Current through all regulations passed and filed through September 16, 2024
(A) Definitions
As used herein, the following terms have the indicated
meaning:
"Fabrication": making up data or results and recording or
reporting them.
"Falsification": manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the research is
not accurately represented in the research record.
"Inquiry": Gathering information and initial fact-finding to
determine whether an allegation or apparent instance of scientific misconduct
warrants an investigation.
"Investigation": the formal examination and evaluation of all
relevant facts to determine if misconduct has occurred and if so, to determine
the responsible person and the seriousness of the misconduct.
"ORI": office of research integrity, the office within the
United States department of health and human services (HHS) that is responsible
for the scientific misconduct and research integrity activities of the public
health service (PHS).
"Plagiarism": the appropriation of another person's ideas,
processed, results, or words without giving appropriate credit.
"Research integrity officer or RIO": the individual appointed
by the provost responsible for assessing allegations of scientific misconduct
and determining when such allegations warrant inquiries and for overseeing
inquiries and investigations.
"Research records": any data, document, computer file, external
hard drive/flash drive, or any other written or non-written account or object
that reasonably may be expected to provide evidence or information regarding
the proposed, conducted, or reported research that constitutes the subject of
an allegation of scientific misconduct. A research record includes, but is not
limited to, grant or contract applications, grant or contract progress and
other reports, laboratory notebooks, notes, correspondence, videos,
photographs, x-ray film, slides, biological materials, manuscripts and
publications, equipment use logs, laboratory procurement records, animal
facility records, human and animal subject protocols, consent forms and patient
record files.
(B) The
university endorses the following introductory statement in the "Framework for
Institutional Policies and Procedures to Deal with Fraud in Research," issued
November 4, 1988, by the "Association of American Universities, National
Association of State Universities and Land-Grant Colleges, and Council of
Graduate Schools."
"Fraud in research undermines the scientific enterprise in ways
that go far beyond the waste of public funds. Although an uncommon event
relative to the large scientific literature, violations of accepted standards
inevitably appear in this as in all human pursuits. Institutions engaged in
research have a major responsibility, not only to provide an environment that
promotes integrity, but also to establish and enforce policies that deal
effectively and expeditiously with allegations or evidence of fraud.
In dealing with this problem it is important not to create an
atmosphere that might discourage openness and creativity. Good and innovative
science cannot flourish in an atmosphere of oppressive regulation. Moreover, it
is particularly important to distinguish fraud from the honest error and
ambiguities of interpretation that are inherent in the scientific process and
are normally corrected by further research."
Generation of new knowledge through scholarly and creative
works is a fundamental goal of the University of Cincinnati. This work is
broadly defined as research. Individuals directly engaged in research, those
charged with supervision of research, and collaborators of university
investigators outside their own units shall bear obligations to pursue their
studies in an ethical manner. Supervisors of research shall bear responsibility
for the ethical conduct of research in their own unit as well as the
laboratories of their collaborators.
This rule is designed to be consistent with the Public Health
Service (PHS) policies on research misconduct, 42 CRF part 93, adopted 16 June
2005. However, the policy and process is generally applicable to all research
irrespective of funding source.
(C) Research misconduct is defined as
fabrication, falsification or plagiarism in proposing, performing, or reviewing
research proposals or in reporting research results. Research misconduct does
not include honest error or differences of opinion that arise out of proposing,
performing, reviewing or reporting research.
(D) Misconduct, which has been established by
a preponderance of evidence, may constitute grounds for administrative action
including termination of the individual's appointment at the university. It
shall be recognized that accusations of falsifying or misrepresenting data or
authorship shall be among the most serious charges that may be lodged against
an investigator. Any person contemplating such accusations shall fully consider
the gravity of the accusation and its consequences and shall make every
reasonable effort to avoid lodging charges that shall prove to be devoid of a
substantial element of truth. Frivolous or false accusations may also
constitute grounds for administrative action. Likewise, it shall be the policy
of the University of Cincinnati that no individual who, in good faith, shall
have reported apparent scientific misconduct of research shall be subject to
retaliation by the university or any member of the university community.
Impermissible retaliation shall be subject to university discipline. The
reputations of all involved parties will be protected to the extent possible
and measures to restore reputations will be undertaken as appropriate.
Documentation of any adverse action taken with respect to any individual
employee shall remain permanently in that employee's personnel file.
