(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.