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UNIVERSITY OF
SOUTH FLORIDA SYSTEM POLICY |
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Number |
Subject of Policy
Statement |
Date of |
Last Amended Date |
Last |
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0-301 |
Misconduct in Research |
12-6-89 |
1-29-09 |
1-29-09 |
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I. INTRODUCTION
A.
Statement of Purpose
The
purpose of research within the University of South Florida system (USF system)
is to create and disseminate, in the appropriate forum, knowledge from all
disciplines represented within the USF system and to foster an active learning
environment for students. Society expects academic research to reflect an honest attempt to
describe research results accurately and without bias. Validity and accuracy in the proposing,
collecting, and reporting of data are essential to the scientific process. Dishonesty in these endeavors is contrary to
the very nature of research, that is, the pursuit of truth.
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 USF system 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 & Innovation web site
(www.research.usf.edu) describe a standard of practice for the ethical
conduct of all research in the USF system.
Misconduct in scholarly research cannot be prevented by
regulation, policy, or law, but rather 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 USF system 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 USF system 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 in the USF system. Their
purpose is to protect the safety, welfare, and rights of the USF system’s faculty, staff, and students, and the integrity of
the USF system itself, so that public confidence
in the USF system'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 USF
system, its agencies, officers, or employees.
B. Scope
This USF system policy
applies to any person paid by, under the control of, or affiliated with the USF system (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 in the USF system, regardless of the funding source.
These procedures will normally be followed when an
allegation of Research Misconduct is received by a USF
system official. Particular
circumstances in an individual case may dictate variation from the normal
procedure when deemed in the best interests of the USF
system. 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 &
Innovation and, if applicable, the highest ranking research administrator at
the respective regional campus or separately
accredited institution where the alleged Research Misconduct occurred,
and must comply with 42 CFR Part 93, if
the underlying research is supported by U.S. 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 USF
system 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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I. “Questionable
Research Practices” means practices that do not
constitute Research Misconduct or unacceptable research practices, but that
require attention because they could erode confidence in the integrity of
research conducted within the USF system. |
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J. “Research,” as used herein, includes all basic, applied, and
demonstration research in all fields 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
USF system will be obligated to use that agency’s definition for purposes of
the USF system’s responsibilities to that agency, as directed by the USF system
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 USF system or one of its USF system 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 & Innovation 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 & Innovation. |
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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 USF system 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 USF system 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 or 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 USF system 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 USF system 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 USF system Research Integrity Officer has responsibility
for implementing institutional policies and procedures governing Research
Misconduct allegations. The Research
Integrity Officer is a USF system 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 & Innovation, the individual conducting the initial
Inquiry, the Standing Committee for Research Misconduct, the Investigation
Panel, the Complainant, the Respondent, and any other individuals or USF system
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 U.S. PHS,
the Research Integrity Officer will inform the Vice President for Research
& Innovation 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 & Innovation 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 & Innovation 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 a USF system
committee that is appointed by the Vice President for Research & Innovation
and is comprised of six faculty members from different colleges or areas within
the USF system. The members of the
Standing Committee serve staggered three-year terms. Membership terms are renewable. The Vice President for Research &
Innovation 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 if the alleged Research Misconduct
took place at a regional campus or separately accredited institution, a
faculty representative from the Respondent’s regional
campus or separately accredited institution. The Standing Committee will hear 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 & Innovation for review and referral to the
Provost, appropriate Vice President, or other appropriate USF system
official(s) for review and action.
E. Vice President for Research & Innovation
The Vice President for Research & Innovation is the
Authorized Institutional Official recognized by Research Sponsors and registered
with the U.S. PHS as the USF system 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 &
Innovation 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 & Innovation 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 & Innovation, in
consultation with the Research Integrity Officer and other appropriate persons,
including the highest ranking research administrator at the respective regional
campus or separately accredited institution if
the allegation of Research Misconduct takes place at a regional campus or separately accredited institution, 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 USF system official(s); and recommends administrative
sanctions or actions relating to the research activities of the Respondent or
other USF system employee(s) as a result of the Investigation.
The Vice President for Research & Innovation 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 system 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, Division of Research Integrity & Compliance,
Office of the Vice President for Research & Innovation.
At any time, an individual 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 USF system Office of 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 USF system
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 USF system, through the
application of the process set forth in this policy, or the Research Sponsor
determine 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 in the USF
system and will refer any instances of alleged retaliation to the appropriate USF
system 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
USF system Office of Audit and Compliance (see USF Policy 0-020 Retaliation,
Retribution, or Reprisals Prohibited).
