|
|

|
Procedures for Responding to Allegations of Misconduct in Scientific Research or Other Scholarly Activity- Introduction
These procedures provide the methods and principles for assessing
allegations and conducting inquiries and investigations related to possible
misconduct in scientific research or other scholarly activity; in particular,
these procedures seek compliance with misconduct procedures for scientific
research that is proposed to or supported by the U.S. Public Health Service
or the National Science Foundation. Included are procedures for reporting
scientific misconduct investigations to these agencies, adopting institutional
actions in response to findings of scientific misconduct, and cooperating
with the PHS Office of Research Integrity (ORI) or the NSF Inspector General
in their review of institutional actions and reports. Hereafter, "research"
connotes any type of scientific research or other scholarly activity and "misconduct"
connotes misconduct in scientific research or in other scholarly activity.
These procedures are intended to govern the assessment of allegations,
the conduct of inquiries and investigations, and the reporting of results
to the appropriate agency. The procedures do not create any right or benefit,
substantive or procedural, enforceable at law by a party against the institution,
its agencies, officers, or employees. These procedures should be read in conjunction with the Old Dominion University
Policy for Responding to Allegations of Misconduct in Scientific Research
and Scholarly Activity. - Definitions
For the purpose of these procedures only, the following terms have
the following meanings:
Allegation means any written statement of possible misconduct in scientific
research or other scholarly activity made to an institutional official,
either the dean of the affected college or to the research integrity officer. Complainant means a person who makes an allegation of misconduct in
scientific research or other scholarly activity. Confidentiality means a state or quality of being confidential. It connotes
the entrustment with secret affairs or purpose and a shared intent to
operate secretly. In many cases of research misconduct, confidentiality
is a legal requirement. Each member involved in the process bears the
duty of protecting the privacy of both the complainant and the respondent;
a member who breaches this duty may be subject to discipline. Conflict of interest means the real or apparent interference of one
person's interests with the interests of another person, where potential
bias may occur due to prior or existing personal or professional relationships.
This definition is not intended to conflict with or replace the State
and Local Government Conflict of Interests Act of the Code of Virginia
2.1-639.1 through 2.1-639.24 (as amended from time to time). Deciding Official means the university official who makes final determinations
on allegations of misconduct and any responsive institutional actions.
The deciding official will normally be the provost and vice president
for academic affairs. For this reason, he or she cannot serve as the research
integrity officer. If the provost and vice president for academic affairs
had direct, prior involvement in the research, inquiry, or allegation
assessment, he or she must rescue him or herself and the president will
appoint an alternate deciding official. Employee or member means, for the purpose of these instructions only,
any person paid by, under the control of, or affiliated with Old Dominion
University, including but not limited to scientists, physicians, trainees,
students, fellows, technicians, nurses, support staff, and guest researchers.
General Counsel means legal counsel who represents Old Dominion University
during the misconduct inquiry and investigation and who is responsible
for advising the research integrity officer, the inquiry and investigation
committees, and the deciding official on relevant legal issues. The general
counsel does not represent the respondent, the complainant, or any other
person participating during the inquiry, investigation, or any follow-up
action, except the university officials responsible for managing or conducting
the misconduct process as part of their official duties. Good faith allegation means an allegation made with the honest belief
that misconduct may have occurred. An allegation is not in good faith
if it is made with reckless disregard for or willful ignorance of facts
that would disprove the allegation. Inquiry means information-gathering and initial fact-finding to determine
whether an allegation or apparent instance of misconduct warrants an investigation. Investigation means the formal examination and evaluation of all relevant
facts to determine if misconduct has occurred and, if so, to determine
the responsible person and the seriousness of the misconduct. - Old Dominion University defines misconduct in scientific research and
other scholarly activity as:
fabrication, falsification, plagiarism, or other practices that
seriously deviate from those that are commonly accepted within the
scientific community for proposing, conducting, or reporting research.
It does not include honest error or honest differences in interpretations
or judgments of data. the retaliation against a person who reported or provided information
about suspected or alleged misconduct and who has not acted in bad
faith. (In such cases, agency notification is limited to the NSF.) Misconduct in scholarly activity connotes any form of attribution
of another's work as the respondent's own work.
The ODU definition is based on how Research Misconduct is defined in the regulations promulgated by the National Science Foundation and Public Human Service.
NSF means the National Science Foundation. NSF regulation means the National Science Foundation regulation establishing
standards for institutional inquiries and investigations into allegations
of misconduct, which is set forth at 45 C.F.R. Part 689, entitled "Misconduct
in Science and Engineering." ORI means the Office of Research Integrity, the office within the U.S.
Department of Health and Human Services (DHHS) that is responsible for
the scientific misconduct and research integrity activities of the U.S.
Public Health Service. PHS means the U.S. Public Health Service, an operating component of
the U.S. Department of Health and Human Services. PHS regulation means the Public Health Service regulation establishing
standards for institutional inquiries and investigations into allegations
of scientific misconduct, which is set forth at 42 C.F.R. Part 50, Subpart
A, entitled "Responsibility of PHS Awardee and Applicant Institutions
for Dealing with Possible Misconduct in Science." PHS or NSF support means PHS or NSF grants, contracts, or cooperative
agreements, or applications therefore. Research Integrity Officer means the institutional official responsible
for assessing allegations of misconduct, for determining when such allegations
warrant inquiries, and for overseeing any inquiries and investigations. Research record means any data, document, computer file, computer diskette,
or any other written or non-written account or object that reasonably
may be expected to provide evidence or information regarding the proposed,
conducted, or reported research that constitutes the subject of an allegation
of 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; exhibitions, productions, or displays;
slides; biological materials; computer files and printouts; manuscripts
and publications; equipment use logs; audio-tape recordings; laboratory
procurement records; animal facility records; human and animal subject
protocols; consent forms; medical charts; and patient research files. Respondent means the person against whom an allegation of misconduct
is directed or the person who is the subject of the inquiry or investigation.
There can be more than one respondent in any inquiry or investigation. Retaliation means any action that adversely affects the employment or
other status of an individual that is taken by an institution or an employee
because the individual has, in good faith, made an allegation of misconduct
or of inadequate institutional response thereto, or has cooperated in
good faith with an investigation of such allegation. Sequester means to separate or isolate documents or material from the
individual concerned and into the custody of a disinterested institutional
official designated by the research integrity officer, such as the general
counsel, who can provide confidential and secure storage.
- General Procedures and Principles
- Responsibility to Report Misconduct
All employees or individuals associated with Old Dominion University should
report observed, suspected, or apparent misconduct to the research integrity
officer directly or through the dean of the affected college. The research
integrity officer will promptly engage in an assessment of the allegation
to determine whether it falls within the definition of misconduct, involves
PHS or NSF support, and provides sufficient information to proceed with
an inquiry. - Protecting the Complainant
Employees who receive or learn of an allegation of misconduct will treat
the complainant with fairness and respect and, when the allegation has
been made in good faith, will take reasonable steps to protect against
retaliation the position and reputation of the complainant and other individuals
who cooperate with Old Dominion University. Employees will immediately
report any alleged or apparent retaliation to the research integrity officer. - Protecting the Respondent
Employees who receive or learn of an allegation of misconduct
will treat the respondent with fairness and respect. The research integrity
officer will take reasonable steps to ensure that the process observes
these procedural safeguards, the PHS regulation, 42 C.F.R. Part 50, Subpart
A, and the NSF regulation, 45 C.F.R. Part 689. Employees will report significant
deviations from these instructions to the research integrity officer.
The research integrity officer will report any allegation not made in
good faith to the deciding official for appropriate action. - Confidentiality
Institutional employees who make, receive, or learn of an allegation of
misconduct will protect, to the maximum extent possible, the confidentiality
of information regarding the complainant, the respondent, and other affected
individuals. The research integrity officer may establish reasonable conditions,
such as confidentiality agreements, to ensure the confidentiality of such
information. - Responding to Allegations
In responding to allegations of misconduct, the research integrity officer
and any other institutional official with an assigned responsibility for
handling such allegations will make diligent efforts to ensure that the
following functions are performed.
