(A) Purpose of the
investigation
The purpose of the investigation is to explore in
detail the allegations, to examine the evidence in depth, and to determine
specifically whether academic research misconduct has been committed, and if
so, the responsible person and the seriousness of the misconduct. The
investigation also will determine whether there are additional instances of
possible academic research misconduct that would justify broadening the scope
beyond the initial allegations. This is particularly important where the
alleged misconduct involves clinical trials, or potential harm to human
subjects or the public, or if it affects research that forms the basis for
public policy, clinical practice, or public health practice. The findings of
the investigation will be set forth in an investigation report.
(B) Sequestration of the research
records
The research integrity officer shall immediately
sequester any additional pertinent research records not previously sequestered
during the inquiry process. This sequestration should occur before or at the
time the respondent is notified that an investigation has begun. The need for
additional sequestration of records may occur for any number of reasons; for
example, the university's decision to investigate additional allegations
not considered during the inquiry stage may require additional documentation
contained within the research records, or the inquiry process may identify
additional research records that will be needed during the
investigation.
(C) Any such administrative actions taken
prior to a final determination should be devised and taken to create minimal
interference with the regular research activities of the respondent and other
involved parties.
(D) Appointment of the investigation
committee
Within ten days of the notification to the
respondent that an investigation will be conducted, or as soon thereafter as
practicable, the research integrity officer, in consultation with other
university officials as appropriate, will appoint an investigation
committee.
(E) Appointees may not have served on the
inquiry committee. The investigation committee should consist of at least three
individuals who do not have any real or apparent unresolved personal,
professional, or financial conflicts of interest with those involved with the
investigation. The members of the investigation committee shall have the
necessary expertise to examine the evidence, interview the principals and key
witnesses, and conduct the investigation. The investigation committee members
may be scientists, subject matter experts, or other qualified persons, and they
may be from inside or outside the university. The investigation committee
selects its own chair.
(F) The research integrity officer shall
notify the respondent of the proposed investigation committee membership within
ten days of the time of the notification to the respondent that an
investigation will be conducted. If within five working days of receiving the
names of the investigation committee members, the respondent submits a written
objection to any appointed :member of the investigation committee based on bias
or conflict of interest, the research integrity officer shall determine within
five working days whether to replace the challenged :member with a qualified
substitute. Substitute members may also be challenged by the respondent within
two working days.
(G) Charge to investigation committee and
the first meeting
(1) Charge to the
committee
The research integrity officer shall define the
subject matter of the investigation in a written charge to the committee that
describes the allegation(s) and related issues identified during the inquiry,
define academic research misconduct, and identify the complainant and the
respondent. The charge shall state that the committee is to evaluate the
evidence and testimony of the respondent, the complainant, and key witnesses to
determine whether there is a preponderance of the evidence academic research
misconduct occurred and, if so, to what extent, who was responsible, and its
seriousness.
(2) During the
investigation, if additional information becomes available that substantially
changes the subject matter of the investigation or would suggest additional
respondents or a modification of the original charge, the committee shall
notify the research integrity officer, who shall determine whether it is
necessary to notify the respondent of the new subject matter or to provide
notice to additional respondents, to modify the original charge, and to
initiate a new inquiry or continue the investigation underway. The respondent
must be notified immediately of any significant change.
(3) A copy of the charge
shall be sent to the respondent
(4) First
meeting
The research integrity officer, with the
assistance of university legal counsel, shall convene the first meeting of the
investigation committee to review the charge, the inquiry report, and the
prescribed procedures and standards for conducting the investigation. It is the
responsibility of the research integrity officer to assist the investigation
committee with plans for organizing the investigation and to answer any
questions raised by the investigation committee members. The research integrity
officer and university legal counsel shall be present or available throughout
the investigation process to advise the investigation committee as
needed.