The USF system 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, an effort will be made 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 appropriate USF
system officials 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 USF system 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 USF
system 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 USF system 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 USF
system actions to restore the Respondent's reputation must be approved by the
appropriate USF system officials, including, if applicable, the highest ranking
research administrator at the respective regional campus or separately accredited institution. 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 USF system shall
consider the circumstances in determining whether any 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 USF system, including the
Research Misconduct process. Therefore, employees have an obligation to
cooperate with and provide relevant information to the Research Integrity
Officer and other USF system 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 USF system, 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 in the USF system.
E.
Integrity of Proceedings
In responding to allegations of Research Misconduct, the
Research Integrity Officer and any other USF system 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.
3.
Interim administrative actions are taken, as appropriate, to protect federal
funds and the public health, and to ensure that the purposes of the federal
financial assistance are carried out.
F.
Notifying the Federal Office of Research Integrity (ORI)
The Vice President for Research & Innovation is
registered with and recognized by the U.S. PHS as the Institutional Official
for matters of Research Misconduct. As
such, the Vice President for Research & Innovation is the only individual in
the USF system authorized to submit official reports to ORI. If an allegation of Research Misconduct
involves PHS funding, pursuant to 42 CFR Part 93, the following
requirements apply.
1.
Notification of Investigation. In the event that an
Investigation of Research Misconduct is deemed warranted, the Vice President
for Research & Innovation will provide written notification of such Investigation,
including the name of the Respondent, the general nature of the allegation, and
the PHS applications or grant number(s) involved to ORI prior to initiating the
Investigation. ORI must also be notified
of the final outcome of the Investigation and must be provided with a copy of
the Investigation Report. Any
significant variations from the provisions of this policy should be explained
in any reports submitted to ORI, including any variances in deadlines.
2. Notification
of Early Termination of Investigation. If the USF system plans to terminate an
Inquiry or Investigation for any reason without completing all relevant
requirements of the PHS regulation, the Vice President for Research &
Innovation will submit a report of the planned termination to ORI, including a
description of the reasons for the proposed termination.
3.
Delay in Completion of Investigation. If the USF system determines
that it will not be able to complete the Investigation in 120 days, the Vice
President for Research & Innovation 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 Vice President for Research & Innovation will file periodic
progress reports as requested by the ORI.
4.
Developments Affecting Funding. The Vice President
for Research & Innovation will keep ORI apprised of any developments during
the course of the Investigation for which facts are disclosed that may affect
current or potential PHS funding for the individual(s) under investigation or for
which the PHS needs to know to ensure appropriate use of federal funds and
otherwise protect the public interest.
5.
Admission of Misconduct. If an admission of
Research Misconduct is made, the Vice President for Research & Innovation
will consult with ORI. Normally, the individual
making the admission will be asked to sign a statement attesting to the
occurrence and extent of Research Misconduct.
When the case involves PHS funds, the USF system cannot accept an
admission of Research Misconduct as a basis for closing a case or not
undertaking an Investigation without prior approval from ORI.
6.
Immediate Notification Required. The Vice President
for Research & Innovation will notify ORI and, if appropriate, the Research
Sponsor at any stage of the Inquiry or Investigation if any of the following
conditions exist:
a.
There is an
immediate health hazard involved.
b.
There is an
immediate need to protect federal funds or equipment.
c.
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 or
her co-investigators and associates, if any.
d.
It is probable
that the alleged incident is going to be reported publicly.
e.
The allegation
involves a public health sensitive issue, e.g., a clinical trial.
f.
There is a
reasonable indication of possible criminal violation. In this instance, the Vice President for
Research & Innovation must inform ORI within 24 hours of obtaining that
information.
G.
Notification of Non-PHS Research Sponsors
For allegations of Research Misconduct involving research
that is not supported by PHS funds, the Vice President for Research &
Innovation will provide written notification to the Research Sponsor at the
conclusion of a Research Misconduct Investigation where Research Misconduct has
been substantiated or at any other point in the Investigation, if a
determination is made that the Research Sponsor needs to know about the
allegations to ensure the appropriate use of funds and otherwise protect the
public interest.
H.
Evidentiary Standards
The following standards will apply
where pertinent in the implementation of this policy:
1. Burden of proof.
a. The USF system has
the burden to substantiate a finding of Research Misconduct. The absence of, or Respondent’s failure to
provide, research records adequately documenting the questioned research
establishes a rebuttable presumption of Research Misconduct that may be relied
upon by the USF system in proving Research Misconduct. Credible information provided corroborating
the research or providing a reasonable explanation for the absence of, or
Respondent’s failure to provide, the research records may be used by the
Respondent to rebut this presumption.
b. Once the USF system
makes an initial showing of Research Misconduct, the Respondent has the burden
of providing any affirmative defenses raised,
including any honest error or differences of opinion, and of presenting any
mitigating factors that the Respondent wants the USF system to consider in
imposing administrative or disciplinary actions following the Research
Misconduct proceedings.
2. Standard of proof.
An institutional finding of Research Misconduct must be
established by a preponderance of the evidence.
I.
