Policies and Procedures Manual
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Subject of Policy Statement |
Effective Date |
Policy No. |
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Misconduct in Research |
Rev: 03/06/07 |
0-301 |
I. INTRODUCTION
A.
Statement of Purpose
The purpose of research within the
Creating and preserving an environment in
which activities that interfere with an honest search for truth are not
tolerated is the shared responsibility of every member of the University
community. Each member must be dedicated
to maintaining the highest standards in the conduct of research. It is the responsibility of each researcher to
become informed of the ethical principles in effect in the research community and
to behave in accord with them. The Guidelines for the Responsible Conduct of Research, authored by the USF Research Council and available
on the Office of Research Web site (www.research.usf.edu) describe a
standard of practice for the ethical conduct of all research at the University.
Misconduct in scholarly research cannot be prevented by University
regulation, University policy, or law, but only by each individual's firm
commitment to academic ideals and integrity. Mentors, project directors, and department and
unit heads must impress the importance of such a commitment upon faculty,
students, staff, research assistants, and collaborators.
The
University recognizes that researchers and scholars typically are highly
principled. Misconduct in research is an infrequent occurrence, but, when it
does occur, it has the potential to impugn the integrity of the University and
the individual researcher and to jeopardize access to external funding for
research. Federal agencies require that
institutions engaged in federally sponsored research implement formal policies
and procedures for handling allegations of misconduct and advise members of the
research community of their responsibility to maintain the highest standards of
academic integrity.
The procedures set forth herein are
consistent with Federal regulation 42 CFR Part 93 and are to be followed
in cases of allegations of Research Misconduct at the University. Their purpose is to protect the safety,
welfare, and rights of the University's faculty, staff, and students, and the
integrity of the University itself, so that public confidence in the University's
research activities is assured. They
provide a guide for investigating allegations of Research Misconduct and for reporting results to federal agencies and Research Sponsors
that is prompt, impartial, and confidential. These procedures describe protections from
malicious or unsupported claims, but do not create any substantive
or procedural rights or benefits enforceable as law by a party against the University,
its agencies, officers, or employees.
B. Scope
This policy
applies to any person paid by, under the control of, or affiliated with the
University (such as, but not limited to, scientists, trainees, technicians and
other staff members, students, fellows, guest researchers, or collaborators)
who are engaged in research conducted at or by the University, regardless of
the funding source.
These procedures
will normally be followed when an allegation of Research Misconduct is received
by a University official. Particular
circumstances in an individual case may dictate variation from the normal
procedure when deemed in the best interests of the University. However, any change from normal procedures
must ensure fair treatment to the subject of the Inquiry or Investigation. Any significant variation should be approved
in advance by the Vice President for Research and, if applicable, the highest
ranking research administrator at the campus where the alleged Research
Misconduct occurred, and must comply with 42 CFR Part 93, if the underlying research is
supported by Public
Health Service (PHS) funds. Justification for
the departure from this process must be documented in the Research Misconduct
case file.
II. DEFINITIONS
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A. “Allegation” means any written or oral statement or other indication
of possible Research Misconduct made to a University official. |
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B. “Complainant” means a person (or persons) making an allegation of
Research Misconduct |
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C.
“Fabrication” is making up data
or results and recording or reporting them. |
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D. “Falsification” is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the research
method or result is not accurately represented in the research record. |
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E. “Inquiry”
means information-gathering and initial fact-finding to determine whether an
allegation or apparent instance of Research Misconduct warrants an
Investigation. |
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F. “Investigation” means the formal
examination and evaluation of all relevant facts by an Investigation Panel to
determine if Research Misconduct has occurred and, if so, to determine the
responsible person and the seriousness of the misconduct. |
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G. “Plagiarism” is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit. Plagiarism
does not encompass disagreements over order of authorship, rights to publish,
or the use of ideas among collaborators. |
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H. “Preponderance
of the Evidence” means the reviewer
believes it more likely than not that, based on the information presented to
the reviewer, the allegation is true.
If the information presented on a particular issue is, in the opinion
of the reviewer, equally balanced, that issue does not represent a
preponderance of the evidence. |
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J. “Research,” as used herein, includes all basic, applied, and
demonstration research in all fields in which research is conducted,
including, but not limited to, science, medicine, education, engineering,
mathematics, statistics, and humanities.
