Case Western Reserve University's Policy for Responding to Allegations of Scientific Misconduct
This is the Case policy as of the OEC symposium on
Responding to Allegations of Research Misconduct in 10/1999.
The university's current policy can be found at the Case research
compliance page.
Table of Contents
I. Introduction
Sections that are based on requirements of the PHS
regulations codified at 42 C.F.R. Part 50, Subpart A have
endnotes that indicate the applicable section number, e.g., 42
C.F.R. β 50.103(d)(1).
- A. General Policy
-
Research misconduct will not be tolerated or accepted at
Case Western Reserve University. Scientific integrity and
ethics are highly valued and expected from all members of
the University community. While ensuring compliance, the
University will make all efforts to protect the rights and
reputations of all individuals including the respondent and
good faith complainant.
The University will educate researchers and staff
members on policies and the importance of compliance.
Preventative measures are by far the most productive and
least damaging to all involved. Our goal is to initiate
department-level discussions among students, faculty, and
staff researchers to examine the contemporary stresses felt
on academic research ethics, and to consider ways to deal
with those stresses.
The University's basic procedural approach to handling
allegations of research misconduct is to investigate as
soon as misconduct is suspected, inform and cooperate with
the Office of Research Integrity (ORI), and to follow the
proceeding policies.
- B. Scope
-
This policy and the associated procedures apply to all
individuals at Case Western Reserve University engaged in
any research whether it is supported by the U.S. Public
Health Service (PHS) or not. The PHS regulation at 42
C.F.R. Part 50, Subpart A applies to any research,
research-training or research-related grant or cooperative
agreement with PHS. This University policy applies to any
person paid by, under the control of, or affiliated with
the institution, such as scientists, trainees, technicians
and other staff members, students, fellows, guest
researchers, or collaborators at Case Western Reserve
University. While the University's authority to
investigate, to compel cooperation, and to impose sanctions
against those who are not members of the University
Community is limited, the University will nonetheless
investigate all allegations of misconduct involving
research.
The policy and associated procedures will normally be
followed when an allegation of possible misconduct in
science is received by a University official. Particular
circumstances in an individual case may dictate variation
from the normal procedure, when such variations are deemed
to be in the best interests of Case Western Reserve
University and PHS. Any change from normal procedures also
must ensure fair treatment to the subject of the inquiry or
investigation
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II. Definitions
- A. Allegation
- means any written or oral statement or other indication
of possible scientific misconduct made to a University
official.
- B. Conflict of interest
- means the real or apparent interference of one person's
interests with the interests of another person, where
potential bias may occur due to prior or existing personal or
professional relationships.
- C. Deciding Official
- means the University official who makes final
determinations on allegations of scientific misconduct and
any responsive institutional actions. The Deciding Official
will not be the same individual as the Research Integrity
Officer and should have no direct prior involvement in the
institution's inquiry, investigation, or allegation
assessment.
- D. Good-faith allegation
- means an allegation made with the honest belief that
scientific misconduct may have occurred. An allegation is not
in good faith if it is made with reckless disregard for or
willful ignorance of facts that would disprove the
allegation.
- E. Inquiry
- means gathering information and initial fact-finding to
determine whether an allegation or apparent instance of
scientific misconduct warrants an investigation.1
- F. Investigation
- means the formal examination and evaluation of all
relevant facts to determine whether misconduct has occurred,
and, if so, to determine the responsible person and the
seriousness of the misconduct.2
- G. ORI
- means the Office of Research Integrity, the office within
the U.S. Department of Health and Human Services (DHHS) that
is responsible for the scientific misconduct and research
integrity activities of the U.S. Public Health Service.
- H. PHS
- means the U.S. Public Health Service, an operating
component of the DHHS.
- I. PHS regulation
- means the Public Health Service regulation establishing
standards for institutional inquiries and investigations into
allegations of scientific misconduct, which is set forth at
42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS
Awardees and Applicant Institutions for Dealing With and
Reporting Possible Misconduct in Science."
- J. PHS support
- means PHS grants, contracts, or cooperative agreements or
applications therefore.
- K. Research Integrity Officer
- means the University official responsible for assessing
allegations of scientific misconduct and determining whether
such allegations warrant inquiries and for overseeing
inquiries and investigations.