Any allegation assessment, inquiry, or investigation is conducted
in a timely, objective, thorough, and competent manner. Reasonable precautions are taken to maintain confidentiality and
avoid bias and real or apparent conflicts of interest on the part
of those involved in conducting the inquiry or investigation. - Immediate notification is provided to the PHS (ORI) or NSF (Inspector
General) if:
there is an immediate health hazard involved; there is an immediate need to protect federal funds or equipment; there is an immediate need to protect the interests of the person(s)
making the allegations or of the individual(s) who is the subject
of the allegations as well as his/her co-investigators and associates,
if any; it is probable that the alleged incident is going to be reported
publicly; the allegation involves a sensitive public health issue, e.g.,
a clinical trial; there is a reasonable indication of a possible Federal criminal
violation. In this instance, the institution must report within
24 hours of obtaining that information; for any other reason, the scientific community or the public
should be informed.
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.
- Employee Cooperation
Employees will cooperate with the research integrity officer and other
institutional officials in the review of allegations and the conduct of
inquiries and investigations. Employees have an obligation to provide
relevant evidence to the research integrity officer or other institutional
officials on misconduct allegations. Further, employees will cooperate
with ORI or NSF in its conduct of inquiries and investigations, its oversight
of institutional inquiries and investigations, and any follow-up actions.
- Evidentiary Standards
The following evidentiary standards apply to findings of misconduct in
research and scholarly activity.
- Burden of Proof
The burden of proof for making a finding of misconduct is on the university. - Standard of Proof
Any finding of misconduct will be established by a preponderance of
the evidence. This means that the evidence shows that it is more likely
than not that the respondent committed misconduct in scientific research
or scholarly activity.
- Completion of Process
The research integrity officer is responsible for ensuring that
the inquiry investigation process and all other steps required by this
investigation and the PHS or NSF regulations are completed even in those
cases where the respondent leaves after allegations are made. - Early Termination
If circumstances suggest the termination of an inquiry or investigation
into PHS- or NSF-funded research prior to completion of all the steps
required by the PHS or NSF regulations, the research integrity officer,
through the Office of Research, will notify the respective agency of the
planned termination and the reasons therefore. The agency will then review
the information provided and advise the institution whether further investigation
should be undertaken. - Referral of Non-Scientific Misconduct Issues
When the institution's review of the allegation identifies non-scientific
misconduct issues, the research integrity officer should refer these matters
to the proper institutional, state, or federal office for action. Some
of the issues meriting referral are described below.
- Criminal Violations
Potential violation of criminal law under DHHS grants and contracts
should be referred to the Office of Inspector General, DHHS-OIG Hot
line, 330 Independence Avenue, SW, Washington, D. C. 20201, telephone
(800) 447-8477. If the possible criminal violation is identical to
the alleged scientific 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 OIG. Potential violation of criminal
law under NSF grants and contracts should likewise be referred to
the Office of the Inspector General, NSF, 4201 Wilson Boulevard, Arlington,
VA 22230, telephone (703) 292-7100. - Violation of Human and Animal Subject Regulations
Potential violation of human subject regulations should
be referred to the Office for Human Research Protection, 1101 Wootton
Parkway, Rockville, MD 20852, telephone (301) 496-7005 or (866) 447-4777. Potential
violations of the Animal Welfare Act should be referred to the Animal
and Plant Health Inspection Service (APHIS) of the U.S. Department
of Agriculture, Eastern Region, Animal Care, 920 Main Campus Drive,
Suite 200, Raleigh, NC 27606, telephone (919) 855-7100. - Violation of FDA Regulations
Potential violations of Food and Drug Administration regulated research
requirements should be referred to the FDA Office of Regulatory Affairs,
Division of Compliance Policy, Bioresearch Program Coordination, 5600
Fishers Lane, Room 12A41, Rockville, MD 20857, telephone (301) 827-3101. - Fiscal Irregularities
Potential violations of cost principles or other fiscal irregularities
should be referred as follows:
For all NIH Agencies-Office of Management Assessment, NIH,
6011 Executive Blvd., Suite 601, Rockville, MD 20852, MSC 7669.
Telephone (301) 496-1873, FAX: (301) 435-1901, email: manuals
@od.nih.gov: URL: http://OMA.OD.NIH.GOV For all other PHS Agencies-PHS Office of Grants and Contracts,
5600 Fishers Lane, Room 5C18, Rockville, MD 20857, telephone (301)
443- 6557. NSF-Office of the Inspector General, NSF, 4201 Wilson Boulevard,
Arlington, VA 22230, telephone (703) 292-7100. Email Chris Boesz
at cboesz@nsf.com
If there are any questions regarding the proper referral of non-scientific
misconduct issues, the research integrity officer may call the ORI
Division of Investigation Oversight at (301) 443-5330, or the NSF
Inspector General at (703) 292-7100, to obtain advice.
- Requirements for Reporting to Federal Agencies
The decision to initiate an investigation into PHS- or NSF-funded
research must be reported in writing to the Director of ORI or the
Inspector General of NSF on or before the date the investigation begins.
At a minimum, the notification should include the name of the person(s)
against whom the allegations have been made, the general nature of
the allegation as it relates to the definition of misconduct, and
the agency's applications or grant number(s) involved. Notification
to the NSF should further include a request for deferral of the NSF
inquiry and investigation. The agency must 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 the institutional policies and procedures should be explained in
any reports. Prior to the decision, for any reason, to terminate an inquiry or
investigation of PHS- or NSF-funded research without completing all
relevant requirements of the PHS or NSF regulation, the research integrity
officer will submit a report of the planned termination to the respective
agency, including a description of the reasons for the proposed termination. If at any time it appears that the university will not be able to
complete the investigation in 120 calendar days, the research integrity
officer will submit to ORI or NSF 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. The request will be submitted through the Office
of Research. If the NSF is the funding agency, the Office of Research
may authorize an extension of the investigation such that the investigation
and all administrative actions will be complete within an additional
60 days. If the request is granted, the research integrity officer
will file periodic progress reports as requested by the agency. When PHS or NSF funding or applications for funding are involved
and an admission of misconduct is made, the research integrity officer
will contact the agency for consultation and advice. Normally, the
individual making the admission of misconduct will be asked to sign
a statement attesting to the occurrence and the extent of misconduct.
When the case involves agency funds, the university will not accept
an admission of misconduct as a basis for closing a case or not undertaking
an investigation without prior approval from the agency. - When PHS or NSF funding is involved, the research integrity officer
will notify ORI or NSF at any stage of the inquiry or investigation
if:
there is an immediate health hazard involved; there is an immediate need to protect federal funds or equipment; there is an immediate need to protect the interests of the person(s)
making the allegations or of the individual(s) who is the subject
of the allegations as well as his/her co-investigators and associates,
if any; it is probable that the alleged incident is going to be reported
publicly; the allegation involves a sensitive public health issue, e.g.,
a clinical trial; there is a reasonable indication of possible criminal violation.
In this instance, the institution must inform ORI within 24 hours
of obtaining that information. for any other reason, the scientific community or the public
should be informed.
- Preliminary Assessment of Allegations
- Allegation Assessment
Upon receiving an allegation of misconduct, the research integrity
officer will immediately assess the allegation to determine whether there
is sufficient evidence to warrant an inquiry, whether PHS, NSF, or other
support or applications for funding are involved, and whether the allegation
falls under the definition of misconduct.
- PHS or NSF Support
Allegations involving research supported by PHS- or NSF-funded grants,
contracts, or cooperative agreements, or applications for funding
connote that agency's support. If the allegation does not involve
agency support, it should be handled under the NSF definition of misconduct (http://www.oig.nsf.gov/misconductmeansold.htm) and procedures except that the reporting and compliance
aspects of 42 C.F.R. Part 50, Subpart A or 45 C.F.R. Part 689 do not
apply. - PHS Definition
The PHS definition of scientific misconduct is found in II. K.1 and
2, and II.P. The allegation should be carefully reviewed to determine
whether it potentially constitutes fabrication, falsification, plagiarism,
or other serious deviation from commonly accepted practices for proposing,
conducting, or reporting research. In case of doubt, the research
integrity officer should consult with the general counsel or ORI on
whether the allegation falls within the PHS definition of scientific
misconduct. - NSF Definition
The NSF definition (II.K.1 and II.M) adds to the PHS definition any
retaliation against the reporting person or any person providing information. - Old Dominion University Definition
The Old Dominion University definition of scientific misconduct is
based on the NSF definition and is found in II.K.1. and 2. The
definition of misconduct in scholarly activity is found in II.K.3.
- Sufficient evidence to proceed
There is not always sufficient evidence or information to permit further
inquiry into the allegation. For example, an allegation that a scientist's
(or scholar's) work should be subjected to general examination for
possible misconduct is not sufficiently substantial or specific to
initiate an inquiry. In case of such a vague allegation, an effort
should be made to obtain more information before initiating an inquiry.