This includes research involving human subjects or animals. |
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K. “Research
Misconduct” means fabrication,
falsification, or plagiarism in proposing, performing, or reviewing research,
or in reporting research results.
Research Misconduct does not include honest error or differences of
opinion. In any Inquiry or
Investigation that involves research sponsored by a federal agency that uses
a definition of Research Misconduct that is different from the one in this
Section II.K., the University will be obligated to use that agency’s
definition for purposes of the University’s responsibilities to that agency,
as directed by the Research Integrity Officer. |
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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 information regarding the proposed,
conducted, or reported research that constitutes the subject of an allegation
of Research 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. |
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M. “Research Sponsor” means the agency, institution, or organization, if any,
that sponsored the research that is at issue in an Inquiry or Investigation. |
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N. “Respondent” means a person (or persons) accused of Research
Misconduct. |
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O. “Retaliation” means
an adverse action taken against a Complainant, witness, or committee member
by this University or one of its University officials in response to (1) a
good faith allegation of Research Misconduct, or (2) good faith cooperation
with a Research Misconduct proceeding. |
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P. “Standing Committee for Research
Misconduct” means the faculty committee,
whose membership is endorsed by the USF Faculty Senate Committee on
Committees and appointed by the Vice President for Research, that oversees
the Investigation portion of the Research Misconduct process. The duties of the Standing Committee
include appointing the Investigation Panel; orienting the Investigation Panel
to the Investigation process; delivering the charge to the Investigation
Panel to investigate the allegations; reviewing the Investigation Panel’s
work; accepting (or rejecting) the Investigation Panel Report; requesting
follow-up from the Investigation Panel; convening a new Investigation Panel,
when necessary; summarizing and commenting on the Investigation Panels’
findings and procedures in a separate report; and communicating all findings
and recommendations to the Vice President for Research. |
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Q. “Sufficient” means that there is some substance to the allegation. The use of this term is intended to separate serious allegations deserving
further evaluation through this process from frivolous, unjustified, or
clearly mistaken allegations. |
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R. “Unacceptable Research Practices” means practices that do not constitute Research
Misconduct, but do violate applicable laws, regulations, or other
governmental requirements or University regulations and policies, of which
the Respondent has received notice or of which the Respondent reasonably
should have been aware. |
III. RIGHTS
AND RESPONSIBILITIES
A. Complainant
The Complainant
will have an opportunity to be interviewed by and present information to the
individual or committee conducting the Inquiry and the Investigation Panel, to
review portions of the Inquiry and Investigation Reports pertinent to his or her
allegations or statements, and to be informed of the initiation and results of
the Inquiry and Investigation.
The Complainant is responsible for making allegations in “good
faith,” maintaining confidentiality, and cooperating with an Inquiry or Investigation. A “good faith”
allegation means that the Complainant made the allegation with a belief in the
truth of the allegation (which a reasonable person in the Complainant’s
position would have done) based upon the information known to the Complainant at
the time the allegation was made. Good
faith encompasses, among other things, an honest belief, the absence of malice
and the absence of design to defraud or to seek an unconscionable advantage. The University prohibits retaliation against
a Complainant who has made an allegation of Research Misconduct in good
faith.
A
Complainant who makes an allegation in “bad faith” may be vulnerable to individually
pursued legal claims by the Respondent, as well as subject to disciplinary or
other sanctions as provided by this policy.
A bad faith allegation means that the Complainant has made an allegation
that is known to be false, or the Complainant is reckless as to the truth of
the allegation, as in where the allegation is so completely unsupported by any detectible
amount of credible information such as to be considered frivolous in nature. Bad faith encompasses, among other things,
malicious intent and a lack of respect for the confidentiality of the proceedings,
such as where disclosure is made to a person or persons not reasonably believed
to be necessary to the resolution of the allegation. A Complainant who brings an allegation later
determined to be in bad faith will not be entitled to anonymity to the extent
provided by this policy and will not enjoy “whistleblower” status for purpose
of the protections afforded by law for persons who bring allegations in good
faith.
