Deans Lecture 4/3/12. ‘Disclosures’ Member of the Scientific Conduct and Disciplinary Committee...
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Transcript of Deans Lecture 4/3/12. ‘Disclosures’ Member of the Scientific Conduct and Disciplinary Committee...
‘Disclosures’Member of the Scientific
Conduct and Disciplinary Committee
Director of Department of Pediatrics
Member of the Advisory Board of the Johns Hopkins School of Medicine
‘Conflict of Interest’
For >25 years a substantial proportion of my salary was paid by NIH research grants
My professional career (Promotion, Directorship, etc) depended on the the success of my research and that of the Pediatrics Faculty
Overview:
Definitions: Research Integrity, Scientific Misconduct
Is it a problem??‘Review of the Literature’Is training in ethical conduct of
research effective?
Mentor/ Mentee Relationship
Research Integrity
“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
Scientific Misconduct
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)
Is it a Problem?
Sandra L.Titus. Facing the Dark Side: Research Misconduct and Strategies to Improve Self Regulation. The Physiologist:51, 1-4, 2008Office of Research Integrity has ~13
cases/yr325,000 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.
http://blogs.nature.com/news/2012/03/the-new-gatekeepers-reducing-research-misconduct.html
Is it a Problem?
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
Is it a Problem?
Sandra L. Titus. Facing the Dark Side: Research Misconduct and Strategies to Improve Self Regulation. The Physiologist:51, 1-4, 2008Martinson B et al. Scientist behaving Badly.
Nature 435: 737-738, 2005Survey 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.
Copyright © by the BMJ Publishing Group Ltd & Institute of Medical Ethics. All rights reserved.
Steen R G J Med Ethics 2011;37:249-253
Number of papers retracted by year, including only 197 papers retracted for fraud (fabrication or falsification) and 234 papers retracted for scientific mistake.
Steen R G J Med Ethics 2011;37:249-253
Copyright © by the BMJ Publishing Group Ltd & Institute of Medical Ethics. All rights reserved.
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;37:249-253
Where retraction noted Retracted papers, n (%)Watermark on pdf 305 (41.1)Journal website 248 (33.4)Not noted anywhere 236 (31.8)Note appended to pdf 128 (17.3)pdf deleted from website 98 (13.2)
Steen R J Med Ethics 2011;37:249-253
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
Is Research Misconduct a Problem?
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 Research Misconduct a Problem?
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
bothOver half first reported by someone other
than mentor63% led to retractions of published papers73% mentors did not look at raw data62% mentors did not have set standards for
recording data53% of trainees reported stress levels as a
factor in misconduct
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 mentorOther 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,
2012Stages of Mentoring
InitiationChoosing is not a random processFormalizing mutual goals and expectations
Relationship phaseBidirectional responsibilitiesFeedbackAssessment of goals
Plan for Change and ClosureAre the rules clearMove from mentee to colleague and advisee
Bearlocher MO et al, European Journal of Internal Medicine 22:e166, 2011Surveyed 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
mentorRequired written mentee progressMentors 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
knowledgeConsist of three components
Emotional and psychological supportAssistance with career and professional
developmentRole modeling
Reciprocal –both mentor and mentee derive emotional and tangible benefits
Involves personal direct interactionTakes advantage of mentors greater experience
influence and achievement
Conclusions:
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.
Conclusions:
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.
Panel Discussion: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