This information may be sought from any reasonable source, including
the complainant, if known.
- Referral of Other Issues
Regardless of whether it is determined that a misconduct inquiry
is warranted, if the allegation involves PHS or NSF support and concerns
possible failure to protect human or animal subjects, financial irregularities,
or criminal activity, the allegation should be referred to the appropriate
office. See section III.J.
- Conducting the Inquiry
- Initiation and Purpose of the Inquiry
Following the preliminary assessment, if the research integrity
officer determines that the allegation provides sufficient information
to allow specific follow-up and falls under the definition of misconduct,
he or she will immediately initiate the inquiry process. In initiating
the inquiry, the research integrity officer should identify clearly the
original allegation and any related issues that should be evaluated. The
purpose of the inquiry is to make a preliminary evaluation of the available
evidence and testimony of the respondent, complainant, and key witnesses
to determine whether there is sufficient evidence of possible misconduct
to warrant an investigation. The purpose of the inquiry is not to reach
a final conclusion about whether misconduct definitely occurred or who
was responsible. The findings of the inquiry must be set forth in an inquiry
report. - First Steps if an Inquiry is Necessary
As soon as practicable after the research integrity officer determines
that an inquiry is required, he or she will:
secure the relevant research records; notify the Office of Research, the general counsel, the respondent,
and if PHS or NSF funding is involved, the ORI or the Inspector General
of NSF through the Office of Research. In the case of NSF funding,
the notification should specifically include a request that NSF defer
independent inquiry; appoint and charge the inquiry committee; and notify ORI or NSF if any of the conditions listed in section III.E.3
of these procedures are present.
The research integrity officer or general counsel may consult with an
affected federal agency at any time regarding appropriate procedures to
be followed. - Sequestration of the Research Records
- Immediate Sequestration
If the relevant research records have not been obtained at the assessment
stage, the research integrity officer will immediately locate, collect,
inventory, and secure them to prevent the loss, alteration, or fraudulent
creation of records. - Institutional Access
Research records produced under PHS or NSF grants and cooperative
agreements are the property of Old Dominion University, and employees
cannot interfere with the university's right of access to them. Under
some federal contracts, certain research records may belong to the
federal agency, which will normally allow access to contract records
in the custody of the university for purposes of reviewing misconduct
allegations. - Original Records
The documents and materials to be sequestered will include all the
original items (or copies if originals cannot be located) that may
be relevant to the allegations. These include, but are not limited
to, research records as defined in section II.S. of this document. - Sequestration of the Records from the Respondent
The research integrity officer should notify the respondent that an
inquiry is being initiated simultaneously with the sequestration so
that the respondent can assist with location and identification of
the research records. The research integrity officer should obtain
the assistance of the respondent's supervisor and the general counsel
in this process, as necessary. If the respondent is not available,
sequestration may begin in the respondent's absence. The respondent
should not be notified in advance of the sequestration of research
records to prevent questions being raised later regarding missing
documents or materials and to prevent accusations against the respondent
of tampering with or fabricating data or materials after the notification.
In addition to securing records under the control of the respondent,
the research integrity officer may need to sequester records from
other individuals, such as coauthors, collaborators, or complainants.
As soon as practicable, and if requested, a copy of each sequestered
record will be provided to the individual from whom the record is
taken. These measures will be undertaken with care to preserve the
confidentiality, privacy, and reputation of the respondent inasmuch
as is reasonable during the sequestration. - Inventory of the Records
A dated receipt should be signed by the sequestering official and
the person from whom an item is collected, and a copy of the receipt
should be given to the person from whom the record is taken. If it
is not possible to prepare a complete inventory list at the time of
collection, one should be prepared as soon as possible, and then a
copy should be given to the person from whom the items were collected. - Security and Chain of Custody.
The research integrity officer will lock records and materials in
a secure place. The persons from whom items are collected may be provided
with a copy of any item. Where feasible, that person will have access
to his or her own original items under the direct and continuous supervision
of a university official. This will ensure that a proper chain of
custody is maintained and that the originals are kept intact and unmodified.
Questions about maintaining the chain of custody of records should
be referred to the general counsel.
- Notification of the Respondent
- Contents of Notification
The research integrity officer will notify the respondent in writing
of the opening of the inquiry. The notification should identify the
research project in question and the specific allegations; define
misconduct; identify the presence, source, and implications of PHS
or NSF funding; list the names of the members of the inquiry committee
(if appointed) and experts (if any); explain the respondent's opportunity
to challenge the appointment of a member of the committee or expert
for bias or conflict of interest, to be assisted by counsel, to be
interviewed, to present evidence to the committee, and to comment
on the inquiry report; address the respondent's obligation as an employee
of the institution to cooperate; describe the institution's policy
on protecting the complainant against retaliation and the need to
maintain the complainant's confidentiality during the inquiry and
any subsequent proceedings. - Potential Respondents
If no specific respondent has been identified at this stage of the
process, the research integrity officer will notify each potential
respondent that an inquiry will be undertaken, e.g., each coauthor
on a questioned article, each investigator on a questioned grant application,
or each co-participant in other scholarly activity. The research integrity
officer will consult with the general counsel on the proper method
of notification under the circumstances.
- Designation of an Official or a Committee to Conduct the Inquiry
The research integrity officer is responsible for conducting
or designating others to conduct the inquiry.
- Use of an Inquiry Committee
In complex cases, the research integrity officer will normally appoint
a committee of three or more persons to conduct the inquiry, following
the procedures set forth in section V.F. (see below). - Use of an Inquiry Official
In cases in which the allegations and apparent evidence are straightforward,
such as an allegation of plagiarism or simple falsification or an
admission of misconduct by the respondent, the research integrity
officer may choose to conduct the inquiry directly or designate another
qualified individual to do so. In such cases, the inquiry official
will nevertheless obtain the necessary expert and technical advice
to consider properly all research issues. - Inquiry Process
The inquiry, whether conducted by a committee or an individual, will
follow each procedural step set forth below.
- Appointment of the Inquiry Committee
If an inquiry committee is to be appointed, the research integrity
officer will use the following procedures.
- Committee Membership
The research integrity officer, in consultation with other university
officials as appropriate, will appoint the committee and committee
chair within 10 calendar days of the initiation of the inquiry. The
inquiry committee should consist of at least three individuals who
do not have real or apparent conflicts of interest in the case, are
believed to be fair and unbiased, and have the necessary expertise
to evaluate the evidence and issues related to the allegation, interview
the principals and key witnesses, and conduct the inquiry. These individuals
may be scientists, subject matter experts, administrators, lawyers,
or other qualified persons, and they may be from inside or outside
of the institution. - Experts
The research integrity officer, in consultation with the committee,
will determine whether additional experts other than those appointed
to the committee need to be consulted during the inquiry to provide
special expertise to the committee regarding the analysis of specific
evidence. In this case, the experts provide a strictly advisory function
to the committee; they do not vote and generally do not interview
witnesses. The experts chosen may be from inside or outside of Old
Dominion University. - Bias or Conflict of Interest
The research integrity officer will take reasonable steps to ensure
that the members of the committee and experts have no bias or personal
or professional conflict of interest with the respondent, complainant,
or the case in question. In making this determination, the research
integrity officer will consider whether the individual (or any members
of his or her immediate family):
has any financial involvement with the respondent or complainant; has been a coauthor on a publication with the respondent or
complainant; has been a collaborator or coinvestigator with the respondent
or complainant; has been a party to a research controversy with the respondent
or complainant; has a supervisory or mentor relationship with the respondent
or complainant; has a special relationship, such as a close personal friendship,
kinship, or a professional/client relationship with the respondent
or complainant; or falls within any other circumstance that might appear to compromise
the individual's objectivity in reviewing the allegations.
- Objection by Respondent
The research integrity officer will notify the respondent of the proposed
committee membership within 10 calendar days. If the respondent submits
a written objection to any appointed member of the inquiry committee
or expert based on bias or conflict of interest within five days,
the research integrity officer will immediately replace the first
challenged member or expert with a qualified substitute and determine
whether to replace other members or experts the respondent challenges. - Confidentiality
Members of the committee and experts will agree in writing to maintain
the confidentiality of the proceedings and any information or documents
reviewed as part of the inquiry. Outside of the official proceedings
of the committee, they may not discuss the proceedings with the respondent,
complainant, witnesses, or anyone not authorized by the research integrity
officer to have knowledge of the inquiry. - Provision of Assistance
The research integrity officer, in consultation with the general counsel,
will provide staff assistance and guidance to the committee and the
experts on the procedures for conducting and completing the inquiry,
including procedures for maintaining confidentiality, conducting interviews,
analyzing data, and preparing the inquiry report.