- L. Research record
- means any data, document, computer file, computer
diskette, 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, whether funded or
unfunded; grant or contract progress and other reports;
laboratory notebooks; notes; correspondence; videos;
photographs; X-ray film; slides; biological materials;
computer files and printouts; manuscripts and publications;
equipment use logs; laboratory procurement records; animal
facility records; human and animal subject protocols; consent
forms; medical charts; and patient research files.
- M. Respondent
- means the person against whom an allegation of scientific
misconduct is directed or the person whose actions are the
subject of the inquiry or investigation. There can be more
than one respondent in any inquiry or investigation.
- N. Retaliation
- means any action that adversely affects the employment or
other institutional status of an individual that is taken by
an institution or an employee because the individual has in
good faith made an allegation of scientific misconduct or of
inadequate institutional response thereto or has cooperated
in good faith with an investigation of such allegation.
- O. Scientific misconduct or misconduct in science
- means fabrication, falsification, plagiarism, or other
practices that seriously deviate from those that are commonly
accepted within the scientific community for proposing,
conducting, or reporting research. It does not include honest
error or honest differences in interpretations or judgments
of data.3
- P. Complainant
- means a person who makes an allegation of scientific
misconduct.
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III. Rights and
Responsibilities
- A. Research Integrity Officer
-
The Assistant Director of Research Administration (or in
her absence the Director of Research Administration) will
serve as the Research Integrity Officer who will have
primary responsibility for implementation of the procedures
set forth in this document. The Research Integrity Officer
will be a University official who is well qualified to
handle the procedural requirements involved and is
sensitive to the varied demands made on those who conduct
research, those who are accused of misconduct, and those
who report apparent misconduct in good faith.
The Research Integrity Officer will appoint the inquiry
and investigation committees and ensure that necessary and
appropriate expertise is secured to carry out a thorough
and authoritative evaluation of the relevant evidence in an
inquiry or investigation. The Research Integrity Officer
will attempt to ensure that confidentiality is
maintained.
The Research Integrity Officer will assist inquiry and
investigation committees and all University personnel in
complying with these procedures and with applicable
standards imposed by government or external funding
sources. The Research Integrity Officer is also responsible
for maintaining files of all documents and evidence and for
the confidentiality and the security of the files.
The Research Integrity Officer will report to ORI as
required by regulation and keep ORI apprised of any
developments during the course of the inquiry or
investigation that may affect current or potential DHHS
funding for the individual(s) under investigation or that
PHS needs to know to ensure appropriate use of Federal
funds and otherwise protect the public interest.4
- B. Complainant
-
The complainant will ordinarily have an opportunity to be
interviewed by the inquiry and investigation committees, to
review portions of the inquiry and investigation reports
pertinent to his/her allegations or testimony, to be
informed of the results of the inquiry and investigation,
and to be protected from retaliation. Also, if the Research
Integrity Officer has determined that the complainant may
be able to provide pertinent information on any portions of
the draft report, these portions may be given to the
complainant for comment.
The complainant is responsible for making allegations in
good faith, maintaining confidentiality, and cooperating
with an inquiry or investigation.
- C. Respondent
-
The respondent will be informed of the allegations when an
inquiry is opened and notified in writing of the final
determinations and resulting actions. The respondent will
also have the opportunity to be interviewed by and present
evidence to the inquiry and investigation committees, to
review the draft inquiry and investigation reports, and to
have the advisor of choice. Advisors, however, may only
consult with the respondent. They may not address the
committee, ask questions of the committee, or participate
in the interviews.
The respondent is responsible for maintaining
confidentiality and cooperating with the conduct of an
inquiry or investigation. If the respondent is not found to
have engaged in scientific misconduct, he or she has the
right to receive institutional assistance in restoring his
or her reputation.5
- D. Deciding Official
- The Vice President for Research and Technology Transfer
(or in his/her absence the Provost) as the Deciding Official
will receive the inquiry and/or investigation report and any
written comments made by the respondent or the complainant on
the draft report. The Deciding Official will consult with the
Research Integrity Officer or other appropriate officials and
will determine whether to conduct an investigation, whether
misconduct occurred, whether to impose sanctions, or whether
to take other appropriate administrative actions [see
section X].