(E) When misconduct shall have been alleged,
a sequence of events shall take place within the institution to provide maximal
opportunity for reaching valid conclusions about the alleged misconduct. In
addition to reaching valid conclusions, it shall be imperative that due process
shall be followed and protection be afforded to the rights and reputation of
both accuser and accused, collaborators of the accused, those investigating the
allegations, any sponsoring agency, any publisher, and the university. Thus,
university legal counsel shall provide advice and counsel throughout the
proceedings.
(F) During inquiry
into and investigation of allegations, confidentiality shall be observed in the
interests of all parties except that the appropriate college dean (hereafter
referred to as dean) shall inform, and keep apprised of the investigation, the
vice president for research and the senior vice president and provost for
baccalaureate and graduate education . The dean may delegate any authority described herein.
(G) Appropriate administrative action may be
taken as necessary to ensure the integrity of the research, to protect the
rights and interests of research subjects and the public, to protect sponsoring
agency funds, and to assure that the purposes of the financial assistance are
met.
Allegations which meet the following criteria for special
circumstances should be reported to the vice president for research, the
research integrity officer, the appropriate funding agencies and office of
research integrity. These include, but are not limited to:
(1) risk to public health or safety including
immediate need to protect human or animal subjects;
(2) Threats to agency resources, reputation
or other interests that need protecting;
(3) any reasonable indication of possible
violations of civil or criminal law;
(4) suspension of research
activities;
(5) need for federal
action to protect the interests of a subject of the investigation or of others
potentially affected; or
(6) the
scientific community or the public should be informed.
(H) All proceedings shall be in accordance
with applicable rules and contractual obligations of the university of
Cincinnati. Any individual meeting with an inquiry or investigating committee
may be accompanied by a representative. Each committee may establish its own
rules of conduct within these guidelines. All members of the university of
Cincinnati community are expected to cooperate with the proceedings, inquiries,
and investigations.
(1) Allegations:
Charges of misconduct shall be brought to the research
integrity officer (RIO) who will assess the allegations to determine whether
they are credible and specific and warrant further investigation. If the
decision is in the affirmative, the RIO will communicate them immediately to
the director or head of the department or unit in which such conduct allegedly
occurred. The director or head shall immediately inform the dean of the
college. If the person being accused is a department or unit director or head,
the charge shall be brought directly to the dean.
Assessment of allegations. The RIO shall make an initial
assessment of whether the reported allegations are credible and specific so
that
(a) Potential evidence of
research misconduct may be identified.
(b) The allegations fall within the
jurisdictional criteria of
42
CFR 93.102(b).
(c) The allegation falls within the
definition of research misconduct in this policy and 42 CFR 92.103 .
If these criteria are met then an inquiry must be conducted.
The assessment should be concluded within one week. The RIO shall convey
charges of misconduct to the dean of the college.
(2) Initial inquiry: if the RIO determines
that the criteria for an inquiry are met, he or she will immediately initiate
the inquiry process. The purpose of the inquiry is to conduct an initial review
of the available evidence to determine whether or not there may be substance to
the allegations that warrants an investigation. All proceedings shall be in
accordance with applicable rules and contractual obligations of the university
of Cincinnati.
(a) Notice to the accused: at
the time of or before beginning an inquiry, a good faith effort must be made to
advise the accused of the allegations in writing.
(b) Prior to or concomitant with,
notification of the respondent concerning the allegation, the RIO will obtain
custody of, inventory and sequester all research records and evidence necessary
to conduct the research misconduct proceedings.
(c) The RIO will consult with the ORI for
advice and assistance where appropriate.
(d) The RIO, in consultation with the dean
shall appoint an inquiry committee of no more than three individuals to conduct
an initial inquiry into the allegations. Appointments shall avoid any real or
apparent conflict of interest. The inquiry committee shall contain individuals
with the necessary and appropriate expertise to interview the principals and
key witnesses, and conduct a thorough and equitable inquiry. University legal
counsel shall advise the inquiry committee. The dean shall identify one member
as the chair of the body. The object of the initial inquiry shall be to
determine whether or not there may be substance to the allegations that
warrants an investigation and to recommend appropriate action to the
dean.