- Charge to the Committee and the First Meeting
The research integrity officer will prepare a charge for the
inquiry committee that describes the allegations and any related issues
identified during the allegation assessment and states that the purpose
of the inquiry is to make a preliminary evaluation of the evidence and
testimony of the respondent, complainant, and key witnesses to determine
whether there is sufficient evidence of possible misconduct to warrant
an investigation pursuant to university, and PHS or NSF requirements if
applicable. The purpose is not to determine whether misconduct definitely
occurred or who was responsible.
At the committee's first meeting, the research integrity officer will
review the charge with the committee, discuss the allegations, any related
issues, and the appropriate procedures for conducting the inquiry, assist
the committee with organizing plans for the inquiry, and answer any
questions raised by the committee. The research integrity officer and
general counsel will be present or available throughout the inquiry
to advise the committee as needed. - General Approaches to Conducting the Inquiry
During the inquiry, the committee will take the following steps.
The committee will collect information relevant to commonly accepted
research practices of the community involved, the questioned practices
at hand, and determine whether any credible information supports characterizing
the questioned practices as misconduct. The scope of the inquiry is
limited; the inquiry should not weigh a conflict in credible information,
but refer it to investigation. The committee will take all necessary steps to avoid bias or conflict
of interest between the committee and experts and the respondent,
complainant, and witnesses. The committee will refer other issues that arise; it will advise
the research integrity officer of any necessary interim actions to
protect the research funds, human or animal subjects, or other steps
required by regulation or policy. See section III.E.3 and III.J.
- General Approaches to Conducting an Interview
- Purpose of the Interview
The purpose of an interview at the inquiry stage is to allow each
respondent, complainant, or witness to tell his or her side of the
story. The committee should not attempt to speculate about what happened
or might have happened or put words in the witnesses' mouths. Also,
the committee should not disclose information obtained from others
interviewed unless this is necessary and can be done without identifying
the source of the information. - Issues to Cover
Before an interview, the committee should provide each witness with
a summary of the matters or issues intended to be covered at the interview.
If the committee raises additional matters, the witness should be
given an opportunity to supplement the record in writing or in another
interview. The witness should be informed that his or her cooperation
and truthful answers are expected. - Confrontation
Witnesses should not be told at this stage whether other testimony
conflicts with theirs, although questions may be asked for purposes
of clarifying the testimony. Avoid leading questions such as, "You
must have made a mistake and thought it was actually this way, right?" - Using Experts
The committee may request that experts attend or participate in interviews
to assist in its evaluation of the allegations and related issues.
If the committee determines that such participation is not appropriate,
it may ask an expert to prepare questions for the committee to use
at the interview. Any expert retained to assist the committee may
read the transcripts or summaries of the interviews. - Transcribing Interviews
Interviews with the respondent will be transcribed or recorded. Interviews
with anyone else will be summarized, tape-recorded, or transcribed.
A transcript or summary of the interview will be provided to each
witness for review and correction of errors. Witnesses may add comments
or information. Changes to the transcript or summary will be made
only to correct factual errors. - Confidentiality of Interviews
Witnesses should be advised that the proceedings are confidential
and that they should not discuss the inquiry or their interview with
anyone else other than their counsel or adviser. - Access to Counsel
Witnesses may be accompanied and advised by legal counsel or by a
non-legal adviser who is not a principal or witness in the case. However,
the counsel or adviser may only advise the witness and may not participate
directly in the interview. Witnesses will respond directly to the
interview questions. - Order of Interviews
The inquiry committee should interview, if possible, the complainant,
key witnesses, and the respondent, in that order. Witnesses should
be asked to provide, in advance if possible, any relevant evidence,
including their own notes, manuscripts, research records, or other
documents that were not sequestered previously but are relevant to
the allegation. - Interviewing the Complainant
In interviewing the complainant, the inquiry committee should attempt
to obtain as much additional evidence regarding the substance of the
allegation as possible and to determine the complainant's view of
the significance and impact of the alleged misconduct. However, it
is not the complainant's responsibility to prove his or her allegations. - Interviewing the Respondent
The respondent should be asked to provide his or her own response
to the allegations, including any analysis of the primary data. If
the respondent claims that an honest error or difference of scientific
or professional judgment occurred, he or she should provide any evidence
to support that claim. If he or she requests, the respondent may make
a closing statement at the end of the interview. - Recording Admissions
If the respondent admits to the misconduct, the respondent should
be asked immediately to sign a statement attesting to the occurrence
and extent of the misconduct. Normally, an admission is a sufficient
basis to proceed directly to an investigation. However, the admission
may not be a sufficient basis for closing a case. Further investigation
may be needed to determine the extent of the misconduct or to explore
additional issues. If an admission is made when PHS or NSF funding
is involved, the research integrity officer through the Office of
Research, or the general counsel may seek advice from ORI or NSF in
determining whether there is a sufficient basis to close a case, after
the admission is fully documented and all appropriate procedural steps
are taken. If the case is closed, the report should be forwarded to
the deciding official with recommendations for appropriate institutional
sanctions and then submitted to agency review, if relevant. If the
respondent admits to the misconduct, the committee may consult with
the general counsel immediately, with the option of seeking advice
from ORI or NSF as needed. - Committee Deliberations
The inquiry committee will evaluate the evidence and testimony obtained
during the inquiry. After consultation with the research integrity
officer and general counsel, the committee members will decide whether
there is sufficient evidence of possible misconduct to recommend further
investigation. The scope of the inquiry does not include deciding
whether misconduct occurred or conducting exhaustive interviews and
analyses.
Committee deliberations should never be held in the presence of
the interviewee. During the interview, the committee members should
not debate among themselves or with witnesses over possible interpretations
of scientific research or other scholarly activity. These questions
should be reserved for private discussions among the inquiry committee
members and expert consultants.
- The Inquiry Report
- Elements of the Inquiry
A written inquiry report must be prepared that states the name
and title of the committee members and experts, if any; the allegations;
the presence and source of PHS or NSF or other support; a summary of the
inquiry process used; a list of the research records reviewed; summaries
of any interviews; a description of the evidence in sufficient detail
to demonstrate whether an investigation is warranted; and the committee's
determination as to whether an investigation is recommended and whether
any other actions should be taken if an investigation is not recommended.
General counsel will review the report for legal sufficiency. All relevant
dates should be included in the report. - Comments on the Draft Report by the Respondent and the Complainant
The research integrity officer will provide the respondent with a copy
of the draft inquiry report for comment and rebuttal and will provide
the complainant, if he or she is identifiable, with those portions of
the draft report that address the complainant's role and opinions in the
investigation.
- Confidentiality
The research integrity officer will establish reasonable conditions
for review to protect the confidentiality of the draft report. - Receipt of Comments
Within 14 calendar days of their receipt of the draft report, the
complainant and respondent will provide their comments, if any, to
the inquiry committee. Any comments that the complainant or respondent
submits on the draft report will become part of the final report and
record. Based on the comments, the inquiry committee may revise the
report as appropriate.
- Inquiry Decision and Notification
- Decision by Deciding Official
The research integrity officer will transmit the final report
and any comments to the deciding official, who will make the determination
of whether findings from the inquiry provide sufficient evidence of
possible misconduct to justify conducting an investigation. The inquiry
is completed when the deciding official makes this determination,
which will be made within 60 calendar days of the first meeting of
the inquiry committee. Any extension of this period will be based
on good cause and recorded in the inquiry file. - Notification
The research integrity officer will notify both the respondent
and the complainant in writing of the deciding official's decision
of whether to proceed to an investigation and will remind them of
their obligation to cooperate in the event an investigation is opened.
The research integrity officer will also notify all appropriate institutional
officials of the deciding official's decision.
- Time Limit for Completing the Inquiry Report
The draft report should be prepared within 36 calendar days in
order to leave time for the inclusion of any comments into the final report
and the deciding official's review within 60 calendar days of the first
meeting of the inquiry committee, unless the research integrity officer
approves an extension for good cause. If the research integrity officer
approves an extension, the reason for the extension will be entered into
the records of the case and the report. The respondent will also be notified
of the extension. The general counsel will review the report for legal
sufficiency.
