Research Integrity:
The Importance of Mentor/Mentee
Relationships
Tina L. Cheng, MD, MPH
July 12, 2016
1
Tina L. Cheng
• No Disclosures
7/12/2016
2
Outline
• What is Research Integrity?
• What is the Problem?
• Research Misconduct
– WHO?
– WHAT?
– WHEN/WHERE?
– WHY?
• As Mentors, HOW can we Ensure
Research Integrity?
Question #1
What is the most common cause of
scientific publication retraction?
A. Error
B. Fraud or Suspected Fraud
C. Duplicate Publication
D. Plagiarism
E. Other
July 12, 2016
4
Question #2
• Your mentee is writing his paper analyzing data
from your large study. He gives you a draft of
the paper that includes the methods section of
your previously published paper verbatim. He
says that since the methods are the same he
didn’t rewrite the methods paragraphs.
• Do you agree? Why or why not?
July 12, 2016
5
Question #3
In the PAST THREE ACADEMIC YEARS, how many
times have you observed or had other direct
evidence of researchers in your department (or
equivalent organizational unit) allegedly committing
research misconduct (falsification, fabrication, or
plagiarism) in proposing, performing, or reviewing
research, or in reporting research results?
____ Zero times
____ One time in the past three academic years
____ Two times in the past three academic years
____ Three times in the past three academic years
____ Four or more times in the past three academic years
Question #4
• Your meticulous project coordinator, PC, has worked
with you for three years on a randomized trial involving
interviews with patients at baseline, 6 and 15 months.
Your team reviews the patient tracking log recording
completion of interviews at your weekly meeting. PC’s
attendance becomes erratic and a covering research
assistant tells you she cannot find copies of ten 6
month interviews that PC stated she had done. Calling
of patients reveals that PC never completed the
interviews that she recorded in the log as completed.
What do you do now?
July 12, 2016
7
Case
• The Players:
– Dr. Eugene Braunwald, mentor
– Dr. John Roland Darsee, mentee
– 47 researchers, co-authors over 3 years
Wright DE et al. Sci Eng
Ethics, 14:323-336, 2008
7/12/2016
8
Darsee Case
• Occurred in the early 1980s
• Scrutiny by Congress, press
• Led to federal research misconduct
regulations by the Public Health Service
and the National Science Foundation
• Office of Research Integrity (ORI)
established
– 800 formal cases in 18 years
Wright DE et al. Sci Eng
Ethics, 14:323-336, 2008
7/12/2016
9
Responsible Conduct of Research
(RCR) Training
• NIH and NSF guidelines require institutions
receiving federal funds to provide ongoing
training and education in RCR
• The areas to be covered include:
–
–
–
–
–
–
–
–
Data Acquisition and Management
Responsible Authorship
Responsible Peer Review
Research Misconduct
Mentoring
Collaborative research
Conflicts of Interest
The scientist as a responsible member of society
Office of Science & Technology,
White House, 2000
Research misconduct is defined as fabrication,
falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting
research results.
• Falsification is manipulating research materials,
equipment, or processes, or changing or omitting
data or results such that the research is not
accurately represented in the research record.
• Fabrication is making up data or results and
recording or reporting them.
• Plagiarism is the appropriation of another person's
ideas, processes, results, or words without giving
appropriate credit.
NIH and Research Integrity
Research integrity includes:
• the use of honest and verifiable methods in
proposing, performing, and evaluating
research
• reporting research results with particular
attention to adherence to rules, regulations,
guidelines,
• and following commonly accepted professional
codes or norms.
http://grants.nih.gov/grants/research
_integrity/index.htm
Johns Hopkins Medicine and
Research Integrity
• Includes the destruction, absence of, or
accused person’s failure to provide research
records accurately documenting the
questioned research
• Does not include honest error or honest
differences of opinion
Johns Hopkins Medicine and
Research Integrity
• Each of the following must be met to
support a finding of research misconduct:
– Significant departure from the accepted
practices of the scientific community
– Committed intentionally, knowingly, or
recklessly
– Allegation has been proven by a
preponderance of the evidence
http://www.hopkinsmedicine.org/Resea
rch/OPC/Research_Integrity/
Outline
• What is Research Integrity?
• What is the Problem?
• Research Misconduct
– WHO?
