Deans Lecture 4/3/12
‘Disclosures’
‘Conflict of Interest’
 Member of the Scientific
Conduct and Disciplinary
Committee
 For >25 years a substantial
proportion of my salary was
paid by NIH research grants
 Director of Department of
Pediatrics
 My professional career
(Promotion, Directorship,
etc) depended on the the
success of my research and
that of the Pediatrics
Faculty
 Member of the Advisory
Board of the Johns Hopkins
School of Medicine
 Definitions: Research Integrity,
Scientific Misconduct
 Is it a problem??
 ‘Review of the Literature’
 Is training in ethical conduct of
research effective?
 Mentor/ Mentee Relationship
 “the process of doing and reporting science in
accordance with accepted practices in their field. This
includes adherence to the principles and practices of
the scientific standards, education and mentoring, and
use of peer and expert review/communication of results
to the scientific community.” Bolton, PA: Scientific
Ethics. 2002
 Responsibility of the researcher and and the research
community--- Research Institution, scientist/faculty,
reviewers/editors/publishers, professional
organizations, funding agencies
Khanyile TD et al Curationis 40-45, March 2006
 Fabrication, falsification or plagiarism in proposing
performing or reviewing research or in reporting
research results. AAMC. White House Office of Science
and Technology Policy
 Also: obstruction of investigations, failure to abide by
research regulation or review boards (biohazards to
protection of human subjects)
 Sandra L.Titus. Facing the Dark Side: Research
Misconduct and Strategies to Improve Self
Regulation. The Physiologist:51, 1-4, 2008
 Office of Research Integrity has ~13 cases/yr
325,000 NIH supported Scientist (1 per 25,000)
 Editor of JCB reports 1/100 accepted papers
rejected because of serious improper digital
images manipulations, that were misleading and
changed experimental results
JCB has one full-time employee checking the figures of
every paper accepted in the journal, looking for digital
traces of manipulation. Not every manipulation will
raise a red flag, but as many as 50% of papers require
at least one figure to be redone because it did not
conform to standards. In about 10–15% of cases,
Williams said, the authors are asked to send in original
data for checking and in about 1% (roughly 35 papers
in the 10 years JCB that has been looking), efforts to
manipulate are so egregious that acceptance of the
paper is revoked.
 Sandra L. Titus. Facing the Dark Side: Research
Misconduct and Strategies to Improve Self
Regulation. The Physiologist: 51, 1-4, 2008
 FDA in 2 years reported 58 warning letters, 3
were for fabrication and falsification while
conducting 1,738 field inspections--~.9/1000/yr
 Sandra L. Titus. Facing the Dark Side: Research
Misconduct and Strategies to Improve Self
Regulation. The Physiologist:51, 1-4, 2008
 Martinson B et al. Scientist behaving Badly.
Nature 435: 737-738, 2005
 Survey of 3247 NIH Scientist- 2,212 full
responses– 192 reported observed or had
direct evidence of misconduct in 265
incidences--3/1000 PI self reported research
behavior that would be considered
misconduct
Martinson B et al. Scientist behaving Badly.
Nature 435: 737-738, 2005
 After review, 201 observations by 164 scientist (60%
fabrication, 36% plagiarism) were validated
 Assuming non responders saw nothing 1.5 cases in
100 scientist
 58% reported to their institutions
 Among 155,000 NIH scientist/yr funded by NIH
equals 1350 cases should have been reported-----not 25
Trends in paper retraction showing the number of papers
retracted by year, including retractions for all reasons.
Steen R G
J Med Ethics
2011;37:249253
Copyright © by the BMJ
Publishing Group Ltd &
Institute of Medical Ethics. All
rights reserved.
Number of papers retracted by year, including only 197
papers retracted for fraud (fabrication or falsification) and
234 papers retracted for scientific mistake.
Copyright © by the BMJ Publishing Group Ltd &
Institute of Medical Ethics. All rights reserved.
Steen R G J
Med Ethics
2011;37:249253
Average time from publication to retraction (in months) for
197 papers retracted for fraud (fabrication or falsification)
and 234 papers retracted for scientific mistake.
Copyright © by the BMJ Publishing Group Ltd
& Institute of Medical Ethics. All rights
reserved.
Steen R G J
Med Ethics
2011;37:249253
Steen R J Med Ethics 2011;37:249-253
Where retraction noted
Retracted papers, n (%)
Watermark on pdf
Journal website
Not noted anywhere
Note appended to pdf
pdf deleted from website
305 (41.1)
248 (33.4)
236 (31.8)
128 (17.3)
98 (13.2)
Fanelli D (2009) How Many Scientists Fabricate and Falsify
Research? A Systematic Review and Meta-Analysis of Survey
Data. PLoS ONE 4(5): e5738.
2% of scientists
admitted to have
fabricated, falsified
or modified data or
results at least once
Fanelli PLoS One 2009; 4:e5738
 Is it a problem?
 YES
 Is it underreported?
 YES
 Does self-reporting or just institutional
reporting work?
 NO, if it picks up only .1% of cases
 Is it a problem?
 YES
 Is it underreported?