Termination of USF system
Employment or Resignation Prior to
Completing Inquiry or Investigation
The termination of the Respondent's employment with the USF
system, by resignation or otherwise, before or after an allegation of possible
Research Misconduct has been reported, will not preclude or terminate the
Research Misconduct process. If the
Respondent, without admitting to the Research 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 will proceed. If the
Respondent refuses to participate in the process after resignation, the Inquiry
Chair or Investigation Panel will use best efforts to reach a conclusion concerning
the allegations, noting in the Inquiry/Investigation Report the Respondent's
failure to cooperate and its effect on the review of all the information
presented. Where Research Misconduct is
substantiated following a complete Investigation, notification of results will
be made to the Respondent, the Complainant, any federal agency as required, and
other appropriate parties at the discretion of USF system officials.
J.
Non-Research Misconduct Issues and Violations
When issues of concern not related to Research Misconduct
are discovered during the review, Inquiry, or Investigation of an allegation,
the Research Integrity Officer should refer such matters to the USF system Office
of Audit and Compliance, which is 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 access and address the allegation. The following are examples of issues
requiring referral:
1.
General Misconduct. Inappropriate conduct, such as falsifying
medical or billing records, false testimony, noncompliance with official
procedures, failure to report or attempting to conceal Research Misconduct,
etc., or other misconduct that does not affect the integrity of the research
process should be reported to the USF system Office of Audit and Compliance for
possible referral or action.
2.
Criminal Violations. Potential theft or other criminal violations
should be referred to the USF system Office of Audit and Compliance. If the possible criminal violation is
identical to the alleged Research Misconduct (e.g., alleged false statements in a PHS grant application), the
criminal charge should be reported to ORI.
ORI will then refer it to the Office of the Inspector General (OIG),
Department of Health and Human Services (DHHS).
3.
Violation of Human Subject or Animal Subject Regulations. Potential violations of human subject or animal subject
regulations, including non-compliance with Food and Drug Administration (FDA)
regulated research requirements, should be referred to the Division of Research
Integrity & Compliance for referral to the USF Institutional Review Board
(IRB) or the Institutional Animal Care and Use Committee (IACUC).
4.
Fiscal Irregularities or Misconduct. Potential violations
of cost principles or other fiscal irregularities, such as mismanagement of
research monies and personnel by contract and/or grant recipients, employees,
or other related persons, should be reported to the USF system Office of Audit
and Compliance for appropriate review and follow-up with the Vice President for
Research & Innovation, USF Controller’s Office, federal agencies, and
Research Sponsors, as appropriate.
5.
Unacceptable or Questionable Research Practices. The Research
Integrity Officer, the USF system Office of Audit and Compliance, an Inquiry or
Investigation Panel, or other individual or entity involved in the Research
Misconduct review process may find that while a Respondent’s conduct does not
warrant an Inquiry or an Investigation, it may nevertheless constitute an
unacceptable or questionable research practice.
Any such finding should be referred to the Vice President for Research
& Innovation, who will communicate this information to the appropriate USF
system official(s), including the highest ranking research administrator at the
respective regional campus or separately accredited
institution if the practice takes place at a regional campus or separately accredited institution, for review and
further appropriate action.
V. Procedures Upon Receiving an Allegation of
Research Misconduct
A. Preliminary Assessment of Allegations
Upon receiving an allegation of Research Misconduct, the
Research Integrity Officer will notify the Chair of the USF Research Council
and request a consultation with the Council’s Ad Hoc Review Committee to review
the allegation. If the alleged Research
Misconduct took place at a regional campus or
separately accredited institution, the highest ranking research
administrator of the respective regional campus or
separately accredited institution will be consulted, and a faculty
member of that regional campus or separately
accredited institution will be included on the Ad Hoc Review Committee.
The Ad Hoc Review Committee will review and assess the
allegation to determine whether there is sufficient information to proceed with an Inquiry, whether federal or other outside
support or applications for funding are involved, whether the allegation falls
under the definition of Research Misconduct as stated in this policy or other
applicable federal agency definition, and whether other issues are involved
that need to be referred to the USF system Office of Audit and Compliance or
other USF system office(s).
If the USF Research Council Ad Hoc
Committee is not readily available to meet, then the allegations may be
reviewed with other individuals deemed appropriate by the Research Integrity
Officer and the Vice President for Research & Innovation. In this case, the Research Integrity Officer,
in consultation with the Vice President for Research & Innovation and other
appropriate individuals, as needed, will determine whether the allegation falls
under the USF system definition of Research Misconduct and whether there is
sufficient information to initiate an Inquiry.
The Research Integrity Officer will alert the Vice President
for Research & Innovation if any of the following conditions exist:
1. There is an
immediate health hazard involved.
2. There is an
immediate need to protect federal funds or equipment.
3. 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 or her co-investigators and associates, if any.