Once a Complainant has made a formal allegation of Research
Misconduct, the Complainant must be treated as any other witness in the
proceeding. The Complainant is not a
"party," does not control or direct the process, does not act as a
decision maker, and does not have unqualified access to the available documents
or research records.
B. Respondent
The Respondent will be informed of the allegations when an Inquiry
is opened and notified in writing of the final determination and resulting
action. The Respondent will also have
the opportunity to be interviewed by and present information to the individual
or committee conducting the Inquiry and/or Investigation Panel, to review the
draft Inquiry and Investigation Reports, and to
be accompanied by a lawyer or any other person when appearing at a meeting of
the Investigation Panel. The role of
such lawyer or other person is as an advisor only, and the advisor may speak to
and consult with the Respondent, but may not serve as an advocate or question
witnesses, Inquiry Committee members, or Investigation Panel members, or
otherwise participate in the proceedings. If the Respondent wishes to have a lawyer
present, he or she shall give the Investigation Panel advance notice in
writing. If the Respondent chooses to have a lawyer as personal
advisor, the Respondent shall bear the burden of any associated expense.
If the Respondent does not wish to have a lawyer or
advisor, it is important to note that the Research Integrity Officer is a
trained administrator who is available to guide the Respondent through the Inquiry
and Investigation processes, answer questions about this policy, and to ensure
that the Respondent is aware of his or her rights.
The Respondent is responsible for maintaining
confidentiality and cooperating with the conduct of an Inquiry or Investigation. If the Respondent is not found guilty of Research
Misconduct, the University may assist the Respondent in mitigating any actual
or perceived damage to the Respondent’s reputation in the research community,
depending on the circumstances.
C. Research Integrity
Officer
The Research Integrity Officer has responsibility for implementing
institutional policies and procedures governing Research Misconduct
allegations. The Research Integrity
Officer will be a University administrator who is well qualified to handle the
procedural requirements involved and who is sensitive to the varied demands
made on those who conduct research, those who are accused of Research
Misconduct and those who report apparent Research Misconduct in good faith.
The Research Integrity Officer will assist the Vice
President for Research, the individual conducting the initial Inquiry, the
Standing Committee for Research Misconduct, the Investigation Panel, the Complainant,
the Respondent, and any other individuals or University personnel involved in
the Research Misconduct process, in complying with this policy, the procedures,
and the applicable standards imposed by government or external Research Sponsors. The Research Integrity Officer will organize
and manage the Inquiry and Investigation processes and will attempt to ensure
that confidentiality is maintained to the extent permissible by law during and
after the Inquiry and Investigation process.
The Research Integrity Officer is also responsible for maintaining files
of all documents and research records and for the confidentiality and the
security of the files.
If
allegations involve research that is funded by the Public Health Service (PHS),
the Research Integrity Officer will inform the Vice President for Research and assist
with required notifications to the Office of Research Integrity, as required by
PHS Regulation 42 CFR Part 93. The
Research Integrity Officer will also inform the Vice President for Research
about required notification to Research Sponsors upon substantiation of an
allegation of Research Misconduct pursuant to this policy, or at any other
point in the Investigation process, if the Vice President for Research determines
that the Research Sponsor needs to know in order to ensure the appropriate use
of federal funds and to otherwise protect the public interest.
D. Standing Committee for Research Misconduct
The Standing Committee for Research Misconduct is appointed
by the Vice President for Research and is comprised of six faculty members from different colleges or areas within
the University. The members of the Standing
Committee serve for staggered terms, with two of the members appointed for one
year, two for two years, and two for three years. Membership terms are renewable. The Vice President for Research designates the
Chair of the Committee.
The
Standing Committee is responsible for appointing the Investigation Panel when
an Inquiry proceeds to an Investigation, for charging the Investigation Panel
with investigating the allegation(s), and for reviewing the Investigation Panel’s
report. The Investigation Panel will
include a specialist in the Respondent’s area of specialization and a faculty
representative from the Respondent’s campus.
The Standing Committee hears the Respondent’s response to the Investigation
Panel’s Report and is responsible for accepting or rejecting findings. The Standing Committee may remand the case to
the original Investigation Panel with instructions for further consideration or
investigation, or may appoint new Investigation Panel members for a de novo review.
