7570 Fall 08 Misconduct

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					      PHIL/MBIOL 7570
Case Studies in Research Ethics
              Fall 2008
              Bryan Benham
          Department of Philosophy
Why Research Ethics?




      Woo Suk Hwang
                                                 2
    Phil 7570: Case Studies in Research Ethics
               S. Korean stem-cell
               scandal
             Success                             Failure

•   Seoul National University       •   Accused of paying for donated
•   1999 announced cow cloning          eggs, from lab techs.
     – But, not confirmed.          •   Gerald Schatten (U Pitt.)
•   Science, March 12, 2004             ceased collaborations, and
     – somatic cloning                  withdrew name from 2005
•   Science, June 17, 2005              Science paper.
     – 11 hESC lines, patient       •   Both Science papers found to
       matched                          have fabricated data;
•   August, 2005                        subsequently retracted.
     – Cloned dog, “Snuppy”         •   Also, charges of
•   Leader of World Stem Cell Hub       embezzlement and
                                        government collusion.
                                    •   Removed from SNU and
                                        WSCH.                           3
      Insult to injury
Review of Hwang Woo Suk’s research shows
his embryonic stem cell lines were likely the
product of parthenogenesis – a form of
asexual reproduction.

“It could have been a seminal finding if they
hadn’t had their blinders on.”
            Kent Vrana, Penn State University

     Reported in New York Times, Aug. 3, 2007 and Scientific American, Aug. 2, 2007.
                         Confirmed by Kim et al. 2007: Cell Stem Cell,1(3): 346-352.
                                                                                   4
                       Consequences?


•   Misconduct: fabricated data
•   Financial conflicts of interest (with gov’t involvement)
•   Coerced lab-members: egg donation*
•   Missed significant finding – parthenogenesis
•   Undermined confidence in collaborations with S. Korea
•   Global public perception of stem cell research affected
•   Set back stem cell advances by a number of years


                                                          5
Perceptions?




               6
               But, “Snuppy” is real…




Hwang Suk currently owns/directs a private company that clones pets the
Sooam BioTech Research Center which recently announced 5 clones of a
pet, Booger, in collaborations with RNL and SNU.
        Houston Chronicle, August 5, 2008: http://www.chron.com/disp/story.mpl/pets/dogs/5926679.html   7
      Outline
• Course Overview
• Research Misconduct
• Ethical Framework



       hum.utah.edu/~bbenham

                                                         8
            Phil 7570: Case Studies in Research Ethics
        Course Objectives
• Serves as an “ethics education” component
  for funding sources and programs across
  campus.

• Increase ethical sensitivity to research ethics
  issues and serve the U as a forum and
  resource for discussing research ethics
  issues.
          hum.utah.edu/~bbenham
                                                              9
                 Phil 7570: Case Studies in Research Ethics
           Course Requirements
•   Course Structure
    –   Ten Week Course (See Schedule)
    –   Lecture and Small Group Discussion of Case Studies
    –   First and last meetings, only lecture*


•   Grade Distribution
    –   Readings & Case Studies (Available Online)
    –   Attendance: no less than 8 of 10 to receive credit
    –   Final Paper: Case Study Analysis and Evaluation


               hum.utah.edu/~bbenham
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                       Phil 7570: Case Studies in Research Ethics
Fall 2008 Schedule
Sept. 4         RCR and Misconduct*
Sept. 11        Authorship
Sept. 18        Data Management
Sept. 25        Mentoring Issues
Oct. 2          Animal Subjects
Oct. 9          Human Subjects
Oct. 16 Fall Break - No Meeting
Oct. 23         Social Pressures on Science
Oct. 30         Commerce & Research
Nov. 6          Science’s Effect on Society
Nov. 13 Social Responsibility*
Nov. 20 Papers Due
                                                       11
          Phil 7570: Case Studies in Research Ethics
                    Course Director
                          – Bryan Benham (Philosophy)


                    Faculty Facilitators
                          –    Kathi Mooney (Nursing)
                          –    Kim Korinek (Sociology)
Faculty – Fall 08