– WHAT?
– WHEN/WHERE?
– WHY?
• As Mentors, HOW can we Ensure
Research Integrity?
Three Study Designs
• Scientist Self Report Surveys of
Misconduct
• Scientist Surveys Reporting
Observation of Misconduct
• Review of Office of Research Integrity
(ORI) Cases of Misconduct
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Scientist Self-Report
Martinson et al Study, 2005
• Anonymous survey of 4160 early and 3600
mid-career scientists funded by NIH
• Response rates: 43% Early career, 52% Mid
career
• 33% had engaged in at least one of the top
ten behaviors during the previous three years
Martinson B et al. Scientist Behaving
Badly. Nature 435: 737-738, 2005
Scientist Self-Report
Martinson et al Study 2005
Martinson B et al. Nature 435: 737-738, 2005
Scientist Self-Report
Martinson et al Study 2005
Martinson B et al. Nature 435: 737-738, 2005
How Many Scientists Fabricate & Falsify Research?
A Systematic Review & Meta-Analysis
2% of scientists
admitted to have
fabricated, falsified
or modified data or
results at least
once
Fanelli D. PLoS One
2009; 4:e5738
Scientist Observation & Reporting
of Misconduct, Gallup Survey 2006
7/12/2016
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Scientist Observation & Reporting
of Misconduct, Gallup Survey 2006
• Anonymous random survey to 4298
principal investigators of NIH R01s at
4298 unique departments at 605
universities, institutes, hospitals
• Response rate 51%
7/12/2016
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Question
In the PAST THREE ACADEMIC YEARS, how many
times have you observed or had other direct
evidence of researchers in your department (or
equivalent organizational unit) allegedly committing
research misconduct (falsification, fabrication, or
plagiarism) in proposing, performing, or reviewing
research, or in reporting research results?
____ Zero times
____ One time in the past three academic years
____ Two times in the past three academic years
____ Three times in the past three academic years
____ Four or more times in the past three academic years
Scientist Observation & Reporting
of Misconduct, Gallup Survey 2006
• 164 scientists (7.4% of sample) reported
observing 201 incidents of meeting the
federal definition of misconduct over 3 yrs
• ~ 3 incidents/100 researchers/yr
• If this rate applied to entire population of
scientists supported by NIH (~155,000)=
2300-4600 incidents per year.
• 58% reported to institutional officials
7/12/2016
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How Many Scientists Fabricate & Falsify Research?
A Systematic Review & Meta-Analysis
Fanelli D.
PLoS One
2009; 4:e5738
JHU SOM Misconduct Cases
JHU School of Medicine
• Approximately 2500 full time and
1300 part time faculty
• Approximately 1500 graduate
students
• Approximately 1600 postdoctoral
trainees (non house staff)
• Approximately 900 house staff
Question #1
What is the most common cause of
scientific publication retraction?
A. Error
B. Fraud or Suspected Fraud
C. Duplicate Publication
D. Plagiarism
E. Other
July 12, 2016
28
Question #1
What is the most common cause of
scientific publication retraction?
A. Error
B. Fraud or Suspected Fraud
C. Duplicate Publication
D. Plagiarism
E. Other
21%
43%
14%
10%
Fang FC et al. PNAS
2012;109;17028-33
July 12, 2016
29
Retractions in Scientific Publications
Number of retracted articles by cause
Fang FC
et al.
PNAS
2012;109;
17028-33
Retractions in Scientific Publications
Percent of publications retracted
Fang FC et al. PNAS
2012;109;17028-33
Retractions in Scientific Publications
Fraudlent vs. Error
• Journal Impact Factor was higher for
fraudulent papers (p<.001)
• Fraudulent papers were more likely to be
written by a first author who had written
other retracted papers than error retraction
papers (53% vs 18%, p<.0001)
• More fraud than error among retracted
papers from the USA compared to the rest
Steen RG J Med Ethics
of the world (p<.05)
2011;37:113-117
Outline
• What is Research Integrity?
• What is the Problem?
• Research Misconduct
– WHO?
– WHAT?
– WHEN/WHERE?
– WHY?
• As Mentors, HOW can we Ensure
Research Integrity?
WHO had Misconduct?
Gallup Survey 2006
Titus SL et al. Nature
2008;453:980-82
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WHO had Misconduct?