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IV. General Policies and
Principles
- A. Responsibility to Report Misconduct
-
All employees or individuals associated with Case Western
Reserve University should report observed, suspected, or
apparent misconduct in science to the Research Integrity
Officer. If an individual is unsure whether a suspected
incident falls within the definition of scientific
misconduct, he or she may call the Research Integrity
Officer at (216) 368-4510 to discuss the suspected
misconduct informally. If the circumstances described by
the individual do not meet the definition of scientific
misconduct, the Research Integrity Officer will refer the
individual or allegation to other offices or officials with
responsibility for resolving the problem.
At any time, an employee may have discussions and
consultations about concerns of possible misconduct with
the Research Integrity Officer and will be counseled about
appropriate procedures for reporting allegations.
- B. Protecting the Complainant
-
The Research Integrity Officer will monitor the treatment
of individuals who bring allegations of misconduct or of
inadequate institutional response thereto, and those who
cooperate in inquiries or investigations. The Research
Integrity Officer will attempt to ensure that these persons
will not be retaliated against in the terms and conditions
of their employment or other status at the institution and
will review instances of alleged retaliation for
appropriate action.
Employees or those affiliated with the University or a
PHS grant should immediately report any alleged or apparent
retaliation to the Research Integrity Officer.
Also the University will protect the privacy of those
who report misconduct in good faith to the maximum extent
possible. For example, if the complainant6 requests anonymity, the
University will make a reasonable effort to honor the
request during the allegation assessment or inquiry within
applicable policies and regulations and state and local
laws, if any. The complainant will be advised that if the
matter is referred to an investigation committee and the
complainant's testimony is required, anonymity may no
longer be guaranteed. The University is required to
undertake diligent efforts to protect the positions and
reputations of those persons who, in good faith, make
allegations.7
- C. Protecting the Respondent
-
Inquiries and investigations will be conducted in a manner
that will ensure fair treatment to the respondent(s) in the
inquiry or investigation and confidentiality to the extent
possible without compromising public health and safety or
thoroughly carrying out the inquiry or
investigation.8
University employees accused of scientific misconduct
may consult with an advisor (who is not a principal or
witness in the case) to seek advice and may bring the
adviser to interviews or meetings on the case. However, the
adviser may only consult with the respondent. Advisors may
not address the committee, ask questions of the committee,
or participate in the interview.
- D. Cooperation with Inquiries and Investigations
- University employees and those working on PHS grants will
cooperate with the Research Integrity Officer and other
institutional officials in the review of allegations and the
conduct of inquiries and investigations. Employees have an
obligation to provide relevant evidence to the Research
Integrity Officer or other University officials on misconduct
allegations.
- E. Preliminary Assessment of Allegations
- Upon receiving an allegation of scientific misconduct,
the Research Integrity Officer will assess the allegation to
determine whether there is sufficient evidence to warrant an
inquiry, whether PHS support or PHS applications for funding
are involved, and whether the allegation falls under the PHS
definition of scientific misconduct.
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V. Conducting the
Inquiry
- A. Initiation and Purpose of the Inquiry
- Following the preliminary assessment, if the Research
Integrity Officer determines that the allegation provides
sufficient information to allow specific follow-up and falls
under the PHS definition of scientific misconduct, he or she
will initiate the inquiry process whether it involves PHS
support or not. In initiating the inquiry, the Research
Integrity Officer should identify clearly the original
allegation and any related issues that should be evaluated.
The purpose of the inquiry is to make a preliminary
evaluation of the available evidence and testimony of the
respondent, complainant, and key witnesses to determine
whether there is sufficient evidence of possible scientific
misconduct to warrant an investigation. The purpose of the
inquiry is not to reach a final conclusion about whether
misconduct definitely occurred or who was responsible. The
findings of the inquiry will be set forth in an inquiry
report.
- B. Sequestration of the Research Records
- After determining that an allegation falls within the
definition of misconduct in science, the Research Integrity
Officer must ensure that all original research records and
materials relevant to the allegation are secured. The
Research Integrity Officer may consult with ORI for advice
and assistance in this regard.