- Federal Oversight
- Decision to Investigate
If the deciding official decides that an investigation of possible
scientific misconduct in PHS- or NSF-funded research will be conducted,
the research integrity officer, through the Office of Research, will notify
ORI or NSF and will forward a copy of the final inquiry report and these
policies and procedures to the respective agency. - Decision Not to Investigate
If the deciding official decides not to proceed to an investigation
and the inquiry was begun at the request of ORI, NSF, or other funding
agency, or if any agency requests a copy, the research integrity officer,
through the Office of Research, will send a copy of the final inquiry
report and the institutional decision to the appropriate agency. Otherwise,
the PHS- or NSF-funded case may be closed without notice to ORI or NSF. - Access to Evidence
If either ORI or NSF is performing an oversight review of the
university's determination not to proceed to an investigation, the research
integrity officer, if so requested, will provide the respective agency
with the report and the inquiry file, including, but not limited to, sequestered
evidence, analyses, and transcripts of interviews. The research integrity
officer will keep all records secure until the agency makes its final
decision on its oversight of the university's inquiry or investigation.
- Referral to Other Agencies
Information obtained during the inquiry regarding allegations other
than scientific misconduct involving PHS or NSF funds should be referred to
the responsible officials or government agencies. See section III.J. - Conducting the Investigation
- Purpose of the Investigation
The purpose of the investigation is to explore in detail the allegations,
to examine the evidence in depth, and to determine specifically whether
misconduct has been committed, by whom, and to what extent. The investigation
will also determine whether there are additional instances of possible
misconduct that would justify broadening the scope beyond the initial
allegations. This is particularly important where the alleged misconduct
involves clinical trials or potential harm to human subjects or the general
public or if it affects research that forms the basis for public policy,
clinical practice, or public health. The findings of the investigation
will be set forth in an investigation report. - 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 a number of reasons, including
the institution's decision to investigate additional allegations not considered
during the inquiry stage or the identification of records during the inquiry
process that had not been previously secured. The procedures to be followed
for sequestration during the investigation are the same procedures that
apply during the inquiry. See section V.B. - Notification of the Respondent
The research integrity officer will notify the respondent as soon as reasonably
possible after the determination is made to open an investigation. The
notification should include: a copy of the inquiry report; the specific
allegations; the presence, source, and implication of PHS or NSF funding;
the definition of misconduct; the procedures to be followed in the investigation,
including the appointment of the investigation committee and experts;
the opportunity of the respondent to be interviewed, to provide information,
to be assisted by counsel, to challenge the membership of the committee
and experts based on bias or conflict of interest, and to comment on the
draft report; the fact that either ORI or NSF may perform an oversight
review of the report if that agency funded the research; and an explanation
of the respondent's right to request a hearing before the agency's appellate
process if there is a finding of misconduct under that agency's definition. - Designation of an Official or a Committee to Conduct the Investigation
The research integrity officer is responsible for conducting or designating
others to conduct the investigation.
- Use of an Investigation Committee
In complex cases, the research integrity officer will normally appoint
a committee to conduct the investigation, following the procedures
set forth in section IX.E. (see below). - Use of an Investigation Official
In cases in which the allegations and apparent evidence are straightforward,
such as an allegation of plagiarism or simple falsification or an
admission of misconduct by the respondent, the research integrity
officer may choose to conduct the investigation directly or designate
another qualified individual to do so. In such cases, the investigation
official will nevertheless obtain the necessary expert and technical
advice to consider properly all scientific or ethical issues. In such
a case, the research integrity officer will offer the respondent a
chance to comment on this decision; any comments will be recorded
as an attachment to the investigation report. - Investigation Process
The investigation, whether conducted by a committee or an individual,
will follow each procedural step set forth below.
- Appointment of the Investigation Committee
If an investigation committee is to be appointed, the research integrity
official will use the following procedures.
- Committee Membership
Normally the Faculty Senate Committee D, Research and Scholarly Activity
will comprise the investigation committee. In general, the investigation
committee should consist of at least three individuals who do not
have real or apparent conflicts of interest in the case, are believed
to be fair and unbiased, and have the necessary expertise to evaluate
the evidence and issues related to the allegations, interview the
principals and key witnesses, and conduct the investigation. If the
Faculty Senate Committee D does not satisfy this standard, or is inappropriate
for the purposes of maintaining confidentiality, then the research
integrity officer, in consultation with the president and general
counsel, will appoint an investigation committee and the committee
chair within 10 calendar days of the notification to the respondent
that an investigation is planned or as soon thereafter as practicable.
These individuals may be scientists, administrators, subject matter
experts , lawyers, or other qualified persons, and they may be from
inside or outside Old Dominion University. Individuals appointed to
the investigation committee may also have served on the inquiry committee.
The research integrity officer will notify the respondent of the
proposed committee membership within five days. If the respondent
submits a written objection to any appointed member of the investigation
committee or expert, the research integrity officer will immediately
replace the first challenged member or expert with a qualified substitute,
observing the 30-day time limit. In additional written objections,
the research integrity officer will determine whether to replace
challenged members or experts with qualified substitutes. - Experts
Experts may be appointed as noted in section V.F.2 (or carried over
from the inquiry) to advise the committee on scientific or other issues. - Bias or Conflict of Interest
The research integrity officer will take reasonable steps to ensure
that the members of the committee and the experts have no bias or
personal or professional conflict of interest with the respondent,
complainant, or the case in question. See section V.F.3. - Objection to Committee or Experts by Respondent
The research integrity officer will notify the respondent of the proposed
committee membership within five days. If the respondent submits a
written objection to any appointed member of the investigation committee
or expert based on bias or conflict of interest, the research integrity
officer will immediately replace the first challenged member or expert
with a qualified substitute and determine whether to replace other
members or experts the respondent challenges. - Confidentiality
Members of the committee and experts will agree in writing to maintain
the confidentiality of the proceedings and any information or documents
reviewed as part of the investigation. Outside of the official proceedings
of the committee, they may not discuss the proceedings with the respondent,
complainant, witnesses, or anyone not authorized by the research integrity
officer to have knowledge of the investigation.
- Charge to the Investigation Committee and the First Meeting
- Charge to the Committee
The research integrity officer will define the subject matter of the
investigation in a written charge to the committee that describes
the allegations and related issues identified during the inquiry,
defines misconduct, and identifies the name of the respondent. The
charge will state that the committee is to evaluate the evidence and
testimony of the respondent, complainant, and key witnesses to determine
whether, based on a preponderance of the evidence, misconduct occurred
and, if so, to what extent, who was responsible, and its seriousness.
During the investigation, if additional information becomes available
that substantially changes the subject matter of the investigation
or would suggest additional respondents, the committee will notify
the research integrity officer, who will determine whether it is
necessary to notify the respondent of the new subject matter or
to provide notice to additional respondents.
The inquiry report will be made available to the investigation committee.
However, the report in no way limits the evidence available to the
committee for consideration. Inasmuch as any decision of an investigation
may conflict with any conclusion of the inquiry, the investigation
will be considered a de novo process. - The First Meeting
The research integrity officer, with the assistance of the general
counsel, will convene the first meeting of the investigation committee
to review the charge, the inquiry report, and the prescribed procedures
and standards for the conduct of the investigation, including the
necessity for confidentiality and for developing a specific investigation
plan. The investigation committee will be provided with a copy of
these instructions and, where federal agency funding is involved,
the PHS or NSF regulation.
- Developing an Investigation Plan
At the initial meeting, the committee should begin development
of its investigative plan and complete it as soon as reasonably possible.
The investigation plan will include an inventory of all previously secured
evidence and testimony; a determination of whether additional evidence
needs to be secured; what witnesses need to be interviewed, including
the complainant, respondent, and other witnesses with knowledge of the
research or events in question; a proposed schedule of meetings, briefing
of experts, and interviews; anticipated analyses of evidence (scientific,
forensic, or other); and a plan for the investigative report. - General Approaches to Conducting the Investigation
During the investigation, the committee will take the following
steps.
- Avoid Bias or Conflict of Interest
All necessary steps must be taken to avoid bias or conflict of interest
between the committee and experts and the respondent, complainant,
and witnesses. - Refer Other Issues
The research integrity officer must be advised of any necessary interim
actions to protect the research funds, human or animal subjects, or
other steps required by regulation or policy. See section III.E.3
and III.J. - Consult with the Research Integrity Officer and General Counsel
The investigation committee should consult the research integrity
officer and general counsel throughout the investigation on compliance
with these procedures, PHS or NSF regulations if applicable, appropriate
investigatory and interviewing methods and strategies, legal issues,
and the standard of proof. The research integrity officer and general
counsel will be present or available throughout the investigation
to advise the committee.