ORI Case Reviews
Fang FC et al.
MBio. 2013 Jan
22;4(1):e00640-12
7/12/2016
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WHAT Misconduct?
Gallup Scientist Survey 2006
• Misconduct observed
– 60% falsification or fabrication w or w/o
plagiarism
– 36% plagiarism only
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Question #2
• Your mentee is writing his paper analyzing data
from your large study. He gives you a draft of
the paper that includes the methods section of
your previously published paper verbatim. He
says that since the methods are the same He
didn’t rewrite the methods paragraphs.
• Do you agree? Why or why not?
• If published, self plagiarism, copyright
infringement
July 12, 2016
37
WHAT Misconduct?
Plagiarism
•
•
•
•
Common!
Plagiarism of ideas
Plagiarism of text
Self plagiarism
Time Editor-at-Large,
CNN host
7/12/2016
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WHAT Misconduct?
Self Plagiarism
• Double dipping: redundant and duplicate
publications
• Salami slicing: data fragmentation,
partitioning one study into multiple
smaller publications
• Copyright infringement
Roig M. Avoiding plagiarism,
• Text recycling
self plagiarism and other
7/12/2016
questionable writing practices:
a guide to ethical writing,
http://www.cse.msu.edu/~alexli
u/plagiarism.pdf
39
WHAT Misconduct?
Gallup Scientist Survey 2006
• A post doc changed the numbers in assays in
order to ‘improve’ the data.
• A colleague duplicated results between three
different papers but differently labelled data in
each paper.
• A co-investigator on a large, interdisciplinary
grant application reported that post doc falsified
data submitted as preliminary data in a grant.
• A colleague used Photoshop to eliminate
background bands on a western blot to make
the data look more specific than they were.
Titus SL et al. Nature
2008;453:980-82
WHAT Misconduct?
Wright ORI Review of Trainee Misconduct
• Closed ORI cases of trainee misconduct 19902004
• 33 post docs, 10 graduate students and 2
additional trainees
• All but three cases involved either or both
fabrication and falsification
• 77% admitted to misconduct
– most signed a Voluntary Exclusion Agreement
with ORI precluding them from receiving federal
funds for research from 3-5 years
– 63% required retractions of publications
– 41% fired or dismissed, 43% resigned
Wright DE et al. Sci Eng
Ethics 2008 14:323-336
WHEN/WHERE was the Misconduct?
Wright ORI Review of Trainee Misconduct
• How was it discovered?
– 39% others could not replicate the data
– 36% case witnesses
– 25% found when researchers wanted to
examine the source data and it could not
be located.
WHEN/WHERE was the Misconduct?
Gallup Survey 2006
Titus SL et al. Nature
2008;453:980-82
7/12/2016
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WHY did they do it?
Wright ORI Review of Trainee Misconduct
• Sociopathology
• Increasing pressure on researchers
• Arrogance, already knowing the right
answer without bothering to do the
experiment
• Ignorance of research standards and
ethical norms, poor mentoring
WHY did they do it?
•
•
•
•
Career advancement and promotion
Competitiveness
Laziness
Ability to get away with it
WHY did they do it?
Wright ORI Review of Trainee Misconduct
• 53% of cases described their stress levels
as a factor that caused or contributed to
their misconduct
– 62% felt pressure to perform well
– 38% felt time-related stress such as submitting
a grant, publication or publication deadline or
complete dissertation
– 17% felt unreasonable pressure from the
mentor to get desired or quick results
WHY did they do it?
Wright ORI Review of Trainee Misconduct
“Even though I had already secured a
position…and had 18 publications, an NIH
fellowship and several awards for my prior
work, I believed myself to be a complete
failure as a scientist…I think that was
going through my mind, had led me to
believe that, if I could just show one piece
of ‘promising’ data on a group meeting, my
supervisor would let me continue working
on the problem and produce real data that
be presented and published…”
WHY did they do it?
Wright ORI Review of Trainee Misconduct
“There was much excitement over this [surprising
and promising preliminary result] and I began to
feel a self-imposed pressure to keep the
positive data coming in. It was at this time that
I began to substitute buffer for the control SSS.