 YES
 Does self-reporting or just institutional
reporting work?
 NO, if it picks up only .1% of cases
The problem is more than just
mentor/mentee relationships?
Anderson MS et al Academic
Medicine 82:853, 2007
 Responses of survey of 1479 early-career (T32/F32 post
doc fellows) and 1768 mid career scientist (initial
R01)from 1999 to 2001
 Surveyed % who had separate course work on ethical
issues, integrated course work, both or neither
Separate
Integrated
Both
None
Early
12%
10%
63%
12%
Mid
8%
14%
41%
37%
Anderson MS et al Academic
Medicine 82:853, 2007
 Surveyed respondents whether they had participated in one
or more misconduct behaviors (falsification/dropping
observations/ overlooking questionable interpretation of data
by others, inadequate record keeping, use of research funds,
outside influence, peer review, credit, cutting corners)
 IN the early group there was NO relationship between training
in research integrity and behaviors that may compromise
integrity of science (‘no training’ was not different that any
training)
 Only those who had both forms of training in mid career
group had an inverse relationship between training and
behavior
Are individual mentors prepared to teach their
mentees all this, and assess their mastery of these
areas.
Responsibilities of the Mentor
 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
 56% of 3,257 researcher admitted inadequate
monitoring of research projects because of work
overload. Anderson MS et al Academic Medicine
82:853, 2007
Wright DE et al. Mentoring and Research Misconduct: An
Analysis of Research Mentoring in Closed ORI Cases.
Science and Engineering Ethics, 14:323-336, 2008
 In review of 33 cases in which trainee found guilty
of scientific misconduct:
 90% involved fabrication, falsification or both
 Over half first reported by someone other than
mentor
 63% led to retractions of published papers
 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 many advisees can one
mentor direct?
Multiple mentors: advisors,
supervisors, and….
Berk RA et al. Measuring the Effectiveness of
Faculty Mentoring Relationships. Academic
Medicine 80: 66-72, 2005
 There is a false sense of consensus, because at a
superficial level everyone ‘knows’ what mentoring
is. But closer examination indicates wide variation
in operational definitions…..L.S. Wrightsman
Ethical mentorship: Maloney M.
Clinics in Dermatology 30: 210-215,
2012
 Scientific success does not equal a good
mentor
 Other skills: confidentiality,
trustworthiness, respect of others,
listening skills, time management, role
modeling
 Trust must be bidirectional
Ethical mentorship: Maloney M.
Clinics in Dermatology 30: 210-215,
2012
 Stages of Mentoring
 Initiation
 Choosing is not a random process
 Formalizing mutual goals and expectations
 Relationship phase
 Bidirectional responsibilities
 Feedback
 Assessment of goals
 Plan for Change and Closure
 Are the rules clear
 Move from mentee to colleague and advisee
Bearlocher MO et al, European Journal of
Internal Medicine 22:e166, 2011
 Surveyed corresponding authors of every fourth
original research article in JAMA, BMJ, CMA, Lancet
From 1998-2003
 25% had no mentors
 14% did not publish with mentor
 14% published > 26 papers with mentor (5% > 51
papers)
 5% were obliged to inappropriately include mentor
on papers
 13% required more than 6 years to separate from
mentor
Cohen JG et al, Characteristics of success in
mentoring….Gynecologic Oncology 125:8-13, 2012
 Survey of professors and research fellows at 10
institutions which had > 4 plenary sessions over 6
years (Group A )compared to 22 with < 4 (Group B).
 Group A had:
 an additional year of research training ( 2
yrs compared to 1yr),
 established program to connect mentors to
mentees,
 mentees reported it was easy to find a
mentor
 Required written mentee progress
 Mentors were given feedback
Berk RA et al. Measuring the Effectiveness of
Faculty Mentoring Relationships. Academic
Medicine 80: 66-72, 2005
 Five general elements:
 Focus on achievement and acquisition of knowledge
 Consist of three components
 Emotional and psychological support
 Assistance with career and professional development
 Role modeling
 Reciprocal –both mentor and mentee derive emotional
and tangible benefits
 Involves personal direct interaction
 Takes advantage of mentors greater experience influence
and achievement
 Responsibility for maintenance of
research integrity is a broad
responsibility that goes far beyond a
sound mentor/mentee relationship.
 Present system of self reporting is not
effective in reducing scientific
misconduct.
 Formal training in the ‘Ethical
Conduct of Research’ alone is not a
deterrent to scientific misbehavior of
young scientist nor is it predictive of
ethical behavior.
 No uniform definition of a mentor or
measurement of a effective
mentor/mentee relationship exists.
 Edward Miller, M.D., the Frances Watt Baker and Lenox
D. Baker, Jr. Dean of the School of Medicine and CEO of
Johns Hopkins Medicine;
 Catherine DeAngelis, M.D. M.P.H., Professor of
Pediatrics at the School of Medicine, Health Policy and
Management at the School of Public Health, and Editor
in Chief Emerita, JAMA;
 Peter Maloney, Ph.D., Professor of Physiology and
Associate Dean of Graduate Student Affairs
 Sheila Garrity, J.D., M.P.H., M.B.A. - Moderator