or OIC not more than ten days after the OVPR or OIC notifies the Investigator of the determination or Management Plan. Untimely challenges may be denied summarily.

An Investigator may appeal an SFCI or SCC determination or Management Plan only if the Investigator makes a timely challenge as provided in the preceding paragraph. An appeal must be filed with the Provost in writing, and received by the Provost not more than ten days after the OIC notifies the Investigator of the disposition of the challenge. An appeal that does not comply with the requirements of this Paragraph may be denied summarily without further appeal. The appeal must state the reason(s) why the SFCI or SCC determination, Management Plan, or OIC determination is legally or factually incorrect.

If a challenge or appeal is filed, the Investigator shall, until the challenge or appeal is adjudicated, either (a.) comply with such precautionary measures as the OIC or OVPR may prescribe temporarily (if any have been directed, and otherwise with the OIC- or OVPR-approved Management Plan), or (b.) remove themselves temporarily from the research.

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.

The OVPR will work with the Investigators to resolve potential or apparent financial conflicts of interest and develop Management Plans as necessary. If the plan is not acceptable to the researcher and OVPR, an Outside Interests Committee will be formed to review the conflict and the Management Plan.

It is the responsibility of the Investigator to monitor and comply with the Management Plan. The University shall have full discretion to require the Investigator (or others associated with the project) to furnish periodic reports, records, interviews, site visits, and other information—upon the request of the VPR or delegate—to evaluate compliance with the Management Plan.

Information related to the review and management of financial interest disclosures is intended to be confidential; however, it may be necessary to disclose information to those with a ‘need to know.’ This can include the release of information related to SFIs, SCCs and financial conflicts of interest and their management to third parties in accordance with laws, regulations, University policies, sponsor regulations or policies, or other requirements necessary to meet legal or ethical obligations.

OVPR is responsible for enforcing the provisions of this Policy. OVPR shall be primarily responsible for investigating reported or suspected violations of this Policy unless that responsibility is delegated by the OVPR to another University unit. Investigations may also be initiated by the University President, Provost, General Counsel, or Vice-President for Compliance. Any violation of this policy may result in:

• Disciplinary action up to and including termination of employment (for employees), expulsion (for students), or termination of contract (for contractors);
• Referral or reporting to non-University parties with an interest in such matters, potentially including (without limitation) research sponsors and collaborators;
• Referral to law enforcement agencies;
• Remediation or remedial training; or
• Modification, suspension, limitation, or termination/cancellation of research projects, and/or access to/use of research services or facilities.

Persons who violate this Policy may also incur civil liability to third-parties.

In accordance with 42 CFR 50.606(c), in any case in which the HHS determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this regulation, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

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.

When the OVPR (or delegate) deems it necessary or desirable for purposes related to the enforcement of this Policy (or related authorities), they may request persons subject to this Policy to disclose pertinent information or records, participate in interviews with OVPR personnel (or delegates), and/or permit OVPR personnel (or delegates) to inspect research facilities and equipment. If an individual, group, or entity subject to this Policy refuses OVPR (or delegate) requests under this Section:

• The OVPR (or delegate) shall not compel an individual’s cooperation without first consulting with the Office of General Counsel;
• The refusal shall not, by itself, serve as the exclusive basis for disciplinary action. However, the OVPR (or delegate) may—exclusively for the purpose of modifying, suspending, limiting, terminating, or calling the individual, group, or entity’s participation in University-sponsored research, services, personnel, and facilities—infer from the refusal that a violation of this Policy has occurred or is occurring.

A disclosure of information or records, when required by this Policy (or related authorities) shall be true and complete to the best knowledge of the discloser at the time of disclosure. A discloser has an ongoing duty to supplement or correct the disclosure when necessary to ensure that the information or records previously disclosed remain true and complete, and not misleading in any material regard, to the best knowledge of the discloser. A person who makes a disclosure required by this Policy (or related authorities) shall be deemed to have attested to the University that the information or records disclosed comply with the requirements of this Section unless a qualified or disclaimed by the discloser, in writing, at the time of the disclosure.

This Policy authorizes the Vice Provost for Research and Innovation to develop procedures and forms to facilitate its oversight and enforcement of this Policy. The current program rules are published in the Conflicts of Interest and Commitment in Research: Program and Procedures (URL).