At the time I realized I was making a grave
error in judgment, but as the excitement over
the results grew and grew I felt more pressure
to manipulate the system…over time I lost
more and more control and felt like I could not
stop falsifying experiments.”
WHY did they do it?
• Association between scientific
misconduct and perceptions of
inequities in resource distribution
processes
Martinson B et al.
Nature 435: 737-738,
2005
WHY did they do it?
Scientist Self Report Survey
• Being expected to obtain external
funding
• Receiving federal research funding
• Private industry involvement
were all associated with significantly
higher reports of misconduct and
neglectful or careless behaviors
7/12/2016
Martinson et al. Acad Med
2009;84:1491-99
52
WHY did they do it?
Scientist Self Report Survey
• “The free play of university and
individual self-interests, combined with,
and contributing to the intense
competition for research funding, may
be undermining scientific integrity.”
Martinson et al. Acad Med
2009;84:1491-99
7/12/2016
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Outline
• What is Research Integrity?
• What is the Problem?
• Research Misconduct
– WHO?
– WHAT?
– WHEN/WHERE?
– WHY?
• As Mentors, HOW can we Ensure
Research Integrity?
Question #4
• Your meticulous project coordinator, PC, has worked
with you for three years on a randomized trial involving
interviews with patients at baseline, 6 and 15 months.
Your team reviews the patient tracking log recording
completion of interviews at your weekly meeting. PC’s
attendance becomes erratic and a covering research
assistant tells you she cannot find copies of ten 6
month interviews that PC stated she had done. Calling
of patients reveals that PC never completed the
interviews that she recorded in the log as completed.
What do you do now?
July 12, 2016
56
Johns Hopkins Medicine and
Research Integrity
• Any faculty member, trainee or staff employee of the
School of Medicine who suspects that research
misconduct has occurred has an obligation to report
that suspicion to the director of the department or
division affected, or to the Dean of the SOM.
• If the report is made to the director of a department,
the department director must report the allegation to
the Dean or the Dean’s designee in a timely fashion,
regardless of the department director’s assessment
concerning whether the activity in question constitutes
possible misconduct.
http://www.hopkinsmedicine.org/Research
/OPC/Research_Integrity/
Institute of Medicine, National
Research Council Report 2002
Integrity in Scientific Research:
Creating an Environment That
Promotes Responsible
Conduct
• Mentoring is key to producing
responsible researchers
7/12/2016
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HOW to Ensure Research Integrity?
Wright ORI Review of Trainee Misconduct
Mentoring and Research Misconduct: An
Analysis of Research Mentoring in Closed
ORI Cases
• Did the mentor review source data?
• Did the mentor teach specific research
standards?
• Did the mentor minimize stressful work
situations?
Wright DE et al. Sci Eng Ethics
2008 14:323-336
HOW to Ensure Research Integrity?
Wright ORI Review of Trainee Misconduct
• 73% mentors did not look at raw data
• 62% mentors did not have set
standards for recording data
• 53% of trainees reported stress levels
as a factor in misconduct
HOW to Ensure Research Integrity?
Wright ORI Review of Trainee Misconduct
What the investigators said:
“Mentor/PIs should provide a more formal
process of initial training for their graduate
students as they join a research project.
This should include coverage of IRB
regulations and the responsibility inherent
in maintaining the integrity of research.
The Board also recommends that [M/PI]
should have more contact with the
graduate students throughout the research
project…”
HOW to Ensure Research Integrity?
Wright ORI Review of Trainee Misconduct
What the investigators said:
“Although outright fraud can circumvent virtually any
review process, we believe that every laboratory
head must take the responsibility to ensure that
procedures are in place… so that the possibility of
fraud is minimized. These include that a) every
manuscript receive adequate review by senior
members of the laboratory, that the PI is directly
informed of the resulting criticisms, and that the PI
reviews the final manuscript…and b) every effort
should be made to provide opportunities for each
investigator to present primary unedited data to an
appropriate group or subgroup of the laboratory for
criticism and feedback.”
HOW to Ensure Research Integrity?
Wright ORI Review of Trainee Misconduct
What the investigators said:
“The committee believes that it is good
practice for the mentor to examine the
primary laboratory notebooks for a student
conducting his/her PhD thesis research in
the mentor’s laboratory. More than just
checking the validity of results, it helps the
mentor better understand some of the
details and nuances of the work which will
help with both the thesis and the
publications.”