                          –    Tom Richmond (Chemistry)
                          –    David Grunwald (Genetics)
                          –    Michael Kay (Biochem)
                          –    Matt Williams (Pathology)
                          –    Jody Rosenblatt (OncSci
                          –    Alana Welm (OncSci)
                          –    Jerry Spangrude (Path)
                          –    Scott Rogers (Neuro&Anat)
                          –    Lorise Gahring (Path)
                          –    Grzegorz Bulaj (MedChem)
                                                                  12
                     Phil 7570: Case Studies in Research Ethics
      Central Dogma
The focus of the course is not merely
understanding “the regulations,” but more
importantly identifying and employing the
underlying ethical principles and values
that guide responsible research, so that
one can (ideally) navigate the rocky shoals
and murky waters of daily research practice.

                                                           13
              Phil 7570: Case Studies in Research Ethics
          Examples
• A professor publishes ideas and experiments
  developed by her graduate student, without giving
  credit to the student.
• A researcher presents a paper that shows 33 data
  points that are consistent with his hypothesis, but
  doesn’t report the other 12 data points that are
  significantly inconsistent with his hypothesis.
• An experimenter recruits subjects for his study on
  cognitive effects of stress on children, but advertises
  it as a study on the role of social interactions in child
  learning.

                                                                 14
                    Phil 7570: Case Studies in Research Ethics
         Examples
• While waiting to hear from a journal about her latest
  paper submission, a new assistant professor hears
  from the editor that the paper is held up by a reviewer
  who has been “extremely busy,” but professor
  suspects the reviewer may be delaying her paper in
  order to publish first with similar findings.
• A researcher published favorable results for a new
  memory enhancing drug, without disclosing that she
  serves as a consultant and holds stocks in the
  company that is developing this new drug.

                                                                15
                   Phil 7570: Case Studies in Research Ethics
       And a bad grad

A FORMER GRADUATE STUDENT at Michigan
State University was sentenced on Monday to 10
months in prison for faking the theft of his own
research materials. The student, Scott M. Doree, was
supposed to be working on a vaccine to prevent a
pneumonialike disease in pigs, but he apparently had
not done any research for several years, authorities
say.
– http://chronicle.com/daily/2003/08/2003082102n.htm.




                                                              16
                 Phil 7570: Case Studies in Research Ethics
      Central Dogma
The focus of the course is not merely
understanding “the regulations,” but more
importantly identifying and employing the
underlying ethical principles and values
that guide responsible research, so that
one can (ideally) navigate the rocky shoals
and murky waters of daily research practice.

                                                           17
              Phil 7570: Case Studies in Research Ethics
      Outline
• Course Overview
• Research Misconduct
• Ethical Framework



       hum.utah.edu/~bbenham

                                                         18
            Phil 7570: Case Studies in Research Ethics
        Integrity vs. Misconduct
…it is vital for leaders of the academic community to ensure that
research conducted on our campuses meets the highest
standards of ethics and integrity*…By integrity of the research
process, the panel means the adherence by scientists and their
institutions to honest and verifiable methods in proposing,
performing, evaluating, and reporting research activities**…
Integrity in science is perhaps better seen today as an extension
of current concerns with quality***… Quality refers to the rigor
with which experiments are designed and carried out; statistical
analyses performed, and results accurately recorded and
reported, with credit given where it is due. Integrity in research
means that the reported results are honest and accurate and are
in keeping with generally accepted research practices.****

                                                                 19
                    Phil 7570: Case Studies in Research Ethics
     Research Misconduct
Research Misconduct comes in two flavors:

  Wide = generally refers to questionable
  research practices (QRP) and implicates
  norms of responsible science.

  Narrow = federal definition restricted to
  certain egregious behaviors, FFP.