(e) In the inquiry stage,
factual information is gathered by the inquiry body and reviewed to determine
if an investigation is warranted. The inquiry is designed to separate
allegations deserving further investigation from unsubstantiated or frivolous
allegations. Private and separate sessions shall be conducted to hear the
accuser, the accused, and others as determined necessary by the inquiry
committee. All relevant evidence that is produced shall be reviewed and
secured. Once sufficient information is obtained to decide whether an
investigation is warranted, the inquiry process shall conclude and an inquiry
report will be submitted to the dean.
The inquiry committee shall make a written report and
recommendation to the dean within fifteen working days after the dean has been
informed of the charge. Under exceptional circumstances the dean may extend
this period. The written report shall state what evidence was reviewed, a
summary of relevant interviews, the reason for any delays, and the
recommendation of the inquiry committee. The determination of the dean shall be
final and should be completed within thirty days of receiving the draft
report.
(f) Two basic
recommendations may follow from this initial inquiry:
(1) the allegations are without merit;
or
(2) the allegations have
sufficient substance to warrant further investigation. In either case,
subsequent action may be recommended. If the student was supported with PHS
funds, the RIO will provide ORI with the dean's written decision and a copy of
the inquiry report. The RIO must provide the following information to the ORI
upon request:
(i) The institutional policies
and procedures under which the inquiry was conducted.
(ii) The research records and evidence
reviewed, transcripts or recordings of any interviews and copies of all
relevant documents.
(iii) The
charges to be considered in the investigation.
(g) The dean shall review the recommendation
of the inquiry committee and decide whether to request complete investigation
as described in paragraph (G)(3) of this rule or take any other appropriate
action pursuant to university rules or contractual agreements. This decision
shall be delivered in writing with the inquiry committee report and
recommendation to the accused, accuser, the inquiry committee, the vice
president for research and the senior vice president and provost for
baccalaureate and graduate education who in turn shall notify the president of
the university without unnecessary delay. Any comments submitted by the accused
may be added to the record. If the dean decides that an investigation is not
warranted, the RIO shall secure and maintain for seven years after the
termination of the inquiry sufficiently detailed documentation of the inquiry
to permit a later assessment by ORI of the reasons why an investigation was not
conducted. These documents must be provided to ORI or other authorized HHS
personnel upon request.
(3) Investigation: (if warranted) An
investigation must begin within thirty days of the completion of the inquiry
and must be completed within one hundred twenty days of its initiation. The
purpose of the investigation is to develop a factual record exploring the
allegations in detail and examining the evidence in depth, leading to
recommended findings on whether research misconduct has been committed, by
whom, and to what extent. If there is evidence to suggest that there are
additional instances of possible research misconduct, the scope of the
investigation may be broadened beyond the initial allegations. This is
particularly important if the alleged misconduct involves clinical trials,
potential harm to human subjects, the general public or if it affects research
that forms the basis for public policy, clinical practice or public health
practice.
(a) The dean shall determine whether
sponsored research is involved and shall so inform the vice president for
research who shall determine if the sponsoring agency shall be notified that an
investigation is under way. If the allegations involve PHS support, on or
before the date on which the investigation begins the RIO must:
(i) Notify the ORI director of the decision
to begin the investigation and provide ORI a copy of the inquiry
report.
(ii) Notify the respondent
in writing of the allegations to be investigated and notice if any new
allegations of misconduct are to included in the investigation.
(b) The RIO, in consultation with
dean shall appoint an investigating committee and the committee chair within
ten days to conduct a complete investigation of the allegations to determine if
misconduct has occurred and, if so, to assess its extent and consequences.
Appointments shall avoid any real or apparent conflict of interest. The
investigating committee shall not be excessive in size but shall contain
individuals with sufficient expertise and dedication to conduct a thorough and
equitable investigation. University legal counsel shall advise the
investigating committee.
(c) The
investigation shall be thorough and timely and shall provide both notice of all
allegations to the accused and an opportunity for the accused to fully respond
to all allegations and findings. It shall require the dedicated attention of
the investigating committee. An investigation must begin within thirty days of
the completion of the inquiry and must be completed within one hundred and
twenty days of its initiation. Extensions may be approved only by the vice
president for research and the senior vice president and provost for
baccalaureate and graduate education who shall first secure any necessary
approvals from sponsoring agencies.
