Current through all regulations passed and filed through December 16, 2024
(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