Research Misconduct
Thomas J. Inzana, Ph.D.
Associate Vice-President for
Research Programs
and
Research Integrity Officer
Federal Laws on Research
Misconduct
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Public concern over research misconduct initially arose
in the early 1980’s.
At the time, research institutions sometimes ignored
or covered up potential misconduct problems rather
than investigate them.
In December 2000 the Office of Science and
Technology Policy adopted a federal policy on
research misconduct.

DHHS enacted regulation effective 6/15/05
 “Public Health Service Policies on Research
Misconduct”
 Implements legislative and policy changes
applicable to research misconduct that occurred
over last several years.
 Covers any entity that applies for a research,
research-training or research-related grant or
cooperative agreement with the Public Health
Service (PHS)
Purpose of Research Misconduct Policies
► Establish
definitions for research misconduct
► Outline procedures for reporting and
investigating misconduct
► Provide protection for whistleblowers and
persons accused of misconduct
Research Misconduct
► What
is it?:
 The Department of Health and Human Services defines
research misconduct as:
 Fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research results.
► Fabrication:
making up results and recording or reporting them
► Falsification: manipulation of research materials, equipment, or
processes, or changing or omitting results such that the research
is not accurately represented in the record.
► Plagiarism: the appropriation of another’s ideas, processes,
results, or words without giving proper credit.
Criteria for Research Misconduct
Represents a significant departure from
accepted practices
 Has been committed intentionally, or
knowingly, or recklessly; and
 Can be proven by a preponderance of
evidence
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What is NOT MISCONDUCT: honest, unintentional
error
+
=
Research Misconduct
SCIENTIFIC MISCONDUCT: How Prevalent Is Fraud?
That's a million-Dollar Question
Science 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663
How often does scientific misconduct occur? There
seems to be no consensus on the answer,
although a range of estimates were presented at a
conference called last month by a key federal
watchdog agency to announce a $1 million grants
program to investigate the prevalence of fraud,
data fabrication, plagiarism, and other
questionable practices in science. The 9-year-old
Office of Research Integrity hopes to support
studies gauging the frequency of misconduct and
assessing efforts to raise ethical standards.
Department of Health & Human Services received
267 reports of research misconduct (2004)
• 50% increase from 2003
• 35% of closed cases involve research misconduct
•
► What
is it not:
 Honest error or differences of opinion
ORI 2007 Annual Report
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In 2007, ORI opened 14 new cases and closed 28 cases.
Of the 28 cases closed by ORI, 10 cases resulted in
sustained findings of research misconduct and/or PHS
administrative actions against the respondents.
Debarments were imposed in 7 of the 10 cases that
resulted in research misconduct findings: 1 for life, 2 for 5
years, and 4 for 3 years. PHS administrative actions
imposed in the remaining cases were one 4-year
supervisory period, two 3-year supervisory periods, and a
3-year certification period.
Thirty-five percent of ORI’s closed cases in 2007 resulted
in PHS misconduct. There is an historical average of about
33 percent of cases are found to be misconduct.
Nature 453, 980-982 (19 June 2008)
► SURVEY
of 2,212 Researchers
 Observed 201 instances of misconduct
 E.G.
► "A
post doc changed the numbers in assays in order to
'improve' the data."
► "A colleague duplicated results between three different papers
but differently labeled data in each paper."
► "A co-investigator on a large, interdisciplinary grant application
reported that a postdoctoral fellow in his laboratory falsified
data submitted as preliminary data in the grant. As principal
investigator of the grant, I submitted supplementary data to
correct the application."
► "A colleague used Photoshop to eliminate background bands on
a western blot to make the data look more specific than they
were."
ORI Recommendations
► Adopt
zero tolerance
► Protect whistleblowers
► Clarify how to report
► Train the mentors
► Model ethical behavior
Top ten “POOR” behaviors
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1. Falsifying or ‘cooking’ research data
2. Ignoring major aspects of human-subject requirements
3. Not properly disclosing involvement in firms whose
products are based on one‘s own research
4. Relationships with students, research subjects or clients
that may be interpreted as questionable
5. Using another’s ideas without obtaining permission or
giving due credit (plagiarism)
6. Unauthorized use of confidential information in
connection with one’s own research
7. Failing to present data that contradict one’s own
previous research ????
