Ohio Administrative Code › Title 3364 - University of Toledo › Chapter 3364-70 - Research Protection and Practices › Section 3364-70-01 - Financial conflicts of interest

Current through all regulations passed and filed through July 1, 2024
(A)
								Policy
			 statement
The United States government requires
				that entities receiving federal funding maintain a written policy on financial
				conflicts of interest that is consistent with current regulations. The
				university of Toledo seeks to ensure that the objectivity and integrity of the
				investigator, the university, and academic research, training, or other
				activities are not compromised or perceived to be compromised by matters of
				financial benefit or personal gain.
(B)
								Purpose of
			 policy
The purpose of this policy is to ensure
				that the design, conduct and reporting of sponsored projects or human subject
				research is free from bias or potential conflicts of interest resulting from an
				investigator's financial interests, and to ensure compliance with applicable
				federal regulations, sponsor requirements and university policies. Federal
				financial conflict of interest (FCOI) regulations have specific requirements
				for FCOI education, disclosure, review, reporting and management. These
				regulations include but are not limited to 2 C.F.R. 200 (uniform administrative
				requirements, cost principles, and audit requirements for federal awards),
				42
				C.F.R. 50.603, and National Science
				Foundation "proposal and award policies and procedures guide," chapter IX,
				section a: "conflict of interest policies."
(C)
								Scope
This policy applies to all university
				faculty, staff, and students (including postdoctoral fellows and scholars)
				regardless of title or position, involved in the design, conduct, or reporting
				of sponsored projects or human subject research, whether funded or unfunded by
				an external sponsor.
The scope of this policy does not
				include provisions of Ohio ethics law as applied to university of Toledo
				employees in their roles as public employees (see rule 3364-25-50 of the
				Administrative Code). Rule
				3364-25-18 of the
				Administrative Code addresses potential conflicts of interest and nepotism in
				hiring and supervision.
(D)
								Definitions
(1)
									Sponsored program
			 means research, training, and instructional activity involving funds,
			 materials, or other compensation from external funding sources and established
			 by grant, contract, cooperative agreement, or other funding
			 mechanism.
(2)
									Investigator includes any individual who is responsible
			 for the design, conduct or reporting of the sponsored program on behalf of the
			 university, or human subject research study personnel as defined by rule
			 3364-70-05 of the Administrative Code, including laboratory personnel,
			 students, trainees, volunteers, subcontractors and consultants.
(3)
									Family member
			 means immediate family, including the investigator's spouse or domestic
			 partner, and dependent children or step-children.
(4)
									Financial
			 interest is any interest of monetary value that belongs to an investigator or
			 the investigator's family member.
(5)
									Institutional
			 responsibilities means an investigator's professional responsibilities on
			 behalf of the university, which may include but are not limited to: research,
			 research consultation, teaching, professional practice, and service on panels
			 including institutional review boards, or safety monitoring
			 boards.
(6)
									External financial interest (EFI) means any foreign or
			 domestic external financial interest of the investigator or family member that
			 reasonably appears to be related to the investigator's institutional
			 responsibilities.
(7)
									Public health service (PHS) agencies include agencies
			 such as the national institutes of health (NIH), the food and drug
			 administration (FDA), the centers for disease control (CDC), the substance
			 abuse and mental health services administration (SAMHSA) and other agencies
			 that require adherence to PHS rules and regulations.
(8)
									Significant
			 financial interest (SFI) means any EFI of the investigator or family member
			 that meets certain criteria determined by the sponsor, as follows:
(a)
										For PHS funded
			 projects or those where sponsors stipulate adherence to PHS requirements, SFI
			 is defined within
			 42
			 C.F.R. 50.603:
(i)
											For any publicly
			 traded entity, a significant financial interest exists if the equity interest
			 is five per cent or greater or if the value of any remuneration received from
			 the entity in the twelve months preceding the disclosure, when aggregated,
			 exceeds five thousand dollars.
(ii)
											For any
			 non-publicly traded entity, a significant financial interest exists if the
			 value of any remuneration received from the entity in the twelve months
			 preceding the disclosure, when aggregated, exceeds five thousand dollars;
			 or
(iii)
											Intellectual property rights and interests from sources
			 other than the university (e.g., patents, copyrights), upon receipt of income
			 related to such rights and interests.
(b)
										For projects
			 funded by a non-PHS agency (i.e., NSF), SFI is defined as:
(i)
											Anything of
			 monetary value, including, but not limited to, salary or other payments for
			 services (e.g., consulting fees or honoraria); equity interest (e.g., stocks,
			 stock options or other ownership interests); and intellectual property rights
			 from sources other than university (e.g., patents, copyrights and royalties
			 from such rights) that exceeds an aggregated value of ten thousand dollars as
			 determined through reference to public prices or other reasonable measures of
			 fair market value, or represents more than a five per cent ownership interest
			 in any single entity.
(ii)
											Not included in SFI:
(a)
												Income from
			 seminars, lectures or teaching engagements sponsored by a federal, state or
			 local government agency, an accredited U.S. college or university, a U.S.
			 academic health center, or a U.S. research institution that is affiliated with
			 U.S. college or university.
(b)
												Service on
			 advisory committees or review panels for a federal, state or local government
			 agency, an accredited U.S. college or university, a U.S. academic health
			 center, or a U.S. research institution that is affiliated with U.S. college or
			 university.
(c)
												All income or remunerations from foreign colleges,
			 universities, governments and entities must be included in EFI and SFI
			 disclosures.
(9)
									Financial
			 conflict of interest (FCOI) exists when the university determines that a
			 financial or management interest could directly and significantly affect, or be
			 perceived to affect, the design, conduct, or reporting of the
			 research.
(10)
									Manage means taking action(s) to address an FCOI to
			 ensure that the design, conduct, and reporting of the sponsored program or
			 research protocol will be free from bias.
(11)
									Institutional
			 officer (IO) means the vice president of research or designee, who shall
			 appoint chair(s) and members of the conflict of interest (COI) review committee
			 and report COI matters to external agencies as required by federal regulations
			 or the terms of sponsored program agreements.