Ohio Administrative Code › Title 3342 - Kent State University › Chapter 3342-10 - University and Administative Policy on Research › Section 3342-10-04.1 - Administrative policy on financial interest in sponsored projects

Current through all regulations passed and filed through July 1, 2024
(A)
								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
			 3342-10-03.1 of the Administrative Code. Sponsored projects for the purpose of
			 this policy includes all direct awards and subawards.
(B)
								Definitions.
(1)
									"Conflict 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" conflict of interest depends on the situation and not on the character
			 or actions of the individual.
(2)
									"Investigator"
			 means the principal investigator/project director, and co-principal
			 investigator. "Investigator" also means any other person who is responsible for
			 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 interests, 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 faculty 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,
			 investigator's spouse, and dependent children, that reasonably appears to be
			 related to the investigator's institutional responsibilities, including:
(a)
										For public health
			 service (PHS) funded projects (PHS includes, but is not limited to NIH, SAMHSA,
			 HRSA, CDC, AHRQ and, for the purpose of this policy, any other funding sponsor
			 that adopts PHS regulations, and including all subawards originating from PHS
			 or a funding sponsor adopting PHS regulations):
(i)
											With regard to
			 any publicly traded entity, combined financial 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 that exceeds five
			 thousand dollars. Remuneration includes salary, any payment for services not
			 identified as salary, equity interests and ownership interests;
(ii)
											With regard to
			 any non-publicly traded entity, combined financial remuneration received from
			 the entity in the twelve months preceding the disclosure that exceeds five
			 thousand dollars, or when the investigator holds any equity interest (e.g.,
			 stock, stock option, or other ownership interest), regardless of the equity
			 value; or
(iii)
											Intellectual property rights and interests (e.g.,
			 patents, copyrights), upon receipt of income related to such rights and
			 interests; or
(iv)
											Any reimbursed or sponsored travel exceeding five
			 thousand dollars from the same entity in the aggregate (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 must be disclosed. Disclosure of
			 this interest will include the purpose and duration of the trip, the identity
			 of the sponsor/organizer, and the travel destination.
(b)
										For
			 all other funding (all non-PHS funded research including, but not limited to
			 national science foundation (NSF) Funding):
(i)
											With regard to a
			 publicly traded entity, combined financial remuneration received from the
			 entity in the twelve months preceding the disclosure that exceeds ten thousand
			 dollars. Remuneration includes salary, any payment for services not identified
			 as salary, equity interests and ownership interests;
(ii)
											With regard to
			 any non-publicly traded entity, combined financial remuneration received from
			 the entity in the twelve months preceding the disclosure that exceeds ten
			 thousand dollars, or when the investigator holds any equity interest (e.g.,
			 stock, stock option, or other ownership interest), regardless of the equity
			 value; or
(iii)
											A five per cent ownership interest in a single publicly
			 traded entity; or
(iv)
											Intellectual property rights and interests upon receipt
			 of income related to those rights and interests that exceeds ten thousand
			 dollars during the prior twelve month period.
(5)
									"Significant financial interests" do not include:
(a)
										Salary,
			 royalties, or other remuneration paid by the university to the investigator if
			 the investigator is currently employed or otherwise appointed by university;
			 or
(b)
										Intellectual property rights assigned to the university
			 and agreement to share in royalties related to such rights; or
(c)
										Income from
			 seminars, lectures, or teaching engagements sponsored by federal, state, or
			 local government agency, an institution of higher education, an academic
			 teaching hospital, a medical center, or a research institute affiliated with an
			 institution of higher education (this exception does not apply to foreign
			 institutions of higher education or governments of another country);
			 or
(d)
										Income from service on advisory committees or review
			 panels for a federal, state, or local government agency, an institution of
			 higher education, an academic teaching hospital, a medical center, or a
			 research institute that is affiliated with an institution of higher education
			 (this exception does not apply to foreign institutions of higher education or
			 governments of another country).
(6)
									"Financial
			 conflict of interest" (FCOI) means a significant financial interest that is
			 related to externally funded university research (i.e., the interest reasonably
			 appears to be affected by the research or is in an entity whose financial
			 interest reasonably appears to be affected by the research) and that could
			 directly and significantly affect the design, conduct, or reporting of
			 research.