8. Circumventing certain minor aspects of human-subject
requirements
Top ten behaviors
(continued)
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9. Overlooking others' use of flawed data or questionable
interpretation of data
10. Changing the design, methodology or results of a study in
response to pressure from a funding source (falsification)
Other behaviors
11. Publishing the same data or results in two or more
publications
12. Inappropriately assigning authorship credit
13. Withholding details of methodology or results in papers or
proposals
14. Using inadequate or inappropriate research designs
15. Dropping observations or data points from analyses based
on a gut feeling that they were inaccurate
16. Inadequate record keeping related to research projects
Why does misconduct happen?
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Publish or Perish Pressure
Desire to “get ahead”
Personal problems
Character issues
Cultural Differences
???
SCIENTIFIC MISCONDUCT:
Scandals Shake Chinese Science
► "Too
many incentives have blurred the
reasons for doing science in some people's
minds“
 Lu Yongxiang, president of the Chinese
Academy of Sciences
► "Though
it is difficult to ascertain the
number of misconduct cases, the negative
impact of these cases should not be
underestimated“
 Ministry of Education spokesperson Wang
Xuming
How is misconduct identified
► Suspected
and reported by a colleague
► Failure to confirm research results
by own lab or others
Institutional Procedures Required to Qualify for
PHS Funding
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The designation of an individual authorized to receive and
investigate allegations of misconduct (RIO)
Provisions for an initial inquiry to determine if allegations
have merit
Provisions for a formal investigation to determine the truth
of the allegations
The designation of an individual authorized to adjudicate
the conclusions of the investigation and impose
administrative actions to redress the misconduct or to
vindicate the person charged (DO)
Provisions for reporting findings to ORI
Investigation Process
► Allegations reported to and assessed by RIO
► RIO reviews allegations, sequesters research
records, and if credible forwards to inquiry
committee
► Inquiry report is made and if investigation is
substantiated records are forwarded to the
investigation committee
► Initial draft reviewed by RIO and DO (Provost),
and final report sent to all parties (respondent,
complainent, RIO, DO)
► Institutional decision and administrative action
Consequences (if misconduct is
substantiated)
► Withdrawal
or correction of all pending and
published papers and abstracts affected by
the misconduct
► Reprimand, removal from project, rank and
salary reduction, dismissal
► Restitution of funds to the granting agency
► Ineligibility to apply for Federal grants for
years
► I.E. the end of your research career!
Case Example - Pat J. Palmer
Fabricated 6 interview
records
Fabricated claim of Ph.D.
(B.S. and M.S. also)
Falsified that she was
co-author on 10 articles
Did I say I have a
Ph.D. in
Epidemiology?
Example
SCIENTIFIC MISCONDUCT: Truth and Consequences
Science 1 September 2006: Vol. 313. no. 5791, pp. 1222 - 1226
MADISON, WISCONSIN--After making the
difficult decision to turn in their adviser for
scientific misconduct, a group of graduate
students is trying to recover from the resulting
damage to their careers.
One afternoon, in the conference room down the
hall from the lab, Ly told Goodwin she was
concerned about her progress: The project she'd
been working on, Ly felt, wasn't yielding usable
results. Despite months of effort, Ly was unable to
replicate earlier observations from the lab.
Misconduct as an Excuse?
Chronicle of Higher Education
► Colorado
Regents Vote to fire Ward Churchill (Prof. of
ethic studies at Univ. Col. Boulder)
 Research misconduct cited, but Professor says decision was
political and sues
► Six
years ago Ward Churchill compared the American
victims of 9/11 to Nazi bureaucrats
► The BOR says that the firing was due to “repeated and
deliberate research misconduct that fell below the
minimum standard of professional integrity, involving
fabrication, improper citation, and plagiarism”.
Nursing Professor at Tennessee State University
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James Linn – admitted research misconduct by "knowingly
and intentionally falsifying and/or fabricating the data and
results of a study in which he purportedly tested the
effects of an intervention to reduce sexual risk behaviors in
high risk, impaired populations of homeless men with
mental illness by reporting false values for variables"
Published in Cellular and Molecular Biology
Funded by National Institute of General Medical Sciences
 Debarred for 3 years from contracting/subcontracting with any
agency of the U.S. Government
 Serving in an advisory capacity to the PHS
Researcher Faces Prison for Fraud in NIH Grant Applications
and Papers
Science 25 March 2005: Vol. 307. no. 5717, p. 1851
A researcher formerly at the University of Vermont College of
Medicine has admitted in court documents to falsifying data in
15 federal grant applications and numerous published articles.