(H) Investigation process
The investigation normally shall include
examination of all documentation including, but not necessarily limited to,
relevant research data materials, proposals, publications, correspondence,
memoranda, and notes of telephone calls. Whenever possible, interviews should
be conducted of all individuals involved either in making the allegation or
against whom the allegation is made, as well as other individuals who might
have information regarding key aspects of the allegations. All interviews
should be tape-recorded. Copies of these interview tapes should be prepared,
and recorded material containing evidence on which the investigation report is
based shall be provided to the respondent, and included as part of the
investigatory file. A copy of the tape of respondent's interview may be
provided to the interviewed party upon request.
(I) Time limit for completing the
investigation report
An investigation should ordinarily be completed
within one hundred and twenty days of its initiation, with the initiation being
defined as the date upon which the committee first meets. This includes time
for conducting the investigation- including providing the respondent with the
opportunity to confront and question all witnesses, preparing the report of
findings, making the report available for comment by the subjects of the
investigation, as well as submitting the report to the research integrity
officer and the "ORI."
(J) The investigation report
The final report, if submitted to ORI shall state
the policies and procedures under which the investigation was conducted,
describe how and from whom information relevant to the investigation was
obtained, state the findings, and explain the basis for the findings. Any final
report shall include the actual text or an accurate summary of the views of any
individual(s) found to have engaged in misconduct, as well as a description of
any intermediate administrative actions taken by the university.
The investigation report must be in writing and
include the following:
(1) Description of the allegations of research
misconduct;
(2) Description and documentation of any PHS support (e.g.,
grant numbers, grant applications, contracts, publications listing PHS
support;
(3) The institutional charge;
(4) The policies and procedures under which the
investigation was conducted;
(5) A summary of the research records and evidence,
including identification of any evidence taken into custody but not
reviewed;
(6) A statement for each separate allegation of research
misconduct of a finding of whether or not research misconduct did or did not
occur, and if so:
Identification of whether the research
misconduct was falsification, fabrication, or plagiarism, and if it was
intentional, knowing, or in reckless disregard;
A summary of the facts and analyses which
support the conclusion and consider the merits of any reasonable explanation by
the respondent;
Identification of specific PHS support;
Identification of whether any publications need
correction or retraction;
Identity of the person(s) responsible for the
misconduct; and
A list of any current support or known
applications or proposal for support that the respondent has pending with
non-PHS federal agencies.
(7) Comments made by the respondent and complainant on the
draft investigation report
All relevant research records and records of
the research misconduct proceeding, including the results of all interviews and
transcripts or recordings of such interviews shall be maintained and provided
to ORI up request.
(K) Comments on the draft investigation
report
(1) Respondent
The research integrity officer shall provide
the respondent with a copy of the draft investigation report and, concurrently,
a copy of or supervised access to the evidence on which the report is based for
comment and rebuttal. The respondent shall be allowed thirty days to review and
to comment on the draft report. The respondent's comments shall be
attached to the final report. In addition to all the other evidence, this
report should take into account the respondent's comments.
(2) Complainant
The research integrity officer shall provide
the complainant, if they are identifiable, with those portions of the draft
investigation report that address the complainant's role and opinions in
the investigation. The report should be modified in its final version, as
appropriate, based on the complainant's comments.
(3) Confidentiality
In distributing the draft report, or portions,
thereof, to the respondent and to the complainant, the research integrity
officer shall inform the recipient of the confidentiality under which the draft
report is made available. The research integrity officer may establish
reasonable conditions to ensure such confidentiality insofar as permitted by
the law of the state of Ohio. For example, the research integrity officer may
request that the recipient sign a confidentiality statement or to come to his
or her office to review the report.
(4) Transmittal of the
final investigation report
After comments have been received and the
necessary changes, if any, have been made in the draft report, the
investigation committee should transmit the final report with attachments,
including the respondent's and the complainant's comments, to the
deciding official, through the research integrity officer.
(5) Decision by
institutional official
Based on the findings presented in the final
investigation report, the deciding official shall determine whether misconduct
has occurred, and what sanctions or administrative actions are to be
undertaken.