4. It is probable that the alleged incident is
going to be reported publicly.
5. The allegation
involves a public health sensitive issue, e.g., a clinical trial.
6. There is a
reasonable indication of possible criminal violation. In this instance, the USF system must inform
ORI within 24 hours of obtaining that information.
The
Vice President for Research & Innovation is responsible for reporting to
Research Sponsors and federal oversight agencies.
B. Initiation and Purpose of the Inquiry
If a determination is made following the preliminary
assessment that the allegation provides sufficient information and falls under
the applicable definition of Research Misconduct, the Research Integrity
Officer will immediately consult with the Vice President for Research &
Innovation to determine the need to inform appropriate USF system officials of
the allegations and to identify an appropriate individual to serve as Inquiry
Chair. The Inquiry Chair shall have no
real or apparent conflicts of interest in the case, be unbiased, and shall have
the necessary expertise and resources to conduct the Inquiry, which involves
evaluating the allegation issues and related information, interviewing the
principals and key witnesses, and preparing an Inquiry Report. This individual may be a scientist, subject
matter expert, administrator, lawyer, or other qualified person from inside or
outside the USF system. In the absence
of any actual or perceived conflict of interest, the Inquiry Chair may also,
but is not required to, be an individual who has some level of supervisory
responsibility over the Respondent.
Note: If the alleged
Research Misconduct took place at a regional campus or
separately accredited institution, the highest-ranking research
administrator of the respective regional campus or
separately accredited institution will be consulted in all phases of the
process.
The Vice President for Research & Innovation will charge
the Inquiry Chair in writing with the conduct of the Inquiry, restating the
original allegation and any apparent related issues that should be
evaluated. The charge should state that
the Inquiry Chair may consult with or delegate duties to any other appropriate
person or may form an Inquiry Committee (see Section V.D. below). The charge should also state that the purpose
of the Inquiry is to make an expeditious and confidential evaluation of the
available research records and statements of the Respondent, Complainant, and
key witnesses and to determine whether an Investigation is warranted. The charge letter should clarify that the
purpose of the Inquiry is not to reach a conclusion about whether
Research Misconduct definitely occurred.
C. Sequestration of the Research Records
After a determination is made that an allegation falls
within the definition of Research Misconduct, the Research Integrity Officer
must ensure that all original research records and materials relevant to the
allegation are immediately secured and sequestered. Records or equipment that
are clearly identifiable as personal and not the property of the USF system will not be made a part of the Inquiry
record. The sequestration of research
records should take place before or concurrently with notification to the
Respondent that an Inquiry will be initiated.
The Research Integrity Officer may consult with any appropriate USF system administrators or agencies for advice and
assistance in this regard. Where
feasible and appropriate, the Research Integrity Officer will work with the
affected laboratories and researcher to provide copies of records to the
Respondent and other research personnel to facilitate the continuation of the
research pending completion of the Inquiry.
D. Notification and
Conduct of the Inquiry
Upon receiving the charge to conduct the Inquiry from the Vice
President for Research & Innovation, the Inquiry Chair will consult with
the Research Integrity Officer to determine whether sequestration of research
records is necessary prior to notification of the Respondent (see Section V.C.
above). If not, the Inquiry Chair will
notify the Respondent in writing of the Inquiry, with a copy of the letter to
the Vice President for Research & Innovation, the Research Integrity
Officer, and other USF system administrative
officials, as appropriate. The notification will include a summary of the
allegations and a copy of the USF Research Misconduct Policy and will invite a
response to the allegations. If there is
a need to sequester relevant research records, the notification should be
delivered in person by the Inquiry Chair or designee and the Research Integrity
Officer, and the relevant records should be sequestered at that time. If there are no research records relevant to
the Inquiry, the notification may be sent to the Respondent by courier or by
certified mail, return receipt requested, in an envelope marked “Confidential.” The Inquiry Chair should also notify the
Complainant that the allegation has been received and an Inquiry initiated.
The Inquiry Chair and/or any other individuals who have been
appointed to assist with the Inquiry (Inquiry Committee) will normally
interview the Complainant, the Respondent, and key witnesses and will examine
relevant research records and materials.
However, if the allegation is clear and no additional information is
needed from the Complainant, the Complainant need not be interviewed. Then, the
Inquiry Chair/Committee will evaluate the research records and statements
obtained during the Inquiry. After
consultation with the Research Integrity Officer, the Inquiry Chair will decide
whether there is sufficient information presented indicating possible Research
Misconduct to warrant further investigation.
The scope of the Inquiry does not include deciding whether Research
Misconduct occurred or conducting exhaustive interviews and analyses.
The Inquiry Report should be completed as soon as practicable, but not longer than
60 days from the date of the charge letter.
The 60-day period includes the 14-day period for receiving comments from
the Respondent and Complainant, as well as subsequent review by the Research
Integrity Officer. If an extension of
time is required, an extension may be requested in writing from the Vice
President for Research & Innovation.