- C. Appointment of the Inquiry Committee
-
The Research Integrity Officer, in consultation with other
University officials as appropriate, will appoint an
inquiry committee and committee chair. The inquiry
committee should consist of individuals who do not have
real or apparent conflicts of interest in the case, are
unbiased, and have the necessary expertise to evaluate the
evidence and issues related to the allegation, interview
the principals and key witnesses, and conduct the inquiry.
These individuals may be scientists, subject matter
experts, administrators, lawyers, or other qualified
persons, and they may be from inside or outside the
University.
The Research Integrity Officer will notify the
respondent of the proposed committee membership. If the
respondent submits a written objection to any appointed
member of the inquiry committee or expert based on bias or
conflict of interest within 5 days, the Research Integrity
Officer will determine whether to replace the challenged
member or expert with a qualified substitute.
- D. Charge to the Committee and the First Meeting
-
The Research Integrity Officer will prepare a charge for
the inquiry committee that describes the allegations and
any related issues identified during the allegation
assessment and states that the purpose of the inquiry is to
make a preliminary evaluation of the evidence and testimony
of the respondent, complainant, and key witnesses to
determine whether there is sufficient evidence of possible
scientific misconduct to warrant an investigation as
required by the PHS regulation. The purpose is not to
determine whether scientific misconduct definitely occurred
or who was responsible.
At the committee's first meeting, the Research Integrity
Officer will review the charge with the committee, discuss
the allegations, any related issues, and the appropriate
procedures for conducting the inquiry, assist the committee
with organizing plans for the inquiry, and answer any
questions raised by the committee. The Research Integrity
Officer and the University Attorney's office will be
available throughout the inquiry to advise the committee as
needed.
- E. Inquiry Process
- The inquiry committee will normally interview the
complainant, the respondent and key witnesses as well as
relevant research records and materials. Then the inquiry
committee will evaluate the evidence and testimony obtained
during the inquiry. After consultation with the Research
Integrity Officer and the University Attorney's office, the
committee members will decide whether there is sufficient
evidence of possible scientific misconduct to recommend
further investigation. The scope of the inquiry does not
include deciding whether misconduct occurred or conducting
exhaustive interviews and analyses.
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VI. The Inquiry
Report
- A. Elements of the Inquiry Report
- A written inquiry report will be prepared. The report
ordinarily will include the name and title of the committee
members and experts, if any; the allegations; the PHS
support; a summary of the inquiry process used; a list of the
research records and evidence reviewed; summaries of any
interviews; and the committee's determination as to whether
an investigation is recommended and whether any other actions
should be taken if an investigation is not recommended. The
University Attorney's office will review the report for legal
sufficiency.
- B. Comments on the Report by the Respondent and the
Complainant
-
The Research Integrity Officer will provide the respondent
with a copy of the inquiry report for comment and rebuttal.
The Research Integrity Officer may provide the complainant,
if he or she is identifiable, with a summary of the inquiry
findings that addresses the complainant's role and opinions
in the investigation.
- Confidentiality - The Research Integrity Officer may
establish reasonable conditions for review to protect the
confidentiality of the report.
- Receipt of Comments - Within 14 calendar days of
receipt of the report or summary, the respondent (and
complainant, if applicable) will provide their comments,
if any, to the inquiry committee. Any comments that the
complainant or respondent submits on the report may
become part of the final inquiry report and record. Based
on the comments, the inquiry committee may revise the
report9
as appropriate.
- C. Inquiry Decision and Notification
-
- Decision by Deciding Official - The Research
Integrity Officer will transmit the final report and any
comments to the Deciding Official, who will make the
determination of whether findings from the inquiry
provide sufficient evidence of possible scientific
misconduct to justify conducting an investigation. The
inquiry is completed when the Deciding Official makes
this determination. The determination is ordinarily made
within 60 days of the first meeting of the inquiry
committee, unless circumstances warrant a longer period.
The reasons for exceeding the 60-day period shall be
documented in the inquiry record.
- Notification - The Research Integrity Officer will
ordinarily notify both the respondent and the complainant
in writing of the Deciding Official's decision of whether
to proceed to an investigation and will remind them of
their obligation to cooperate in the event an
investigation is opened. The Research Integrity Officer
will also notify all appropriate University officials of
the Deciding Official's decision.