HOW to Ensure Research Integrity?
Wright ORI Review of Trainee Misconduct
• Regular review of trainee raw data
• Standard setting
• Attention to trainee stress levels
HOW to Ensure Research Integrity?
Research Integrity Measures
• Survey of 6698 researchers with NIH
grant support
• 67% response rate
7/12/2016
Survey of Research Integrity Measures
Utilized in Biomedical Research
Laboratories. American Institutes for
Research, 2003
66
HOW to Ensure Research Integrity?
Research Integrity Measures
• Data stored digitally (42%) or notebooks
(39%) retained for mean of 12.9 years
after publication
• Lab meetings to discuss research 30x/yr
(median) with each researcher presenting
6 (median) to 12 (mean) times a year
• PI supervises five researchers spending
2 hrs/week with each Survey of Research Integrity Measures
7/12/2016
Utilized in Biomedical Research
Laboratories. American Institutes for
67
Research, 2003
HOW to Ensure Research Integrity?
Research Integrity Measures
• Less than 5% of PIs utilized written
guidelines for
– authorship, reproducibility, prevention of
fragmentation of publications, prevention of
multiple submissions of the same manuscript
to more than one journal simultaneously,
promotion of sharing data, methods, reagents
and other materials and for the proper handling
of correction or retraction of publications
7/12/2016
Survey of Research Integrity Measures Utilized in
Biomedical Research Laboratories. American
Institutes for Research, 2003 68
HOW to Ensure Research Integrity?
Gallup Survey 2006
• Scientist recommendations to prevent
or detect misconduct
– Close supervision including reviewing data,
reproducing results, audit, quality control
procedures
– Place responsibility on the principal
investigator
– Open communication
– Whistleblower protections
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HOW to Ensure Research Integrity?
• Proactive quality assurance mechanisms
– Review data collection forms, lab notebooks,
computerized records
– Double data collection and double data entry
for a sample
– Audio or videotape research encounters
– Unannounced observations of research work
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HOW to Ensure Research Integrity?
Redefine misconduct as distorted reporting
• “any omission or misrepresentation of the information
necessary and sufficient to evaluate the validity and
significance of research, at the level appropriate to the
context in which the research is communicated.”
• Authors should be held accountable for what
they write, and for recording what they did.
• Writing guidelines for many biomedical
techniques or study designs
– EQUATOR Network (equator-network.org)
– Minimum Information for Biological and Biomedical
Investigations (mibbi.sourceforge.net).
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Fanelli D. Nature. 2013;494(7436):149
HOW to Ensure Research Integrity?
Recommendations from DHHS ORI
Six recommendations are made to institutions
for fostering a culture of integrity:
1. adopt a zero tolerance for research misconduct
2. protect whistleblowers
3. implement a clear system for reporting alleged
research misconduct
4. train mentors on establishing and maintaining
research rules and minimizing opportunities to
commit research misconduct
5. develop continuing mechanisms for reviewing and
evaluating the research and training environments
6. model ethical behavior
Titus SL et al. Nature 2008;453:980-82
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Mentors: C’s
• Content mentor
• Coaching mentor
Career mentor
• Critiquing/Challenging mentor
• Connecting mentor
• Cheerleader mentor
•
Zeldich’s Dimensions of Good
Mentoring
• “Advisors: people with career experience willing to share
their knowledge
• Supporters: people who give emotional and moral
encouragement
• Tutors: people who give specific feedback on one’s
performance
• Masters: employers to whom one is apprenticed
• Sponsors: sources of information about and aid in
obtaining opportunities
• Models of identity: of the kind of person one should be…”
7/12/2016
Titus & Ballou. Sci Eng Ethics
6/3/2012
75
https://members.aamc.org/
eweb/upload/Compact%2
0Between%20Postdoctorl
%202006.pdf
https://www.aamc.org/download/49868/data/
gradcompact.pdf
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Compact Between Postdoctoral
Appointees & Their Mentors (AAMC 2006)
Commitment of Mentors (11 bullets)
• I will ensure that a mutually agreed upon set of expectations and
goals are in place at the outset and I will work with the postdoc
appointee to create an individual career development plan.
