Lawriter - OAC - 3342-3-07.1 Administrative policy on financial interest in sponsored projects.

3342-3-07.1 Administrative policy on financial interest in sponsored projects.

(A) Purpose. In accordance with state and federal regulations, the university is required to manage, reduce or eliminate any actual or potential conflicts of interest that may be presented by a significant financial interest of an investigator. Thus, the university requires that investigators disclose all significant financial interests that may present an actual or potential conflict of interest in relation to a sponsored project, as defined in rule 3342-3-04.1 of the Administrative Code. These requirements apply to all recipients of subawards.

(B) Definitions.

(1) "Confiict of interest" occurs when the relationship between an individual's private interests and his or her professional obligations to the university is such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An "actual" confiict of interest depends on the situation and not on the character or actions of the individual.

(2) "Investigator" means the principal investigator/project director, co-principal investigator, and any other person who is responsible or involved in the design, conduct, or reporting of research, instructional or service activities funded, or proposed for funding, by an external sponsor. For the purposes of the requirement relating to financial interest, investigator includes spouses and dependent children.

(3) "Project" means any externally funded scholarly activity such as basic, applied, or developmental research, instructional or curricular activities, student aid, career development, or other activity conducted by facult or staff members on behalf of the university.

(4) "Significant financial interest" means anything of monetary value or potential monetary value held by an investigator (and by the Investigator's spouse and dependent children! and that reasonably appears to be related to the investigator's institutional responsibilities, as follows:

(a) With regard to any publicly traded entity, remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds ten thousand dollars(for PHS funded research, this amount is five thousand dollars). For purposes of the definition of significant financial interest, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship! equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

(b) With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds ten thousand dollars (for PHS funded research, this amount is five thousand dollars) or any equity interest (e.g., stock, stock option, or other ownership interest): or

(c) Intellectual property rights and interests (e.g., patents, copyrights! upon receipt of income related to such rights and interests: or

(d) A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.

(e) For Investigators applying for or conducting research funded by the PHS. any reimbursed or sponsored travel (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) related to the Investigator's institutional responsibilities. Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.

(5) "Financial conflict of interest" (FCOI) means a significant financial interest that is related to proposed university research (i.e., the interest reasonably appears to be affected by the research or is in an entity whose financial interest reasonable appears to be affected by the research) and that could directly and significantly affect the design, conduct, or reporting of research.

(C) Requirements.

(1) Disclosure requirements. All investigators must submit a listing of the following significant financial interests:

Any significant financial interest that would reasonably appear to be affected by the research, instructional or service activities funded, or proposed for funding, by an external sponsor: or any significant financial interest in an entity whose financial interest would reasonably appear to be affected by the research, instructional or service activities funded, or proposed for funding, by an external sponsor.

(2) Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, is encouraged to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potential embarrassing or harmful allegations of misconduct.

(D) Procedures.

(1) Special requirements/disclosures for PHS-funded research. Pursuant to public health service (PHS) regulations ( 42 CFR 50 ) institutions receiving funds from any PHS agency [PHS agencies include NIH, SAMHSA, OPHS, IHS, HRSA, FDA, CDC, AHRQ] or other agencies adopting PHS financial conflict or interest policies, must comply with the following requirements:

(a) Each investigator who is planning to participate in PHS-funded research is required to disclose to Kent state university officials the investigator's significant financial interests (and those of the investigator's spouse and dependent children) no later than the time of application for PHS-funded research. Each investigator must complete the appropriate certification process required by the university.

(b) Each investigator who is participating in PHS-funded research is required to complete an updated certification either within thirty days of discovering or acquiring a new significant financial interest, or at least on an annual basis during the period of the PHS funding award.

(c) Disclosure of all externally-funded travel reimbursements: PHS-funded investigators must disclose all travel reimbursements that are either sponsored by (that is paid by an outside entity directly to the investigator) or reimbursed directly to the investigator from an outside entity for travel that occurs after August 24, 2012, with some exceptions. Exception include: travel reimbursements from an institution of higher education, a federal/state/local government, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. This disclosure requirement does not apply to funding provided to the investigator by the institution (for example as part of sponsored research projects, paid from departmental discretionary or gift funds). Travel reimbursements must be reported within thirty days of its occurrence.

(d) Mandatory training requirements: All PHS-funded investigators must complete online FCOI training provided by Kent state university prior to the expenditure of funds of any newly-funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. Online training is available for KSU personnel. Current PHS awards are not subject to these new requirements until the noncompeting continuation award. For these purposes, the term "investigator" includes the principal investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research.

(2) Review by conflict of interest review committee. The vice president for research, or official designee, will conduct an initial review of all disclosure statements submitted to determine whether a financial conflict of interest (FCOI) exists and, if so, determine what actions should be taken by the university to manage, reduce, or eliminate the FCOI. If a determination is made that there may be a potential or actual FCOI, the investigator, in cooperation with his/her dean, chair or director, will develop and present to the vice president for Research a plan to manage, reduce or eliminate any potential or actual FCOI presented by the disclosed significant financial interest.

(3) The proposed plan shall be referred to the university conflict of interest review committee (CIRC) which will advise the vice president for research. The CIRC shall contain, at a minimum, faculty members representing a cross section of academic disciplines. Committee members are appointed by the vice president for research.

(4) The CIRC shall review the plan and recommend it as presented, or suggest conditions or restrictions which may include the following:

(a) Modification of the research plan;

(b) Disqualification from participation in all or the portion of the funded research that would be affected by the significant financial interest;

(c) Divestiture of significant financial interests; or

(d) Severance of relationships that create conflicts.

(5) If the CIRC determines that imposing conditions or restrictions would be inequitable, or that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or public health and welfare, then the CIRC may recommend that the research go forward without imposing such conditions or restrictions.

(6) The plan, if approved by the vice president for research, will be incorporated into a memorandum of understanding that details the conditions or restrictions imposed upon the investigator in the conduct of the project and/or the relationship with the business enterprise or entity. The memorandum of understanding shall be signed by the investigator and the investigator's cognizant university official (usually a dean, chair or director) and the vice president for research. Actual or potential conflicts of interest must be satisfactorily managed, reduced, or eliminated in accordance with these guidelines prior to expenditure of any funds under the award. If actual or potential conflict cannot be satisfactorily managed, the sponsoring agency must be informed.

(7) Non-compliance. When an investigator is found to have violated this policy or the terms of the memorandum of understanding, the CIRC may recommend to the appropriate vice president that sanctions be imposed consistent with procedures established by university policy and/or an applicable collective bargaining agreement affecting the employee and his/her employment relationship with the university. Disciplinary action may range from a letter of reprimand to dismissal and termination of employment. If the violation results in a collateral proceeding under university policies regarding misconduct in science, the CIRC shall defer a decision on sanctions until the misconduct in science process is completed. In cases of violation, the vice president for Research will notify the appropriate funding agency.

(8) Reporting. The university will provide initial and ongoing reports of its management of FCOI to external sponsors of university research as required by law and in accordance with this policy.

(9) Records. Records relating to all investigator disclosures of significant financial interests and the university's review and management of such disclosures, will be maintained by the university in the case of externally-funded research for(a) three years from the date of submission of the final expenditures report (in the case of grants and cooperative agreements): or(b) three years from the final payment (in the case of research contracts), or(c) resolution of any government action involving the records, or(d) as otherwise required by law.

Replaces: 3342-3-07.1

Effective: 3/1/2015
Promulgated Under: 111.15
Statutory Authority: 3341.01
Rule Amplifies: 3341.01 , 3341.04
Prior Effective Dates: 3/21/1996, 6/1/2007, 8/22/2012