Eric Poehlman, an expert on menopause, aging, and metabolism,
faces up to 5 years in jail and a $250,000 fine and has been
barred for life from receiving any U.S. research funding.
The number and scope of falsifications discovered, along with the
stature of the investigator, are quite remarkable. "This is
probably one of the biggest misconduct cases ever,"
Poehlman, 49, first came under suspicion in 2000 when Walter
DeNino, then a 24-year-old research assistant, found
inconsistencies in spreadsheets used in a longitudinal study on
aging.
In an effort to portray worsening health in the subjects, DeNino
tells Science, "Dr. Poehlman would just switch the data points."
Who is investigated and who is held
accountable?
► Investigated
 All authors that are involved in the specific data
in question
► Held
accountable
 Primary author
 Other authors whose results are found culpable
 The PI
Mentor Responsibilities
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Mentors have the responsibility to ensure that
all trainees (post-docs, grad students,
undergrads) are aware of the responsible
conduct of research
 Define the Relationship
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Role of Trainee
Publication/Authorship
Serving as PI or Co-PI
Obligation to report
 Good faith report
VT Requirements
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Establish policies and procedures for
investigating and reporting instances of
alleged research misconduct
Respond to allegations
Promote responsible conduct of
research
Provide assurances necessary to permit
VT to participate in Federally supported
research
Provide annual report
Procedures for Responding to Allegations of Misconduct in
Research
Undergraduate
Honor System
Complainant
Anonymous
Referrals of Research
Misconduct
Graduate Honor
System
HHS or Other
Sponsor
VT Official
Committee on
Faculty Ethics
Submit Allegations to RIO
(Falsification, Fabrication, Plagiarism in Research)
Within 7 days
Refer to
appropriate
University
unit
No
RIO performs assessment of
allegation
Is allegation within
definition of
Misconduct in
Research?
Yes
Non-sponsored research
and Respondent is either:
Classified staff
Graduate students
Undergraduate students
No
Does allegation
warrant inquiry
Yes
Potential Evidence of Misconduct
Identified
No
Yes
Not sufficiently
credible and specific
Review with standing
members of Inquiry
Committee
No
Dismiss
Allegation
Procedures for Responding to Allegations of Misconduct in
Research (continued)
Research Records
Obtain Custody
RIO
Initiates Inquiry
Process
Provide written notification
Respondent
Within 10 days
RIO Convenes Inquiry Committee
·
1 standing member
·
1 CFE member
·
Members and experts as
appointed by RIO for the case
·
RIO charge to committee
·
·
Brief on Allegation
Plan on Inquiry
Provide written notification
objection to members
(within 10 days)
Resolve conflicts of interest
within committee
Inquiry Committee
Initiates Inquiry Process
·
·
·
60 calendar days for completion
Interviews
Examine research records
Evaluate evidence
Prepare Initial Inquiry Report
·
·
Review by RIO for
compliance with policy
Modification as
appropriate in consultation
with RIO
Respondent
Procedures for Responding to Allegations of Misconduct
in Research (continued)
Revise Initial Inquiry Report
(if required)
Respondent Review
10 days for comments
Report to Include
·
Name and position of Respondent
·
Description of allegations
·
Contract/ funding source information
·
Basis for recommendation including list
of research records reviewed
·
Attach Respondent’s and
Complainant’s comments
·
Name and titles of committee members
·
Whether any action should be taken if
investigation not recommended
Complainant Review
10 days for comments
Discuss comments on report
(Inquiry Committee, the RIO, and DO)
No
Investigation
·
·
·
No
Retain records for 7 years
Provide notices
Provide guidance to
Respondent if needed
Prepare Final Inquiry Report
Is Investigation Warranted?
(Majority vote of Inquiry Committee)
(Within 60 days of start of
Inquiry Process unless
documented extension.)