• I will strive to maintain a relationship that is based on trust and
mutual respect. I acknowledge that open communication and
periodic formal performance reviews…will help ensure that the
expectations of both parties are met.
• I will promote all ethical standards for conducting research including
compliance with all institutional and federal regulations as they
related to responsible conduct in research, privacy and human
subjects research, animal care and use, laboratory safety, and use
of radioisotopes. I will clearly define expectations for conduct of
research in my lab and make myself available to discuss ethical
concerns as they arise.
77
Compact Between Postdoctoral
Appointees & Their Mentors (AAMC 2006)
Commitment of Postdoctoral Appointees (11 bullets)
•
I acknowledge that I have the primary responsibility for the development of
my own career.
•
I will perform my research activities conscientiously, maintain good
research records, and catalog and maintain all tangible research materials
that result from the research project.
•
I will respect all ethical standards when conducting my research including
compliance with all institutional and federal regulations as they related to
responsible conduct in research, privacy and human subjects research,
animal care and use, laboratory safety, and use of radioisotopes. I
recognize that this commitment includes asking for guidance when
presented with ethical or compliance uncertainties and reporting on
breeches of ethical or compliance standards by me and/or others.
•
At the end of my appointment, in accordance with institutional policy, I will
leave behind all original notebooks, computerized files, and tangible
research materials so that other individuals can carry on related research…
78
Compact Between Biomedical Graduate
Students & Their Advisors (AAMC 2008)
Commitment of Graduate Students (13 bullets)
• I will participate in my institution’s Responsible Conduct of
Research Training Program and practice those guidelines
in conducting my thesis/dissertation research.
• I will maintain a detailed, organized, and accurate
laboratory notebook. I am aware that my original
notebooks and all tangible research data are the property
of my institution but that I am able to take a copy of my
notebooks with me after I complete my thesis/dissertation.
• I will discuss policies on authorship and attendance at
professional meetings with my research advisor.
79
Compact Between Postdoctoral
Appointees & Their Mentors (AAMC 2006)
This compact serves both as a pledge and a
reminder to mentors and their postdoctoral
appointees that their conduct in fulfilling their
commitments to one another should reflect
the highest professional standards and
mutual respect.
80
An Emerging Culture for Health Care
Darrell Kirch, MD, AAMC, 2012
NIH and Team Science
“The scale and complexity of today's biomedical
research problems demand that scientists move
beyond the confines of their individual disciplines and
explore new organizational models for team science.
Advances in molecular imaging, for example, require
collaborations among diverse groups–radiologists,
cell biologists, physicists, and computer
programmers. NIH wants to stimulate new ways of
combining skills and disciplines in the physical,
biological, and social sciences to realize the great
promise of 21st century medical research.”
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Research Integrity Challenges in
Team Science
• More team members
• Rely on team members to know
different content areas
• Rely on team members to teach and
supervise trainees
• More “farming out” parts of research to
others
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What Do Mentoring & Training in the RCR
Have To Do With Scientists’ Misbehavior?
• Survey of 1479 early-career (T32/F32
post doc fellows) and 1768 mid career
scientists (initial R01)
• There was NO consistent relationship
between training in research integrity
and behaviors that may compromise
integrity of science
Anderson MS et al
Academic Medicine
82:853, 2007
Responsibilities of the Mentor
• 56% of 3,257 researcher admitted inadequate
monitoring of research projects because of
work overload. (Anderson MS et al Academic Medicine
82:853, 2007)
• Only 33% of 2,000 research lab directors who
supervised on average 4.7 individuals had a
mentor who had prepared them to be a good
mentor. (Robhard D, Survey of research integrity measures
utilized in biomedical research labs. ORI report 2003)
Conclusion
• Fostering an environment that promotes
research integrity is important for public
trust
• A culture of research integrity is
essential
• Mentoring is a critical component to
producing responsible researchers
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References
• Previous Research Integrity Lectures:
http://www.hopkinsmedicine.org/Research/OPC/Resear
ch_Integrity/responsible_conduct_DeanRILectures_1
2_13.html.
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Panel Discussion
• Arlene Butz, Sc.D.
• George Dover, M.D.
• Pamela Zeitlin, M.D., Ph.D.
• Sheila Garrity, J.D., M.P.H., M.B.A.
– Moderator
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