The anticipated completion date and reason for the request should be
clearly stated. This information should
also be documented in the Inquiry Report.
E.
Elements of the Inquiry Report
The findings of the Inquiry must be set forth in an Inquiry
Report, which will be submitted to the Vice President for Research &
Innovation (with a copy to the Research Integrity Officer), who will consider
the Inquiry Chair’s recommendation and, in consultation with other appropriate USF system officials, determine whether an
Investigation is warranted.
The Inquiry Report shall include the following elements, if
applicable, as well as any relevant dates:
1. Introduction
a. Background information,
sufficient to ensure a full understanding of
the issues as they relate to the definition of Research Misconduct.
b.
Summary of allegations.
c.
Facts leading to Inquiry.
d.
Description of the research study involved.
e.
Relationship of Complainant to Respondent (if
known).
f.
Other relevant facts.
2. Formal Statement of Allegations
a.
Allegations raised by the Complainant, including the basis (grounds)
for the allegation, except where
anonymity would be compromised
or where the source is irrelevant.
b.
Additional allegations arising during the Inquiry.
3. Any Funding Agencies Providing Support for the
Research
Summary of the Inquiry Process
a.
Composition of Inquiry Committee, if any (names, degrees, departmental
affiliation, and expertise).
b.
Charge to the Inquiry Chair.
c.
Persons interviewed.
d.
Evidence secured, reviewed, and described in sufficient detail to
demonstrate whether investigation is warranted.
e.
Security measures to protect evidence obtained.
f.
Other relevant factors that influenced proceedings.
4. Analysis of Each Allegation
For each
allegation:
a.
Describe the matter at issue and how it came to be under investigation.
b.
Describe all information reviewed, including summaries of relevant
interviews, and the source of the information and how it factors into the conclusion.
c.
Whether any outside experts were consulted.
d.
Describe any defenses raised to the allegation and any inconsistencies
among the defenses.
e.
Describe the weight given to various pieces of evidence, credibility,
and persuasiveness.
f. Describe any information reviewed indicating that the
Respondent acted intentionally in engaging in the alleged misconduct.
g.
Describe any information reviewed that would support the conclusion
that this was honest error or that there may be differences of scientific opinion.
h.
Conclusion
a. Describe whether the Inquiry
found sufficient information indicating possible Research Misconduct to warrant
investigation. If not, describe why the information presented was insufficient.
b.Describe any other institutional actions that should
be taken, if investigation is not warranted.
F.
Distribution and Disposition of the Inquiry Report
The Inquiry Chair shall submit
the Draft Report to the Research Integrity Officer, who will distribute the
Draft Report to the Respondent for comment and will distribute a summary of the
Inquiry findings and/or relevant portions of the Report to the Complainant for
comment. Within 14 days of receipt of
the Draft Report, or portions thereof, the Complainant and the Respondent will
provide their comments, if any, to the Inquiry Chair. Any comments that the Complainant or
Respondent submit on the Draft Report will become part
of the record, whether or not the comments are incorporated into the Final
Report. The Inquiry Chair may revise the
Report based on the responses, if appropriate.
The Inquiry Chair shall provide the revised draft of the Inquiry Report
to the Research Integrity Officer for review prior to finalizing.
Once the Inquiry Report has been
finalized, the Inquiry Chair shall submit the Report to the Vice President for
Research & Innovation. The Vice President for Research & Innovation, in
consultation with appropriate USF
system officials,
including the highest ranking research administrator at the respective regional
campus or separately accredited
institution if the
alleged Research Misconduct took place at a regional campus or separately accredited institution, will determine whether the
findings as stated in the Inquiry Report indicate possible Research Misconduct
and, thus, warrant an Investigation. If
the findings of the Inquiry Report are not supported by the information
presented or if the findings are inconsistent with the information presented,
the Vice President for Research & Innovation may remand the Inquiry Report
to the Inquiry Chair and request that additional support be
provided for the findings.
Based on the outcome of the
Inquiry, the following will occur:
1. Determination
of Insufficient Evidence to Warrant Investigation.
If there is not sufficient information presented indicating Research
Misconduct to proceed with an Investigation, the Vice President will notify the
Respondent of the dismissal of the matter, with a copy to the Complainant. The official record of the matter will be
maintained by the Research Integrity Officer in accordance with Florida
requirements for records retention, with disclosure of the documents governed
by Florida Statute, §1012.91(1)(b), and federal requirements (seven years), if
applicable. The determination of the Vice
President for Research & Innovation regarding dismissal of the matter will
be final, with no right of appeal or subsequent review.
2. Determination of Sufficient Evidence to
Warrant Investigation. If there
is sufficient information presented indicating Research Misconduct to proceed
with an Investigation, the Vice President will refer the Inquiry Report and all supporting documentation to the
Standing Committee on Research Misconduct with the charge to initiate an
Investigation in accordance with the procedures herein.
