Current through all regulations passed and filed through December 16, 2024
(A) Policy statement. Recognizing the need
for objectivity in research, Youngstown state university
("university") shall maintain procedures that control conflicts and
potential conflicts in funded research. Such procedures are consistent with the
university's professional conduct
policies (see rules 3356-9-06
and 3356-7-01 of the Administrative Code) and
relevant state and federal laws.
(B) Purpose. The intent of this policy and
these procedures is to ensure that the design, conduct, and reporting of
research projects and other sponsored activities are not compromised, nor would
reasonably appear to be affected, by any significant financial interest
and/or commitment of the responsible faculty and
staff members.
(C)
Scope. This policy applies to all members of the
Youngstown state university community, including faculty, staff and students
during the course of conducting sponsored research or projects at or on behalf
of the university.
(D) Definitions.
(1) "Project" is an 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 at
or on behalf of the university.
(2) "Investigator" includes the principal
investigator, co-investigators, and other persons (e.g., technicians, students,
research associates) responsible, in whole or in part, for the design, conduct,
or reporting of the project; and for reporting purposes, includes the
investigator's spouse and dependent children.
(3) "Significant financial interest" is
anything of monetary value including, but not limited to, salary or other
payments for services such as consulting fees or honoraria; equity interests
such as stocks, stock options, or other ownership interests; and intellectual
property rights such as patents, copyrights and royalties from such rights.
Not included in this definition are:
(a) Salary, royalties, promotion in rank, or
other remuneration from the university;
(b) Income from seminars, lectures, or
teaching engagements sponsored by public or nonprofit entities;
(c) Income from service on advisory
committees or review panels from public or nonprofit entities;
(d) Financial interest arising solely by
reason or investment in a business by a mutual, pension, or other institutional
investment fund over which the employee does not exercise control;
(e) Equity interest that when aggregated for
the investigator and the investigator's spouse and dependent children, does not
exceed ten thousand dollars in value, as determined by public prices or other
reasonable measures of fair market values, and does not represent more than
five per cent ownership interest for any one enterprise or entity;
(f) Salaries, royalties, or other payments
that when aggregated for the investigator and the investigator's spouse and
dependent children over the next twelve months, are not expected to exceed ten
thousand dollars; and
(g) The
financial interest is an ownership interest in a business which is the
applicant organization under phase I of a small business innovative research
("SBIR") program or phase I of a small business technology transfer ("SBTR")
program and the university is a subcontractor under the business'
application.
(4)
"Conflict of interest" means an action, omission, or situation that may or may
reasonably appear to affect or compromise the objectivity or integrity of an
investigator's design, conduct or reporting of a project.
A conflict of commitment is a type of conflict of
interest, which can arise when the external activities burden or interfere with
the university member's primary obligations and commitments to the
university.
A potential conflict of
interest may exist if the director of research services
determines that a significant financial interest and/or
commitment could directly and significantly affect the design, conduct,
or reporting of a project.
(5) "Disclosure" is a written statement
submitted by the investigator describing the nature of any significant
financial interests and/or commitments, and the
relationship of these to the externally funded project.
(D) Parameters.
(1) All faculty and staff members or other
university-affiliated individuals who apply for, receive, or are currently
working on a grant, contract, cooperative agreement, sub-grant, subcontract, or
sub-cooperative agreement which is funded in whole or in part by federal funds
or other external sources must adhere to this policy and its
procedures.
(2) The
director of research services is designated to solicit
and review financial and commitment disclosure
statements from investigators.
(E) Principles.
(1) Complex relationships among universities,
government agencies, and industry require adherence to standards of conduct in
federally funded and other externally sponsored activities. Application of
these standards must serve both project requirements and the public interest.
Protecting the integrity of cooperating entities requires that both real and
perceived conflicts of interest be avoided.
(2) Faculty or staff members engaging in a
federally or other externally sponsored project are subject to the provisions
of federal and state laws and any requirements of the sponsoring or
entity.
(3) To avoid bias in the
design, conduct, or reporting of the sponsored project, full disclosure must be
made when a faculty or staff member consults for a business, nonprofit agency,
government agency, or other non-university contractor, in the same technical
field as the externally sponsored project.
(F) Procedures.
(1) Prior to submitting an application to
conduct an externally funded project, the investigator shall disclose to the
director of research services any significant
financial interests or other possible conflict situations:
(a) That would appear to be affected by the
project for which the funding is sought; and
(b) In entities whose financial interests
would appear to be affected by such project.
A conflict of interest statement shall be included within the
proposal routing form process and shall be circulated for review and approval
for all proposals.
(2) Throughout the duration of a sponsored
research project, investigators shall update the conflict of interest statement
at least annually. If an investigator acquires a significant reportable
financial interest in or commitment to an entity,
the investigator shall submit a revised or new conflict of interest statement
to the director of research services
within five working days after acquisition.
(3) The director of
research services shall review the disclosure and make an initial
determination whether a potential conflict of interest exists. If the
disclosure is determined not to be a potential conflict of interest, the
director of research services shall provide
documentation of this determination that shall be retained with the other
project records and shall so advise the investigator, the chair, and the
appropriate college dean.
(4) If
the disclosure is determined to be a potential conflict of interest, the
director of research services shall consult with the
dean of the college and the university general counsel. They shall review the
disclosure, consult with the investigator, and seek any additional information
to determine whether a conflict of interest exists. If they determine that a
conflict of interest exists, they shall determine a plan of action, and
document in writing the conditions or restrictions that shall be required by
the university to manage, reduce, or eliminate such actual or apparent conflict
of interest. If all parties accept the plan, the director of research services shall notify all
involved parties and the provost of the final determination in
writing.
(5) If a mutually
acceptable method for managing, reducing, or eliminating the conflict of
interest cannot be agreed upon, the director of research
services shall refer the disclosure to the provost, who shall consult
with the university general counsel prior to appointment a conflict of interest
review committee for final determination.
(6) The provost shall notify the
investigator, the investigator's chairperson and dean, and the
director of research services of the final
determination.
(7) In addition to
possible legal action, the university may take disciplinary action against
individuals who fail to file a disclosure statement or intentionally file an
incomplete or misleading disclosure statement. Breaches of this policy may be
referred to a conflict of interest review committee to investigate and
recommend sanctions. If sanctions are necessary, they will be imposed in
accordance with any applicable university policy, procedure, or collective
bargaining agreement.
(8) Prior to
the expenditure of any funds under a federally funded project award, the
university will, as required by law, report to the appropriate federal agency
the existence of a conflict of interest and assure that the conflict has been
managed, reduced, or eliminated.
(9) When the university identifies a conflict
of interest subsequent to the university's initial report under the federally
funded project award, the university will report the conflict of interest to
the appropriate federal agency and manage, reduce, or eliminate the conflict
within sixty days of identifying the same.
(10) The director of
research services shall ensure that the required records, identifiable to
each award, are retained for a period of not less than three years after the
termination of the award, or until three years after the resolution of any
action taken by the sponsor involving these records, whichever is longer.
Records for proposals that are not funded by sponsoring agencies will be
retained for a period of one year after the decision of the sponsoring
agency.