Garcia Ethics 2016

1. What is Ethics in Research &
Why is It Important?
Ernest V. Garcia, PhD
Material by: David B. Resnik, J.D., Ph.D.
http://www.niehs.nih.gov/research/resources/bioethics/whatis.cfm

2. AMERICAN BOARD OF RADIOLOGY FOUNDATION
ANNOUNCES THE LAUNCH OF FREE ONLINE
EDUCATIONAL MODULES ON ETHICS AND
PROFESSIONALISM (OCT 14, 2011)
The American Board of Radiology Foundation (ABRF) announces
the launch of 10 web-based instructional modules: Online
Modules on Ethics and Professionalism. The modules were
developed with the support of six organizations: the American
Association for Physicists in Medicine (AAPM), the American Board
of Radiology (ABR), the American College of Radiology (ACR), the
American Radium Society (ARS), the American Society for
Radiation Oncology (ASTRO), and the Radiological Society of
North American (RSNA). They are available on the ABRF website
at https://www.abronline.org/asp/abrf/.

3. In 1995, the National Academy of
Sciences said that scientists are
advised that "someone who has
witnessed scientific misconduct has
an unmistaken obligation to act“…

4. What is Ethics?
• norms for conduct that distinguish
between acceptable and unacceptable
behavior.
• Ethics and law are not the same
– Actions may be legal but unethical
– Actions may be ethical but illegal

5. What is research?
• Research is a search for truth.
– Only truth leads to wisdom - CFC
• All research is biased to some degree
– By some variables that are difficult to control
• Referral bias
• Prevalence of the disease in the community
• Available diagnostic equipment
• Practice of medicine in the community
– By many variables that can be controlled
• Statistics used
• Acquisition/processing protocols

6. Why is it important to adhere to
ethical norms in research?
• promote the aims of research
• promote the values that are essential to
collaborative work
• ensure that researchers can be held
accountable to the public
• help to build public support for research
• promote a variety of other important
moral and social values

7. Codes and Policies for Research Ethics
• From Government agencies
– NIH, NSF, FDA, EPA, USDA
• Professional Societies
• Journals
• The Nuremberg Code and The
Declaration of Helsinki

8. Common Ethical Principles
• Honesty
• Objectivity
• Integrity
• Carefulness
• Openness
• Respect for IP
• Confidentiality
• Responsible
publication
• Respect for colleagues
• Social Responsibility
• Non discrimination
• Competence
• Legality
• Animal care
• Human subjects
protection

9. Ethical Decision Making
• Case 1
– The research protocol for a study of a drug on
hypertension requires the administration of the drug
at different doses to 50 laboratory mice, with chemical
and behavioral tests to determine toxic effects of the
drug. Tom has almost finished the experiment for Dr.
Q. He has only 5 mice left to do. However, he really
wants to finish his work in time to go to Florida on
spring break with his friends, who are leaving tonight.
He has injected the drug in all 50 mice but has not
completed all of the tests. He therefore decides to
extrapolate from the 45 completed results to produce
the 5 additional results.

10. Dr. John R Darsee
• In May of 1981, Darsee's associates and supervisors at
Harvard caught him fabricating data. Other investigations
led to the conclusion that Darsee fabricated research
publications beginning when he was a biology student at
Notre Dame, continuing through his medical residency
and cardiology fellowship at Emory University, and
ending at Harvard. More than 10 primary journal articles
and more than 45 abstracts were retracted as a result of
the investigations. The Darsee case highlighted the
problem of using so-called "gift authors" on papers. Gift
authors have little or no contact with the person giving
them the authorship, but the presence of the prestigious
names may influence an editor to consider a paper for
publication.
http://ccnmtl.columbia.edu/projects/rcr/rcr_misconduct/foundation/index.html#1_B_3

11. Robert A. Slutsky, MD
• Robert A. Slutsky, (a nuclear cardiologist) working in
radiology at the University of California, San Diego, also
brought to light the problem with co- authors. Slutsky
apparently was publishing one paper every 10 days for
years and including names of many co-authors to
mislead editors and cover up for what later was learned
to be a false output. His behavior continued until 1985.
At the time, he was up for promotion, and a reviewer
noted duplicated data in two of Slutsky's articles. Slutsky
resigned, but an investigation later found that, of his 137
publications, 77 were valid, 48 were questionable, and
12 were fraudulent.
http://ccnmtl.columbia.edu/projects/rcr/rcr_misconduct/foundation/index.html#1_B_3

12. Ethical Decision Making
• Case 2
• Dr. T has just discovered a mathematical error in
a paper that has been accepted for publication
in a journal. The error does not affect the overall
results of his research, but it is potentially
misleading. The journal has just gone to press,
so it is too late to catch the error before it
appears in print. In order to avoid
embarrassment, Dr. T decides to ignore the
error.