VI. Procedures
Upon Determining That an Investigation Is Warranted
A. Purpose of the
Investigation
The purpose of an Investigation is to explore in detail the
allegations, to examine the evidence in depth, and to determine specifically
whether Research Misconduct has
been committed, by whom, and to what extent.
The Investigation will also determine whether there are additional
instances of possible Research
Misconduct that would justify broadening the scope beyond the initial
allegations. This is particularly
important where the alleged Research
Misconduct involves potential harm to human subjects or the general
public, or if it affects research that forms the basis for public policy or
public health practice.
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 USF
system’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.
C. Referral
to the Standing Committee on Research Misconduct and Nomination of
Investigation Panel
The Vice President for Research & Innovation shall
forward the Inquiry Report and all supporting documentation to the Chair of the
Standing Committee on Research Misconduct, along with the charge to initiate an
Investigation. The Standing Committee on Research Misconduct will meet within
14 days of receiving the charge.
The Standing Committee will appoint an Investigation Panel
of no fewer than three individuals to investigate the allegation(s). Panel members and experts must be free from
bias and have no real or apparent conflicts of interest, either with the
parties involved or with the subject matter.
Consequently, these individuals should be free of professional,
financial, personal, or other substantial ties to the Respondent or
Complainant. Panel members shall also
have the necessary expertise to evaluate the evidence and issues related to the
allegations and adequate time available to interview the principals and key
witnesses and to conduct the Investigation.
If experts are appointed to the Investigation Panel, the experts may be
either outside researchers or the USF system’s own experts. However, persons who are directly responsible
for the laboratory or research project where the Research Misconduct is alleged to have occurred may have
conflicts of interest as mentors, co-authors, and/or supervisors of the
Respondent that would compromise their objectivity in reviewing the
allegations; these persons would not be eligible for appointment to the
Investigation Panel.
The Investigation Panel shall include at least one faculty
member and at least one USF system employee in the same employee classification
plan as the Respondent (if the Respondent is not a faculty member). The Investigation Panel will include a
specialist in the Respondent’s area of specialization and if the alleged Research Misconduct took place at a regional
campus or separately accredited institution, a faculty representative
from the Respondent’s regional campus or separately
accredited institution. No member
of the Standing Committee shall be an Investigation Panel member. The Standing Committee Chair will notify the
Respondent of the proposed Investigation Panel membership
and the Respondent will have three (3) business days to object
to the Investigation Panel's proposed membership based on grounds of bias or
conflict of interest. The Standing
Committee Chair will consider any objections and will make the determination
whether to replace or retain the Investigation Panel member.
D. Charge to Panel and Orientation
Within 10 days of appointing an Investigation Panel, the
Chair of the Standing Committee will charge the Investigation Panel with the
Investigation of the allegation(s). The
charge shall be in writing, delivered by the Chair of the Standing Committee or
designee and shall be specific enough to be fair to the Respondent while
leaving the Investigation Panel free to examine relevant related information
that may emerge in the course of the process.
The Research Integrity Officer or designee will meet with the
Investigation Panel at the time the Investigation Panel receives the charge to
explain the USF system’s policy, the role of the Investigation Panel in the
process, the conduct of the Investigation, and the importance of
confidentiality. Panel members should be
informed that their names will be available to the Respondent and Complainant,
and that they may be interviewed by ORI during its oversight process.
At the time of its initial meeting, the Investigation Panel
will elect a Panel Chair who will be responsible for coordinating Investigation
Panel meetings and witness interviews, assigning tasks to Investigation Panel
members, ensuring that the Investigation is completed within the designated
timeframe, and preparing the Investigation Panel’s Investigation Report. In the alternative, the Standing Committee
may appoint the Panel Chair from among the Investigation Panel members.
The Research Integrity Officer, through staff and other
resources available in the Division of Research Integrity & Compliance,
will provide scheduling, copying, courier, and other such support for the
Standing Committee and Investigative Panel, if needed.
E. Conduct of Investigation
The Investigation will normally involve an 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. The Investigation Panel should interview the
Complainant(s), the Respondents(s), and other individuals who might have
information regarding aspects of the allegations. All interviews should be transcribed or
otherwise documented. Summaries of
transcripts or details of the interviews should be provided to the interviewed
party for comment or clarification and should be included as part of the Panel’s
Investigation File. The Investigation
Panel will provide the Respondent with a copy of his or her interview
transcript or notes, if requested.
During the Investigation, all documents related to the
Investigation are treated as limited-access documents and may only be released
pursuant to Florida Statutes, §1012.91(1)(b) and to
the extent required by federal or state law or applicable federal regulation.