Procedures for Responding to Allegations of Misconduct
in Research (continued)
Yes
Provide Written Notification
Secure Additional Records
& Evidence
ORI
·
·
·
Decision to begin
Copy of report
Other information as
requested
Begin Investigation
Within 30 calendar days
Respondent
·
·
Allegations to be
investigated as a
result of inquiry
New allegations to be
investigated within
scope of initial
allegations
RIO charge to committee
·
·
RIO Convenes Investigation Committee
·
2 standing member
·
1 CFE member
·
Members and experts as appointed
by RIO for the case
·
Provide written notification
Respondent
objection to members
(within 10 days)
Resolve conflicts of interest
within committee
Investigation Committee Initiates
Investigation Process
Brief on Allegation
Discuss procedures
and requirements
Pursue Investigation
·
·
·
Interviews
Examination of research records and evidence
Pursue new issues and leads discovered that are relevant
Procedures for Responding to Allegations of Misconduct
in Research (continued)
Draft Investigation Report
+ copy of (or supervised
access to) evidence
+ copy of (or supervised
access to) evidence
·
·
·
·
Respondent Review
·
·
Describes allegations
Identifies respondent
Identifies & summarize
research records &
evidence
Describe and document
any federal support
Describe policy and
procedures used
Statement of findings
for each allegation
Provide comments within 30 days
Discuss Comments on Report
(Investigation Committee, RIO
and DO)
Prepare Final
Investigation Report
Is there Misconduct in Research?
Committee findings (Positive or
Negative)
(majority vote)
Complainant Review
Provide comments within 30 days
Procedures for Responding to Allegations of Misconduct in
Research (continued)
DO Final Determination
(Findings and administrative actions)
Notice to Respondent and Complainant
Within 10 days
File Appeal
Process
Findings
No Appeal
Deciding Official
review
Within 120 days start of
Investigation
Within 120 days of
start of appeal
Procedural Noncompliance
RIO Review
Recommendations
to Investigation
Committee and
DO
DO Determination
Final Decision
Appeal
Faculty Review Committee or
Appropriate Grievance
Procedure
Procedures for Responding to Allegations of Misconduct
in Research (continued)
Final Decision
(continued)
RIO Provides
Written Notifications
Institutional Administrative Action
Notice to other
sponsors
DO Determination
Respondent
No Misconduct
Notice to ORI
(Within 120 days start of
investigation or appeal process)
Appropriate
administrative
actions
Restoration of
Respondent
Reputation
Complainant
Misconduct
Protections of
Complainants, witnesses,
and committee members
·
·
·
·
·
·
·
Withdrawal or correction
of publications
Removal of person from
project
Restitution to sponsor
Other internal institutional
actions
·
Others as
appropriate
(paper, magazine)
Final Investigation Report with
attachments
Statement of whether institution accepts
findings (or outcomes of appeal)
Statement of Whether institution found
misconduct
Description of any pending or completed
administrative action
SCIENCE: Vol 435|9, p.737 June 2005
COMMENTARY
Scientists behaving badly
“To protect the integrity of science, we must
look beyond falsification, fabrication and
plagiarism, to a wider range of questionable
research practices”
Brian C. Martinson, Melissa S. Anderson
and Raymond de Vries.
Responsible Research Conduct
The Office of Research
Integrity (ORI) defines
research integrity as
“adherence to rules,
regulations, guidelines, and
commonly accepted
professional codes or norms.”
• Research integrity is essential
to ensure the reliability of
research results and to
preserve public support for
research.
•
Information Sources
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DHHS 42 CFR Parts 50 and 93; Federal Register/Vol 70, No. 94, 2005.
“Fraud and the Role of Intensions” On Being A Scientist, Committee on
the Conduct of Science, National Academy of Sciences. National
Academy Press, Washington, D.C., 1989, page 15, ISBN 0-309-04091-4
Martinson, B., Anderson, M.,& de Vries, R., “Scientists behaving badly”.
Journal of Nature 435, 737-738, June 2005.
Office of Research Integrity http://ori.dhhs.gov/
Office of Research Integrity: Case Summary-Pat J. Palmer. Federal
Register: February 17, 2004, 69:31, 7488-7489.
Steneck, Nicholas H. (2004) ORI: Introduction to the Responsible
Conduct of Research.
WEBSITE FOR THIS POWER POINT FILE:
http://www.research.vt.edu/reports/Research_Misconduct.ppt
Contact Us

Dr. Thomas Inzana, Associate Vice President for Research Programs, Office of the Vice
President for Research
[email protected]
http://www.research.vt.edu/announcement/misconduct.html
https://www.fdi.vt.edu/public/modules/selfenroll/_viewevent.php?eventPk1=5885


231-5188
Linda Bucy, Interim Assistant Vice President
Office of Sponsored Programs
[email protected]
231-9477
Carol Roberson, Special Assistant for Research Contract Affairs
Office of the Vice President for Research
[email protected]
231-5520
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