- D. Time Limit for Completing the Inquiry Report
- The inquiry committee will normally complete the inquiry
and submit its report in writing to the Research Integrity
Officer no more than 60 calendar days following its first
meeting,10 unless the Research Integrity Officer approves
an extension because circumstances warrant a longer period.
If the Research Integrity Officer approves an extension, the
reason for the extension will be entered into the
records.11 The respondent also may be notified of the
extension.
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VII. Conducting the
Investigation
- 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 misconduct has been committed,
by whom, and to what extent. The investigation will also
determine whether there are additional instances of possible
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 general 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 will immediately sequester
any additional pertinent research records that were not
previously sequestered during the inquiry. 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,
including the University's decision to investigate additional
allegations not considered during the inquiry stage or the
identification of records during the inquiry process that had
not been previously secured. The procedures to be followed
for sequestration during the investigation are the same
procedures that apply during the inquiry.
- C. Appointment of the Investigation Committee
-
The Research Integrity Officer, in consultation with other
University officials as appropriate, will appoint an
investigation committee and the committee chair as
practicable after the respondent has been notified that an
investigation is planned. The investigation committee
should consist of at least three individuals who do not
have real or apparent conflicts of interest in the case,
are unbiased, and have the necessary expertise to evaluate
the evidence and issues related to the allegations,
interview the principals and key witnesses, and conduct the
investigation.12 These individuals may be scientists,
administrators, subject matter experts, lawyers, or other
qualified persons, and they may be from inside or outside
the University. Individuals appointed to the investigation
committee may also have served on the inquiry committee.
The Research Integrity Officer will notify the
respondent of the proposed committee membership. If the
respondent submits a written objection to any appointed
member of the investigation committee or expert, the
Research Integrity Officer will determine whether to
replace the challenged member or expert with a qualified
substitute.
- D. Charge to the Committee and the First Meeting
-
- Charge to the Committee - The Research Integrity
Officer will define the subject matter of the
investigation in a written charge to the committee that
describes the allegations and related issues identified
during the inquiry, defines scientific misconduct, and
identifies the name of the respondent. The charge will
state that the committee is to evaluate the evidence and
testimony of the respondent, complainant, and key
witnesses to determine whether, based on a preponderance
of the evidence, scientific misconduct occurred and, if
so, to what extent, who was responsible, and its
seriousness.
During the investigation, if additional information
becomes available that substantially changes the
subject matter of the investigation or would suggest
additional respondents, the committee will notify the
Research Integrity Officer, who will determine whether
it is necessary to notify the respondent of the new
subject matter or to provide notice to additional
respondents.
- The First Meeting - The Research Integrity Officer,
with the University Attorney's office, will convene the
first meeting of the investigation committee to review
the charge, the inquiry report, and the prescribed
procedures and standards for the conduct of the
investigation, including the necessity for
confidentiality and for developing a specific
investigation plan. The investigation committee will be
provided with a copy of these instructions and, where PHS
funding is involved, the PHS regulation.
- E. Investigation Process
-
The investigation committee will be appointed and the
process initiated within 30 days of the completion of the
inquiry, if findings from that inquiry provide a sufficient
basis for conducting an investigation.13
The investigation will normally involve examination of
all documentation including, but not necessarily limited
to, relevant research records, computer files, proposals,
manuscripts, publications, correspondence, memoranda, and
notes of telephone calls.14 Whenever possible, the committee
should interview the complainant(s), the respondents(s),
and other individuals who might have information regarding
aspects of the allegations.15 Summaries or transcripts of the
interviews should be prepared, provided to the interviewed
party for comment or revision, and included as part of the
investigatory file.16
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VIII. The
Investigation Report
- A. Elements of the Investigation Report
- The final report submitted to ORI must describe 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. The report will 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 sanctions imposed and administrative
actions taken by the institution.17
- B. Comments on the Draft Report
-
- Respondent - The Research Integrity Officer will
provide the respondent with a copy of the draft
investigation report for comment and rebuttal. The
respondent will be allowed 10 days to review and comment
on the draft report. The respondent's comments will be
attached to the final report. The findings of the final
report may take into account the respondent's comments in
addition to all the other evidence.
- Complainant - The Research Integrity Officer will
provide the complainant, if he or she is identifiable,
with those portions of the draft investigation report
that address the complainant's role and opinions in the
investigation. The report may be modified, as
appropriate, based on the complainant's comments.