1. Misconduct
or Other Deviations Not Included in the Original Charge. If in the course of
investigating an allegation, the Investigation Panel becomes aware of
additional matters of potential concern to the USF system, including Research
Misconduct not included in the original charge to the Investigation Panel or
other deviant conduct, the Investigation Panel shall immediately report these matters
to the Standing Committee for evaluation and consideration of whether the new
allegations should be included in the current Investigation. The Standing Committee shall confer with the
Research Integrity Officer to determine whether to expand the charge to the
existing Investigation Panel to include the new allegations or to handle the
new allegations in another manner.
2.Panel Deliberations. Upon the conclusion of information gathering, the
Investigation Panel shall deliberate to determine whether the information
reviewed supports a finding of Research Misconduct. In reaching its conclusions, the
Investigation Panel will use a Preponderance of the Evidence standard. The
Investigation Panel may also provide recommendations for corrective action; however,
such recommendations shall not be binding upon the Standing Committee or
individuals responsible for implementing disciplinary or corrective action.
F.
Panel Investigation Report
The
Panel Chair will oversee the preparation of an Investigation Report to the
Chair of the Standing Committee that will document the Investigation Panel’s
findings with respect to whether Research Misconduct has occurred and the
Investigation Panel’s recommendations for what, if any, actions should be
taken.
The Panel’s Investigation Report shall include the following
elements, if applicable, as well as any relevant dates:
1. Introduction
a.
Background
information, sufficient to ensure a full understanding
of the issues as they relate to the definition of
Research Misconduct.
b.
Summary
of allegations.
c.
Facts
leading to the Investigation.
d.
Description
of the research study involved.
e.
Other
relevant facts.
2.Formal Statement of Allegations
a. Allegations raised by the
Complainant, including the basis (grounds) for the allegation, except where
anonymity would be compromised, or where the source is irrelevant.
b. Additional allegations arising during the Investigation.
3.Any Funding Agencies Providing Support for the
Research
4.Summary of the Investigation Process
a.
Composition
of the Investigation Panel (names, degrees, departmental affiliation, and
expertise).
b.
Charge to
the Panel.
c.
Persons
interviewed.
d.
Any
additional evidence secured and reviewed.
e.
Security
measures to protect evidence obtained.
f.
Other
relevant factors that influenced proceedings.
5.Analysis of Each Allegation
For
each allegation, if applicable:
a. Describe the matter at issue and
how it came to be under investigation.
b. Describe all evidence reviewed,
including summaries of relevant statements, and the source of the information
and how it factors into the conclusion.
c. Note whether any outside experts
were consulted and describe.
d. Describe any defenses raised to
the allegation and any inconsistencies among the defenses.
e. Describe the weight given to
various pieces of evidence, credibility, and persuasiveness.
f.
Describe any evidence that the Respondent acted intentionally in
engaging in the alleged Research Misconduct.
g. Describe any evidence information
reviewed that would support the conclusion that this was honest error or that
there may be differences of scientific opinion.
6. Conclusion
a.
Concisely state
the Investigation Panel’s finding for each identified issue and whether
Research Misconduct occurred for
each individual issue.
b.
For each issue
where Research Misconduct is identified, state the type of Research Misconduct
(fabrication, falsification, plagiarism) and the extent and seriousness of the
misconduct (effect on research findings, publications, subjects, and on the
laboratory or project).
c.
If the Investigation
Panel suspects malicious motivation on the part of the Complainant, state
evidence to support such a finding.
d.
Present
recommendations for corrective or administrative action for consideration by
the Standing Committee, Vice President for Research & Innovation and
others, as appropriate. Recommendations
that involve the retraction or correction of published data should identify the
published reports or other source of scientific information (e.g., databases)
that should be retracted or corrected.
G.
Standing Committee Review and Action
Upon receipt of the Panel’s Investigation Report, the Chair
of the Standing Committee will distribute the Report to the Respondent and the
members of the Standing Committee on Research Misconduct.
The Respondent will have 5 days from the date of receipt of
the Report to notify the Standing Committee that the Respondent will respond to
the Investigation Report either orally, at a meeting with the Standing
Committee, or in writing. If a meeting
is requested, the meeting shall be held no sooner than 10 days and no later
than 20 days after the Respondent’s notice to the committee. If the Respondent desires to submit a written
response, such written response shall be provided to the Committee within 15
days of the Respondent’s notice, and the Standing Committee will not meet prior
to the expiration of the 15 days.
If the Respondent does not provide notice of a desire to
present a response to the Investigation Report within 5 days, the Standing
Committee may meet at any time thereafter to discuss the Investigation Panel’s
Report and to prepare its response to the Investigation Report. If the Respondent does respond, the Standing
Committee may meet at any time after receipt of the Respondent’s submission
presentation.
After review of the Investigation
Report and the Respondent’s response, if any, the Standing Committee has the
following options:
1.