The Standing Committee issues
its own Report summarizing the review of the Investigation Panel Report,
describing how and from whom relevant information was obtained, the findings, and
an accurate summary of the views of the Respondent; recommendations for corrective
or disciplinary action may be included, but are not binding. The Standing Committee Report is transmitted by
the Standing Committee Chair to the Vice President for Research for review and referral
to the Provost, appropriate Vice President, or other appropriate University
official(s) for review and action.
E. Vice President for Research
The Vice President for Research
is the Authorized Institutional Official recognized by Research Sponsors and
registered with the Public Health Service as the USF individual responsible for
reporting matters of Research Misconduct to Research Sponsors and oversight agencies,
such as the federal Office of Research Integrity. The Vice President for Research may take
interim administrative actions, as appropriate, to protect federal funds and to
ensure that the purposes of the federal financial assistance are carried out.
The Vice President for Research serves as an advisor and
facilitator in the Research Misconduct process, but is not responsible for
determining if facts found during the course of the Inquiry or Investigation
constitute Research Misconduct or for determining what, if any, disciplinary
action may be taken.
The Vice President for Research, in consultation with the
Research Integrity Officer and other appropriate persons, including the highest ranking research administrator at the regional
campus if the allegation of Research Misconduct takes place at a regional
campus, determines
who will conduct the initial Inquiry; charges that person with the Inquiry; receives
the Inquiry Report; and at the close of the Inquiry process, if deemed
necessary, charges the Standing Committee with overseeing the Investigation;
receives and reviews the Standing Committee’s Investigation Report to make
certain that proper procedure has been followed; forwards the Inquiry Report
and/or Investigation Report to the Provost, appropriate Vice President, or
other appropriate University official(s); and recommends administrative sanctions
or actions relating to the research activities of the Respondent or other
University employee(s) as a result of the Investigation.
The Vice President for Research consults with the Research
Integrity Officer on matters of procedure and with other individuals familiar
with the practices and standards in the relevant field of the research on
matters concerning the substance of the Inquiry or Investigation.
IV. GENERAL
POLICIES AND PRINCIPLES
A. Responsibility to Report Misconduct
Any person suspecting or observing apparent Research
Misconduct should report such to the USF Research Integrity Officer or to the
administrator responsible for research programs within the college, school or
unit where the Respondent is employed/appointed/affiliated. Any administrator who receives a report of
possible Research Misconduct is responsible for forwarding such report to the
Research Integrity Officer, USF Division of Research Integrity & Compliance,
Office of the Vice President for Research.
At any time, an employee may discuss concerns of possible
misconduct with the Research Integrity Officer and will be counseled about
appropriate procedures for reporting allegations. If an individual is unsure whether a suspected
incident falls within the definition of Research Misconduct, he or she may contact
the Research Integrity Officer to discuss the suspected misconduct
informally. If the circumstances
described by the individual do not meet the definition of Research Misconduct,
the Research Integrity Officer will refer the individual or allegation to the
Office of University Audit and Compliance, the
office responsible for identifying the nature of the allegation and referring
the matter in whole or in part to other offices or officials to assess and
address the allegation. However, once an allegation of Research
Misconduct is reported, even anonymously, the University has a responsibility
to evaluate the merits of the allegation.
Therefore, if the circumstances described meet the definition of Research
Misconduct, the Research Integrity Officer will be obligated to follow-up, based
on the information provided, and to request an Inquiry into the matter, with or
without the cooperation of the individual reporting the alleged Research
Misconduct.
B.
Protecting the Complainant
Regardless of whether the University, through the
application of the process set forth in this policy, or the Research Sponsor
determines that Research Misconduct occurred, the Research Integrity Officer
will undertake reasonable steps to protect individuals who make allegations of Research
Misconduct in good faith (honestly and without intent to defraud, seek a
competitive or other unfair advantage, and without deception or malicious
intent) and others who cooperate with Inquiries and Investigations of such
allegations, including monitoring the treatment of such individuals throughout
the process. At a minimum, the Research
Integrity Officer will ensure that these persons will not be retaliated against
in the terms and conditions of their employment or other status at the University
and will refer any instances of alleged retaliation to the appropriate University
official for evaluation and action.