- Reviewing the Evidence
The investigation committee will obtain and review all relevant documentation
and perform or cause to be performed necessary analyses of the evidence,
including scientific, forensic, statistical, or other analyses as needed. - Conducting Interviews
The investigation committee will conform to the following guidelines.
- Conducting the Interviews
The investigation committee will conduct the interviews as described
in section V.I., except that at the investigative stage interviews
should be in-depth and all significant witnesses should be interviewed.
Each witness should have the opportunity to respond to inconsistencies
between his or her testimony and the evidence or other testimony,
subject to the need to take reasonable steps to maintain the confidentiality
of the testimony of the respondent and other witnesses. - Preparing for Interviews
The investigation committee will prepare carefully for each interview.
All relevant documents and research data should be reviewed in advance
and specific questions or issues that the committee wants to cover
during the interview should be identified. The committee should appoint
one individual to take the lead on each interview. If significant
questions or issues arise during an interview that require committee
deliberation, the committee should take a short recess to discuss
the issues. Committee deliberations should never be held in the presence
of the interviewee. - Objectivity
The investigation committee will conduct all interviews in a professional
and objective manner, without implying guilt or innocence on the part
of any individual. - Transcribing Interviews
Any interview with the respondent will be transcribed or recorded.
Interviews with anyone else will be summarized, tape-recorded, or
transcribed. A transcript or summary of the interview will be provided
to each witness for review and correction of errors. Witnesses may
add comments or additional information, but changes to the transcript
or summary will only be made to correct factual errors. - Recording Admissions of Misconduct
If the respondent admits to the misconduct, he or she should be asked
immediately to sign a statement attesting to the occurrence and extent
of the misconduct, acknowledging that the statement was voluntary
and stating that the respondent was advised of his or her right to
seek the advice of counsel. The committee should consult with the
general counsel on the specific form and procedure for obtaining this
statement. The admission may not be used as a basis for closing the
investigation unless the committee has adequately determined the extent
and significance of the misconduct and all procedural steps for completion
of the investigation have been met. If applicable, the committee may
ask the research integrity officer or general counsel to consult with
ORI or NSF when deciding whether an admission has adequately addressed
all the relevant issues such that the investigation can be considered
completed. The investigation should not be closed unless the respondent has been appropriately notified and given an opportunity to comment
on the investigative report. If the case is considered complete, it
should be forwarded to the deciding official with recommendations
for appropriate institutional actions and, if applicable, to ORI or
NSF for review.
- Committee Deliberations
- Burden and Standard of Proof
In reaching a conclusion on whether there was misconduct and who committed
it, the burden of proof is on the university to support its conclusions
and findings by a preponderance of the evidence. See section III.G. - Definition of Misconduct
In the case of PHS-funded research, to comply with PHS regulations,
the committee will consider whether falsification, fabrication,
or plagiarism occurred in proposing, conducting, or reporting
research or whether and why there was a serious deviation from
accepted practices in the scientific or professional community
at the time the actions were committed. In the case of NSF-funded research, to comply with NSF regulations,
the committee will consider whether falsification, fabrication,
or plagiarism occurred in proposing, conducting, or reporting
research or whether and why there was a serious deviation from
accepted practices in the scientific or professional community
at the time the actions were committed. In addition, the committee
will consider whether there was retaliation against a person who
reported or provided information about suspected or alleged misconduct
and who has not acted in bad faith. Notwithstanding subparagraphs a. and b., the committee will
always consider the Old Dominion University definition of misconduct
(as defined in Section IV.A.4) for appropriate university response
in the absence of federal agency funding. Included in this category
are cases of possible retaliation for the reporting of misconduct
in PHS-funded research. Accordingly, the investigation committee
will consider whether falsification, fabrication, or plagiarism
occurred in proposing, conducting, or reporting research or whether
and why there was a serious deviation from accepted practices
in the scientific or professional community at the time the actions
were committed. In addition, the committee will consider whether
there was retaliation against a person who reported or provided
information about suspected or alleged misconduct and who has
not acted in bad faith.
- Sufficient Evidence
The committee will consider whether there is sufficient evidence of
intent such that the university can meet its burden of proving misconduct
by a preponderance of the evidence. The committee will also consider
whether the respondent has presented substantial evidence of honest
error or honest differences in interpretations or judgments of data,
such that misconduct cannot be proven by a preponderance of the evidence.
- The Investigation Report
- Elements of the Investigation Report
- Background
The report will include sufficient background information to ensure
a full understanding of the issues. This section should describe the
facts leading to the investigation, including a chronology of the
research at issue, the persons involved in the alleged misconduct,
and the role of the complainant. If PHS or NSF funding is involved,
the report should include any associated grant applications or publications
and any public health issues. This section should summarize the university's
inquiry and investigation processes, including the composition of
the committees, the persons interviewed, the evidence secured and
reviewed, the policies and procedures used, and any other factors
that may have influenced the proceedings. All relevant dates should
be included.
Because the PHS definition of scientific misconduct does not include
retaliation, information and findings about retaliation may be omitted
from the main body of the report submitted to ORI. Information
about the allegation of retaliation will be referenced in an appendix
to the main report as described in X.A.5.e. and X.A.6.b. Notwithstanding
this variation in the definition of misconduct and the attendant
variation in reporting requirements, Old Dominion University will
always treat retaliation as misconduct for the purposes of internal
administrative response. This requirement does not arise in research not funded by PHS because
the Old Dominion University definition of misconduct in scientific
research or in other scholarly activity includes retaliation, thereby
conforming to the NSF definition. - Allegations
The report will list all the allegations raised by the complainant
and any additional misconduct issues that arose during the inquiry
and investigation stages. The source and basis for each allegation
or issue should be cited except to the extent that the confidentiality
of a complainant requesting anonymity is compromised or the identity
of the source is irrelevant or unnecessary. In the case of possible
retaliation in NSF-funded research, this section would describe both
the core misconduct reported and the retaliation that has been alleged. - PHS or NSF Support
In the absence of PHS or NSF support, the report will include a brief
statement of the sources of research funding, if any. For each allegation
of misconduct under the PHS or NSF definition, the report will identify
the PHS or NSF support for the research or report at issue. - Respondent's Claims
The report should summarize each claim that the respondent raises
in his or her defense against the misconduct allegations and cite
the source of each claim. Any inconsistencies among the respondent's
various claims should be noted. The report should not consider claims
that do not address the allegations at issue; allegations of personal
bias by the complainant, for example, should not be addressed in the
report unless they are relevant to the report's conclusions. - Analysis
The report will provide a detailed analysis of the evidence
that either supports or does not support a finding of misconduct.
This analysis should take into account all the relevant statements,
claims, rebuttals, documents, and other evidence related to the
case. Any use of expert analysis should be noted. The analysis should be consistent with the appropriate definition
of misconduct as noted in section II. It should describe the relative
weight given to the various witnesses and pieces of evidence,
noting inconsistencies, credibility, and persuasiveness. It should
demonstrate how a consideration of the evidence as a whole led
to the report's findings. A finding of misconduct should be supported
by a preponderance of the evidence. The report should summarize or quote relevant statements, including
rebuttals, made by the complainant, respondent, and other witnesses
pertinent to the report's analysis and findings. The report should
provide references to the appropriate sources. If the investigation committee determines that the respondent
committed fabrication, falsification, or plagiarism, the report
should indicate the extent and seriousness of the fabrication,
falsification, or plagiarism, including its effect on prior research
findings, research subjects, and the laboratory or project in
which the misconduct occurred. If the investigation committee
determines that the respondent committed misconduct by seriously
deviating from "other commonly accepted practices," the report
should thoroughly document the commonly accepted practice of the
relevant scientific or professional community at the time the
misconduct occurred and indicate the extent of the respondent's
deviation from that standard. Publications, university standards,
or relevant professional societies, state and federal regulations,
expert opinion, and other sources should be described and cited
as the basis for the commonly accepted practice. The serious deviation there from should be described in detail, including
an analysis of why it is a serious ethical deviation. If the investigation committee determines that the respondent
retaliated against a person reporting misconduct or relevant information,
that information will be treated differently based on the source
of funding. If the research was PHS supported, these findings
will be included as an appendix to the report submitted to ORI.
The appendix will include the Old Dominion University definition
of misconduct and explain why the PHS definition does not apply.
