Current through all regulations passed and filed through September 16, 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.
(D)
Disclosure and
training
(1)
All investigators must complete an EFI disclosure for themselves and family
member(s) according to the following requirements:
(a)
Before submitting
any proposal for a sponsored project or any protocol for human subject research
(unfunded or funded);
(b)
At least annually, during the period of a sponsored
project award or upon protocol renewal;
(c)
Within thirty
days of discovering or acquiring (i.e. through purchase, marriage, or
inheritance) a new external financial interest; and
(d)
Upon being added
as an investigator to a funded project or human subject research
protocol.
(2)
Investigators who have not properly disclosed their EFI
or whose disclosures have expired may be prohibited from conducting sponsored
program activities or human subject research until a current disclosure has
been submitted and reviewed.
(3)
Financial
conflict of interest training All investigators participating on any PHS
sponsored research must complete training:
(a)
At least every
four years;
(b)
When the university substantially revises the FCOI
policy in a manner that affects the requirements for
investigators;
(c)
When the investigator is new to the university;
or
(d)
When an investigator is found to be out of compliance
with this FCOI policy or any current FCOI management
plan.
(E)
Determinations
The COI committee, or administrative
staff on behalf of the committee, will:
(1)
Review new and
updated EFIs.
The reviewer(s) may require
investigators to provide additional information regarding the nature of the
EFI.
(2)
Determine whether an EFI is related to a particular
sponsored project or protocol on a case-by-case basis.
(3)
When an FCOI is
identified, develop a management plan for implementation to eliminate, mitigate
or manage the conflict.
(a)
For human subject research protocols, the SFIs and
FCOIs will be reported to the appropriate institutional review board (IRB). The
convened IRB will have full and final authority for implementing the COI
committee decisions.
(b)
Management plans will be provided to the investigator's
department chair or unit supervisor, grants accounting, or other individuals or
departments as needed to ensure compliance with the management plan through the
completion of the project.
(4)
As required by
PHS rules, the IO or designee, shall report FCOIs to the sponsor prior to
expenditure of federal funding or within sixty days of the university
discovering an FCOI after the project has begun.
(F)
Appeal
An individual may appeal a COI
committee decision in writing to the IO within thirty days of the date of the
committee's notification of that decision. The IO will respond within fourteen
days of receipt of a written appeal, either affirming or reversing the decision
and notify the relevant committee and investigator of his/her
decision.
(G)
Record retention and confidentiality
(1)
EFI and all
actions taken by the university with respect to these interests will be
maintained for at least three years from the termination of the grant,
contract, agreement or protocol.
(2)
The information
received to comply with this policy shall be handled confidentially, to the
extent possible, unless public disclosure is part of the management plan or
such disclosure is required by university, federal or state regulations or
sponsoring agencies.
(H)
Noncompliance
The COI committee will work
cooperatively with investigators to avoid or resolve issues of
noncompliance.
The university will conduct
retrospective reviews for PHS projects within one hundred twenty days of a
determination that SFIs have not been properly disclosed or when an FCOI is not
identified or managed in a timely manner.
Flagrant or repeated noncompliance with
policies, procedures or management requirements will be handled through
university disciplinary procedures.
(I)
References
(1)
UT FCOI
procedures: local URL TBD
(2)
PHS federal regulations, 4 2 C.F.R. part 50 subpart
F-"Promoting Objectivity in Research":
https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=42:1.0.1.4.23#sp42.1.50.fReplaces: 3364-70-01