(d) Investigative process: necessary support
(e.g., clerical, information gathering, witnesses, organizational, security,
record keeping and confidentiality) shall be arranged by the office of the
dean. The investigation committee and the RIO must:
(i) Ensure that the investigation is thorough
and sufficiently documented and includes examination of all research records
and evidence relevant to reaching a decision on the merits of each
allegation.
(ii) Take reasonable
steps to ensure the investigation is impartial and unbiased to the maximum
extent practical
(iii) Conduct
private and separate sessions to hear the accuser, the accused and others as
determined necessary by the investigating committee.
(iv) Produce and review all relevant evidence
(including, but not limited to research data, publications, correspondence and
telephone memoranda) that has been produced shall be reviewed and
secured.
(v) Interviews with any
individuals shall be recorded by tape recorder or court reporter unless the
investigating committee shall otherwise be advised by legal counsel.
(e) The investigative report: the
investigating committee shall provide a written report of its findings,
conclusions and recommendations, together with all pertinent documentation and
evidence, to the dean. The RIO will assist the investigation committee in
finalizing the draft report to be submitted to ORI within one hundred twenty
days. Each member of the investigating committee shall sign the report or
submit a signed dissenting report. The dean will determine in writing,
(i)
whether the institution accepts the investigation report, its findings and the
recommendations and (ii) the appropriate institutional actions in response
to the finding. If this determination varies from the findings of the
committee, the dean will, as part of the written determination, explain in
detail the basis for rendering a decision different from the
committee.
(4) External
review:
The dean may appoint an external committee of faculty members
and/or administrators from another institution or institutions to review and
provide written comment on the findings, conclusions and recommendations of the
investigating committee. They shall be appointed in a manner that ensures the
official nature of their involvement and provides them with legal protections
available to university employees to the extent possible.
(5) Administrative action:
(a) The dean shall review the report of the
investigating committee and the comments of the external committee, if any, and
recommend further action to the vice president for research and the senior vice
president and provost for baccalaureate and graduate education. This
recommendation shall be delivered in writing together with the committee report
and any comments from the external committee to the accused, the accuser, and
the investigating committee. Any comments submitted by the accused shall also
become part of the record. The vice president for research and the senior vice
president and provost for baccalaureate and graduate education shall inform the
president of the university without unnecessary delay.
(b) With the advice of the university legal
counsel, the vice president for research and the senior vice president and
provost for baccalaureate and graduate education shall decide how to proceed
under applicable university rules and contractual agreements and shall deliver
that decision in writing to the accused, the accuser, both committees, the
dean, and the president without unnecessary delay. A copy shall be permanently
placed in the personnel file of the accused. Collaborators of the accused shall
be advised of any substantiated misconduct or questions related to their
research. The president shall advise the board of trustees as
necessary.
(c) At any time that
misconduct as defined herein or significant errors are substantiated in any
sponsored or reported research, the vice president for research and the senior
vice president and provost for baccalaureate and graduate education shall
notify the sponsoring agency or publisher without delay in writing.
(d) If PHS funds are involved, the dean will
make the final determination whether to accept the investigation report, its
finding and recommendations for action. If this determination varies from that
of the investigation committee, the dean will explain in detail the basis for
rendering a decision in the report transmitted to ORI. The RIO must maintain
and provide to ORI upon request records of research misconduct proceedings as
that term is defined by
42
CFR 93.317. Unless custody has been
transferred to HHS or ORI has advised in writing that the records no longer
need to be retained, records of research misconduct proceedings must be
maintained in a secure manner for seven years after completion of the
proceeding or the completion of any PHS proceeding involving the research
misconduct allegation. The RIO is also responsible for providing any
information, documentation, research records, evidence or clarification
requested by ORI to carry out its review of an allegation of research
misconduct or of the institution's handling of such an allegation.
(e) Following a final finding of no research
misconduct, including ORI concurrence where required by 42 CFR Part 93, the RIO
will, at the request of the respondent, undertake all reasonable and practical
efforts to restore the respondent's reputation. Depending on the particular
circumstances and the views of the respondent, the RIO should consider
notifying those individuals aware of or involved in the investigation of the
final outcome, publicizing the final outcome in any forum in which the
allegation of research misconduct was previously publicized, and expunging all
reference to the research misconduct allegation from the respondent's personnel
file. Any institutional actions to restore the respondent's reputation should
first be approved by the dean.
Replaces: 3361:10-17-05