Employees should immediately report any alleged or apparent
retaliation to their immediate or next-level supervisor, if feasible, or to the
Office of University Audit and Compliance (see USF Policy 0-020 Retaliation,
Retribution, or Reprisals Prohibited).
The University will also protect the privacy of those who
report misconduct in good faith to the extent possible without compromising the
investigation. For example, if the Complainant
requests anonymity, the University will make an effort to honor the request
during the allegation assessment or Inquiry within applicable policies and
regulations and state and local laws. However,
anonymity may not always be able to be preserved. The Complainant will be advised that, if the
matter is referred to the Investigation stage of the process and the Complainant’s
statement is required, anonymity may no longer be guaranteed. If it is determined that an allegation has
been brought in bad faith, anonymity will not be preserved.
Upon completion of an Investigation, the University may
consult with the Complainant to determine what steps, if any, are needed to
restore the Complainant’s position or reputation. Any institutional actions to restore the Complainant’s
reputation must be approved by the appropriate University officials.
C.
Protecting the Respondent
Inquiries and Investigations will be conducted in a manner that
will ensure fair treatment of the Respondent in the Inquiry and/or Investigation.
Participants will treat the Respondent
with respect and will protect the Respondent’s confidentiality to the extent
possible without compromising public health and safety or the thoroughness of
the Inquiry or Investigation. The
University will not comment publicly on an Inquiry or Investigation in
progress. Any deviation from these
procedures or breaches of confidentiality should be reported to the Research
Integrity Officer immediately.
Individuals accused of Research Misconduct may consult with
legal counsel or a non-lawyer personal advisor (who is not a principal or
witness in the case) to seek advice and may bring the counsel or personal advisor
to interviews or meetings on the case. If
the Respondent does not wish to have a lawyer or personal advisor, it is
important to note that the Research Integrity Officer is a trained
administrator who is available to guide the Respondent through the Inquiry and Investigation
processes, to answer questions about this policy, and to ensure that the
Respondent is aware of his or her rights.
If the allegation is not substantiated, the University may consult
with the Respondent to identify reasonable steps that may be taken to restore
the Respondent's reputation. Depending
on the particular circumstances, reasonable steps may include 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 Research
Misconduct was previously publicized, or giving extra publicity to the
Respondent’s research. Any University actions
to restore the Respondent's reputation must be approved by the appropriate
University officials, including, if applicable,
the highest ranking research administrator at the regional campus.
In the event that a determination of questionable or unacceptable research
practices or other misconduct has been found that does not meet the definition of
Research Misconduct, the University shall consider the circumstances in
determining whether any University action to restore the Respondent’s
reputation would be advisable.
This process is designed to provide protection against
false claims by including an initial Inquiry process to ensure that the information
presented to indicate Research Misconduct is substantial prior to proceeding
with an Investigation. Further,
Complainants who make allegations in bad faith will be subject to disciplinary
action and other sanctions.
D.
Cooperation with Inquiries and
Investigations
Employees are required, as a condition of employment, to
cooperate with the processes and procedures of the University, including the Research
Misconduct process. Therefore, employees have an obligation to cooperate with and
provide relevant information to the Research Integrity Officer and other
institutional officials in the review of allegations and the conduct of
inquiries and investigations. Employees also have an obligation to cooperate
with Research Sponsors and federal or state agencies in the conduct of Inquiries
and Investigations, the oversight of the Research Misconduct process, and any
follow-up actions. All other individuals
who are affiliated with the University, including students, fellows, guest researchers,
and others, are expected to cooperate with these processes and procedures as a
condition of their affiliation and as a professional responsibility associated
with the privilege of conducting research at the University.
E.
Integrity of Proceedings
In
responding to allegations of Research Misconduct, the Research Integrity
Officer and any other University official with an assigned responsibility for
handling such allegations will make diligent efforts to ensure that the
following functions are performed.
1.
Any allegation
assessment, Inquiry, or Investigation is conducted in a timely, objective,
thorough, and competent manner.
2.Reasonable precautions are taken to avoid bias and real or
apparent conflicts of interest on the part of those involved in conducting the Inquiry
or Investigation.