If the research was not funded by PHS, but by NSF or other, then
the report need not have this appendix, but merely should indicate
the extent and seriousness of the retaliation and the surrounding
circumstances in the body of the main report. Misconduct does not include honest error or honest differences
in interpretations or judgments of data. If the investigation
committee concludes that misconduct occurred, the report should
describe the evidence that shows that the respondent acted with
intent to commit the misconduct. Specifically, the report should
describe any evidence that the respondent knowingly committed
the falsification, fabrication, plagiarism, or other conduct that
constitutes serious ethical deviation from commonly accepted practices.
If the investigation committee concludes that honest error or
difference of scientific opinion occurred with respect to any
issue, the report should describe the evidence supporting that
finding. All significant pieces of evidence should be referenced in the
analysis, and copies of the significant evidence should be appended
to the report.
- Findings
- Issues
The report will concisely state the investigation committee's
finding for each identified issue. The final investigation report
should make separate findings regarding whether each issue constitutes
misconduct, using the appropriate definition of "misconduct."
See sections II. and IV.A.2. If the investigation committee finds
misconduct on one or more issues, the report should identify the
type of misconduct for each issue; i.e., "fabrication," "falsification,"
"plagiarism," or "other practices that seriously deviate from
those that are commonly accepted within the scientific or professional
community." - Misconduct found under the University's definition but not the
PHS definition
The investigation committee may determine that an issue, such
as retaliation, that does not constitute misconduct under the
PHS definition is, nevertheless, misconduct under the Old Dominion
University definition (Section II.K). Any issue that the investigation
committee determines to be misconduct under the Old Dominion University
definition should be identified as such in an appendix to the
report. These findings are not subject to ORI's jurisdiction,
if ORI agrees that they do not meet the PHS definition.
- Old Dominion University Response
Based on its findings, the investigation committee will recommend
the administrative actions that it believes the university should
take consistent with its policies and procedures, including appropriate
actions against the respondent, such as a letter of reprimand, special
supervision, probation, or other action. These actions will include,
where appropriate, a plan to restore the reputation of any innocent
respondent or complainant and to protect good faith complainants against
retaliation. The committee may identify any published research reports
or professional contributions that should be retracted or corrected
based on the finding of misconduct and take steps to assure that journal
editors are notified. - Summary
The final investigation report should conclude with a detailed and
specific summary of the institution's finding for each issue, an overall
finding of whether misconduct occurred, and if applicable, the PHS
or NSF support for each finding of misconduct under that agency's
definition.
- Standard Format of the Investigation Report
The following outline should be used in preparing the Investigation
Report, except when special factors suggest a different approach. The
outline should incorporate all of the elements described in section X.A.
- Overview and Summary of Findings
Funding (Jurisdictional Requirement for PHS or NSF Funding) - Background
List of allegations and other issues identified by the investigation
committee Institutional Inquiry: Process and Recommendations - Institutional Investigation: Process
- Institutional Investigation: Analysis
For each issue:
Conclusions and Recommended Institutional Actions Optional Appendix of X.A.6.b. Attachments
- Documenting the Investigative File
- Index of Evidence
The investigation committee should maintain an index of all the relevant
evidence it secured or examined in conducting the investigation, including
any evidence that may support or contradict the report's conclusions.
Evidence includes, but is not limited to: research records, transcripts
or recordings of interviews, committee correspondence, administrative
records, grant applications and awards, manuscripts, publications,
and expert analyses. - Purpose of Documentation
The purpose of the documentation is to substantiate the investigation's
findings. - Record Retention
After completion of a case and all ensuing related actions, the research
integrity officer will prepare a complete file, including the records
of any inquiry or investigation and copies of all documents and other
materials furnished to the research integrity officer or committees.
The research integrity officer will keep the file for three years
after completion of the case to permit later assessment of the case.
NSF, ORI or other authorized DHHS personnel will be given access to
the records upon request.
- Comments on the Draft Report
- Respondent
The research integrity officer will provide the respondent with a
copy of the draft investigation report for comment and rebuttal. The
respondent will be allowed ten days to review and comment on the draft
report. The respondent's comments will be attached to the final report.
The findings of the final report should take into account the respondent's
comments in addition to all the other evidence. - Complainant
The research integrity officer will provide the complainant, if he
or she is identifiable, with those portions of the draft investigation
report that address the complainant's role and opinions in the investigation.
The report should be modified, as appropriate, based on the complainant's
comments. - General Counsel
The draft investigation report will be transmitted to the general
counsel for a review of its legal sufficiency. Comments should be
incorporated into the report as appropriate. - Confidentiality
In distributing the draft report, or portions thereof, to the respondent
and complainant, the research integrity officer will inform the recipient
of the confidentiality under which the draft report is made available
and will establish conditions to ensure such confidentiality. For
example, the research integrity officer may request the recipient
to sign a confidentiality statement or to come to his or her office
to review the report.
- Institutional Review and Decision
Based on a preponderance of the evidence, the deciding official
will make the final determination whether to accept the investigation
report, its findings, and the recommended actions. If this determination
varies from that of the investigation committee, the deciding official
will explain in detail the basis for rendering a decision different from
that of the investigation committee. In the case of PHS or NSF funding,
this letter will be included in the letter transmitting the report to
ORI or the NSF inspector general. The deciding official's explanation
should be consistent with the appropriate definition of misconduct, the
university's policies and procedures, and the evidence reviewed and analyzed
by the investigation committee. The deciding official may also return
the report to the investigation committee with a request for further fact-finding
or analysis. In the case of PHS-funded research, the deciding official's
determination, together with the investigation committee's report, constitutes
the final investigation report for purposes of ORI review.
When a final decision on the case has been reached, the research integrity
officer will notify both the respondent and the complainant in writing.
In addition, the deciding official will determine whether law enforcement
agencies, professional societies, professional licensing boards, editors
of journals in which falsified reports may have been published, collaborators
of the respondent in the work, or other relevant parties should be notified
of the outcome of the case. The research integrity officer is responsible
for ensuring compliance with all notification requirements of funding
or sponsoring agencies. - Transmittal of the Final Investigation Report
After comments have been received and the necessary changes have
been made to the draft report, the investigation committee should transmit
the final report with attachments, including the respondent's and complainant's
comments, to the deciding official, through the research integrity officer.
- Time Limit for Completing the Investigation Report
The final investigation report will be completed within 120 calendar
days of the first meeting of the investigation committee. In the case
of PHS or NSF funding, the report will be submitted to ORI or NSF within
these 120 calendar days unless the university submits a written request
for extension and the agency grants the extension. All attachments to
the final report should be submitted with the report. The research integrity
officer should maintain all other evidence and materials for possible
agency review.
- Institutional Administrative Actions
Old Dominion University will take appropriate administrative actions against
individuals when an allegation of misconduct has been substantiated.
If the deciding official determines that the alleged misconduct is substantiated
by the findings, he or she will decide on the appropriate actions to be
taken, after consultation with the research integrity officer. The actions
may include: withdrawal or correction of all pending or published abstracts, papers
emanating from the research, and exhibits or displays where misconduct
was found. removal of the responsible person from the particular project, letter
of reprimand, or special monitoring of future work. sanctions such as probation, suspension, salary reduction, or initiation
of steps leading to possible rank reduction or termination of employment.
restitution of funds as appropriate.
- Other Considerations
- Termination of Employment or Resignation Prior to Completing
Inquiry or Investigation
The termination of the respondent's employment, by resignation
or otherwise, before or after an allegation of possible misconduct has
been reported, will not preclude or terminate the misconduct procedures.
If the respondent, without admitting to the misconduct, elects to resign
his or her position prior to the initiation of an inquiry, but after
an allegation has been reported, or during an inquiry or investigation,
the inquiry or investigation will proceed. If the respondent refuses
to participate in the process after resignation, the committee will
use its best efforts to reach a conclusion concerning the allegations,
noting in its report the respondent's failure to cooperate and its effect
on the committee's review of all the evidence. - Restoration of the Respondent's Reputation
If the institution finds no misconduct and, if applicable, the
ORI or NSF concurs, after consulting with the respondent, the research
integrity officer will undertake reasonable efforts to restore the respondent's
reputation. Depending on the particular circumstances, the research integrity
officer should consider notifying those individuals aware of or involved
in the investigation of the final outcome, publicizing the final outcome
in forums in which the allegation of misconduct was previously publicized,
or expunging all reference to the misconduct allegation from the respondent's
personnel file. Any actions to restore the respondent's reputation must
first be approved by the deciding official. - Protection of the Complainant and Others
Regardless of whether a determination of misconduct is made or if an agency
concurs, the research integrity officer will undertake reasonable efforts
to protect complainants who made allegations of misconduct in good faith
and others who cooperate in good faith with inquiries and investigations
of such allegations. Upon completion of an investigation, the deciding
official will determine, after consulting with the complainant, what steps,
if any, are needed to restore the position or reputation of the complainant.