- Review by University Attorney's Office - The draft
investigation report will be transmitted to the
University Attorney's office for a review of its legal
sufficiency. Comments should be incorporated into the
report as appropriate.
- Confidentiality - In distributing the draft report,
or portions thereof, to the respondent and complainant,
the Research Integrity Officer will inform the recipient
of the confidentiality under which the draft report is
made available and may establish reasonable conditions to
ensure such confidentiality. For example, the Research
Integrity Officer may request the recipient to sign a
confidentiality statement or to come to his or her office
to review the report.
- C. University Review and Decision
-
Based on a preponderance of the evidence, the Deciding
Official will make the final determination whether to
accept the investigation report, its findings, and the
recommended University actions. If this determination
varies from that of the investigation committee, the
Deciding Official will explain in detail the basis for
rendering a decision different from that of the
investigation committee in the institution's letter
transmitting the report to ORI. The Deciding Official's
explanation should be consistent with the PHS definition of
scientific misconduct, the University's policies and
procedures, and the evidence reviewed and analyzed by the
investigation committee. The Deciding Official may also
return the report to the investigation committee with a
request for further fact-finding or analysis. The Deciding
Official's determination, together with the investigation
committee's report, constitutes the final investigation
report for purposes of ORI review.
When a final decision on the case has been reached, the
Research Integrity Officer will notify both the respondent
and the complainant in writing of the decision. In
addition, the Deciding Official will determine whether law
enforcement agencies, professional societies, professional
licensing boards, editors of journals in which falsified
reports may have been published, collaborators of the
respondent in the work, or other relevant parties should be
notified of the outcome of the case. The Research Integrity
Officer is responsible for ensuring compliance with all
notification requirements of funding or sponsoring
agencies.
- D. Transmittal of the Final Investigation Report
- After comments have been received and the necessary
changes have been made to the draft report, the investigation
committee should transmit the final report with attachments,
including the respondent's and complainant's comments, to the
Deciding Official, through the Research Integrity
Officer.
- E. Time Limit for Completing the Investigation
Report
- An investigation should ordinarily be completed within
120 days of its initiation,18 with the initiation ordinarily
beginning with the first meeting of the investigation
committee. This includes conducting the investigation,
preparing the report of findings, making the draft report
available to the subject of the investigation for comment,
submitting the report to the Deciding Official for approval,
and submitting the report to the ORI.19 If the University will not
be able to complete the investigation in 120 days, it will
submit to ORI a written request for an extension and an
explanation for the need for an extension. (See IX.C)
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IX. Requirements for
Reporting to ORI
- A.
- The University's decision to initiate an investigation
will be reported in writing to the Director, ORI, on or
before the date the investigation begins. (Only actions
involving respondents who receive funding from PHS will be
reported to ORI.)20 At a minimum, the notification should include
the name of the person(s) against whom the allegations have
been made, the general nature of the allegation as it relates
to the PHS definition of scientific misconduct, and the PHS
applications or grant number(s) involved.21 ORI must also be
notified of the final outcome of the investigation and must
be provided with a copy of the investigation report.22 Any
significant variations from the provisions of the University
policies and procedures should be explained in any reports
submitted to ORI.
- B.
- If the University plans to terminate an inquiry or
investigation for any reason without completing all relevant
requirements of the PHS regulation, the Research Integrity
Officer will submit a report of the planned termination to
ORI, including a description of the reasons for the proposed
termination.23
- C.
- If the University determines that it will not be able to
complete the investigation in 120 days, the Research
Integrity Officer will submit to ORI a written request for an
extension that explains the delay, reports on the progress to
date, estimates the date of completion of the report, and
describes other necessary steps to be taken. If the request
is granted, the Research Integrity Officer will file periodic
progress reports as requested by the ORI.24
- D.
- When the case involves PHS funds, the University cannot
accept an admission of scientific misconduct as a basis for
closing a case or not undertaking an investigation without
prior approval from ORI.25
- E.