                                                           20
              Phil 7570: Case Studies in Research Ethics
            “Wide” misconduct
• Wide misconduct is the general notion of questionable scientific
  practice (QRP) and implicitly appeals to norms of responsible
  science:
    – Technically competent, creative; and
    – Ethically responsible


• Specific norms of responsible research
    – Critical, Honest, Open, Disinterested, Safe, Responsive, etc.


• Positive ideal is helpful, but limited without some clearer
  idea about when, e.g., honesty and openness is
  applicable.
                                                                      21
           Norms & Realities

“Many plausible-sounding rules [ideals] for defining
ethical conduct might be destructive to the aims of
scientific inquiry… Behavior that may seem at first
glance morally un attractive can, in a properly
functioning system, produce results that are generally
beneficial.”


               James Woodward and David Goodstein
Conduct, Misconduct and the Structure of Science, American Scientist 84(5): 468-478.

                                                                                       22
                           Phil 7570: Case Studies in Research Ethics
        Critical Developments
Scientific research is increasingly:
• Professional & Career-Oriented
• Collaborative
• Specialized
• Competitive

Each puts stress on accepted norms of
  responsible science.
                                                              23
                 Phil 7570: Case Studies in Research Ethics
            “Narrow” misconduct
Federal – Office of Science and Technology Policy, 2000:



"fabrication, falsification, or plagiarism in
proposing, performing, or reviewing
research, or in reporting research results."

                                  a.k.a: FFP
This is not meant to include honest mistake or error in research. But a finding of
misconduct does require "that there be a significant departure from accepted
practices of the relevant research community" proven by the preponderance
of evidence.
                                                                                 24
          FFP?
Fabrication
   – is making up results and recording or reporting the fabricated
     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.

Plagiarism
   – is the appropriation of another person's ideas, processes,
     results, or words without giving appropriate credit and
     without specific approval, including those obtained through
     confidential review of others' research proposals and
     manuscripts.                                                25
                      Phil 7570: Case Studies in Research Ethics
   Please Note
            University of Utah
Misconduct is "fabrication, falsification,
plagiarism, or other practices that seriously
deviate from those practices that are
commonly accepted within the research
community for proposing, conducting, or
reporting research. It does not include
honest error or honest difference in
interpretations or judgments of data."
                                                         26
            Phil 7570: Case Studies in Research Ethics
                 Jan Hendrik Schön – Bell Labs
                 (See Science 24 May 2002 and 5 July 2002.)



•   September 2002 an investigating committee
    found that a series of extraordinary advances
    in molecular-scale transistors by Schön, 32,
    were based on falsified experimental data.

•   Resulted in the retraction of at least 17
    papers published in various journals,
    including Science and Nature, between 1998
    and 2001.

•   Schön was fired from Bell Labs. No other co-
    authors were found guilty of misconduct.

•   Disheartening because “this was the first
    case of misconduct at Bell Laboratories;, and
    the work was of Nobel quality.”                           27
             Victor Ninov – LBNL
             (See New York Times, 15 October 2002.)


• Ninov was recognized expert in detecting
  decay chains of unstable trans-uranium
  elements; involved in discovery of elements
  110, 111, and 112. Hired to compete with
  German and Russian teams.

• Investigation found that published report of
  synthesizing element 118 was based on
  fabricated data. Ninov plus 14 co-authors.

• Ninov denied accusations, but was fired in
  2001 from LBNL. Other co-authors
  reprimanded for “not being vigilant
  enough.”                                            28
             As reported:
             (New York Times, 15 October 2002.)


As the final report put it: “The committee finds it incredible that
not a single collaborator checked the validity of Ninov’s
conclusions of having found three element 118 decay chains
by tracing these events back to the raw data tapes.” But
members of the group say it is routine in this type of complex
experiments to delegate responsibility. “The fundamental
assumption is that of trust in the honesty and competence of
your colleagues, especially if they have distinguished
reputations, as was the case here,”

Note: as a result of the Schön and Ninov cases the American Physical Society adopts
more stringent professional ethics guidelines by 2004.