The research integrity officer is responsible for implementing any steps
the deciding official approves. The research integrity officer will also
take appropriate steps during the inquiry and investigation to prevent
any retaliation against the complainant. - Allegations Not Made in Good Faith
If relevant, the deciding official will determine whether the complainant's
allegations of misconduct were made in good faith. If an allegation was
not made in good faith, the deciding official will determine whether any
administrative action should be taken against the complainant. - Interim Administrative Actions
The dean of the affected college and the Office of Research will
take appropriate interim administrative actions to protect any federal
funds involved and ensure that the purposes of the federal financial assistance
are carried out.
- Agency Review of the Investigation Report and Follow-up
- Purpose of ORI or NSF Review
Funding agencies review the final investigation report, the supporting
materials, and the deciding official's determinations to decide whether
the investigation has been performed in a timely manner and with sufficient
objectivity, thoroughness, and competence. Based on its review, the agency
may:
request additional information; accept all the findings and conclusions of the report; accept all or part of the factual findings of the report and make
its own conclusions; request additional investigation; reject the report and conduct its own investigation; impose administrative actions on the respondent beyond those recommended
by the institution; refer the case for review of the university's regulatory compliance;
or - take any other action deemed to be in the public interest and within
the agency's authority.
ORI will attempt to complete its review of the institution's report
within 180 days of its receipt, except where additional follow-up
activities are required, such as an ORI request for additional information
or analysis or where further investigation is necessary. NSF will
normally assess the accuracy and completeness of an investigation
report within 30 days; similarly, NSF will evaluate the procedure,
recommend adoption of the findings in whole or in part, or initiate
a new investigation.
- Cooperation with Agency Review
For research they fund, ORI (PHS) and the NSF are authorized to review
institutional reports on allegations of misconduct. In reviewing the report,
an agency may request additional information or other assistance from
the research integrity officer or other university officials. If the university
official receiving the ORI or NSF request is unsure how to respond, he
or she should consult with the research integrity officer or general counsel.
The general counsel may consult with agency counsel prior to advising
the university official on how to respond. - Request for Additional Documents and Information
The research integrity officer will cooperate with any agency request
for additional relevant documents and information by responding to all
requests in a timely and responsive fashion. The research integrity officer
may consult with the general counsel for advice as needed. - Notification of Agency Determination
- ORI Concurrence
If ORI concurs with the university's findings, ORI will notify the
respondent and appropriate university officials in writing and will
send the respondent and appropriate university officials a summary
or copy of the concurrence and notice of any additional PHS actions.
If there is an ORI finding of misconduct, the respondent will be notified
of his or her opportunity to appeal to the DHHS Departmental Appeals
Board (DAB). See 59 Fed. Reg. 29809 (1994). - ORI Nonconcurrence
If ORI does not concur with the university's findings, ORI will notify
the appropriate university official of the basis for that decision.
If ORI does not concur with a finding of no misconduct, the university
may be requested to conduct a further investigation, either with the
same or a different investigation committee, or ORI may conduct its
own investigation. In the latter instance, ORI will notify the appropriate
individuals of its investigation. - NSF Concurrence
If NSF concurs with a university finding of no misconduct, the NSF
inspector general will notify the subject of the investigation and
the appropriate university personnel. If NSF concurs with a finding
of misconduct, in a case in which NSF considers debarment an appropriate
disposition, that case will be referred to the debarring official.
If NSF concurs in a case in which debarment is not an appropriate
disposition, then that case will be referred to the deputy director
for a decision on the recommended disposition within 45 days after
completion of the investigation; the deputy director may concur, initiate
further hearings or investigation, or specify additional actions.
An affected individual may appeal the deputy director's decision in
writing within 30 days after receiving notification. Otherwise the
decision becomes a final administrative action. - NSF Nonconcurrence
If NSF does not concur with the university's findings, NSF will notify
the appropriate university official of the basis for that decision.
If NSF does not concur with a finding of no misconduct, the university
may be requested to conduct a further investigation, either with the
same or a different investigation committee, or NSF may conduct its
own investigation.
- Cooperation in Appealed Cases
For cases in which ORI concurs with the institution's findings of misconduct
under the PHS definition or makes its own finding of misconduct, ORI will
request institutional employees to cooperate in presenting ORI findings
of misconduct before the DAB if the respondent appeals the findings. Cooperation
includes providing evidence, testimony, or any other information needed
to assist in the preparation and presentation of ORI's case before the
DAB. Institutional employees may consult with the research integrity officer
or institutional counsel in responding to ORI's request for cooperation.
- Record Retention
After completion of a case and all ensuing related actions, the research integrity
officer will prepare a complete file, including the records of any inquiry
or investigation and copies of all documents and other materials furnished
to the research integrity officer or committees. The research integrity officer
will keep the file for at least three years after completion of the case to
permit later assessment of the case. Authorized agency personnel will be given
access to the records upon request.
This appendix summarizes the responsibilities assigned to the deciding official
and the research integrity officer. The appendix is a review of the duties
assigned to these two officials. Responsibilities of the Deciding Official
Determines whether an investigation is warranted Determines whether to accept the investigation report Determines institutional administrative actions if misconduct is found Explains why the institution does not agree with the investigation report
in a transmittal letter to ORI or NSF Determines institutional administrative actions against "bad faith" complainants Informs ORI or NSF that an investigation is not warranted if the agency
requested the inquiry
Responsibilities of the Research Integrity Officer
Receipt of Allegations Receives allegations of misconduct Receives allegations of retaliation Receives reports of "bad faith" allegations Receives reports of violations of PHS or NSF regulations
Assessment of Allegations
Conducts preliminary assessment of allegations Determines whether an inquiry is warranted Refers non-scientific misconduct issues to appropriate institutional
or Federal office
Conduct of Inquiry
Initiates inquiry process Notifies appropriate institutional officials, the respondent, and, if
necessary, the appropriate agency that an inquiry is underway Sequesters research or other relevant records May conduct the inquiry in appropriate cases Appoints the inquiry official or committee, as required Replaces the first challenged person with a qualified substitute and
determines whether to replace other challenged persons Determines whether additional expertise is needed Establishes conditions of confidentiality Protects against bias or conflicts-of-interest Develops the charge Provides the inquiry official or committee with advice on appropriate
procedures Meets ORI or NSF notification requirements Takes appropriate interim administrative actions Seeks advice from federal agencies when an admission of misconduct is
made Determines whether a time extension will be allowed Provides a draft report to the respondent Provides appropriate portions of the draft report to complainant Transmits the final report and comments to the deciding official Communicates the decision of the deciding official to the inquiry committee,
complainant, and respondent. Notifies ORI or NSF if an investigation will be conducted Provides the final report and inquiry file to ORI or NSF upon request,
if relevant Retains all inquiry records Reports "bad faith" allegations to the deciding official Undertakes reasonable efforts to restore the reputation of cleared respondents Undertakes reasonable efforts to protect "good faith" complainants
and others who cooperated with the inquiry
Conduct of Investigation
Notifies the respondent that an investigation will be conducted Sequesters additional research records when necessary May conduct the investigation in appropriate cases Appoints the investigation official or committee Replaces the first challenged person and determines whether to replace
persons challenged later Determines whether additional expertise is needed Establishes conditions of confidentiality Protects against bias or conflicts-of-interest Develops the charge Convenes the first meeting of the investigation committee Provides the investigation official or committee with advice on appropriate
procedures Meets ORI or NSF notification requirements, if relevant Takes appropriate interim administrative actions Seeks advice from federal agencies when an admission of misconduct is
made Requests an extension if necessary from ORI or NSF and submits progress
reports Submits plan to terminate an investigation to ORI or NSF - Provides a draft report to the respondent
Provides appropriate portions of the draft report to the
complainant Transmits the final report and comments to the deciding official Notifies the respondent and complainant of the institution's findings
and actions Retains all records of investigation Reports "bad faith" allegations to the deciding official Undertakes reasonable efforts to restore the reputation of cleared respondents Undertakes reasonable efforts to protect "good faith" complainants
and others who cooperated with the inquiry
Post-Investigation
|
|