Accept the
Report.
2.
Reject the
Report, and remand the case to the original Investigation Panel with
instructions for further consideration or investigation.
3.
Nominate new
Investigation Panel members for de novo review.
If the case is remanded to the
original Investigation Panel, the Investigation Panel shall follow the Standing
Committee’s instructions for further consideration and/or investigation and
shall prepare a Supplemental Report to the Standing Committee within 20 days of
receipt of the Standing Committee’s charge.
If a new Investigation Panel is convened, the new Investigation Panel
shall follow the procedures as set forth in Sections VI. D.-F.,
herein.
Upon receipt of a Supplemental
Report or a Report from a newly convened Investigation Panel, the Standing
Committee will proceed as set forth in this Section VI.G., including providing
the Respondent with the Supplemental Report or new Report and inviting a
response for the consideration of the Standing Committee in its review of the
matter.
H. Standing Committee Report
The Standing Committee’s Report shall be issued within 20
days after receipt of the final response of the Respondent or within 20 days of
the expiration of the response period, if no response is received.
The report shall include:
1.
A summary of its
review of the Investigation Panel Report.
2.
An explanation of
any rejection of findings or additional instructions
to the Investigation Panel.
3.
A summary of the
views of the Respondent.
4. The Standing
Committee’s findings based on the information provided
in the Investigation Panel Report.
5. Any
recommendations for corrective or administrative action (optional and
non-binding).
The Standing Committee will provide a copy of its Report,
the Investigation Panel Report, and the comments of the Respondent within 120
days of initiation of the Investigation to the Vice President for Research
& Innovation.
I. Determination of Misconduct
The Vice President for Research & Innovation, upon
receipt of the Standing Committee’s Report, will review the Report to make
certain that proper procedure has been followed and refer it to the Provost,
appropriate Vice President, or other appropriate USF system official(s) for
review and action. The Vice President
for Research & Innovation will notify the Standing Committee that the
Report has been reviewed for proper procedure and appropriately referred.
The Vice President for Research & Innovation,
shall be included in discussions about any restrictions or other sanctions
relating to the Respondent’s research activities within the USF system that may
come about as a result of the Investigation.
When a final decision on the matter has been reached, the
Provost, appropriate Vice President, or other appropriate USF system official,
will notify the Respondent and the Complainant in writing. In addition, the appropriate USF system officials
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 Vice President for Research & Innovation is the
Institutional Official responsible for notifying Research Sponsors or federal
oversight agencies of the determination, when required.
VII. DISCIPLINARY ACTION AND Sanctions for Research Misconduct and Bad
Faith Allegations
A.
The USF system will
take appropriate disciplinary action against individuals through the USF system’s
established disciplinary processes when an allegation of Research Misconduct
has been substantiated in accordance with the policies and procedures set forth
herein.
The USF system may impose
restrictions or other sanctions relating to the Respondent’s research
activities within the USF system including, but not limited to:
1. Withdrawal or
correction of all pending or published abstracts and papers emanating from the
research where Research Misconduct was found.
2.
Removal of the
responsible person from the particular project, letter of reprimand, or special
monitoring of future work.
3.
Restitution of
funds.
The Vice President for Research & Innovation may take
interim administrative action, when needed to protect federal funds or the
welfare of research subjects, and to ensure that the purposes of the federal
financial assistance are carried out.
Notification of any final disciplinary action or sanctions
imposed shall be provided to the Vice President for Research & Innovation
for inclusion in the official USF system file relating to the Research
Misconduct Investigation.
B. If
the evidence substantiates that a Complainant’s allegations of Research
Misconduct were not made in good faith, appropriate administrative or
disciplinary action may be taken against the Complainant. If the Complainant is not a USF system employee,
USF system officials may consider other appropriate notifications or
actions.
VIII. Record Management and Retention
Upon initiation of a Research
Misconduct allegation, the Research Integrity Officer will prepare and maintain
a file that will include the complete records of any Inquiry or Investigation
and copies of all correspondence, documents, and other materials furnished to
the Research Integrity Officer or other administrative officials or
committees. The records relating to
Research Misconduct Inquiries and Investigations are limited-access records and
may be released in accordance with the provisions of Florida Statutes
§1012.91(1)(b), which allows such records to be released upon conclusion of an
Investigation and any disciplinary action that may be imposed in connection
with a finding of employee misconduct.
The Research Misconduct Investigation file will be maintained in
accordance with the records retention requirements of the State of
Florida. In compliance with 42 CFR Part 93.317, the complete records
of any Inquiry and/or Investigation, which must be maintained for seven years,
will be made available upon request to personnel of the U.S. Department of
Health and Human Services (DHHS), including the Director of the Office of
Research Integrity (ORI).
Authorized and Signed by:
Karen A. Holbrook, Vice President for Research
& Innovation
Judy Genshaft, President