                                                                                      29
Plagiarism?
   Scientific American




   See also Nature 451, 24 January 2008.            30
       Phil 7570: Case Studies in Research Ethics
              What does this tell us about
              “narrow” misconduct?
• Temptations of modern scientific research
   – Junior and senior scientists alike
   – Competition and Professionalism


• Collaborations pose special problems
   – Technical specialization in collaborations
   – Strains norms of trust and honesty


• Other Issues Involved:
   – Authorship and Data Management
   – Peer Review
   – Mentoring and Institutional Oversight

                                                  31
            FFP Underreported
• Repairing research integrity – Nature 453(19), 2008
   – Surveyed 2,212 scientists
   – 8.7% (192) observed or had evidence of one or more incidents of
     misconduct over the past three years (2002-05) in their department. (Total
     of 265 incidents, methodology cut to 201.)
   – Equivalent to 3 incidents per 100 researchers per year; Extrapolations to al
     DHHS-funded researchers = 2,300 observations of potential misconduct
     (FFP).
   – However, reported number of investigations remains low: average 24
     institutional reports to Office of Research Integrity (ORI) per year.


• Misconduct (FFP) is underreported…and may be a much larger
  problem.



                                                                                32
                          Phil 7570: Case Studies in Research Ethics
     Wide Misconduct
  FFP is only the tip of the iceberg

Questionable research practices that
are not FFP may be more pervasive
and erosive for the integrity of the
research enterprise.


                                                         33
            Phil 7570: Case Studies in Research Ethics
          Two Studies
• Ethics and the welfare of the physics profession –
  Physics Today, Nov. 2004
   – Surveyed junior membership of APS and others*
   – 39% of junior respondents reported observing or having
     knowledge of ethical violations
   – 4% of those incidents were misconduct (see chart)

• Scientists behaving badly – Nature 435, 2005
   – Surveyed 3,247 early and mid career scientists funded by
     NIH
   – 28% early and 38% mid-career (33% overall) reported
     engaging in one or more of the top ten questionable
     research practices
                                                                34
Distribution of ethics
violations
Kirby & Houle. 2004. Ethics and the welfare of the physics profession. Physics Today,
November. (Figure 1)




                                                                                        35
                         Top 10 ethics violations
                         Martinson, Anderson, & De Vries. 2005. Scientists behaving badly. Nature 435(9). (Table 1.)




 Who Did It?*
Early-career = 28%
 Mid-career = 38%
       Total = 33%
*Under-reporting bias



FFP: 1 & 5 = <2%
Others = 5% or higher,
    often above 10%




                                                                                                                  36
          A Culture of Misconduct?
  Research suggests misconduct is pervasive, perhaps
  a “culture” of irresponsible research or unreflective
  research practice in combination with modern
  practices of research leads to sloppy science,
  unethical science, or worse.

History Testifies to Problems:
   – Human Participation: Nazis, Willowbrook, Tuskegee, etc.
   – Misconduct: “Baltimore Affair,” S. Korean Debacle, etc.
   – COI: Jesse Gelsinger & “Global Warming” Policies

                                                                  37
                     Phil 7570: Case Studies in Research Ethics
      Central Dogma
The focus of the course is not merely
understanding “the regulations,” but more
importantly identifying and employing the
underlying ethical principles and values
that guide responsible research, so that
one can (ideally) navigate the rocky shoals
and murky waters of daily research practice.

                                                           38
              Phil 7570: Case Studies in Research Ethics
       What is “Ethics”?
• Determining what one should do…
  – Right/wrong, good/bad, better/worse
  – Principled and Practical
  – Promotion and Prevention

• Not mysterious, subjective, arcane
  practice of analysis or deliberation,
  – but a balancing act…
                                                            39
               Phil 7570: Case Studies in Research Ethics
        What is the difference between an
        ethical and unethical action?
       Ethical                                Unethical
•   Leads to good                       • Leads to bad
    consequences.                         consequences.

•   Weighs interests                    • Doesn’t weigh
    fairly.                               interests fairly.