-
The Research Integrity Officer will notify ORI at any stage
of the inquiry or investigation if:
- there is an immediate health hazard
involved;26
- there is an immediate need to protect Federal funds
or equipment;27
- there is an immediate need to protect the interests
of the person(s) making the allegations or of the
individual(s) who is the subject of the allegations as
well as his/her co-investigators and associates, if
any,28
- it is probable that the alleged incident is going to
be reported publicly; or29
- the allegation involves a public health sensitive
issue, e.g., a clinical trial; or
- there is a reasonable indication of possible criminal
violation. In this instance, the institution must inform
ORI within 24 hours of obtaining that
information.30
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X. Institutional
Administrative Actions
Case Western Reserve University will take appropriate
administrative actions against individuals when an allegation
of misconduct has been substantiated.31
If the Deciding Official determines that the alleged
misconduct is substantiated by the findings, he or she will
decide on the appropriate actions to be taken, after
consultation with the Research Integrity Officer. The actions
may include:
- withdrawal or correction of all pending or published
abstracts and papers emanating from the research where
scientific misconduct was found.
- removal of the responsible person from the particular
project, letter of reprimand, special monitoring of future
work, probation, suspension, salary reduction, or initiation
of steps leading to possible rank reduction or termination of
employment;
- restitution of funds as appropriate.
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XI. Other
Considerations
- A. Termination of University Employment or Resignation
Prior to Completing Inquiry or Investigation
-
The termination of the respondent's employment with the
University, by resignation or otherwise, before or after an
allegation of possible scientific misconduct has been
reported, ordinarily will not preclude or terminate the
misconduct procedures.
If the respondent, without admitting to the misconduct,
elects to resign his or her position prior to the
initiation of an inquiry, but after an allegation has been
reported, or during an inquiry or investigation, the
inquiry or investigation ordinarily will proceed. If the
respondent refuses to participate in the process after
resignation, the committee will use its best efforts to
reach a conclusion concerning the allegations, noting in
its report the respondent's failure to cooperate and its
effect on the committee's review of all the evidence.
- B. Restoration of the Respondent's Reputation
- If the University finds no misconduct or that the
allegation of misconduct cannot be substantiated and ORI
concurs, after consulting with the respondent, the Research
Integrity Officer will undertake reasonable efforts to
restore the respondent's reputation. Depending on the
particular circumstances, the Research Integrity Officer
should consider notifying those individuals aware of or
involved in the investigation of the final outcome,
publicizing the final outcome in forums in which the
allegation of scientific misconduct was previously
publicized, or expunging all reference to the scientific
misconduct allegation from the respondent's personnel
file.
- C. Protection of the Complainant and Others32
- Regardless of whether the University or ORI determines
that scientific misconduct occurred, the Research Integrity
Officer will undertake reasonable efforts to protect
complainants who made allegations of scientific misconduct in
good faith and others who cooperate in good faith with
inquiries and investigations of such allegations. Upon
completion of an investigation, the Research Integrity
Officer will determine, after consulting with the
complainant, what steps, if any, are needed to protect or
restore the position or reputation of the complainant. The
Research Integrity Officer will also take appropriate steps
during the inquiry and investigation to prevent any
retaliation against the complainant.
- D. Allegations Not Made in Good Faith
- If relevant, the Research Integrity Officer will
determine whether the complainant's allegations of scientific
misconduct were made in good faith. If an allegation was not
made in good faith, the Research Integrity Officer will
determine whether any administrative action should be taken
against the complainant.
- E. Interim Administrative Actions
- University officials will take interim administrative
actions, as appropriate, to protect Federal funds and ensure
that the purposes of the Federal financial assistance are
carried out.33
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XII. Record
Retention
After completion of a case and all ensuing related actions,
the Research Integrity Officer will prepare a complete file,
including the records of any inquiry or investigation and
copies of all documents and other materials furnished to the
Research Integrity Officer or committees. The Research
Integrity Officer will keep the file for at least three years
after completion of the case to permit later assessment of the
case. ORI or other authorized DHHS personnel will be given
access to the records upon request.34
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Cite this page:
"Case Western Reserve University's Policy for Responding to Allegations of Scientific Misconduct"
Online Ethics Center for Engineering
2/16/2006
National Academy of Engineering
Accessed: Thursday, February 09, 2012
<www.onlineethics.org/Topics/RespResearch/ResEssays/5664/prasm.aspx>