13. Deviations from acceptable
research practice - 1
• Publishing the same paper in two different journals
without telling the editors
• Submitting the same paper to different journals without
telling the editors
• Not informing a collaborator of your intent to file a patent
in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return
for a favor even though the colleague did not make a
serious contribution to the paper
• Discussing with your colleagues data from a paper that
you are reviewing for a journal
• Trimming outliers from a data set without discussing
your reasons in paper

15. How should you handle outliers?
1. Remove them from the data, these are
obviously an anomaly - recalculate
statistics.
2. Give the outliers back to the technologist
and tell him to reprocess these studies
since the values are too high.
3. Give the outliers back to the technologist
to reprocess and do not tell her why.
4. Either leave them in the data and try to
explain why – or reprocess the entire set.

16. • Bypassing the peer review process and announcing your
results through a press conference without giving peers
adequate information to review your work
• Conducting a review of the literature that fails to
acknowledge the contributions of other people in the field
or relevant prior work
• Stretching the truth on a grant application in order to
convince reviewers that your project will make a
significant contribution to the field
• Stretching the truth on a job application or curriculum
vitae
• Giving the same research project to two graduate
students in order to see who can do it the fastest
• Using an inappropriate statistical technique in order
to enhance the significance of your research
Deviations from acceptable
research practice - 2

17. Using Statistical Tricks to Deceive
Perfect Correlation
0
10
20
30
40
50
60
70
80
90
100
0 20 40 60 80 100
Tumor size 1
Tumorsize2
Series1

18. Retrospective vs. Prospective
CAD
0
0.2
0.4
0.6
0.8
1
0 0.2 0.4 0.6 0.8 1
1 - specificity
sensitivity
Can’t use data to determine
an optimal cut-point value
for a parameter and then
apply it to the same data
and claim it establishes the
accuracy of the technique.

19. • Overworking, neglecting, or exploiting graduate or post-
doctoral students
• Keeping original data at home or taking it with you when
you move
• Failing to maintain research data for a reasonable period
of time
• Making derogatory comments and personal attacks in
your review of author's submission
• Making significant deviations from the research protocol
approved by your institution's Animal Care and Use
Committee or Institutional Review Board for Human
Subjects Research without telling the committee or the
board
• Not reporting an adverse event in a human research
experiment
Deviations from acceptable
research practice - 3

20. • Exposing students and staff to biological risks in violation
of your institution's biosafety rules
• Rejecting a manuscript for publication without even
reading it
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or
computer programs
• Owning over $10,000 in stock in a company that
sponsors your research and not disclosing this financial
interest
• Deliberately overestimating (or under) the clinical
significance of a new drug (or device) in order to
obtain economic benefits
Deviations from acceptable
research practice - 4

23. Conflict of Interest
• COI by itself is not scientific
misconduct.
• COI when disclosed and managed is
acceptable practice in research
• COI becomes misconduct when it
leads to fabrication and/or
falsification.

24. Ethical Decision Making
• Case 3
• Dr. S is a post-doctoral student in computer science
working on some programs that eliminate computer
viruses. Two other graduate students are working with
her on the project, which is directed by a senior
researcher. Dr. S has just received an email from a
research team that is working on a similar project at
another university. The other team would like Dr. S to
share some preliminary data and designs related to the
project. Dr. S has not applied for a patent on this
research, although she has discussed possible patents
with her supervisor.

25. Ethical Decision Making
• Case 4
• You just reviewed a manuscript that proves incorrect a
hypothesis that your colleague’s graduate student just
got approved as her dissertation topic. You know that it
will take at least one year for this manuscript to be
published if it is accepted. What should you do?

26. Most serious crimes in research
• Fabrication
• Falsification
• Plagiarism

27. 868 F.2d 1313: Heidi S. Weissmann, M.d., Plaintiff-
appellant, Cross-appellee, v. Leonard M. Freeman,
M.d., Defendant-appellee, Cross-appellant
• This appeal presents the paradigm of the problems that
arise when a long relationship between accomplished
professor and brilliant assistant comes to an end.
Together the two had researched and co-authored
scholarly scientific works. When the appellant--the
younger assistant--individually wrote what she
considered a new work, the appellee--the mentor--
believing himself a co-author of the new piece, used his
assistant's work, styling it as his own, and thereby
precipitated the instant litigation.
• Individual derivative work vs. Joint work
http://law.justia.com/cases/federal/appellate-courts/F2/868/1313/17123/

30. Take home message
• Conduct your research ethically so that
your actions pass your own smell test
– Trust your instincts
• ….. with the expectation that every action
will become public knowledge
– In research, it will!
• You can’t fool all of the people all of the
time………PT Barnum
• Misconduct always leads to ruined careers