•   In accord with an                   • Violates an ethical
    ethical principle.                    principle.
                                                                40
                 Phil 7570: Case Studies in Research Ethics
            Balancing Three
            Questions
1. What are the consequences?
   – Short term and long term consequences.
   – Consequences to whom? (see next.)


2. Who’s interests are involved?
   – Who will benefit? Who will be at risk? Who is responsible? Who has the power?
   – Individuals, groups, society at large
   – Professional interests, research enterprise, commercial interests, academic
     interests, public interests, non-human animals…


3. What principles or rules apply?
   – General: don’t kill, harm, lie, cheat, steal; do good, protect the vulnerable, etc.
   – Research Oriented: Honesty, Openness, Disinterested, Safe, Responsive,
     Beneficial
                                                                                    41
                           Phil 7570: Case Studies in Research Ethics
         Ethical Framework

Principles                                                Consequences

             P                                 C




                              I


                   Interests
                                                                  42
             Phil 7570: Case Studies in Research Ethics
                                                                P            C
         Sample Case Study
                                                                    I
  A researcher presents a paper that shows 33 data
  points that are consistent with his hypothesis, but
  doesn’t report the other 12 data points that are
  significantly inconsistent with his hypothesis.

• Is this falsification of data? Why or why not?

• Does it make a difference if his results are
  reproducible? Or fail to be exactly reproduced?

• Why is this important for research?
                                                                        43
                   Phil 7570: Case Studies in Research Ethics
                Robert Andrews Millikan
                (1868-1953)
•   Nobel laureate in physics (1923) for
    measuring charge on electron and work
    on photoelectric effect.
•   Oil drop experiment:
     – 1913 paper: error of 0.2% which bested
       the current 3%. He reports “…this is not
       a select group of drops but represents
       all of the drops experimented upon
       during 60 consecutive days….”
     – But review of notebooks demonstrates
       he used only 57 of 75-100 trial results.
       Charges of fraud, “cosmic surgery,” and
       “…extensively misrepresented his work
       in order to make his experimental results
       seem more convincing than was in fact
       the case.”
                                                   44
                         What does this tell us about
                         research ethics?
•     A look at Millikan’s notebooks revealed cryptic remarks about why he
      rejected this or that experiment, including “too high” and “doesn’t fit.”
      While no one denies Millikan’s finding, they do question the reliability of
      his experiment and his choice of data points.

•     Science is messy…
        – Frederick Grinnell (2000) argues that “at the edge of knowledge” discovery
          requires confounding experiments in which no clear line divides a signal
          from noise. From the outside it might look like arbitrary decisions, but the
          final test is whether the science community is convinced.
        – Perception is that ethics violations can draw a clear line between
          acceptable experimental manipulation and unacceptable manipulation.


•     Thus the importance of an accurate and reliable research record and
      an understanding of how science works.
                                                                                                                                 45
Grinnell, Frederick. 2000. The Practice of Science at the Edge of Knowledge. The Chronicle of Higher Education, March 24; B11.
Repairing research integrity – Nature 453(19), 2008          46
                Phil 7570: Case Studies in Research Ethics
P       C

    I




            Repairing research integrity – Nature 453(19), 2008          47
                            Phil 7570: Case Studies in Research Ethics
Repairing research integrity – Nature 453(19), 2008          48
                Phil 7570: Case Studies in Research Ethics
          Solutions?
•   Education and Deterrence
•   Institutional Level Response
•   Mentoring & Culture of Responsibility
•   Zero Tolerance
•   Protect Whistleblowers
•   Clear Expectations

        Repairing research integrity – Nature 453(19), 2008          49
                        Phil 7570: Case Studies in Research Ethics
Consider Perceptions




                       50
         Summary
• Why Research Ethics?
   – Culture and Developments


• Research Misconduct
   – Wide and Narrow


• Ethical Framework: 3 Questions
   – Consequences
   – Interests
   – Principles
               hum.utah.edu/~bbenham
                                                                 51
                    Phil 7570: Case Studies in Research Ethics

				
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